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CAVHANZA Nilotinib 60 mg Tablet, Orally Disintegrating, 112-count — NDC 70709-0191-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CAVHANZA Nilotinib 60 mg Tablet, Orally Disintegrating, 112-count — NDC 70709-191-12 (Billing 70709-0191-12)

by Cycle Pharmaceuticals Ltd · 112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE

This is a package of 112 tablets of CAVHANZA Nilotinib 60 mg Tablet, Orally Disintegrating from Cycle Pharmaceuticals Ltd, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 70709-0191-12
🏷️ FDA NDC (as labeled) 70709-191-12 billing pads the product 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

⚠️
Other active recalls for Nilotinib (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Feb 18, 2026 — Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. (Cipla USA, Inc.) · FDA recall D-0381-2026
Class III · Feb 18, 2026 — Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. (Cipla USA, Inc.) · FDA recall D-0382-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70709-191-12
Product NDC 70709-191
11-digit billing NDC 70709019112
NCPDP billing unit EA — each (per item)
RxCUI 2747509, 2747516, 2747518, 2747520
UNII F41401512X
UPC 0370709191126
Application # NDA217379
SPL Set ID 98b197ea-bca4-427e-8737-97f70a3262bc
Established class (EPC) Kinase Inhibitor
Mechanism of action Bcr-Abl Tyrosine Kinase Inhibitors; Cytochrome P450 2C8 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 2B6 Inducers; Cytochrome P450 2C8 Inducers; UGT1A1 Inhibitors; P-Glycoprotein Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-30
Route ORAL
Dosage form TABLET, ORALLY DISINTEGRATING
Substance NILOTINIB
Quick answers
  • RxCUI (RxNorm): 2747509
Why two NDCs? The FDA registers this code as 70709-191-12 — 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 → 70709-0191-12. 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 Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) BCR-ABL tyrosine kinase inhibitors
How it works Bcr-Abl Tyrosine Kinase Inhibitors, Cytochrome P450 2D6 Inhibitors, P-Glycoprotein Inhibitors, Cytochrome P450 2C8 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

📗 Our plain-language guide HelloPharmacist
  • It treats Ph+ CML, a type of chronic myeloid leukemia. It is used in newly diagnosed patients and in those whose earlier treatment, such as imatinib, stopped working or caused prob...
  • Take it by mouth twice a day, about 12 hours apart. Tasigna and nilotinib capsules must be taken with no food 2 hours before and 1 hour after. Danziten and Cavhanza can be taken wi...
  • Not on your own. Danziten and Cavhanza do not convert milligram for milligram with other nilotinib products, and a mix-up could mean too much or too little drug. Always check with...
  • Rash, itching, headache, nausea, tiredness, and constipation or diarrhea are common. Regular blood tests will track your blood counts and liver and other labs. Call right away for...
📖 Read our full Nilotinib 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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70709-0191-12 You're viewing this Main listing 112 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE 2026-06-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cavhanza 60 mgthis 70709-0191-12 Cycle 112 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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
First FDA approval
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🛡️
2041
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 29, 2026 RLD RS ⏳ ~14.6 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 12016861 — method of use (U-4554)
US 12016861 — method of use (U-4555)
US 12016861 — method of use (U-4554)
US 12016861 — method of use (U-4555)
US 11389450 — method of use (U-4556)
US 11389450 — method of use (U-4557)
US 11389450 — method of use (U-4556)
US 11389450 — method of use (U-4557)
US 12029740 — drug product
US 12029740 — drug product
US 11559485 — drug product
US 11559485 — drug product
2026 2028 2030 2032 2034 2036 2038 2040
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 12016861 ↗ Method of use U-4554 Jan 29, 2041
US 12016861 ↗ Method of use U-4555 Jan 29, 2041
US 12016861 ↗ Method of use U-4554 Jan 29, 2041
US 12016861 ↗ Method of use U-4555 Jan 29, 2041
US 11389450 ↗ Method of use U-4556 Jan 29, 2041
US 11389450 ↗ Method of use U-4557 Jan 29, 2041
US 11389450 ↗ Method of use U-4556 Jan 29, 2041
US 11389450 ↗ Method of use U-4557 Jan 29, 2041
US 12029740 ↗ Drug product — Jan 29, 2041
US 12029740 ↗ Drug product — Jan 29, 2041
US 11559485 ↗ Drug product — Apr 30, 2041
US 11559485 ↗ Drug product — Apr 30, 2041
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Apr 2041 — an estimate, not a guaranteed launch date.
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 white
ShapeRound
Imprint15;7
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 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII A7ZHS2RJ34
    A cellulose-derived polymer made by chemically modifying plant fiber. It acts as a film-former and enteric coating to protect medicine from stomach acid and control where it dissolves in the digestive tract.
  • 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 0D957QQ54N
    A sugar alcohol derivative used as a filler and bulking agent in tablets and capsules. It helps give the medicine its solid form and may aid in moisture control.
  • 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 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

8 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

LabelerCycle Pharmaceuticals Ltd
Application holderFLEX PHARMA LLC
FDA applicationNDA217379 (NDA)
Labeler code70709
First marketedJun 2026
Product typeHuman Prescription Drug
Portfolio10 products on file
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 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: QT PROLONGATION and SUDDEN DEATHS Nilotinib prolongs the QT interval. Prior to CAVHANZA administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies [see Warnings and Precautions ( 5.3 )] . Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments [see Warnings and Precautions ( 5.3 , 5.4 , 5.8 , 5.12 )] .

Sudden deaths have been reported in patients receiving nilotinib [see Warnings and Precautions ( 5.4 )] . Do not administer CAVHANZA to patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Contraindications ( 4 ), Warnings and Precautions ( 5.3 )] . Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors [see Drug Interactions ( 7.1 , 7.2 )] .

WARNING: QT PROLONGATION and SUDDEN DEATHS See full prescribing information for complete boxed warning. Nilotinib prolongs the QT interval. Prior to CAVHANZA administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies.

( 5.3 ) Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments. ( 5.3 , 5.4 , 5.8 , 5.12 ) Sudden deaths have been reported in patients receiving nilotinib. ( 5.4 ) Do not administer CAVHANZA to patients with hypokalemia, hypomagnesemia, or long QT syndrome.

( 4 , 5.3 ) Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors. ( 7.1 , 7.2 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE CAVHANZA is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. ( 1.2 )

1.1Adult Patients with Newly Diagnosed Ph+ CML-CP CAVHANZA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

1.2Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP CAVHANZA is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information

1.1Adult Patients with Newly Diagnosed Ph+ CML-CP CAVHANZA is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

1.2Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP CAVHANZA is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION To avoid medication errors and overdosage or underdosage, note that CAVHANZA may have different strengths and dosages than other nilotinib products and may not be substitutable with other nilotinib products on a milligram per milligram basis. ( 2.1 ) Recommended Adult Dose: Newly diagnosed Ph+ CML-CP: 120 mg orally twice daily. Resistant or intolerant Ph+ CML-CP and CML-AP: 160 mg orally twice daily.

( 2.2 ) See Dosage and Administration for full administration instructions, dosing instructions, and dose-reduction instructions for toxicity. ( 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 ) Reduce starting dose in patients with baseline hepatic impairment. ( 2.8 ) Eligible newly diagnosed adult patients with Ph+ CML-CP who have received CAVHANZA for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) and patients with Ph+ CML-CP resistant or intolerant to imatinib who have received CAVHANZA for at least 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation.

( 2.3 , 2.4 , 5.16 )

2.1Important Use and Administration Instructions Nilotinib is available in different formulations, dosage forms, and strengths that are approved with different indications and recommended dosages. CAVHANZA may not be substitutable with other nilotinib products, including other nilotinib tablets, on a milligram per milligram basis; to avoid medication errors, including overdosage or underdosage, when using CAVHANZA ensure that the recommended dosage of CAVHANZA (not the recommended dosage of other nilotinib products) is prescribed [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )].

When switching between CAVHANZA (nilotinib) orally disintegrating tablets and Tasigna (nilotinib) capsules, use the dosage conversion table [see Dosage and Administration ( 2.2 )].

2.2Recommended Dosage and Administration Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP The recommended dosage of CAVHANZA is 120 mg orally twice daily at approximately 12-hour intervals with or without food [see Clinical Pharmacology ( 12.3 )]. Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP The recommended dosage of CAVHANZA is 160 mg orally twice daily at approximately 12-hour intervals with or without food [see Clinical Pharmacology ( 12.3 )]. Additional Administration Instructions Use dry hands when opening the bottle and handling tablets.

Place the tablet(s) on top of the tongue and allow to disintegrate, then swallow with saliva. Administration with liquid is not necessary. CAVHANZA may also be chewed prior to swallowing with saliva or swallowed intact with water.

CAVHANZA should not be crushed prior to administration. If a dose of CAVHANZA is missed, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time.

Switching Instructions Use Table 1 when switching between CAVHANZA and Tasigna based on dosage equivalence. Table 1: Recommendations for Switching Between CAVHANZA and Tasigna Approved Indications CAVHANZA dosage Tasigna dosage Newly diagnosed Ph+ CML-CP 120 mg orally twice daily 300 mg orally twice daily Resistant or intolerant Ph+ CML-CP and CML-AP 160 mg orally twice daily 400 mg orally twice daily Optional Concomitant Therapy CAVHANZA may be given in combination with hematopoietic growth factors, such as erythropoietin or G-CSF if clinically indicated.

CAVHANZA may be given with hydroxyurea or anagrelide if clinically indicated. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s Tasigna (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, the drug product is not labeled with that pediatric information.

2.3Discontinuation of Treatment After a Sustained Molecular Response (MR4.5) on CAVHANZA Patient Selection Eligibility for Discontinuation of Treatment Ph+ CML-CP… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 49 words ▾

3 DOSAGE FORMS AND STRENGTHS Orally disintegrating tablets: 60 mg strength: white to tan, round, debossed on one side with “15” over “5” 80 mg strength: white to tan, round, debossed on one side with “15” over “7” Orally disintegrating tablets: 60 mg and 80 mg ( 3 )

⛔ Contraindications 40 words ▾

4 CONTRAINDICATIONS CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning and Warnings and Precautions ( 5.3 )] . CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Substitution with Other Nilotinib Products and Risk of Medication Errors: CAVHANZA (nilotinib) orally disintegrating tablets may not be substitutable with other nilotinib products, including other nilotinib tablets, on a milligram per milligram basis. Confirm that the intended nilotinib product is being prescribed and dispensed. ( 5.1 ) Myelosuppression: Monitor complete blood count (CBC) during therapy and manage by treatment interruption or dose reduction.

( 5.2 ) Cardiac and Arterial Vascular Occlusive Events: Evaluate cardiovascular status, monitor and manage cardiovascular risk factors during CAVHANZA therapy. ( 5.5 ) Pancreatitis and Elevated Serum Lipase: Monitor serum lipase; if elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis. ( 5.6 ) Hepatotoxicity: Monitor hepatic function tests monthly or as clinically indicated.

( 5.7 ) Electrolyte Abnormalities: CAVHANZA can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating CAVHANZA and monitor periodically during therapy. ( 5.8 ) Tumor Lysis Syndrome: Maintain adequate hydration and correct uric acid levels prior to initiating therapy with CAVHANZA.

( 5.9 ) Hemorrhage: Hemorrhage from any site may occur. Advise patients to report signs and symptoms of bleeding and medically manage as needed. ( 5.10 ) Fluid Retention: Monitor patients for unexpected rapid weight gain, swelling, and shortness of breath.

Manage medically. ( 5.13 ) Effects on Growth and Development in Pediatric Patients: Growth retardation has been reported in pediatric patients treated with nilotinib. Monitor growth and development in pediatric patients.

( 5.14 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. ( 5.15 , 8.1 , 8.3 ) Treatment Discontinuation: Patients must have typical BCR-ABL transcripts.

An FDA-authorized test with a detection limit below MR4.5 must be used to determine eligibility for discontinuation. Patients must be frequently monitored by the FDA authorized test to detect possible loss of remission. ( 5.16 )

5.1Substitution with Other Nilotinib Products and Risk of Medication Errors Nilotinib is available in different formulations, recommended dosages, and strengths, and for different indications. CAVHANZA (nilotinib) orally disintegrating tablets may not be substitutable with other nilotinib products, including other nilotinib tablets, on a milligram per milligram basis . When switching patients between other nilotinib products and CAVHANZA (nilotinib) orally disintegrating tablets, a dose conversion is required [see Dosage and Administration ( 2.1 and 2.2 )] .

Substitution of CAVHANZA (nilotinib) orally disintegrating tablets for another nilotinib product to achieve the same daily nilotinib dosage on a milligram per milligram basis may result in a clinically significant: Increase in nilotinib exposure which may increase the risk of nilotinib-associated adverse reactions. Decrease in nilotinib exposure which may reduce CAVHANZA effectiveness. Confirm that the intended nilotinib product is being prescribed and dispensed.

5.2Myelosuppression Treatment with CAVHANZA can cause Grade 3/4 thrombocytopenia, neutropenia, and anemia. Perform CBCs every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible and usually managed by withholding CAVHANZA temporarily or dose reduction [see Dosage and Administration ( 2.6 )] .

5.3QT Prolongation Nilotinib has been shown to prolong cardiac ventricular repolarization as measured by the QT interval on the surface electrocardiogram (ECG) in a concentration-dependent manner [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.2 )] . Prolongation of the QT interval can result in a type of vent… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions can occur with CAVHANZA and are discussed in greater detail in other sections of labeling: Myelosuppression [see Warnings and Precautions ( 5.2 )] QT Prolongation [see Boxed Warning , Warnings and Precautions ( 5.3 )] Sudden Deaths [see Boxed Warning , Warnings and Precautions ( 5.4 )] Cardiac and Arterial Vascular Occlusive Events [see Warnings and Precautions ( 5.5 )] Pancreatitis and Elevated Serum Lipase [see Warnings and Precautions ( 5.6 )] Hepatotoxicity [see Warnings and Precautions ( 5.7 )] Electrolyte Abnormalities [see Boxed Warning , Warnings and Precautions ( 5.8 )] Hemorrhage [see Warnings and Precautions ( 5.10 )] Fluid Retention [see Warnings and Precautions ( 5.13 )] The most commonly reported non-hematologic adverse reactions (≥ 20%) in patients were nausea, rash, headache, fatigue, pruritus, vomiting, diarrhea, cough, constipation, arthralgia, nasopharyngitis, pyrexia, and night sweats.

Hematologic adverse drug reactions include myelosuppression: thrombocytopenia, neutropenia, and anemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-800-841-0898 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CAVHANZA (nilotinib) orally disintegrating tablets has been established from adequate and well-controlled studies of Tasigna ® (nilotinib) capsules, which has different recommended dosages than CAVHANZA, in adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) and adult patients with CP and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib [see Clinical Studies ( 14 )] .

Below is a display of the adverse reactions of Tasigna ® (nilotinib) capsules in these adequate and well-controlled studies. In Adult Patients with Newly Diagnosed Ph+ CML-CP The data below reflect exposure to nilotinib from a randomized trial in patients with newly diagnosed Ph+ CML in chronic phase treated at the equivalent recommended dosage of 120 mg of CAVHANZA twice daily (n = 279). The median time on treatment at the equivalent recommended dosage of 120 mg of CAVHANZA twice daily group was 61 months (range, 0.1 to 71 months).

The most common (greater than 10%) non-hematologic adverse drug reactions were rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, and upper abdominal pain. Constipation, diarrhea, dry skin, muscle spasms, arthralgia, abdominal pain, peripheral edema, vomiting, and asthenia were observed less commonly (less than or equal to 10% and greater than 5%). Increase in QTcF greater than 60 msec from baseline was observed in 1 patient (0.4%) at the equivalent recommended dosage of 120 mg of CAVHANZA twice daily treatment group.

No patient had an absolute QTcF of greater than 500 msec while on study drug. The most common hematologic adverse drug reactions (all Grades) were myelosuppression, including: thrombocytopenia (18%), neutropenia (15%), and anemia (8%). See Table 10 for Grade 3/4 laboratory abnormalities.

Discontinuation due to adverse reactions, regardless of relationship to study drug, was observed in 10% of patients. In Adult Patients With Resistant or Intolerant Ph+ CML-CP and CML-AP In the single-arm, open-label multicenter clinical trial, a total of 458 patients with Ph+ CML-CP and CML-AP resistant to or intolerant to at least one prior therapy, including imatinib were treated (CML-CP = 321; CML-AP = 137) at the equivalent recommended dosage of 160 mg of CAVHANZA twice daily. The median duration of exposure in days for CML-CP and CML-AP patients is 561 (range, 1 to 1096) and… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 217 words ▾

7 DRUG INTERACTIONS Strong CYP3A Inhibitors: Avoid concomitant use with CAVHANZA or reduce CAVHANZA dose if concomitant use cannot be avoided. ( 7.1 ) Strong CYP3A Inducers: Avoid concomitant use with CAVHANZA. ( 7.1 )

7.1Effect of Other Drugs on CAVHANZA Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with CAVHANZA. If concomitant use cannot be avoided, reduce CAVHANZA dose [see Dosage and Administration ( 2.9 )] . Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )].

Concomitant use with a strong CYP3A inhibitor increases nilotinib exposure [see Clinical Pharmacology ( 12.3 )], which may increase the risk of CAVHANZA adverse reactions. Strong CYP3A Inducers Avoid concomitant use of strong CYP3A inducers with CAVHANZA. Nilotinib is a CYP3A substrate [see Clinical Pharmacology ( 12.3 )].

Concomitant use with a strong CYP3A inducer decreases nilotinib exposure [see Clinical Pharmacology ( 12.3 )] which may reduce CAVHANZA efficacy.

7.2Drugs That Prolong the QT Interval Avoid coadministration of CAVHANZA with agents that may prolong the QT interval, such as anti-arrhythmic drugs [see Boxed Warning , Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.3 ), Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.2 )] . Nilotinib is associated with a clinically significant concentration-dependent QT prolongation [see Clinical Pharmacology ( 12.2 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation : Advise women not to breastfeed. ( 8.2 ) Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

8.1Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, CAVHANZA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of nilotinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal lethality, fetal effects, and fetal variations in rats and rabbits at maternal exposures (AUC) approximately 2 and 0.5 times, respectively, the exposures in patients at the recommended dose (see Data).

Advise pregnant women of the potential risk to a fetus. The 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 miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of nilotinib up to 100 mg/kg/day and 300 mg/kg/day, respectively, during the period of organogenesis. In rats, oral administration of nilotinib produced embryo-lethality/fetal effects at doses ≥ 30 mg/kg/day.

At ≥ 30 mg/kg/day, skeletal variations of incomplete ossification of the frontals and misshapen sternebra were noted, and there was an increased incidence of small renal papilla and fetal edema. At 100 mg/kg/day, nilotinib was associated with maternal toxicity (decreased gestation weight, gravid uterine weight, net weight gain, and food consumption) and resulted in a single incidence of cleft palate and two incidences of pale skin were noted in the fetuses. A single incidence of dilated ureters was noted in a fetus also displaying small renal papilla at 100 mg/kg/day.

Additional variations of forepaw and hindpaw phalanx unossified, fused sternebra, bipartite sternebra ossification, and incomplete ossification of the cervical vertebra were noted at 100 mg/kg/day. In rabbits, oral administration of nilotinib resulted in the early sacrifice of two females, maternal toxicity and increased resorption of fetuses at 300 mg/kg/day. Fetal skeletal variations (incomplete ossification of the hyoid, bent hyoid, supernumerary short detached ribs and the presence of additional ossification sites near the nasals, frontals and in the sternebral column) were also increased at this dose in the presence of maternal toxicity.

Slight maternal toxicity was evident at 100 mg/kg/day but there were no reproductive or embryo-fetal effects at this dose. At 30 mg/kg/day in rats and 300 mg/kg/day in rabbits, the maternal systemic exposure (AUC) were 72700 ng*hr/mL and 17100 ng*hr/mL respectively, representing approximately 2 and 0.5 times the exposure in humans at the highest recommended dose 400 mg twice daily (equivalent to 160 mg twice daily of CAVHANZA). When pregnant rats were dosed with nilotinib during organogenesis and through lactation, the adverse effects included a longer gestational period, lower pup body weights until weaning and decreased fertility indices in the pups when they reached maturity, all at a maternal dose of 60 mg/kg (i.e., 360 mg/m 2 , approximately 0.7 times the clinical dose of 400 mg [equivalent to 160 mg of CAVHANZA] twice daily based on body surface area).

At doses up to 20 mg/kg (i.e., 120 mg/m 2 , approximately 0.25 times the clinical dose of 400 mg twice daily based on body surface area) no adverse eff… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and the mechanism of action, CAVHANZA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of nilotinib to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes, including embryo-fetal lethality, fetal effects, and fetal variations in rats and rabbits at maternal exposures (AUC) approximately 2 and 0.5 times, respectively, the exposures in patients at the recommended dose (see Data).

Advise pregnant women of the potential risk to a fetus. The 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 miscarriage in clinically recognized pregnancies are 2%-4% and 15%-20%, respectively. Data Animal Data In embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of nilotinib up to 100 mg/kg/day and 300 mg/kg/day, respectively, during the period of organogenesis. In rats, oral administration of nilotinib produced embryo-lethality/fetal effects at doses ≥ 30 mg/kg/day.

At ≥ 30 mg/kg/day, skeletal variations of incomplete ossification of the frontals and misshapen sternebra were noted, and there was an increased incidence of small renal papilla and fetal edema. At 100 mg/kg/day, nilotinib was associated with maternal toxicity (decreased gestation weight, gravid uterine weight, net weight gain, and food consumption) and resulted in a single incidence of cleft palate and two incidences of pale skin were noted in the fetuses. A single incidence of dilated ureters was noted in a fetus also displaying small renal papilla at 100 mg/kg/day.

Additional variations of forepaw and hindpaw phalanx unossified, fused sternebra, bipartite sternebra ossification, and incomplete ossification of the cervical vertebra were noted at 100 mg/kg/day. In rabbits, oral administration of nilotinib resulted in the early sacrifice of two females, maternal toxicity and increased resorption of fetuses at 300 mg/kg/day. Fetal skeletal variations (incomplete ossification of the hyoid, bent hyoid, supernumerary short detached ribs and the presence of additional ossification sites near the nasals, frontals and in the sternebral column) were also increased at this dose in the presence of maternal toxicity.

Slight maternal toxicity was evident at 100 mg/kg/day but there were no reproductive or embryo-fetal effects at this dose. At 30 mg/kg/day in rats and 300 mg/kg/day in rabbits, the maternal systemic exposure (AUC) were 72700 ng*hr/mL and 17100 ng*hr/mL respectively, representing approximately 2 and 0.5 times the exposure in humans at the highest recommended dose 400 mg twice daily (equivalent to 160 mg twice daily of CAVHANZA). When pregnant rats were dosed with nilotinib during organogenesis and through lactation, the adverse effects included a longer gestational period, lower pup body weights until weaning and decreased fertility indices in the pups when they reached maturity, all at a maternal dose of 60 mg/kg (i.e., 360 mg/m 2 , approximately 0.7 times the clinical dose of 400 mg [equivalent to 160 mg of CAVHANZA] twice daily based on body surface area).

At doses up to 20 mg/kg (i.e., 120 mg/m 2 , approximately 0.25 times the clinical dose of 400 mg twice daily based on body surface area) no adverse effects were seen in the maternal animals or the pups.

🧒 Pediatric Use 131 words ▾

8.4Pediatric Use CAVHANZA is not approved for use in pediatric patients. Laboratory abnormalities of hyperbilirubinemia and transaminase elevation were reported at a higher frequency in pediatric patients than in adults [see Adverse Reactions ( 6.1 )]. For pediatric growth and development, growth retardation has been reported in pediatric patients treated with nilotinib [see Warnings and Precautions ( 5.14 ), Adverse Reactions ( 6.1 )].

The safety and effectiveness of nilotinib in pediatric patients below the age of 1 year with newly diagnosed, or resistant or intolerant Ph+ CML in chronic phase and accelerated phase, have not been established. Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

🧓 Geriatric Use 153 words ▾

8.5Geriatric Use In the clinical trials of nilotinib (patients with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP), approximately 12% and 30% of patients were 65 years or over respectively. Patients with newly diagnosed Ph+ CML-CP: There was no difference in major molecular response between patients aged less than 65 years and those greater than or equal to 65 years. Patients with resistant or intolerant CML-CP: There was no difference in major cytogenetic response rate between patients aged less than 65 years and those greater than or equal to 65 years.

Patients with resistant or intolerant CML-AP: The hematologic response rate was 44% in patients less than 65 years of age and 29% in patients greater than or equal to 65 years. No major differences for safety were observed in patients greater than or equal to 65 years of age as compared to patients less than 65 years.

🆘 Overdosage 42 words ▾

10 OVERDOSAGE Overdose with nilotinib has been reported, where an unspecified number of nilotinib were ingested in combination with alcohol and other drugs. Events included neutropenia, vomiting, and drowsiness. In the event of overdose, observe the patient and provide appropriate supportive treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML.

Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

12.2Pharmacodynamics A relationship between nilotinib exposure and a greater likelihood of response and safety events, including a higher occurrence of total bilirubin elevations, was observed in clinical studies. Nilotinib time course of pharmacodynamic response is unknown. Cardiac Electrophysiology Nilotinib is associated with concentration-dependent QT prolongation.

At the equivalent recommended dosage of 160 mg CAVHANZA twice daily given without food in healthy subjects, the maximum mean placebo-adjusted QTcF changes were 10.4 msec (90% CI: 2.85, 18.0). Peak plasma concentrations in a QT study were 26% lower than or comparable with those observed in patients enrolled in a single-arm study [see Boxed Warning , Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] .

12.3Pharmacokinetics Nilotinib single-dose maximum concentration (Cmax) and area under the time concentration curve (AUC) in fasted subjects receiving the CAVHANZA approved recommended dosages are presented in Table 11. Table 11: Nilotinib mean ±SD single-dose exposure in fasted subjects receiving the CAVHANZA approved recommended dosages CAVHANZA Dosage Cmax AUC 120 mg 848 ± 315 ng/mL 13240 ± 6030 ng*hr/mL 160 mg 1042 ± 383 ng/mL 15460 ± 6020 ng*hr/mL Abbreviations: Cmax= maximum concentration; AUC = area under the time concentration curve Absorption There were no differences in the rate and extent of nilotinib systemic exposures when the orally disintegrating tablet was swallowed intact relative to allowing the tablet to orally disintegrate prior to swallowing.

The median time (range) to reach maximal plasma concentration (T max ) of nilotinib is 2 hours (1-8 hours) in the fasted state after oral administration. Median steady-state trough concentration of nilotinib was decreased by 53% in patients with total gastrectomy compared to patients who had not undergone surgeries [see Warnings and Precautions ( 5.10 )] . Effect of Food The AUC and Cmax increased by no more than 14% and 13%, respectively, when administered with a high-fat (50% fat), moderate-fat (37% fat), or low-fat (25% fat) meal relative to the fasted state.

Distribution The blood-to-serum ratio of nilotinib is 0.68. Serum protein binding is approximately 98%. Elimination The geometric mean (coefficient of variation) apparent first-order terminal elimination half-life was 13.6 h (36.4%) for a single 160 mg dose of CAVHANZA.

The geometric mean (coefficient of variation) clearance was

10.9L/h (44.8%) for a single 160 mg dose (fasted) of CAVHANZA. Metabolism Nilotinib is primarily metabolized via CYP3A4-mediated oxidation and to a minor extent by CYP2C8. Nilotinib is the main circulating component in the serum.

None of the metabolites contribute significantly to the pharmacological activity of nilotinib. Excretion After a single dose of radiolabeled nilotinib, more than 90% of the administered dose was eliminated within 7 days: 93% of the dose in feces. Parent drug accounted for 69% of the dose.

Specific Populations No clinically meaningful differences in the pharmacokinetic of nilotinib were observed based on age, sex, race/ethnicity, or body weight. The effect of renal impairment on nilotinib pharmacokinetics is unknown. Patients with Hepatic Impairment Following a single dose of nilotinib capsules 200 m… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 107 words ▾

12.1Mechanism of Action Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML.

Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

📦 How Supplied / Storage and Handling 123 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied CAVHANZA (nilotinib) orally disintegrating tablets are available in bottles containing desiccant with a child-resistant closure as described in Table 16. Table 16: CAVHANZA Trade Presentations NDC Number Strength Description Tablets per Bottle 70709-191-12 60 mg white to tan tablets debossed on one side with “15” over “5” 112 70709-192-12 80 mg white to tan tablets debossed on one side with “15” over “7” 112 Storage and Handling CAVHANZA (nilotinib) orally disintegrating tablets should be stored at 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].

Store and dispense to patient in original container only. Replace cap securely each time after opening. Do not discard desiccants.

📋 Description 93 words ▾

11 DESCRIPTION CAVHANZA orally disintegrating tablets contain nilotinib, a kinase inhibitor. The chemical name of nilotinib is 4-methyl-N-[3-(4-methyl-1H-imidazol-1- yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide. The molecular formula is C28H22F3N7O and molecular weight is 529.5 g/mol.

The solubility of nilotinib in aqueous solutions decreases with increasing pH. The pKa1 was determined to be 2.6; pKa2 was determined to be 4.2. Nilotinib has the following structure: CAVHANZA (nilotinib) orally disintegrating tablets, contain 60 mg or 80 mg nilotinib with the following inactive ingredients: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose acetate succinate, magnesium stearate, mannitol, microcrystalline cellulose, and starch. structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Taking CAVHANZA Advise patients that CAVHANZA may not be substitutable, on a milligram per milligram basis, with other nilotinib products. Advise patients to take CAVHANZA exactly as prescribed [see Warnings and Precautions ( 5.1 )].

Advise patients to take CAVHANZA doses twice daily approximately 12 hours apart. CAVHANZA may be orally disintegrated and swallowed with saliva, chewed and swallowed with saliva, or swallowed intact with water. CAVHANZA may be taken with or without food.

Patients should not consume grapefruit products and other foods that are known to inhibit CYP3A4 at any time during CAVHANZA treatment [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 )]. If the patient misses a dose of CAVHANZA, the patient should take the next scheduled dose at its regular time. The patient should not take two doses at the same time.

Compliance Advise patients of the following: Continue taking CAVHANZA every day for as long as their doctor tells them. This is a long-term treatment. Do not change dose or stop taking CAVHANZA without first consulting their doctor.

Myelosuppression Advise patients that treatment with nilotinib can cause serious thrombocytopenia, neutropenia, and anemia. Advise patients to seek immediate medical attention if symptoms suggestive of low blood counts occur, such as fever, chills or other signs of infection, unexplained bleeding or bruising, or unexplained weakness or shortness of breath [see Warnings and Precautions ( 5.2 )] . QT Prolongation Advise patients that nilotinib can cause possibly life-threatening, abnormal heartbeat.

Advise patients to seek immediate medical attention if symptoms of abnormal heartbeat occur, such as feeling light-headed, faint or experiencing an irregular heartbeat [see Warnings and Precautions ( 5.3 )] . Cardiac and Arterial Vascular Occlusive Events Advise patients that cardiovascular events (including ischemic heart disease, peripheral arterial occlusive disease, and ischemic cerebrovascular events) have been reported. Advise patients to seek immediate medical attention if any symptoms suggestive of a cardiovascular event occur, such as chest or leg pain, numbness or weakness, or problems walking or speaking occur suddenly [see Warnings and Precautions ( 5.5 )] .

Pancreatitis and Elevated Serum Lipase Advise patients that nilotinib can increase the risk of pancreatitis and that patients with a previous history of pancreatitis may be at greater risk. Advise patients to seek immediate medical attention if symptoms suggestive of pancreatitis occur, such as sudden stomach area pain with accompanying nausea and vomiting [see Warnings and Precautions ( 5.6 )] . Hepatotoxicity Advise patients that nilotinib can increase the risk of hepatotoxicity and that patients with previous history of liver diseases may be at risk.

Advise patients to seek immediate medical attention if any symptoms suggestive of hepatotoxicity occur, such as stomach pain, yellow skin and eyes, and dark-colored urine [see Warnings and Precautions ( 5.7 )]. Tumor Lysis Syndrome Advise patients that nilotinib can cause TLS and to seek immediate medical attention if any symptoms suggestive of TLS occur, such as an abnormal heartbeat or less urine production [see Warnings and Precautions ( 5.9 )] . Hemorrhage Advise patients that serious hemorrhagic events, including fatal events, have occurred in patients with CML treated with nilotinib.

Advise patients to seek immediate medical attention if symptoms suggestive of hemorrhage occur, such as uncontrolled bleeding, changes in eyesight, unconsciousness, or sudden headache or sudden confusion in surroundings [see Warnings and Precautions ( 5.10 )] . Fluid Retention Inform patients that nilotinib can cause fluid retention and advise them to seek immediate medical attention if any symptoms suggestive of fluid retention, such as shortness of… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: Jun 2026 MEDICATION GUIDE CAVHANZA (CAV-HAN-ZA) (nilotinib) orally disintegrating tablets, for oral use What is the most important information I should know about CAVHANZA?

CAVHANZA can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Your healthcare provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG): • before starting CAVHANZA • 7 days after starting CAVHANZA • with any dose changes • regularly during CAVHANZA treatment You may lower your chances for having QTc prolongation with CAVHANZA if you: Do not drink grapefruit juice, eat grapefruit, or take any supplements containing grapefruit extract during treatment with CAVHANZA.

Grapefruit products increase the amount of nilotinib in your body. Avoid taking other medicines or supplements with nilotinib that can also cause QTc prolongation. Nilotinib can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects.

Do not take any other medicine during treatment with CAVHANZA unless your healthcare provider tells you it is okay to do so. For more information, see “How should I take CAVHANZA?” Tell your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with CAVHANZA. These can be symptoms of QTc prolongation.

See “What are the possible side effects of CAVHANZA?” for more information about side effects. What is CAVHANZA? CAVHANZA is a prescription medicine used to treat: adults who have been newly diagnosed with a certain type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. adults with chronic phase Ph+ CML or accelerated phase Ph+ CML who: are no longer benefiting from other treatments, including imatinib (Gleevec), or have taken other treatments, including imatinib (Gleevec), and cannot tolerate them.

It is not known if nilotinib is safe and effective in children younger than 1 year of age with newly diagnosed, resistant, or intolerant Ph+ CML in chronic phase and accelerated phase. The long-term effects of treating children with nilotinib for a long period of time are not known. Who should not take CAVHANZA?

Do not take if you have: low levels of potassium or magnesium in your blood long QTc syndrome Before taking CAVHANZA, tell your healthcare provider about all of your medical conditions, including if you: have heart problems have had a stroke or other problems due to decreased blood flow to the brain have problems with decreased blood flow to your legs have irregular heartbeat have QTc prolongation or a family history of it have had pancreatitis have liver problems have low blood levels of potassium or magnesium in your blood have bleeding problems had a surgical procedure involving the removal of the entire stomach (total gastrectomy) are pregnant or plan to become pregnant.

CAVHANZA can harm your unborn baby. Tell your healthcare provider right away if you are pregnant, or if you become pregnant during treatment with CAVHANZA. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with CAVHANZA.

Use effective birth control (contraception) during treatment with CAVHANZA and for 14 days after the last dose. are breastfeeding or plan to breastfeed. It is not known if nilotinib passes into your breast milk. Do not breastfeed during treatment and for 14 days after your last dose of CAVHANZA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. CAVHANZA can interact with many medicines and supplements and increase your chance for serious and life-threatening side effects. See “What is the most important i… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Nilotinib single-dose maximum concentration (Cmax) and area under the time concentration curve (AUC) in fasted subjects receiving the CAVHANZA approved recommended dosages are presented in Table 11. Table 11: Nilotinib mean ±SD single-dose exposure in fasted subjects receiving the CAVHANZA approved recommended dosages CAVHANZA Dosage Cmax AUC 120 mg 848 ± 315 ng/mL 13240 ± 6030 ng*hr/mL 160 mg 1042 ± 383 ng/mL 15460 ± 6020 ng*hr/mL Abbreviations: Cmax= maximum concentration; AUC = area under the time concentration curve Absorption There were no differences in the rate and extent of nilotinib systemic exposures when the orally disintegrating tablet was swallowed intact relative to allowing the tablet to orally disintegrate prior to swallowing.

The median time (range) to reach maximal plasma concentration (T max ) of nilotinib is 2 hours (1-8 hours) in the fasted state after oral administration. Median steady-state trough concentration of nilotinib was decreased by 53% in patients with total gastrectomy compared to patients who had not undergone surgeries [see Warnings and Precautions ( 5.10 )] . Effect of Food The AUC and Cmax increased by no more than 14% and 13%, respectively, when administered with a high-fat (50% fat), moderate-fat (37% fat), or low-fat (25% fat) meal relative to the fasted state.

Distribution The blood-to-serum ratio of nilotinib is 0.68. Serum protein binding is approximately 98%. Elimination The geometric mean (coefficient of variation) apparent first-order terminal elimination half-life was 13.6 h (36.4%) for a single 160 mg dose of CAVHANZA.

The geometric mean (coefficient of variation) clearance was

10.9L/h (44.8%) for a single 160 mg dose (fasted) of CAVHANZA. Metabolism Nilotinib is primarily metabolized via CYP3A4-mediated oxidation and to a minor extent by CYP2C8. Nilotinib is the main circulating component in the serum.

None of the metabolites contribute significantly to the pharmacological activity of nilotinib. Excretion After a single dose of radiolabeled nilotinib, more than 90% of the administered dose was eliminated within 7 days: 93% of the dose in feces. Parent drug accounted for 69% of the dose.

Specific Populations No clinically meaningful differences in the pharmacokinetic of nilotinib were observed based on age, sex, race/ethnicity, or body weight. The effect of renal impairment on nilotinib pharmacokinetics is unknown. Patients with Hepatic Impairment Following a single dose of nilotinib capsules 200 mg (0.5 times the maximum approved recommended dosage and equivalent to 80 mg of CAVHANZA), the mean AUC of nilotinib increased 1.4-fold, 1.4-fold, and 1.6-fold in subjects with mild (Child-Pugh class A), moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, compared to subjects with normal hepatic function.

Drug Interaction Studies Clinical Studies Gastric Acid Reducing Agents : Following concomitant use of multiple doses of esomeprazole (PPI) 40 mg daily, the total systemic exposure (AUC) of CAVHANZA decreased by approximately 0.5%. CAVHANZA can be coadministered with proton pump inhibitors, H2 antagonists, and antacids. Strong CYP3A Inhibitors: Nilotinib AUC increased by approximately 3-fold following concomitant administration of ketoconazole (strong CYP3A inhibitor) 400 mg once daily for 6 days.

Nilotinib AUC increased by 1.3-fold with concomitant use with double-strength grapefruit juice. Strong CYP3A Inducers: Nilotinib AUC decreased by approximately 80% following concomitant use with rifampicin (strong CYP3A inducer) 600 mg daily. Moderate CYP3A Inhibitors: Following coadministration of nilotinib 400 mg twice daily with imatinib (a moderate CYP3A inhibitor) 400 mg daily or 400 mg twice daily, the AUC increased 30% to 50% for nilotinib and approximately 20% for imatinib.

CYP3A4 Substrates: Multiple doses of nilotinib capsules increased the systemic exposure of oral midazolam (a substrate of CYP3A4) 2.6-fold. CYP2C9 S… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 115 words ▾

12.2Pharmacodynamics A relationship between nilotinib exposure and a greater likelihood of response and safety events, including a higher occurrence of total bilirubin elevations, was observed in clinical studies. Nilotinib time course of pharmacodynamic response is unknown. Cardiac Electrophysiology Nilotinib is associated with concentration-dependent QT prolongation.

At the equivalent recommended dosage of 160 mg CAVHANZA twice daily given without food in healthy subjects, the maximum mean placebo-adjusted QTcF changes were 10.4 msec (90% CI: 2.85, 18.0). Peak plasma concentrations in a QT study were 26% lower than or comparable with those observed in patients enrolled in a single-arm study [see Boxed Warning , Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] .

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adult Newly Diagnosed Ph+ CML-CP The effectiveness of 120 mg twice daily of CAVHANZA (nilotinib) orally disintegrating tablets for the treatment of adult patients with newly diagnosed Ph+ CML-CP has been established from an adequate and well-controlled study of Tasigna ® (nilotinib) capsules, which has a different recommended dosage than CAVHANZA. Below is a display of the results of Tasigna ® (nilotinib) capsules in this adequate and well-controlled study. The ENESTnd (Evaluating Nilotinib Efficacy and Safety in clinical Trials-Newly Diagnosed patients) study ( NCT00471497 ) was an open-label, multicenter, randomized trial conducted to determine the efficacy of nilotinib versus imatinib tablets in adult patients with cytogenetically confirmed newly diagnosed Ph+ CML-CP.

Patients were within 6 months of diagnosis and were previously untreated for CML-CP, except for hydroxyurea and/or anagrelide. Efficacy was based on a total of 846 patients: 283 patients in the imatinib 400 mg once daily group, 282 patients in the nilotinib dosage equivalent to 120 mg of CAVHANZA twice daily group, 281 patients in the nilotinib dosage equivalent to 160 mg of CAVHANZA twice daily group. Median age was 46 years in the imatinib group and 47 years in the nilotinib group, with 12% and 13% of patients greater than or equal to 65 years of age in imatinib 400 mg once daily, nilotinib dosage equivalent to 120 mg of CAVHANZA twice daily and nilotinib dosage equivalent to 160 mg of CAVHANZA twice daily treatment groups, respectively.

There were slightly more male than female patients in all groups (56% and 56%, in imatinib 400 mg once daily, nilotinib dosage equivalent to 120 mg and 160 mg CAVHANZA twice daily treatment groups, respectively). Approximately 60% of all patients were White, and 25% were Asian. The primary data analysis was performed when all 846 patients completed 12 months of treatment (or discontinued earlier).

Subsequent analyses were done when patients completed 24, 36, 48, and 60 months of treatment (or discontinued earlier). The median time on treatment was approximately 61 months in all three treatment groups. The primary efficacy endpoint was major molecular response (MMR) at 12 months after the start of study medication.

MMR was defined as less than or equal to 0.1% BCR-ABL/ABL % by international scale measured by RQ-PCR, which corresponds to a greater than or equal to 3 log reduction of BCR-ABL transcript from standardized baseline. Efficacy endpoints are summarized in Table 12. Two patients in the nilotinib arm progressed to either accelerated phase or blast crisis (both within the first 6 months of treatment) while 12 patients on the imatinib arm progressed to either accelerated phase or blast crisis (7 patients within first 6 months, 2 patients within 6 to 12 months, 2 patients within 12 to 18 months and 1 patient within 18 to 24 months).

Table 12: Efficacy (MMR and CCyR) of Nilotinib Compared to Imatinib in Adult Newly Diagnosed Ph+ CML-CP (ENESTnd) nilotinib 300 mg Twice Daily* imatinib 400 mg Once Daily N = 282 N = 283 MMR at 12 months (95% CI) 44% (38.4, 50.3) 22% (17.6, 27.6) P-Value a < 0.0001 CCyR b by 12 months (95% CI) 80% (75.0, 84.6) 65% (59.2, 70.6) MMR at 24 months (95% CI) 62% (55.8, 67.4) 38% (31.8, 43.4) CCyR b by 24 months (95% CI) 87% (82.4, 90.6) 77% (71.7, 81.8) Abbreviation: CI, confidence interval. *equivalent to CAVHANZA 120 mg twice daily a CMH test stratified by Sokal risk group. b CCyR: 0% Ph+ metaphases.

Cytogenetic responses were based on the percentage of Ph+ metaphases among greater than or equal to 20 metaphase cells in each bone marrow sample. By 60 months, MMR was achieved by 77% of patients on nilotinib and 60% of patients on imatinib; MR4.5 was achieved by 53.5% of patients on nilotinib and 31.4% on imatinib. Median overall survival was not reached in either arm.

At the time of the 60-month final analysis, the estimated survival rate was 93.7% for patients on nilotinib… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year carcinogenicity study was conducted orally in rats at nilotinib doses of 5, 15, and 40 mg/kg/day. Exposures in animals at the highest dose tested were approximately 2- to 3-fold the human exposure (based on AUC) at the nilotinib dose of 400 mg (equivalent to 160 mg of CAVHANZA) twice daily. The study was negative for carcinogenic findings.

A 26-week carcinogenicity study was conducted orally in Tg.rasH2 mice, a model genetically modified to enhance susceptibility to neoplastic transformation, at nilotinib doses of 30, 100, and 300 mg/kg/day. Nilotinib induced in the skin and subcutis statistically significant increases in the incidence of papillomas in females and of papillomas and combined papillomas and carcinomas in males at 300 mg/kg/day. The no-observed-adverse- effect-level (NOAEL) for skin neoplastic lesions was 100 mg/kg/day.

Nilotinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, did not induce DNA damage (comet assay) in L5178Y mouse lymphoma cells, nor was it clastogenic in an in vivo rat bone marrow micronucleus assay with two oral treatments at doses up to 2000 mg/kg/dose. There were no effects on male or female rat and female rabbit mating or fertility at doses up to 180 mg/kg in rats (approximately 4- to 7-fold for males and females, respectively, the AUC in patients at the dose of 400 mg twice daily) or 300 mg/kg in rabbits (approximately one-half the AUC in patients at the dose of 400 mg twice daily).

The effect of nilotinib on human fertility is unknown. In a study where male and female rats were treated with nilotinib at oral doses of 20 to 180 mg/kg/day (approximately 1- to 6.6-fold the AUC in patients at the dose of 400 mg twice daily) during the pre-mating and mating periods and then mated, and dosing of pregnant rats continued through gestation Day 6, nilotinib increased post-implantation loss and early resorption, and decreased the number of viable fetuses and litter size at all doses tested.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year carcinogenicity study was conducted orally in rats at nilotinib doses of 5, 15, and 40 mg/kg/day. Exposures in animals at the highest dose tested were approximately 2- to 3-fold the human exposure (based on AUC) at the nilotinib dose of 400 mg (equivalent to 160 mg of CAVHANZA) twice daily. The study was negative for carcinogenic findings.

A 26-week carcinogenicity study was conducted orally in Tg.rasH2 mice, a model genetically modified to enhance susceptibility to neoplastic transformation, at nilotinib doses of 30, 100, and 300 mg/kg/day. Nilotinib induced in the skin and subcutis statistically significant increases in the incidence of papillomas in females and of papillomas and combined papillomas and carcinomas in males at 300 mg/kg/day. The no-observed-adverse- effect-level (NOAEL) for skin neoplastic lesions was 100 mg/kg/day.

Nilotinib was not mutagenic in a bacterial mutagenesis (Ames) assay, was not clastogenic in a chromosome aberration assay in human lymphocytes, did not induce DNA damage (comet assay) in L5178Y mouse lymphoma cells, nor was it clastogenic in an in vivo rat bone marrow micronucleus assay with two oral treatments at doses up to 2000 mg/kg/dose. There were no effects on male or female rat and female rabbit mating or fertility at doses up to 180 mg/kg in rats (approximately 4- to 7-fold for males and females, respectively, the AUC in patients at the dose of 400 mg twice daily) or 300 mg/kg in rabbits (approximately one-half the AUC in patients at the dose of 400 mg twice daily).

The effect of nilotinib on human fertility is unknown. In a study where male and female rats were treated with nilotinib at oral doses of 20 to 180 mg/kg/day (approximately 1- to 6.6-fold the AUC in patients at the dose of 400 mg twice daily) during the pre-mating and mating periods and then mated, and dosing of pregnant rats continued through gestation Day 6, nilotinib increased post-implantation loss and early resorption, and decreased the number of viable fetuses and litter size at all doses tested.

📄 Package Label / Principal Display Panel 90 words ▾

PRINCIPAL DISPLAY PANEL - 60 mg 112 Tablets NDC: 70709- 191 -12 CAVHANZA™ (nilotinib) orally disintegrating tablets 60 mg Rx only WARNING: Nilotinib orally disintegrating tablets and other nilotinib products are NOT substitutable on a mg-to-mg basis Dispense with enclosed Medication Guide 60 mg label

PRINCIPAL DISPLAY PANEL - 80 mg 112 Tablets NDC: 70709- 192 -12 CAVHANZA™ (nilotinib) orally disintegrating tablets 80 mg Rx only WARNING: Nilotinib orally disintegrating tablets and other nilotinib products are NOT substitutable on a mg-to-mg basis Dispense with enclosed Medication Guide 80 mg label

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

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