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Eltrombopag olamine 50 mg Tablet, Film Coated, 30-count

by Amerisyn, LLC · 30 TABLET, FILM COATED in 1 BOTTLE (87564-034-30)

NDC 87564-0034-30

🏷️ FDA NDC (as labeled) 87564-034-30 billing pads the product segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Sep 17, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 87564-034-30

Product NDC 87564-034

11-digit billing NDC 87564003430

RxCUI 825421, 825427, 884617, 1245001

UNII 4U07F515LG

Application # ANDA219638

SPL Set ID 52ba8e06-aa7d-caa6-e063-6294a90a5ce5

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 ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-06-30

Route ORAL

Dosage form TABLET, FILM COATED

Substance ELTROMBOPAG OLAMINE

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 87564-034-30 — a 5-3-2 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 product segment → 87564-0034-30. 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.

🏭 Manufacturer & labeler

LabelerAmerisyn, LLC

Application holderSOMERSET THERAPEUTICS LLC

FDA applicationANDA219638 (ANDA)

Labeler code87564

First marketedJun 2026

Product typeHuman Prescription Drug

Portfolio8 products on file

🔎 All NDCs from Amerisyn, LLC

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.

🩺 Clinical

📖 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 ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

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.

💊 What it looks like

Color orange / white / red / blue

ShapeRound

ImprintIII

Size1 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 J9EQA3S2JM
FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
UNII S4255P4G5M
Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
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 4AQJ3LG584
A synthetic blue dye combined with aluminum to create a stable colorant. It's used in medicines and supplements to add blue color or create specific shades for product identification and appearance.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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 S870P55O2W
Isomalt is a sugar alcohol made from sugar that's used as a sweetener and bulking agent in medicines. It helps give tablets and powders the right texture and sweetness while having minimal calories.
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 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

13 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.

💲 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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Eltrombopag olamine 50 mg 70069-0839-01	Somerset	30 tablets	—	AB	FDA listed	—
Promacta 50 mg 00078-0686-15	Novartis	30 tablets	—	AB	FDA listed	—
Eltrombopag 50 mg 00054-0964-13	Hikma	30 tablets	—	AB	FDA listed	—
eltrombopag 50 mg 72205-0158-19	Novadoz	19 tablets	—	AB	FDA listed	—
Eltrombopag olamine 50 mgthis 87564-0034-30	Amerisyn,	30 tablets	—	AB	FDA listed	—
Eltrombopag 50 mg 70377-0185-11	Biocon	14 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

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

🏛️

2026

On the market since

Jun 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Eltrombopag Olamine — the program that covers self-administered drugs. 6 manufacturers.

⚠️ 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 Eltrombopag Olamine. 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

$105.41M

Claims incl. refills

10.3K

Beneficiaries

4.7K

Spend / beneficiary

$22,380.68

Spend / claim

$10,226.33

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
87564-0034-30 You're viewing this	30 TABLET, FILM COATED in 1 BOTTLE (87564-034-30)	2026-06-30	Active

🧭 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)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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 FDA registers it as 87564-034-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87564-0034-30, written without dashes as 87564003430. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 87564-0034-30, the first segment (87564) is the labeler code FDA assigned to Amerisyn, LLC; the middle segment (0034) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Amerisyn, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Amerisyn, LLC 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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

🚨 Boxed Warning 145 words ▾

WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY. THESE HIHGLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 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, eltrombopag tablets in combination with interferon and ribavirin may increase the risk of hepatic decompensation.

(5.1) Eltrombopag tablets may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. (5.2) In patients with chronic hepatitis C, eltrombopag tablets in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)] .

Eltrombopag tablets 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)] .

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Eltrombopag tablets are thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets 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 patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Eltrombopag tablets 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) in combination with standard immunosuppressive therapy for the first- line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

(1.3) Limitations of Use: Eltrombopag tablets are 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 Eltrombopag tablets are indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets 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 Eltrombopag tablets are indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets 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 Eltrombopag tablets are indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. Eltrombopag tablets are indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

1.4Limitations of Use Eltrombopag tablets are 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 Take eltrombopag tablets without a meal or with a meal low in calcium (≤ 50 mg). Take eltrombopag tablets 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 eltrombopag tablets at 50 mg orally once daily for most adult and pediatric patients 6 years and older, and at 25 mg orally once daily for pediatric patients aged 1 to 5 years.

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 75 mg per day.

(2.1, 8.6, 8.7) Chronic Hepatitis C-associated Thrombocytopenia:Initiate eltrombopag tablets at 25 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 100 mg.

(2.2) First-line Severe Aplastic Anemia:Initiate eltrombopag tablets orally once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old), or 150 mg for patients aged 12 years and older concurrently with standard immunosuppressive therapy. Reduce initial dose in patients of East-/Southeast-Asian ancestry. Modify dosage for toxicity or elevated platelet counts.

(2.3, 8.7) Refractory Severe Aplastic Anemia:Initiate eltrombopag tablets orally at 50 mg 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 150 mg per day. (2.3, 8.6, 8.7)

2.1Persistent or Chronic Immune Thrombocytopenia Use the lowest dose of eltrombopag tablets 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 eltrombopag tablets to normalize platelet counts [see Warnings and Precautions (5.4)].

In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag tablets and decreased within 1 to 2 weeks after discontinuing eltrombopag tablets [see Clinical Studies (14.1)] . Initial Dose Regimen: Adult and Pediatric Patients 6 Years and Older with ITP: Initiate eltrombopag tablets at a dose of 50 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 eltrombopag tablets at a reduced dose of 25 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 eltrombopag tablets at a reduced dose of 25 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 eltrombopag tablets at a reduced dose of 12.5 mg orally once daily [see Clinical Pharmacology (12.3)] . Pediatric Patients with ITP Aged 1 to 5 Years: Initiate eltrombopag tablets at a dose of 25 mg orally once daily [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)] .

Monitoring and Dose Adjustment: After initiating eltrombopag tablets, 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 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with eltrombopag tablets and modify the dosage regimen of eltrombopag tablets based on platelet counts as outlined in Table 1.

During therapy with eltrombopag tablets, assess complete blood counts (CBCs) wit…

💊 Dosage Forms and Strengths 136 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets 12.5 mg tablets —– White to off-white, round, biconvex film-coated tablets with "I" debossed on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 12.5 mg of eltrombopag free acid. 25 mg tablets —– Orange to brown, round, biconvex film-coated tablets with "II" debossed on one side.

Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid. 50 mg tablets —– Blue, round, biconvex film-coated tablets with "III" debossed on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 50 mg of eltrombopag free acid.

75 mg tablets —– Red to brown, round, biconvex film-coated tablets with "IV" debossed on one side. Each tablet, for oral administration, contains eltrombopag olamine, equivalent to 75 mg of eltrombopag free acid.

⛔ Contraindications 3 words ▾

4 CONTRAINDICATIONS None.

⚠️ 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 tablets. Monitor platelet counts regularly. (5.4)

5.1Hepatic Decompensation in Patients With Chronic Hepatitis C In patients with chronic hepatitis C, eltrombopag tablets 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 tablets 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 tablets plus antivirals.

Discontinue eltrombopag tablets if antiviral therapy is discontinued.

5.2Hepatotoxicity Eltrombopag tablets may increase the risk of severe and potentially life-threatening hepatotoxicity [see Adverse Reactions (6.1)] . One patient (< 1%) with ITP treated with eltrombopag tablets in clinical trials experienced drug-induced liver injury. Eleven patients (1%) with chronic hepatitis C treated with eltrombopag tablets 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 eltrombopag tablets, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose [see Drug Interactions (7.5)] . Eltrombopag tablets 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 eltrombopag tablets 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 eltrombopag tablets is considered to outweigh the risk for hepatotoxicity, then consider cautiously reintroducing eltrombopag tablets and measure serum liver tests weekly during the dose adjustment phase. Hepatotoxicity may reoccur if eltrombopag tablets is reinitiated. If liver test abnormalities persist, worsen, or recur, then permanently discontinue eltrombopag tablets.

First-Line Treatment of Severe Aplastic Anemia Measure ALT, AST, and bilirubin prior to initiation of eltrombopag tablets, every other day while hospitalized for h-ATG therapy, and then every 2 weeks during treatment. During treatment, manage increases in ALT or AST levels as recommended in Table 6.

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 tablets (n = 179) or placebo (n = 177) was terminated due to lack of efficacy…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 Somerset Therapeutics, LLC at 1-800-417-9175 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following clinically significant adverse reactions associated with eltrombopag tablets 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)]

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. 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 tablets. Other serious adverse reactions included thrombotic/thromboembolic complications [see Warnings and Precautions (5.4)] .

The data described below reflect exposure of eltrombopag tablets 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 tablets was administered to 330 patients for at least 6 months and 218 patients for at least 1 year. Table 8 presents the most common adverse drug reactions (experienced by greater than or equal to 3% of patients receiving eltrombopag tablets) from the three placebo-controlled trials, with a higher incidence in eltrombopag tablets versus placebo.

Table 8. Adverse Reactions (≥ 3%) From Three Placebo-controlled Trials in Adults With Persistent or Chronic Immune Thrombocytopenia Adverse reaction Eltrombopag tablets 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 tablets and in no patients who received placebo. Among 302 patients with persistent or chronic ITP who received eltrombopag tablets in the single-arm extension trial, the adverse reactions occurred in a pattern similar to that seen in the placebo-controlled trials. Table 9 presents the most common treatment-related adverse reactions (experienced by greater than or equal to 3% of patients receiving eltrombopag tablets) from the extension trial.

Table 9. Treatment-related Adverse Reactions (≥ 3%) From Extension Trial in Adults With Persistent or Chronic Immune Thrombocytopenia Adverse reaction Eltrombopag tablets 50 mg n = 302 (%) Headache 10 ALT increased 5 AST increased 5 Cataract 5 Fatigue 5 Blood bilirubin increased 4 Nausea 4 Hyperbilirubinemia 3 Diarrhea 3 Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase. In the three controlled persistent or chronic ITP trials, serum liver test abnormalities (predominantly Grade 2 or less in severity) were reported…

🔄 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 eltrombopag tablets 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 eltrombopag tablets due to chelation [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)] .

7.2Transporters Use caution when concomitantly administering eltrombopag tablets 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 tablets, a dose reduction of rosuvastatin by 50% was recommended.

7.3Protease Inhibitors HIV Protease Inhibitors: No dose adjustment is recommended when eltrombopag tablets are 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 eltrombopag tablets are 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 eltrombopag tablets are coadministered with peginterferon alfa-2a (PEGASYS ® ) or -2b (PEGINTRON ® ).

7.5Interference with Clinical Laboratory Tests Eltrombopag 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 eltrombopag tablets. 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 tablets 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 tablets, breast…

🤰 Pregnancy ~3 min read ▾

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 ~2 min read ▾

8.4Pediatric Use The safety and efficacy of eltrombopag tablets have been established in pediatric patients 1 year and older with persistent or chronic ITP and in pediatric patients 2 years and older with IST-naïve severe aplastic anemia (in combination with h-ATG and cyclosporine). Safety and efficacy in pediatric patients below the age of 1 year with ITP have not been established. Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established.

The safety and efficacy of eltrombopag tablets in pediatric patients 1 year 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 evaluated in 168 pediatric patients 1 year and older with ITP dosed once daily [see Clinical Pharmacology (12.3)] . See Dosage and Administration (2.1) for dosing recommendations for pediatric patients 1 year and older.

The safety and efficacy of eltrombopag tablets in combination with h-ATG and cyclosporine for the first-line treatment of severe aplastic anemia in pediatric patients 2 years and older were evaluated in a single-arm, open-label trial [see Adverse Reactions (6.1), Clinical Studies (14.3)] . A total of 26 pediatric patients (ages 2 to < 17 years) were evaluated; 12 children (aged 2 to < 12 years) and 14 adolescents (aged 12 to < 17). See Dosage and Administration (2.3) for dosing recommendations for pediatric patients 2 years and older.

The safety and efficacy of eltrombopag tablets in combination with h-ATG and cyclosporine in pediatric patients younger than 2 years for the first-line treatment of severe aplastic anemia have not yet been established. In patients 2 to 16 years of age, 69% of patients experienced serious adverse events compared to 42% in patients 17 years and older. Among the 12 patients who were 2 to 11 years of age in the eltrombopag tablets D1-M6 cohort and reached the 6-month assessment or withdrew earlier, the complete response rate at Month 6 was 8% versus 46% in patients age 12 to 16 years and 50% in patients 17 years of age and older.

🧓 Geriatric Use 124 words ▾

8.5Geriatric Use Of the 106 patients in two randomized clinical trials of eltrombopag tablets, 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets 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 tablets. Cardiac Electrophysiology At doses up to 150 mg (the maximum recommended dose) daily for 5 days, eltrombopag tablets 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. Eltrombopag for oral suspension delivered 22% higher plasma AUC 0-INF than the tablet formulation. Absorption Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration.

Oral absorption of drug-related material following administration of a single 75-mg solution dose was estimated to be at least 52%. Effect of Food A standard high-fat breakfast (876 calories, 52 g fat, 71 g carbohydrate, 34 g protein, and 427 mg calcium) significantly decreased plasma eltrombopag AUC 0-INF by approximately 59% and C max by 65% and delayed T max by 1 hour. The decrease in exposure is primarily due to the high calcium content.

A meal low in calcium (≤ 50 mg calcium) did not significantly impact plasma eltrombopag exposure, regardless of calorie and fat content. The effect of administration of a single 25-mg dose of eltrombopag for oral suspension with a high-calcium, moderate-fat, moderate calorie meal on AUC 0-INF and C max in healthy adult subjects is presented in Table 14. Table 14.

Effect on Plasma Eltrombopag Pharmacokinetic Parameters After Administration of a Single 25-mg Dose of Eltrombopag for Oral Suspension with a High Calcium Meala in Healthy Adult Subjects Timing of eltrombopag for oral suspension dose Mean (90% CI) reduction in plasma eltrombopag AUC 0-INF Mean (90% CI) reduction in plasma eltrombopag C max With a high-calcium, moderate-fat, moderate-calorie meal 75% (71%, 88%) 79% (76%, 82%) 2 hours after the high-calcium, moderate-fat, moderate-calorie meal 47% (40%, 53%) 48% (40%, 54%) 2 hours before the high-calcium, moderate-fat, moderate-calorie meal 20% (9%, 29%) 14% (2%, 25%) a 372 calories, 9 g fat, and 448 mg calcium.

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,…

🧬 Mechanism of Action 39 words ▾

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1Tablets The 12.5 mg tablets are white to off-white, round, biconvex film-coated tablets with "I" debossed on one side and are available in bottles of 30: NDC 70069-837-01 The 25 mg tablets are orange to brown, round, biconvex film-coated tablets with "II" debossed on one side and are available in bottles of 30: NDC 70069-838-01 The 50 mg tablets are blue, round, biconvex film-coated tablets with "III" debossed on one side and are available in bottles of 30: NDC 70069-839-01 The 75 mg tablets are red to brown, round, biconvex film-coated tablets with "IV" debossed on one side and are available in bottles of 30: NDC 70069-840-01 Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Dispense in original bottle.

📋 Description 201 words ▾

11 DESCRIPTION Eltrombopag tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4- ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2).

It has the molecular formula C 25 H 22 N 4 O 4 • 2(C 2 H 7 NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula: Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water.

Eltrombopag tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of eltrombopag tablets are: Tablet Core: microcrystaline cellulose, mannitol, povidone, isomalt, calcium silicate, sodium starch glycolate, and magnesium stearate. Coating: 12.5 mg: hypromellose 2910, titanium dioxide, triacetin.

25 mg: hypromellose 2910, titanium dioxide, triacetin, ferric oxide yellow, ferric oxide red. 50 mg: hypromellose 2910, titanium dioxide, triacetin, FD&C Blue No. 1/brilliant blue FCF aluminum lake, FD&C Blue No.

2/indigo carmine aluminum lake, ferrosoferric oxide. 75 mg: hypromellose 2910, titanium dioxide, triacetin, ferric oxide red. molecule

💬 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 eltrombopag tablets: Risks Hepatotoxicity Therapy with eltrombopag tablets 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 eltrombopag tablets 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 Eltrombopag Tablets Discontinuation Advise patients that thrombocytopenia and risk of bleeding may reoccur upon discontinuing eltrombopag tablets, particularly if eltrombopag tablets is discontinued while the patient is on anticoagulants or antiplatelet agents.

Advise patients that during therapy with eltrombopag tablets, they should continue to avoid situations or medications that may increase the risk for bleeding. Thrombotic/Thromboembolic Complications Advise patients that too much eltrombopag tablets 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 eltrombopag tablets and be monitored for signs and symptoms of cataracts during therapy [see Warnings and Precautions (5.5)] .

Drug Interactions Advise patients to take eltrombopag tablets 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 eltrombopag tablets [see Use in Specific Populations (8.2)] . Administration of Eltrombopag Tablets For patients with persistent or chronic ITP, therapy with eltrombopag tablets are 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 eltrombopag tablets are 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 eltrombopag tablets 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)] . The brands listed are trademarks or registered trademarks of their respective owners.

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE MEDICATION GUIDE Eltrombopag (el trom′ boe pag) tablets What is the most important information I should know about eltrombopag tablets? Eltrombopag tablets can cause serious side effects, including: Liver problems: If you have chronic hepatitis C virus and take eltrombopag tablets with interferon and ribavirin treatment, eltrombopag tablets 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 eltrombopag tablets.

Eltrombopag tablets 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 eltrombopag tablets and during your treatment. Your healthcare provider may stop your treatment with eltrombopag tablets 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) right upper stomach area (abdomen) pain unusual darkening of the urine confusion unusual tiredness swelling of the stomach area (abdomen) See "What are the possible side effects of eltrombopag tablets?" for other side effects of eltrombopag tablets. What are eltrombopag tablets? Eltrombopag tablets are a prescription medicine used to treat adults and children 1 year 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.

Eltrombopag tablets are also used to treat people with: low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon. o severe aplastic anemia (SAA) in combination with other medicines to treat SAA, as the first treatment for adults and children 2 years of age and older. severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough. Eltrombopag tablets are used to try to raise platelet counts in order to lower your risk for bleeding.

Eltrombopag tablets are not used to make platelet counts normal. Eltrombopag tablets are 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 eltrombopag tablets are safe and effective when used with other antiviral medicines to treat chronic hepatitis C.

It is not known if eltrombopag tablets are safe and effective in children: younger than 1 year with ITP with low blood platelet counts due to chronic hepatitis C whose severe aplastic anemia (SAA) has not improved after previous treatments. younger than 2 years when used in combination with other medicines to treat SAA as the first treatment for SAA. Before you take eltrombopag tablets, 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-/Southeast-Asian ancestry.

You may need a lower dose of eltrombopag tablets. are pregnant or plan to become pregnant. It is not known if eltrombopag tablets will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with eltrombopag tablets. o Females who are able to become pregnant, should use effective birth control (contraception) during treatment with eltrombopag tablets and for at least 7 days after stopping treatment with eltrombopag tablets.

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 tr…

Glossary — plain-language definitions of medical terms used in this label:

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

immunosuppressive: Describes something that lowers the activity of the immune system.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

alopecia: Loss of hair from the scalp or body.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

aplastic anemia: A serious condition where the bone marrow stops making enough new blood cells.

ascites: A buildup of fluid inside the belly.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

BCRP: A protein pump that moves certain drugs out of cells, affecting how much of the drug is absorbed.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cataract: A clouding of the eye's normally clear lens that can blur or dim vision.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperbilirubinemia: A higher-than-normal level of bilirubin in the blood, which can cause yellowing of the skin or eyes.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

maximum recommended dose: The largest amount of a medicine that should be taken within a given period.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

OATP: A group of transporter proteins that carry certain drugs into cells, especially in the liver.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

P-glycoprotein: A tiny pump in cells that pushes certain medicines back out, affecting how much of a medicine is absorbed or stays in the body.

P-gp: A protein pump in cells that pushes certain drugs back out, limiting how much is absorbed or reaches tissues.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

postpartum: The period of time right after a woman gives birth.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pyrexia: A raised body temperature; a fever.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

refractory: Describing a disease that does not respond to, or improve with, treatment.

serum creatinine: A waste product measured in a blood test; higher levels can mean the kidneys are not filtering as well as normal.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

UGT: A family of enzymes that attach a sugar-like molecule to a drug, making it easier for the body to remove.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

upper respiratory tract infection: An infection of the nose, sinuses, or throat, such as the common cold.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 87564-0033-30 · Amerisyn, 87564-0035-30 · Amerisyn, →

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.

Eltrombopag olamine 50 mg Tablet, Film Coated, 30-count

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