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ALVAIZ Eltrombopag 54 mg Tablet, Film Coated, 30-count — NDC 00480-3276-56 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ALVAIZ Eltrombopag 54 mg Tablet, Film Coated, 30-count — NDC 0480-3276-56 (Billing 00480-3276-56)

by Teva Pharmaceuticals, Inc. · 30 TABLET, FILM COATED in 1 BOTTLE

This is a package of 30 tablets of ALVAIZ Eltrombopag 54 mg Tablet, Film Coated from Teva Pharmaceuticals, Inc., marketed since Feb 2024 and currently FDA-listed. It is this product's only package size.

NDC 00480-3276-56
🏷️ FDA NDC (as labeled) 0480-3276-56 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0480-3276-56 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0480 labeler · 3276 product · 56 package
Package marketed since
Feb 13, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC)
0304803274560, 0304803273563
Medicaid fills, this package
50 prescriptions in the last four reported quarters
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0480-3276-56
Product NDC 0480-3276
11-digit billing NDC 00480327656
NCPDP billing unit EA — each (per item)
RxCUI 2675187, 2675193, 2675195, 2675197, 2675199, 2675201, 2675203, 2675205
UNII F9G8XE24IB
UPC 0304803274560, 0304803273563
Application # NDA216774
SPL Set ID ed51e463-7a03-4858-bbd2-882ce4753d5a
Established class (EPC) Thrombopoietin Receptor Agonist; Thrombopoietin Receptor Ago
Mechanism of action Breast Cancer Resistance Protein Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors
Physiologic effect Increased Megakaryocyte Maturation; Increased Platelet Production
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-02-13
Route ORAL
Dosage form TABLET, FILM COATED
Substance ELTROMBOPAG CHOLINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 085564
GCN 55074
HICL code 049330
Ingredient (HICL) Eltrombopag Choline
HIC1 code N
Therapeutic class — broad (HIC1) Bone Marrow
HIC2 code N1
Therapeutic class — intermediate (HIC2) Affecting Blood, Non-Iron Hematinics And Others
HIC3 code N1F
Therapeutic class — specific (HIC3) Thrombopoietin Receptor Agonists
AHFS code 20:16.00.00
AHFS class Hematopoietic Agents
FDB label name ALVAIZ 54 MG TABLET
FDB brand name Alvaiz
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 085564
  • GCN: 55074
  • HICL (First Databank): 049330
  • AHFS class code: 20:16.00.00
  • RxCUI (RxNorm): 2675187
Why two NDCs? The FDA registers this code as 0480-3276-56 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00480-3276-56. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Thrombopoietin Receptor Agonist class.

Pharmacologic class Thrombopoietin Receptor Agonist
Drug family (ATC) Other systemic hemostatics
How it works Thrombopoietin Receptor Agonists, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Breast Cancer Resistance Protein Inhibitors, UGT1A1 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ALVAIZ 54 MG TABLET Ingredient Eltrombopag Choline
📖 What it is MedlinePlus · NLM

Eltrombopag is used to treat thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) and aplastic anemia (condition in which the body does not make enough new blood cells). Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It raises low platelet counts in persistent or chronic ITP and in chronic hepatitis C, so hepatitis C treatment with interferon can proceed. It also treats severe aplastic anemia....
  • Take it by mouth, usually once a day, on an empty stomach or with a low-calcium meal. Keep it 2 hours before or 4 hours after antacids, dairy, and mineral supplements. Follow your...
  • Calcium and other minerals bind eltrombopag and keep your body from absorbing it. A high-calcium meal cut absorption a lot in studies. Spacing them out keeps the medicine working.
  • Common ones include nausea, diarrhea, headache, tiredness, fever, and cough. Liver blood tests can also rise, which is why they are checked often.
📖 Read our full Eltrombopag guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $600.52 $18,015.45 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $632.26 $18,967.72 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00480-3276-56 You're viewing this Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2024-02-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alvaiz 54 mgthis 00480-3276-56 Teva 30 tablets — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
First FDA approval
Nov 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Nov 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 29, 2023 RLD RS ⏳ ~12.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 11072586 — drug substance (U-3936)
US 11072586 — drug substance (U-3937)
US 11072586 — drug substance (U-3937)
US 11072586 — drug substance (U-3937)
US 11072586 — drug substance (U-3937)
US 11072586 — drug substance (U-3938)
US 11072586 — drug substance (U-3938)
US 11072586 — drug substance (U-3938)
US 11072586 — drug substance (U-3938)
US 11072586 — drug substance (U-3936)
US 11072586 — drug substance (U-3936)
US 11072586 — drug substance (U-3936)
2023 2025 2027 2029 2031 2033 2035 2037 2039
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (12)
PatentTypeUse codeExpires
US 11072586 ↗ Drug substance U-3936 Nov 5, 2038
US 11072586 ↗ Drug substance U-3937 Nov 5, 2038
US 11072586 ↗ Drug substance U-3937 Nov 5, 2038
US 11072586 ↗ Drug substance U-3937 Nov 5, 2038
US 11072586 ↗ Drug substance U-3937 Nov 5, 2038
US 11072586 ↗ Drug substance U-3938 Nov 5, 2038
US 11072586 ↗ Drug substance U-3938 Nov 5, 2038
US 11072586 ↗ Drug substance U-3938 Nov 5, 2038
US 11072586 ↗ Drug substance U-3938 Nov 5, 2038
US 11072586 ↗ Drug substance U-3936 Nov 5, 2038
US 11072586 ↗ Drug substance U-3936 Nov 5, 2038
US 11072586 ↗ Drug substance U-3936 Nov 5, 2038
Common questions
Is there a generic version of ALVAIZ 54 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for ALVAIZ 54 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color blue / white / red / orange
ShapeRound
ImprintTV;Z54
Size12 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII LQA7B6G8JG
    A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII 333AG72FWJ
    Povidone K12 is a synthetic polymer derived from petroleum. It acts as a binder and disintegrant in tablets and capsules, helping hold ingredients together and allowing the tablet to break apart for absorption.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTeva Pharmaceuticals, Inc.
Application holderTEVA PHARMACEUTICALS INC
FDA applicationNDA216774 (NDA)
Labeler code00480
First marketedFeb 2024
Product typeHuman Prescription Drug
Portfolio166 products on file

More NDCs from Teva Pharmaceuticals, Inc. labeler code 00480

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 138 words ▾

WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, ALVAIZ in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions ( 5.1 )] . ALVAIZ may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions ( 5.2 )] .

WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. In patients with chronic hepatitis C, ALVAIZ in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ( 5.1 ) ALVAIZ may increase the risk of severe and potentially life-threatening hepatotoxicity.

Monitor hepatic function and discontinue dosing as recommended. ( 5.2 )

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE ALVAIZ is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2 ) for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3 ) Limitations of Use: ALVAIZ is not indicated for the treatment of patients with myelodysplastic syndrome (MDS).

( 1.4 ) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4 )

1.1Treatment of Thrombocytopenia in Patients with Persistent or Chronic Immune Thrombocytopenia ALVAIZ ® (eltrombopag tablets) are indicated for the treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ALVAIZ should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

1.2Treatment of Thrombocytopenia in Patients with Hepatitis C Infection ALVAIZ is indicated for the treatment of thrombocytopenia in adult patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. ALVAIZ should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.

1.3Treatment of Severe Aplastic Anemia ALVAIZ is indicated for the treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

1.4Limitations of Use ALVAIZ is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions ( 5.3 )] . Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION ALVAIZ is not substitutable with other eltrombopag products on a milligram per milligram basis. ( 2.1 ) Take ALVAIZ without a meal or with a meal low in calcium (≤ 50 mg). Take ALVAIZ at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods, and mineral supplements.

( 2.4 , 7.1 , 12.3 ) Persistent or Chronic ITP: Initiate ALVAIZ at 36 mg orally once daily for most adult and pediatric patients 6 years and older. Dose reductions are needed for patients with hepatic impairment and some patients of East-/Southeast-Asian ancestry. Adjust to maintain platelet count greater than or equal to 50 x 10 9 /L.

Do not exceed 54 mg per day. ( 2.1 , 8.6 , 8.7 ) Chronic Hepatitis C-associated Thrombocytopenia: Initiate ALVAIZ at 18 mg orally once daily for all patients. Adjust to achieve target platelet count required to initiate antiviral therapy.

Do not exceed a daily dose of 72 mg. ( 2.2 ) Refractory Severe Aplastic Anemia: Initiate ALVAIZ at 36 mg orally once daily. Reduce initial dose in patients with hepatic impairment or patients of East-/Southeast-Asian ancestry.

Adjust to maintain platelet count greater than 50 x 10 9 /L. Do not exceed 108 mg per day. ( 2.3 , 8.6 , 8.7 )

2.1Important Dosage Information Eltrombopag is available for different indications and in different dosage forms and tablet strengths. ALVAIZ is not substitutable with other eltrombopag products on a milligram per milligram basis due to the observed bioavailability in studies conducted on ALVAIZ. Patients must be able to swallow ALVAIZ tablets whole [see Dosage and Administration ( 2.5 )] .

2.2Recommended Dosage for Persistent or Chronic Immune Thrombocytopenia Use the lowest dose of ALVAIZ to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use ALVAIZ to normalize platelet counts [see Warnings and Precautions ( 5.4 )] .

In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting ALVAIZ and decreased within 1 to 2 weeks after discontinuing ALVAIZ [see Clinical Studies ( 14.1 )] . Initial Dose Regimen: Adult and Pediatric Patients 6 Years and Older with ITP: Initiate ALVAIZ at a dose of 36 mg orally once daily, except in patients who are of East-/Southeast-Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C). For patients of East-/Southeast-Asian ancestry with ITP, initiate ALVAIZ at a reduced dose of 18 mg orally once daily [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] .

For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate ALVAIZ at a reduced dose of 18 mg orally once daily [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . For patients of East-/Southeast-Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A, B, C), consider initiating ALVAIZ at a reduced dose of 9 mg orally once daily [see Clinical Pharmacology ( 12.3 )] . Monitoring and Dose Adjustment: After initiating ALVAIZ, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding.

Do not exceed a dose of 54 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with ALVAIZ and modify the dosage regimen of ALVAIZ based on platelet counts as outlined in Table 1. During therapy with ALVAIZ, assess complete blood counts (CBCs) with differentials, including platelet counts, weekly until a stable platelet count has been achieved.

Obtain CBCs with differentials, including platelet counts, monthly thereafter. Table 1. Dose Adjustments of ALVAIZ in Patients with Persistent or Chronic Immune Thrombocytopenia Platelet Count Result Dose Adjustment or Response < 50 x 10 9 /L following a… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 94 words ▾

3 DOSAGE FORMS AND STRENGTHS 9 mg, round, biconvex, blue film-coated tablets, debossed with “TV” on one side and “Z9” on the other side. 18 mg, round, biconvex, off-white film-coated tablets debossed with “TV” on one side and “Z18” on the other side. 36 mg, round, biconvex, red film-coated tablets, debossed with “TV” on one side and “Z36” on the other side.

54 mg, round, biconvex, orange film-coated tablets, debossed with “TV” on one side and “Z54” on the other side. Tablets: 9 mg, 18 mg, 36 mg, and 54 mg ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Monitor liver function before and during therapy. ( 5.2 ) Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia. ( 5.3 ) Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving eltrombopag. Monitor platelet counts regularly. ( 5.4 )

5.1Hepatic Decompensation in Patients with Chronic Hepatitis C In patients with chronic hepatitis C, ALVAIZ in combination with interferon and ribavirin may increase the risk of hepatic decompensation. In two controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, ascites and encephalopathy occurred more frequently on the arm receiving treatment with eltrombopag plus antivirals (7%) than the placebo plus antivirals arm (4%). Patients with low albumin levels (less than 3.5 g/dL) or Model for End-Stage Liver Disease (MELD) score greater than or equal to 10 at baseline had a greater risk for hepatic decompensation on the arm receiving treatment with eltrombopag plus antivirals.

Discontinue ALVAIZ if antiviral therapy is discontinued.

5.2Hepatotoxicity ALVAIZ may increase the risk of severe and potentially life-threatening hepatotoxicity [see Adverse Reactions ( 6.1 )] . One patient (< 1%) with ITP treated with eltrombopag in clinical trials experienced drug-induced liver injury. Eleven patients (1%) with chronic hepatitis C treated with eltrombopag in clinical trials experienced drug-induced liver injury.

Treatment of ITP, Chronic Hepatitis C-associated Thrombocytopenia, and Refractory Severe Aplastic Anemia Measure serum ALT, AST, and bilirubin prior to initiation of ALVAIZ, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose [see Drug Interactions ( 7.5 )] . ALVAIZ inhibits UDP-glucuronosyltransferase (UGT)1A1 and organic anion-transporting polypeptide (OATP)1B1, which may lead to indirect hyperbilirubinemia. If bilirubin is elevated, perform fractionation.

Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until resolved or stabilized. Discontinue ALVAIZ if ALT levels increase to greater than or equal to 3 x ULN in patients with normal liver function or greater than or equal to 3 x baseline (or greater than 5 x ULN, whichever is the lower) in patients with pre-treatment elevations in transaminases and are: progressively increasing, or persistent for greater than or equal to 4 weeks, or accompanied by increased direct bilirubin, or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.

If the potential benefit for reinitiating treatment with ALVAIZ is considered to outweigh the risk for hepatotoxicity, then consider cautiously reintroducing ALVAIZ and measure serum liver tests weekly during the dose adjustment phase. Hepatotoxicity may reoccur if ALVAIZ is reinitiated. If liver test abnormalities persist, worsen, or recur, then permanently discontinue ALVAIZ.

5.3Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia A randomized, double-blind, placebo-controlled, multicenter trial in patients with International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2 or high risk MDS with thrombocytopenia, receiving azacitidine in combination with either eltrombopag (n = 179) or placebo (n = 177) was terminated due to lack of efficacy and safety reasons, including increased progression to acute myeloid leukemia (AML). Patients received eltrombopag or placebo at a starting dose of 200 mg once daily, up to a maximum of 300 mg once daily, in combination with azacitidine for at least six cycles.

The incidence of death (overall survival) was 32% (57/179) in the eltrombopag arm versus 29% (51/177) in the placebo arm (HR [95% CI] = 1.42 [0.97, 2.08], showing an increased relative risk of death in t… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions associated with ALVAIZ are described in other sections. Hepatic Decompensation in Patients with Chronic Hepatitis C [see Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia [see Warnings and Precautions ( 5.3 )] Thrombotic/Thromboembolic Complications [see Warnings and Precautions ( 5.4 )] Cataracts [see Warnings and Precautions ( 5.5 )] Across all indications, the most common adverse reactions (≥ 20% in any indication) were: anemia, nausea, pyrexia, alanine aminotransferase increased, cough, fatigue, headache, and diarrhea.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ALVAIZ has been established based on adequate and well-controlled studies of eltrombopag olamine in adult and pediatric patients 6 years and older with persistent or chronic ITP, adult patients with chronic hepatitis C-associated thrombocytopenia, and adult patients with refractory severe aplastic anemia.

Below is a display of the adverse reactions of eltrombopag olamine in these adequate and well-controlled studies. Persistent or Chronic Immune Thrombocytopenia: Adults: In clinical trials, hemorrhage was the most common serious adverse reaction and most hemorrhagic reactions followed discontinuation of eltrombopag. Other serious adverse reactions included thrombotic/thromboembolic complications [see Warnings and Precautions ( 5.4 )] .

The data described below reflect exposure of eltrombopag to patients with persistent or chronic ITP aged 18 to 85 years, of whom 66% were female, in three placebo-controlled trials and one open-label extension trial [see Clinical Studies ( 14.1 )] . Eltrombopag was administered to 330 patients for at least 6 months and 218 patients for at least 1 year. Table 4 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of patients receiving eltrombopag) from the three placebo-controlled trials, with a higher incidence in eltrombopag versus placebo.

Table 4. Adverse Reactions (≥ 3%) From Three Placebo-controlled Trials in Adults with Persistent or Chronic Immune Thrombocytopenia Adverse Reaction Eltrombopag 50 mg n = 241 (%) Placebo n = 128 (%) Nausea 9 3 Diarrhea 9 7 Upper respiratory tract infection 7 6 Vomiting 6 < 1 Urinary tract infection a 5 4 Increased ALT 5 3 Myalgia 5 2 Oropharyngeal pain 4 3 Increased AST 4 2 Pharyngitis 4 2 Back pain 3 2 Influenza 3 2 Paresthesia 3 2 Rash 3 2 Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase. a Includes PTs of urinary tract infection, cystitis, urinary tract infection bacterial, and bacteriuria.

In the three controlled clinical persistent or chronic ITP trials, alopecia, musculoskeletal pain, blood alkaline phosphatase increased, and dry mouth were the adverse reactions reported in 2% of patients treated with eltrombopag and in no patients who received placebo. Among 302 patients with persistent or chronic ITP who received eltrombopag in the single-arm extension trial, the adverse reactions occurred in a pattern similar to that seen in the placebo-controlled trials. Table 5 presents the most common treatment-related adverse reactions (experienced by greater than or equal to 3% of patients receiving eltrombopag) from the extension trial.

Table 5. Treatment-related Adverse Reactions (≥3%) From Extension Trial in Adults with Persistent or Chronic Immune Thrombocytopenia Adverse Reaction Eltrombopag 50 mg n = 302 (%) Headache 10 ALT increased 5… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

7.1Polyvalent Cations (Chelation) Eltrombopag chelates polyvalent cations (such as iron, calcium, aluminum, magnesium, selenium, and zinc) in foods, mineral supplements, and antacids. Take ALVAIZ at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, dairy products, and mineral supplements to avoid significant reduction in absorption of ALVAIZ due to chelation [see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 )] .

7.2Transporters Use caution when concomitantly administering ALVAIZ and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). Monitor patients closely for signs and symptoms of excessive exposure to the drugs that are substrates of OATP1B1 or BCRP and consider reduction of the dose of these drugs, if appropriate.

In clinical trials with eltrombopag, a dose reduction of rosuvastatin by 50% was recommended.

7.3Protease Inhibitors HIV Protease Inhibitors: No dose adjustment is recommended when ALVAIZ is coadministered with lopinavir/ritonavir (LPV/RTV). Drug interactions with other HIV protease inhibitors have not been evaluated. Hepatitis C Virus Protease Inhibitors: No dose adjustments are recommended when ALVAIZ is coadministered with boceprevir or telaprevir. Drug interactions with other hepatitis C virus (HCV) protease inhibitors have not been evaluated.

7.4Peginterferon Alfa-2a/b Therapy No dose adjustments are recommended when ALVAIZ is coadministered with peginterferon alfa-2a (PEGASYS ® ) or -2b (PEGINTRON ® ).

7.5Interference with Clinical Laboratory Tests Eltrombopag (ALVAIZ) is highly colored and can cause patient sample discoloration, which is reported to interfere with some clinical laboratory tests, including, but not limited to bilirubin and creatinine. Bilirubin Testing : Eltrombopag can cause both positive and negative interference with bilirubin assays. If the laboratory results for bilirubin are inconsistent with clinical observations, further evaluation of liver function should be performed to clarify the clinical status of the patient.

Evaluating contemporaneous aminotransferase values (AST, ALT) may help determine the validity of normal total bilirubin levels in the presence of clinical jaundice. Creatinine Testing : Eltrombopag can cause positive interference with creatinine measurements, leading to falsely elevated creatinine levels. In the event of an unexpected serum creatinine test result, further evaluation of renal function should be performed.

Blood urea should be evaluated if serum creatinine is unexpectedly high. Communicate to the lab conducting testing if the patient is taking ALVAIZ. Re-testing using other methods may also help in determining the validity of the test results.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed during treatment. ( 8.2 )

8.1Pregnancy Risk Summary Available data from a small number of published case reports and postmarketing experience with eltrombopag use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses. These effects were observed at doses resulting in exposures that were six times the human clinical exposure based on area under the curve (AUC) in patients with persistent or chronic ITP at 75 mg/day, and three times the AUC in patients with chronic hepatitis C at 100 mg/day (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data In an early embryonic development study, female rats received oral eltrombopag at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day). Increased pre- and post-implantation loss and reduced fetal weight were observed at the highest dose which also caused maternal toxicity. In an embryo-fetal development study eltrombopag was administered orally to pregnant rats during the period of organogenesis at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Decreased fetal weights (6% to 7%) and a slight increase in the presence of cervical ribs were observed at the highest dose which also caused maternal toxicity. However, no evidence of major structural malformations was observed. In an embryo-fetal development study eltrombopag was administered orally to pregnant rabbits during the period of organogenesis at doses of 30, 80, or 150 mg/kg/day (0.04, 0.3, and 0.5 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.02, 0.1, and 0.3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

No evidence of fetotoxicity, embryolethality, or teratogenicity was observed. In a pre- and post-natal developmental toxicity study in pregnant rats (F0), oral eltrombopag was administered from gestation Day 6 through lactation Day 20. No adverse effects on maternal reproductive function or on the development of the offspring (F1) were observed at doses up to 20 mg/kg/day (2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and similar to the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Eltrombopag was detected in the plasma of offspring (F1). The plasma concentrations in pups increased with dose following administration of drug to the F0 dams.

8.2Lactation Risk Summary There are no data regarding the presence of eltrombopag or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. However, eltrombopag was detected in the pups of lactating rats 10 days postpartum suggesting the potential for transfer during lactation. Due to the potential for serious adverse reactions in a breastfed child from eltrombopag, breastfeeding is n… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from a small number of published case reports and postmarketing experience with eltrombopag use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, oral administration of eltrombopag to pregnant rats during organogenesis resulted in embryolethality and reduced fetal weights at maternally toxic doses. These effects were observed at doses resulting in exposures that were six times the human clinical exposure based on area under the curve (AUC) in patients with persistent or chronic ITP at 75 mg/day, and three times the AUC in patients with chronic hepatitis C at 100 mg/day (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data In an early embryonic development study, female rats received oral eltrombopag at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day). Increased pre- and post-implantation loss and reduced fetal weight were observed at the highest dose which also caused maternal toxicity. In an embryo-fetal development study eltrombopag was administered orally to pregnant rats during the period of organogenesis at doses of 10, 20, or 60 mg/kg/day (0.8, 2, and 6 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.3, 1, and 3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Decreased fetal weights (6% to 7%) and a slight increase in the presence of cervical ribs were observed at the highest dose which also caused maternal toxicity. However, no evidence of major structural malformations was observed. In an embryo-fetal development study eltrombopag was administered orally to pregnant rabbits during the period of organogenesis at doses of 30, 80, or 150 mg/kg/day (0.04, 0.3, and 0.5 times, respectively, the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.02, 0.1, and 0.3 times, respectively, the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

No evidence of fetotoxicity, embryolethality, or teratogenicity was observed. In a pre- and post-natal developmental toxicity study in pregnant rats (F0), oral eltrombopag was administered from gestation Day 6 through lactation Day 20. No adverse effects on maternal reproductive function or on the development of the offspring (F1) were observed at doses up to 20 mg/kg/day (2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and similar to the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Eltrombopag was detected in the plasma of offspring (F1). The plasma concentrations in pups increased with dose following administration of drug to the F0 dams.

🧒 Pediatric Use 169 words ▾

8.4Pediatric Use The safety and effectiveness of ALVAIZ have been established in pediatric patients 6 years and older with persistent or chronic ITP. The safety and effectiveness of eltrombopag in pediatric patients 6 years and older with persistent or chronic ITP were evaluated in two double-blind, placebo-controlled trials [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] . The pharmacokinetics of eltrombopag have been established in 130 pediatric patients 6 years and older with ITP dosed once daily [see Clinical Pharmacology ( 12.3 )] .

See Dosage and Administration ( 2.1 ) for dosing recommendations for pediatric patients 6 years and older. The safety and effectiveness of ALVAIZ have not been established in pediatric patients less than 6 years of age with persistent or chronic ITP. Pediatric patients must be able to swallow ALVAIZ tablets whole [see Dosage and Administration ( 2.5 )].

The safety and effectiveness in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established.

🧓 Geriatric Use 121 words ▾

8.5Geriatric Use Of the 106 patients in two randomized clinical trials of eltrombopag 50 mg in persistent or chronic ITP, 22% were 65 years of age and over, while 9% were 75 years of age and over. Of the 1439 patients in two randomized clinical trials of eltrombopag in patients with chronic hepatitis C and thrombocytopenia, 7% were 65 years of age and over, while < 1% were 75 years of age and over. Of the 196 patients who received eltrombopag for the treatment of severe aplastic anemia, 18% were 65 years of age and over, while 3% were 75 years of age and over.

No overall differences in safety or effectiveness were observed between these patients and younger patients.

🆘 Overdosage 167 words ▾

10 OVERDOSAGE In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In one report, a subject who ingested 5000 mg of eltrombopag had a platelet count increase to a maximum of 929 x 10 9 /L at 13 days following the ingestion. The patient also experienced rash, bradycardia, ALT/AST elevations, and fatigue.

The patient was treated with gastric lavage, oral lactulose, intravenous fluids, omeprazole, atropine, furosemide, calcium, dexamethasone, and plasmapheresis; however, the abnormal platelet count and liver test abnormalities persisted for 3 weeks. After 2 months’ follow-up, all events had resolved without sequelae. In case of an overdose, consider oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations to chelate eltrombopag and thus limit absorption.

Closely monitor platelet counts. Reinitiate treatment with eltrombopag in accordance with dosing and administration recommendations [see Dosage and Administration ( 2.1 , 2.2 )] . Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Eltrombopag is a TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.

12.2Pharmacodynamics In clinical trials, treatment with eltrombopag resulted in dose-dependent increases in platelet counts following repeated (daily) dosing. The increase in platelet counts reached a maximum approximately two weeks after the initiation of dosing, and returned to baseline within approximately two weeks after the last dose of eltrombopag. Cardiac Electrophysiology At doses up to 150 mg (the maximum recommended dose) daily for 5 days, eltrombopag did not prolong the QT/QTc interval to any relevant extent.

12.3Pharmacokinetics Eltrombopag demonstrated a dose-proportional increase in exposure between doses of 50 to 150 mg/day in healthy adult subjects. Eltrombopag AUC was approximately 1.7-fold higher in patients with persistent or chronic ITP and approximately 2.8-fold higher in patients with HCV compared to healthy subjects. Steady-state was achieved after approximately 1 week of once daily treatment, with geometric mean accumulation ratio of 1.56 (90% confidence interval 1.20, 1.63) at 75 mg/day.

Eltrombopag AUC was approximately 3.2-fold higher in patients with definitive immunosuppressive therapy-naïve severe aplastic anemia compared to healthy subjects suggesting higher relative exposure compared to healthy subjects or patients with ITP and similar exposure compared to patients with chronic hepatitis C. Absorption Eltrombopag is absorbed with a peak concentration occurring 1.5 to 5.5 hours after oral administration under fasting conditions and 1.0 to 8.0 hours after oral administration under fed conditions (high-fat, high-calorie meal).

Effect of Food Administration of eltrombopag after a high fat, high calorie meal decreased AUC inf by approximately 36% and C max by approximately 39%, and delayed T max by 0.5 hours as compared to fasted conditions. A meal low in calcium (≤ 50 mg calcium) did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content. Distribution The concentration of eltrombopag in blood cells is approximately 50% to 79% of plasma concentrations based on a radiolabel study.

In vitro studies suggest that eltrombopag is highly bound to human plasma proteins (greater than 99%). Eltrombopag is a substrate of BCRP, but is not a substrate for P-glycoprotein (P-gp) or OATP1B1. Elimination The plasma elimination half-life of eltrombopag is approximately 21 to 32 hours in healthy subjects and 26 to 35 hours in patients with ITP.

Metabolism: Absorbed eltrombopag is extensively metabolized, predominantly through pathways, including cleavage, oxidation, and conjugation with glucuronic acid, glutathione, or cysteine. In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for the oxidative metabolism of eltrombopag. UGT1A1 and UGT1A3 are responsible for the glucuronidation of eltrombopag.

Excretion: The predominant route of eltrombopag excretion is via feces (59%), and 31% of the dose is found in the urine. Unchanged eltrombopag in feces accounts for approximately 20% of the dose; unchanged eltrombopag is not detectable in urine. Specific Populations Ethnicity Eltrombopag concentrations in East-/Southeast-Asian ancestry patients with ITP or chronic hepatitis C, were 50% to 55% higher compared with non-Asian subjects [see Dosage and Administration ( 2.1 , 2.3 )] .

Eltrombopag exposure in healthy African-American subjects was approximately 40% higher than that observed in Caucasian subjects in one clinical pharmacology trial and similar in three other clinical pharmacology trials. The effect of African-American ethnicity on exposure and related safety and efficacy of eltrombopag has not been established. Hepatic Impairment Following a single dose of… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action Eltrombopag is a TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.

📦 How Supplied / Storage and Handling 166 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied ALVAIZ (eltrombopag tablets) is for oral administration and are available as follows. 9 mg - Blue, round, biconvex, film-coated tablets debossed with “TV” on one side and “Z9” on the other side. The tablets are available in bottles of 30 (NDC 0480-3273-56).

18 mg - Off-white, round, biconvex, film-coated tablets debossed with “TV” on one side and “Z18” on the other side. The tablets are available in bottles of 30 (NDC 0480-3274-56). 36 mg - Red, round, biconvex, film-coated tablets debossed with “TV” on one side and “Z36” on the other side.

The tablets are available in bottles of 30 (NDC 0480-3275-56). 54 mg - Orange, round, biconvex, film-coated tablets debossed with “TV” on one side and “Z54” on the other side. The tablets are available in bottles of 30 (NDC 0480-3276-56).

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description 216 words ▾

11 DESCRIPTION ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1).

It has the molecular formula C 30 H 35 N 5 O 5 . The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid. Eltrombopag choline has the following structural formula: Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8.

ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are: Tablet Core: anhydrous lactose, copovidone, croscarmellose sodium, edetate disodium dihydrate, magnesium stearate, poloxamer 188, polyethylene glycol 4000, povidone K12, silicified microcrystalline cellulose, and silicon dioxide. Coating: Strength 9 mg: FD&C Blue No.

1 aluminum lake, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. 18 mg: Hypromellose 2910, polyethylene glycol 4000, talc, and titanium dioxide. 36 mg: Iron oxide red, iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.

54 mg: FD&C Red #40 aluminum lake, hypromellose 2910, iron oxide yellow, polyethylene glycol 400, and titanium dioxide. structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Prior to treatment, patients should fully understand and be informed of the following risks and considerations for ALVAIZ: Risks Hepatotoxicity Therapy with ALVAIZ may be associated with hepatobiliary laboratory abnormalities [see Warnings and Precautions ( 5.2 )] . Advise patients with chronic hepatitis C and cirrhosis that they may be at risk for hepatic decompensation when receiving ALVAIZ with alfa interferon therapy [see Warnings and Precautions ( 5.1 )] .

Advise patients that they should report any of the following signs and symptoms of liver problems to their healthcare provider right away [see Warnings and Precautions ( 5.2 )] . yellowing of the skin or the whites of the eyes (jaundice) unusual darkening of the urine unusual tiredness right upper stomach area pain confusion swelling of the stomach area (abdomen) Risk of Bleeding Upon ALVAIZ Discontinuation Advise patients that thrombocytopenia and risk of bleeding may reoccur upon discontinuing ALVAIZ, particularly if ALVAIZ is discontinued while the patient is on anticoagulants or antiplatelet agents.

Advise patients that during therapy with ALVAIZ, they should continue to avoid situations or medications that may increase the risk for bleeding. Thrombotic/Thromboembolic Complications Advise patients that too much ALVAIZ may result in excessive platelet counts and a risk for thrombotic/thromboembolic complications [see Warnings and Precautions ( 5.4 )] . Cataracts Advise patients to have a baseline ocular examination prior to administration of ALVAIZ and be monitored for signs and symptoms of cataracts during therapy [see Warnings and Precautions ( 5.5 )] .

Drug Interactions Advise patients to take ALVAIZ at least 2 hours before or 4 hours after calcium-rich foods, mineral supplements, and antacids which contain polyvalent cations, such as iron, calcium, aluminum, magnesium, selenium, and zinc [see Dosage and Administration ( 2.4 ), Drug Interactions ( 7.1 )] . Lactation Advise women not to breastfeed during treatment with ALVAIZ [see Use in Specific Populations ( 8.2 )] . Administration of ALVAIZ For patients with persistent or chronic ITP, therapy with ALVAIZ is administered to achieve and maintain a platelet count greater than or equal to 50 x 10 9 /L as necessary to reduce the risk for bleeding [see Indications and Usage ( 1.1 )] .

For patients with chronic hepatitis C, therapy with ALVAIZ is administered to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin [see Indications and Usage ( 1.2 )] . Advise patients to take ALVAIZ without a meal or with a meal low in calcium (≤ 50 mg) and at least 2 hours before or 4 hours after other medications (e.g., antacids) and calcium-rich foods [see Dosage and Administration ( 2.4 )] . Brands listed are the trademarks of their respective owners.

Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 1/2026

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE ALVAIZ ® (al-VAYZ) (eltrombopag) tablets What is the most important information I should know about ALVAIZ? ALVAIZ may cause serious side effects, including: Liver problems: If you have chronic hepatitis C virus and take ALVAIZ with interferon and ribavirin treatment, ALVAIZ may increase your risk of liver problems. If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking ALVAIZ.

ALVAIZ may increase your risk of liver problems that may be severe and possibly life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking ALVAIZ and during your treatment. Your healthcare provider may stop your treatment with ALVAIZ if you have changes in your liver function blood tests.

Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice) unusual darkening of the urine unusual tiredness right upper stomach area (abdomen) pain confusion swelling of the stomach area (abdomen) See “What are the possible side effects of ALVAIZ ?” for other side effects of ALVAIZ . What is ALVAIZ? ALVAIZ is a prescription medicine used to treat: adults and children 6 years of age and older with low blood platelet counts due to persistent or chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough. adults with low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon. severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough.

ALVAIZ is used to try to raise platelet counts in order to lower your risk for bleeding. ALVAIZ is not used to make platelet counts normal. ALVAIZ is not for use in people with a pre-cancerous condition called myelodysplastic syndrome (MDS), or in people with low platelet counts caused by certain other medical conditions or diseases.

It is not known if ALVAIZ is safe and effective when used with other antiviral medicines to treat chronic hepatitis C. It is not known if ALVAIZ is safe and effective in children: younger than 6 years with persistent or chronic ITP with low blood platelet counts due to chronic hepatitis C whose severe aplastic anemia (SAA) has not improved after previous treatments Before you take ALVAIZ , tell your healthcare provider about all of your medical conditions, including if you: have liver problems have a precancerous condition called MDS or a blood cancer have or had a blood clot have a history of cataracts have had surgery to remove your spleen (splenectomy) have bleeding problems are of East-Asian or Southeast-Asian ancestry.

You may need a lower dose of ALVAIZ. are pregnant or plan to become pregnant. It is not known if ALVAIZ will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with ALVAIZ.

Females who are able to become pregnant, should use effective birth control (contraception) during treatment with ALVAIZ and for at least 7 days after stopping treatment with ALVAIZ. Talk to your healthcare provider about birth control methods that may be right for you during this time. are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with ALVAIZ.

Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ALVAIZ may affect the way certain medicines work.

Certain other medicines may affect the way ALVAIZ works. Especially tell your healthcare provider if you take: certain medicines used to treat high cholesterol, called “statins” a blood thinner medicine Certain medicines may keep ALVAIZ from working correctly. Take ALVAIZ at least… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Eltrombopag demonstrated a dose-proportional increase in exposure between doses of 50 to 150 mg/day in healthy adult subjects. Eltrombopag AUC was approximately 1.7-fold higher in patients with persistent or chronic ITP and approximately 2.8-fold higher in patients with HCV compared to healthy subjects. Steady-state was achieved after approximately 1 week of once daily treatment, with geometric mean accumulation ratio of 1.56 (90% confidence interval 1.20, 1.63) at 75 mg/day.

Eltrombopag AUC was approximately 3.2-fold higher in patients with definitive immunosuppressive therapy-naïve severe aplastic anemia compared to healthy subjects suggesting higher relative exposure compared to healthy subjects or patients with ITP and similar exposure compared to patients with chronic hepatitis C. Absorption Eltrombopag is absorbed with a peak concentration occurring 1.5 to 5.5 hours after oral administration under fasting conditions and 1.0 to 8.0 hours after oral administration under fed conditions (high-fat, high-calorie meal).

Effect of Food Administration of eltrombopag after a high fat, high calorie meal decreased AUC inf by approximately 36% and C max by approximately 39%, and delayed T max by 0.5 hours as compared to fasted conditions. A meal low in calcium (≤ 50 mg calcium) did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content. Distribution The concentration of eltrombopag in blood cells is approximately 50% to 79% of plasma concentrations based on a radiolabel study.

In vitro studies suggest that eltrombopag is highly bound to human plasma proteins (greater than 99%). Eltrombopag is a substrate of BCRP, but is not a substrate for P-glycoprotein (P-gp) or OATP1B1. Elimination The plasma elimination half-life of eltrombopag is approximately 21 to 32 hours in healthy subjects and 26 to 35 hours in patients with ITP.

Metabolism: Absorbed eltrombopag is extensively metabolized, predominantly through pathways, including cleavage, oxidation, and conjugation with glucuronic acid, glutathione, or cysteine. In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for the oxidative metabolism of eltrombopag. UGT1A1 and UGT1A3 are responsible for the glucuronidation of eltrombopag.

Excretion: The predominant route of eltrombopag excretion is via feces (59%), and 31% of the dose is found in the urine. Unchanged eltrombopag in feces accounts for approximately 20% of the dose; unchanged eltrombopag is not detectable in urine. Specific Populations Ethnicity Eltrombopag concentrations in East-/Southeast-Asian ancestry patients with ITP or chronic hepatitis C, were 50% to 55% higher compared with non-Asian subjects [see Dosage and Administration ( 2.1 , 2.3 )] .

Eltrombopag exposure in healthy African-American subjects was approximately 40% higher than that observed in Caucasian subjects in one clinical pharmacology trial and similar in three other clinical pharmacology trials. The effect of African-American ethnicity on exposure and related safety and efficacy of eltrombopag has not been established. Hepatic Impairment Following a single dose of eltrombopag, plasma eltrombopag AUC 0-INF was 41% higher in patients with mild hepatic impairment (Child-Pugh Class A) compared with subjects with normal hepatic function.

Plasma eltrombopag AUC 0-INF was approximately 2-fold higher in patients with moderate (Child-Pugh Class B) and severe hepatic impairment (Child-Pugh Class C) compared with subjects with normal hepatic function. The half-life of eltrombopag was prolonged 2-fold in these patients. This clinical trial did not evaluate protein-binding effects.

Chronic Liver Disease Following repeat doses of eltrombopag in patients with thrombocytopenia and with chronic liver disease, mild hepatic impairment resulted in an 87% to 110% higher plasma eltrombopag AUC (0-τ) and moderate hepatic impairment resulted in approximately 141% to 240% higher plasma eltrombopag AUC (0-τ) values comp… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 76 words ▾

12.2Pharmacodynamics In clinical trials, treatment with eltrombopag resulted in dose-dependent increases in platelet counts following repeated (daily) dosing. The increase in platelet counts reached a maximum approximately two weeks after the initiation of dosing, and returned to baseline within approximately two weeks after the last dose of eltrombopag. Cardiac Electrophysiology At doses up to 150 mg (the maximum recommended dose) daily for 5 days, eltrombopag did not prolong the QT/QTc interval to any relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The effectiveness of ALVAIZ has been established based on adequate and well-controlled studies of eltrombopag olamine in adult and pediatric patients 6 years and older with persistent or chronic ITP, adult patients with chronic hepatitis C-associated thrombocytopenia, and adult patients with refractory severe aplastic anemia. Below is a display of the efficacy information for eltrombopag olamine in these adequate and well-controlled studies.

14.1Persistent or Chronic ITP Adults: The efficacy and safety of eltrombopag in adult patients with persistent or chronic ITP were evaluated in three randomized, double-blind, placebo-controlled trials and in an open-label extension trial. In Study TRA100773B and Study TRA100773A (referred to as Study 773B and Study 773A, respectively [NCT00102739]), patients who had completed at least one prior ITP therapy and who had a platelet count less than 30 x 10 9 /L were randomized to receive either eltrombopag or placebo daily for up to 6 weeks, followed by 6 weeks off therapy.

During the trials, eltrombopag or placebo was discontinued if the platelet count exceeded 200 x 10 9 /L. The median age of the patients was 50 years and 60% were female. Approximately 70% of the patients had received at least 2 prior ITP therapies (predominantly corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine) and 40% of the patients had undergone splenectomy.

The median baseline platelet counts (approximately 18 x 10 9 /L) were similar among all treatment groups. Study 773B randomized 114 patients (2:1) to eltrombopag 50 mg or placebo. Of 60 patients with documented time since diagnosis, approximately 17% met the definition of persistent ITP with time since diagnosis of 3 to 12 months.

Study 773A randomized 117 patients (1:1:1:1) among placebo or 1 of 3 dose regimens of eltrombopag , 30 mg, 50 mg, or 75 mg each administered daily. Of 51 patients with documented time since diagnosis, approximately 14% met the definition of persistent ITP. The efficacy of eltrombopag in this trial was evaluated by response rate, defined as a shift from a baseline platelet count of less than 30 x 10 9 /L to greater than or equal to 50 x 10 9 /L at any time during the treatment period (Table 10).

Table 10. Studies 773B and 773A: Platelet Count Response (≥ 50 x 10 9 /L) Rates in Adults with Persistent or Chronic Immune Thrombocytopenia Study Eltrombopag 50 mg Daily Placebo 773B 43/73 (59%) a 6/37 (16%) 773A 19/27 (70%) a 3/27 (11%) a p -value < 0.001 for eltrombopag versus placebo. The platelet count response to eltrombopag was similar among patients who had or had not undergone splenectomy.

In general, increases in platelet counts were detected 1 week following initiation of eltrombopag and the maximum response was observed after 2 weeks of therapy. In the placebo and 50-mg dose groups of eltrombopag, the trial drug was discontinued due to an increase in platelet counts to greater than 200 x 10 9 /L in 3% and 27% of the patients, respectively. The median duration of treatment with the 50-mg dose of eltrombopag was 43 days in Study 773B and 42 days in Study 773A.

Of 7 patients who underwent hemostatic challenges, additional ITP medications were required in 3 of 3 placebo group patients and 0 of 4 patients treated with eltrombopag. Surgical procedures accounted for most of the hemostatic challenges. Hemorrhage requiring transfusion occurred in one placebo group patient and no patients treated with eltrombopag.

In the RAISE study (NCT00370331), 197 patients were randomized (2:1) to receive either eltrombopag 50 mg once daily (n = 135) or placebo (n = 62) for 6 months, during which time the dose of eltrombopag could be adjusted based on individual platelet counts. Of 145 patients with documented time since diagnosis, 19% met the definition of persistent ITP. Patients were allowed to taper or discontinue concomitant ITP medications after being treated with eltrombopag for 6 weeks.

Pa… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Eltrombopag does not stimulate platelet production in rats, mice, or dogs because of unique TPO receptor specificity. Data from these animals do not fully model effects in humans. Eltrombopag was not carcinogenic in mice at doses up to 75 mg/kg/day or in rats at doses up to 40 mg/kg/day (exposures up to 4 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 2 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats (micronucleus and unscheduled DNA synthesis, 10 times the human clinical exposure based on C max in patients with ITP at 75 mg/day and 7 times the human clinical exposure based on C max in patients with chronic hepatitis C at 100 mg/day). In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (less than 3-fold increase in mutation frequency). Eltrombopag did not affect female fertility in rats at doses up to 20 mg/kg/day (2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and similar to the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Eltrombopag did not affect male fertility in rats at doses up to 40 mg/kg/day, the highest dose tested (3 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 2 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

13.2Animal Toxicology and/or Pharmacology Treatment-related cataracts were detected in rodents in a dose- and time-dependent manner. At greater than or equal to 6 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 3 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day, cataracts were observed in mice after 6 weeks and in rats after 28 weeks of dosing. At greater than or equal to 4 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 2 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day, cataracts were observed in mice after 13 weeks and in rats after 39 weeks of dosing [see Warnings and Precautions ( 5.5 )] .

Renal tubular toxicity was observed in studies up to 14 days in duration in mice and rats at exposures that were generally associated with morbidity and mortality. Tubular toxicity was also observed in a 2-year oral carcinogenicity study in mice at doses of 25, 75, and 150 mg/kg/day. The exposure at the lowest dose was 1.2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 0.6 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day.

No similar effects were observed in mice after 13 weeks at exposures greater than those associated with renal changes in the 2-year study, suggesting that this effect is both dose- and time-dependent.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Eltrombopag does not stimulate platelet production in rats, mice, or dogs because of unique TPO receptor specificity. Data from these animals do not fully model effects in humans. Eltrombopag was not carcinogenic in mice at doses up to 75 mg/kg/day or in rats at doses up to 40 mg/kg/day (exposures up to 4 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 2 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats (micronucleus and unscheduled DNA synthesis, 10 times the human clinical exposure based on C max in patients with ITP at 75 mg/day and 7 times the human clinical exposure based on C max in patients with chronic hepatitis C at 100 mg/day). In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (less than 3-fold increase in mutation frequency). Eltrombopag did not affect female fertility in rats at doses up to 20 mg/kg/day (2 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and similar to the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

Eltrombopag did not affect male fertility in rats at doses up to 40 mg/kg/day, the highest dose tested (3 times the human clinical exposure based on AUC in patients with ITP at 75 mg/day and 2 times the human clinical exposure based on AUC in patients with chronic hepatitis C at 100 mg/day).

📄 Recent Major Changes 18 words ▾

Warnings and Precautions, Laboratory Test Interference (5.6) 6/2025 Warnings and Precautions, Laboratory Test Interference ( 5.6 ) 7/2025

📄 Package Label / Principal Display Panel 151 words ▾

PACKAGE.LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-3273-56 Rx only Alvaiz ® (eltrombopag tablets) 9 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis. 30 Tablets 9mg30s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-3274-56 Rx only Alvaiz ® (eltrombopag tablets) 18 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis. 30 Tablets 18mg30s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-3275-56 Rx only Alvaiz ® (eltrombopag tablets) 36 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis. 30 Tablets 36mg30s

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0480-3276-56 Rx only Alvaiz ® (eltrombopag tablets) 54 mg* PHARMACIST: Dispense the accompanying Medication Guide to each patient. Alvaiz is NOT substitutable with other eltrombopag products on a milligram-per-milligram basis. 30 Tablets 54mg30s

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
50
Units reimbursed last 4 qtrs
1.7K
Gross reimbursed last 4 qtrs
$1.01M
Avg / prescription
$20,249.37
Avg / unit
$600.52
Latest quarter Q1 2026
14Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 50 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,686 units · 4.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.34.3
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 California 4.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Alvaiz — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Alvaiz. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$12.95M
Claims incl. refills
1.5K
Beneficiaries
629
Spend / beneficiary
$20,594.04
Spend / claim
$8,782.13
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Teva Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Teva Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00480-3275-56 · Teva 00480-3290-01 · Teva →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.