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Bosutinib 100 mg Tablet, Film Coated, 120-count — NDC 62332-311-35 (Billing 62332-0311-35)

by Alembic Pharmaceuticals Inc. · 120 TABLET, FILM COATED in 1 BOTTLE

This is a package of 120 tablets of Bosutinib 100 mg Tablet, Film Coated from Alembic Pharmaceuticals Inc., marketed since May 2026 and currently FDA-listed. It is this product's only package size.

NDC 62332-0311-35
🏷️ FDA NDC (as labeled) 62332-311-35 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62332-311-35
Product NDC 62332-311
11-digit billing NDC 62332031135
NCPDP billing unit EA — each (per item)
RxCUI 1307624, 1307633
UNII 5018V4AEZ0
UPC 0362332311354, 0362332312306
Application # ANDA209543
SPL Set ID 2ea1617f-41d3-479a-87d5-177013d39193
Established class (EPC) Kinase Inhibitor
Mechanism of action Bcr-Abl Tyrosine Kinase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-19
Route ORAL
Dosage form TABLET, FILM COATED
Substance BOSUTINIB
TE code (Orange Book) AB · RLD · RS

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

GCN Seq No 069928
GCN 33199
HICL code 039590
Ingredient (HICL) Bosutinib
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1Q
Therapeutic class — specific (HIC3) Antineoplastic Systemic Enzyme Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name BOSUTINIB 100 MG TABLET
FDB brand name Bosutinib
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 069928
  • GCN: 33199
  • HICL (First Databank): 039590
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1307624
Why two NDCs? The FDA registers this code as 62332-311-35 — 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 → 62332-0311-35. 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name BOSUTINIB 100 MG TABLET Ingredient Bosutinib
📖 What it is MedlinePlus · NLM

Bosutinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells), including treatment in adults who have been recently found to have this condition and in those who can no longer benefit from other medications for CML or who cannot take these medications because of side effects. Bosutinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • You have a type of leukemia called Ph+ CML, which is driven by a faulty protein in your blood cells called BCR-ABL. Think of it like a stuck 'on' switch that keeps telling those ce...
  • What exactly is bosutinib treating in my body?
  • Yes — this is actually pretty important. Food significantly increases how much of the medicine your body absorbs, so taking it on an empty stomach means you'd be getting much less...
  • Do I have to take it with food every single time?
📖 Read our full Bosutinib 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
62332-0311-35 You're viewing this Main listing 120 TABLET, FILM COATED in 1 BOTTLE 2026-05-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bosulif 100 mg 00069-0135-01 Pfizer 120 tablets — AB FDA listed —
Bosutinib 100 mg 46708-0311-35 Alembic 120 tablets — AB FDA listed —
Bosutinib 100 mgthis 62332-0311-35 Alembic 120 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

🏛️
2025
First FDA approval
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
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.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2026. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 23, 2025 AB TE-rated RLD RS ⏳ ~0.2 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
Exclusivity PC
Exclusivity PC
2025 2027
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.

FDA exclusivity
CodeWhat it grantsExpires
PCPediatric Exclusivity (+6 months)Dec 8, 2026
PCPediatric Exclusivity (+6 months)Dec 8, 2026
Common questions
Is there a generic version of BOSUTINIB 100 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for BOSUTINIB 100 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAlembic Pharmaceuticals Inc.
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA209543 (ANDA)
Labeler code62332
First marketedMay 2026
Product typeHuman Prescription Drug
Portfolio492 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.
🎯 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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 141 words ▾

1 INDICATIONS AND USAGE Bosutinib tablets are indicated for the treatment of: • Adult patients with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), resistant or intolerant to prior therapy [see Clinical Studies (14.2)]. • Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)] . Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

Bosutinib is a kinase inhibitor indicated for the treatment of: • adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), resistant or intolerant to prior therapy. ( 1 ) • adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Adult patients with chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy: 500 mg orally once daily with food. ( 2.1 ) • Consider dose escalation by increments of 100 mg once daily to a maximum of 600 mg daily in adult patients who do not reach complete hematologic, cytogenetic, or molecular response and do not have Grade 3 or greater adverse reactions. ( 2.2 ) • Adjust dosage for toxicity and organ impairment ( 2 )

2.1Recommended Dosage The recommended dosage is taken orally once daily with food. Swallow tablets whole. Do not cut, crush, break or chew tablets.

Continue treatment with bosutinib tablets until disease progression or intolerance to therapy. If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day. Dosage in Adult Patients with CP, AP, or BP Ph+ CML with Resistance or Intolerance to Prior Therapy The recommended dosage of bosutinib tablet is 500 mg orally once daily with food.

Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

2.2Dose Escalation In clinical studies of adult patients with Ph+ CML, dose escalation by increments of 100 mg once daily to a maximum of 600 mg once daily was allowed in patients who did not achieve or maintain a hematologic, cytogenetic, or molecular response and who did not have Grade 3 or higher adverse reactions at the recommended starting dosage. The maximum dose in adult patients is 600 mg once daily. Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets.

However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

2.3Dosage Adjustments for Non-Hematologic Adverse Reactions Elevated liver transaminases: If elevations in liver transaminases greater than 5×institutional upper limit of normal (ULN) occur, withhold bosutinib tablets until recovery to less than or equal to 2.5×ULN and resume at 400 mg once daily thereafter. If recovery takes longer than 4 weeks, discontinue bosutinib tablets. If transaminase elevations greater than or equal to 3×ULN occur concurrently with bilirubin elevations greater than 2×ULN and alkaline phosphatase less than 2×ULN (Hy’s law case definition), discontinue bosutinib tablets [see Warnings and Precautions (5.3)].

Diarrhea: For National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 to 4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment), withhold bosutinib tablets until recovery to Grade less than or equal to 1. Bosutinib tablets may be resumed at 400 mg once daily [see Warnings and Precautions (5.1)] . For other clinically significant, moderate or severe non-hematological toxicity, withhold bosutinib tablets until the toxicity has resolved, then consider resuming bosutinib tablets at a dose reduced by 100 mg taken once daily.

If clinically appropriate, consider re-escalating the dose of bosutinib tablets to the starting dose taken once daily. Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

2.4Dosage Adjustments for Myelosuppression Dose reductions for severe or persistent neutropenia and thrombocytopenia are described below (Table 3). Table 3: Dose Adjustments for Neutropenia and Thrombocytopenia in Adult Patients ANC a less than 1000 x10 6 /L or Platelets less than 50,000 x10 6 /L Withhold bosutinib tablets until ANC greater than or equal to 1000x10 6 /L and platelets greater than or equal to 50,000x10 6 /L. Resume treatment with bosutinib tablets at the same dose if recovery occurs within 2 weeks.

If blood counts remain low for greater than 2 weeks, upon rec… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS • 100 mg are yellow colored, oval shaped, biconvex, film coated tablet, debossed with L603 on one side and plain on other side. • 500 mg are red colored, oval shaped, biconvex, film coated tablet debossed with L604 on one side and plain on the other. Tablets: 100 mg and 500 mg. ( 3 ).

⛔ Contraindications 31 words ▾

4 CONTRAINDICATIONS Bosutinib tablet is contraindicated in patients with a history of hypersensitivity to bosutinib. Reactions have included anaphylaxis [see Adverse Reactions (6.1)] . Hypersensitivity to bosutinib tablets. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Gastrointestinal Toxicity: Monitor and manage as necessary. Withhold, dose reduce, or discontinue bosutinib tablets. ( 2.3 , 5.1 ) • Myelosuppression: Monitor blood counts and manage as necessary.

Withhold, dose reduce or discontinue bosutinib tablets ( 2.4 , 5.2 ) • Hepatic Toxicity: Monitor liver enzymes at least monthly for the first 3 months and as needed. Withhold, dose reduce, or discontinue bosutinib tablets. ( 2.3 , 5.3 ) • Cardiovascular Toxicity: Monitor and manage as necessary.

Interrupt, dose reduce, or discontinue bosutinib tablets. ( 5.4 ) • Fluid Retention: Monitor patients and manage using standard of care treatment. Interrupt, dose reduce, or discontinue bosutinib tablets.

( 2.3 , 5.5 ) • Renal Toxicity: Monitor patients for renal function at baseline and during therapy with bosutinib tablets. ( 5.6 ) • Embryo-Fetal Toxicity: Bosutinib tablets can cause fetal harm. Advise female patients of reproductive potential of potential risk to a fetus and to use effective contraception.

( 5.7 )

5.1Gastrointestinal Toxicity Diarrhea, nausea, vomiting, and abdominal pain occur with bosutinib tablets treatment. Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and fluid replacement. Among 546 adult patients in a single-arm study in patients with CML who were resistant or intolerant to prior therapy, the median time to onset for diarrhea (all grades) was 2 days and the median duration per event was 2 days.

Among the patients who experienced diarrhea, the median number of episodes of diarrhea per patient during treatment with bosutinib tablets was 3 (range 1 to 268). To manage gastrointestinal toxicity, withhold, dose reduce, or discontinue bosutinib tablets as necessary [see Dosage and Administration (2.3) and Adverse Reactions (6)] . Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets.

However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

5.2Myelosuppression Thrombocytopenia, anemia and neutropenia occur with bosutinib tablets treatment. Perform complete blood counts weekly for the first month of therapy and then monthly thereafter, or as clinically indicated. To manage myelosuppression, withhold, dose reduce, or discontinue bosutinib tablets as necessary [see Dosage and Administration (2.4) and Adverse Reactions (6)] .

5.3Hepatic Toxicity Bosutinib may cause elevations in serum transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]). Two cases consistent with drug induced liver injury (defined as concurrent elevations in ALT or AST greater than or equal to 3×ULN with total bilirubin greater than 2×ULN and alkaline phosphatase less than 2×ULN) have occurred without alternative causes. This represented 2 out of 1711 patients in bosutinib tablets clinical trials.

Among the 546 adult patients in a single-arm study in patients with CML who were resistant or intolerant to prior therapy, the incidence of increased ALT was 53.3% and AST elevation was 46.7%. Sixty percent of the patients experienced an increase in either ALT or AST. Most cases of transaminase elevations in this study occurred early in treatment; of patients who experienced increased transaminase of any grade, more than 81% experienced their first increase within the first 3 months.

The median time to onset of increased ALT and AST was 22 and 29 days, respectively, and the median duration for each was 21 days. Perform hepatic enzyme tests monthly for the first 3 months of bosutinib tablets treatment and as clinically indicated. In patients with transaminase elevations, monitor liver enzymes more frequently.

Withhold, dose reduce, or discontinue bosutinib tablets as necessary [see Dosage and Administration (2.3) and Adverse Reactions (6)] . Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal toxicity [see Warnings and Precautions (5.1)] . Myelosuppression [see Warnings and Precautions (5.2)] . Hepatic toxicity [see Warnings and Precautions (5.3)] .

Cardiovascular toxicity [see Warnings and Precautions (5.4)]. Fluid retention [see Warnings and Precautions (5.5)] . Renal toxicity [see Warnings and Precautions ( 5.6)] . • Most common adverse reactions (≥20%), in adult patients with CML are diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, and respiratory tract infection.

The most common laboratory abnormalities (≥20%) in adult patients are creatinine increased, hemoglobin decreased, lymphocyte count decreased, platelets decreased, ALT increased, calcium decreased, white blood cell count decreased, AST increased, absolute neutrophil count decreased, glucose increased, phosphorus decreased, urate increased, alkaline phosphatase increased, lipase increased, creatine kinase increased, and amylase increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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 most common adverse reactions, in ≥20% of adults with resistance or intolerance to prior therapy (N=814) were diarrhea (80%), rash (44%), nausea (44%), abdominal pain (43%), vomiting (33%), fatigue (33%), hepatic dysfunction (33%), respiratory tract infection (25%), pyrexia (24%), and headache (21%).

The most common laboratory abnormalities that worsened from baseline in ≥20% of adults were creatinine increased (93%), hemoglobin decreased (90%), lymphocyte count decreased (72%), platelets decreased (69%), ALT increased (58%), calcium decreased (53%), white blood cell count decreased (52%), absolute neutrophils count decreased (50%), AST increased (50%), glucose increased (46%), phosphorus decreased (44%), urate increased (41%), alkaline phosphatase increased (40%), lipase increased (36%), creatine kinase increased (29%), and amylase increased (24%).

Adverse Reactions in Adult Patients With Imatinib-Resistant or-Intolerant Ph+ CP, AP, and BP CML The single-arm clinical trial enrolled patients with Ph+ CP, AP and BP CML and with resistance or intolerance to prior therapy [see Clinical Studies (14.2)]. The safety population (received at least 1 dose of bosutinib tablets) included 546 CML patients: • two hundred eighty-four (284) patients with CP CML previously treated with imatinib only who had a median duration of bosutinib tablets treatment of 26 months (range: 0.2 to 155 months), and a median dose intensity of 437 mg/day. • one hundred and nineteen (119) patients with CP CML previously treated with both imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) who had a median duration of bosutinib tablets treatment of 9 months (range: 0.2 to 148 months), and a median dose intensity of 427 mg/day. • one hundred forty three (143) patients with advanced phase (AdvP) CML including 79 patients with AP CML and 64 patients with BP CML.

In the patients with AP CML and BP CML, the median duration of bosutinib tablets treatment was 10 months (range: 0.1 to 140 months) and 3 months (range: 0.03 to 71 months), respectively. The median dose intensity was 406 mg/day, and 456 mg/day, in the AP CML and BP CML cohorts, respectively. Serious adverse reactions occurred in 30% of patients in the safety population of the single-arm trial in patients with CML (N=546) who were resistant or intolerant to prior therapy.

Serious adverse reactions reported in >2% of patients included p… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 204 words ▾

7 DRUG INTERACTIONS • Strong and Moderate CYP3A Inhibitors: Avoid concomitant use with bosutinib tablets. ( 7.1 ) • Strong CYP3A Inducers: Avoid concomitant use with bosutinib tablets. ( 7.1 ) • Proton Pump Inhibitors: Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors. ( 7.1 )

7.1Effect of Other Drugs on Bosutinib Tablets Strong or Moderate CYP3A Inhibitors Avoid the concomitant use of strong or moderate CYP3A inhibitors with bosutinib tablets. Bosutinib is a CYP3A substrate. Concomitant use with a strong or moderate CYP3A inhibitor increases bosutinib C max and AUC [see Clinical Pharmacology (12.3)] which may increase the risk of toxicities.

Strong CYP3A Inducers Avoid the concomitant use of strong CYP3A inducers with bosutinib tablets. Bosutinib is a CYP3A substrate. Concomitant use with a strong CYP3A inducer decreases bosutinib C max and AUC [see Clinical Pharmacology (12.3)] which may reduce bosutinib tablets efficacy.

Proton Pump Inhibitors (PPI) As an alternative to PPIs, use short-acting antacids or H2 blockers and separate dosing by more than 2 hours from bosutinib tablets dosing. Bosutinib displays pH dependent aqueous solubility, Concomitant use with a PPI decreases bosutinib C max and AUC [see Clinical Pharmacology (12.3)] which may reduce bosutinib tablets efficacy.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breastfeed. ( 8.2 ) Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, bosutinib tablets 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 conducted in rats and rabbits, oral administration of bosutinib during organogenesis caused adverse developmental outcomes, including structural abnormalities, embryo-fetal mortality, and alterations to growth at maternal exposures (AUC) as low as 1.2 times the human exposure at the dose of 500 mg/day (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 to 4% and 15 to 20%, respectively. Data Animal Data In a rat fertility and early embryonic development study, bosutinib was administered orally to female rats for approximately 3 to 6 weeks, depending on day of mating (2 weeks prior to cohabitation with untreated breeder males until gestation day [GD] 7). Increased embryonic resorptions occurred at greater than or equal to 10 mg/kg/day of bosutinib (1.6 and 1.2 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively), and decreased implantations and reduced number of viable embryos at 30 mg/kg/day of bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively).

In an embryo-fetal development study conducted in rabbits, bosutinib was administered orally to pregnant animals during the period of organogenesis at doses of 3, 10 and 30 mg/kg/day. At the maternally-toxic dose of 30 mg/kg/day of bosutinib, there were fetal anomalies (fused sternebrae, and 2 fetuses had various visceral observations), and an approximate 6% decrease in fetal body weight. The dose of 30 mg/kg/day resulted in exposures (AUC) approximately 5.1 and 3.8 times the human exposures at the recommended doses of 400 and 500 mg/day, respectively.

Fetal exposure to bosutinib-derived radioactivity during pregnancy was demonstrated in a placental-transfer study in pregnant rats. In a rat pre-and postnatal development study, bosutinib was administered orally to pregnant animals during the period of organogenesis through lactation day 20 at doses of 10, 30, and 70 mg/kg/day. Reduced number of pups born occurred at greater than or equal to 30 mg/kg/day bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively), and increased incidence of total litter loss and decreased growth of offspring after birth occurred at 70 mg/kg/day bosutinib (6.9 and 5.1 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively).

8.2Lactation Risk Summary No data are available regarding the presence of bosutinib or its metabolites in human milk or its effects on a breastfed child or on milk production. However, bosutinib is present in the milk of lactating rats. Because of the potential for serious adverse reactions in a nursing child, breastfeeding is not recommended during treatment with bosutinib tablets and for 2 weeks after the last dose.

Animal Data After a single radiolabeled bosutinib dose to lactating rats, radioactivity was present in the plasma of suckling offspring for 24 to 48 hours.

8.3Females and Males of Reproductive Potential Based on findings from animal studies, bosutinib tablets can cau… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, bosutinib tablets 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 conducted in rats and rabbits, oral administration of bosutinib during organogenesis caused adverse developmental outcomes, including structural abnormalities, embryo-fetal mortality, and alterations to growth at maternal exposures (AUC) as low as 1.2 times the human exposure at the dose of 500 mg/day (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 to 4% and 15 to 20%, respectively. Data Animal Data In a rat fertility and early embryonic development study, bosutinib was administered orally to female rats for approximately 3 to 6 weeks, depending on day of mating (2 weeks prior to cohabitation with untreated breeder males until gestation day [GD] 7). Increased embryonic resorptions occurred at greater than or equal to 10 mg/kg/day of bosutinib (1.6 and 1.2 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively), and decreased implantations and reduced number of viable embryos at 30 mg/kg/day of bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively).

In an embryo-fetal development study conducted in rabbits, bosutinib was administered orally to pregnant animals during the period of organogenesis at doses of 3, 10 and 30 mg/kg/day. At the maternally-toxic dose of 30 mg/kg/day of bosutinib, there were fetal anomalies (fused sternebrae, and 2 fetuses had various visceral observations), and an approximate 6% decrease in fetal body weight. The dose of 30 mg/kg/day resulted in exposures (AUC) approximately 5.1 and 3.8 times the human exposures at the recommended doses of 400 and 500 mg/day, respectively.

Fetal exposure to bosutinib-derived radioactivity during pregnancy was demonstrated in a placental-transfer study in pregnant rats. In a rat pre-and postnatal development study, bosutinib was administered orally to pregnant animals during the period of organogenesis through lactation day 20 at doses of 10, 30, and 70 mg/kg/day. Reduced number of pups born occurred at greater than or equal to 30 mg/kg/day bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively), and increased incidence of total litter loss and decreased growth of offspring after birth occurred at 70 mg/kg/day bosutinib (6.9 and 5.1 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively).

🧒 Pediatric Use 90 words ▾

8.4Pediatric Use The safety and effectiveness of bosutinib tablets in pediatric patients younger than 1 year of age with newly diagnosed CP Ph+ CML, pediatric patients younger than 1 year of age with CP Ph+ CML that is resistant or intolerant to prior therapy, and pediatric patients with AP Ph+ CML or BP Ph+ CML have not been established. Pediatric use information is approved for PF PRISM CV’s BOSULIF® (bosutinib) tablets. However, due to PF PRISM CV’s marketing exclusivity rights, this drug product is not labeled with that information.

🧓 Geriatric Use 81 words ▾

8.5Geriatric Use In the single-arm study in patients with CML who were resistant or intolerant to prior therapy of bosutinib tablets in patients with Ph+ CML, 20% were age 65 and over, 4% were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 44 words ▾

10 OVERDOSAGE Experience with bosutinib tablets overdose in clinical studies was limited to isolated cases. There were no reports of any serious adverse events associated with the overdoses. Patients who take an overdose of bosutinib tablets should be observed and given appropriate supportive treatment.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bosutinib is a TKI. Bosutinib inhibits the BCR-ABLkinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL kinase expressed in murine myeloid cell lines. Bosutinib did not inhibit the T315I and V299L mutant cells.

12.2Pharmacodynamics A greater likelihood of response and a greater likelihood of safety events were observed with higher bosutinib exposure in clinical studies. The time course of bosutinib pharmacodynamic response has not been fully characterized. Cardiac Electrophysiology At a single oral dose of 500 mg bosutinib tablet with ketoconazole (a strong CYP3A inhibitor), bosutinib tablets does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics Bosutinib pharmacokinetics were assessed following oral dosing with food in adult patients with CML and were presented as geometric mean (CV%), unless otherwise specified. Bosutinib exhibits dose proportional increases in C max and AUC over the oral dose range of 200 to 800 mg (0.33 to 1.3 times the maximum approved recommended dosage of 600 mg). Bosutinib steady state C max was 127 ng/mL (31%), C trough was 68 ng/mL (39%) and AUC was 2370 ng•h/mL (34%) following multiple oral doses of bosutinib tablets 400 mg; Bosutinib steady state C max was 171 ng/mL (38%),C trough was 91 ng/mL (42%) and AUC was 3150 ng•h/mL (38%) following multiple oral doses of bosutinib tablets 500 mg.

No clinically significant differences in the pharmacokinetics of bosutinib were observed following administration of either the tablet or capsule dosage forms of bosutinib at the same dose, under fed conditions. Absorption The median bosutinib (minimum, maximum) time-to-C max (t max ) was 6 (6, 6) hours following oral administration of a single oral dose of bosutinib tablets 500 mg with food. The absolute bioavailability was 34% in healthy subjects.

Effect of Food Bosutinib C max increased 1.8-fold and AUC increased 1.7-fold when bosutinib tablets were given with a high fat meal to healthy subjects compared to administration under fasted condition. The high-fat meal (800 to 1000 total calories) consisted of approximately 150 protein calories, 250 carbohydrate calories, and 500 to 600 fat calories. Distribution The mean (SD) apparent bosutinib volume of distribution is 6080 (1230) L after an oral dose of 500 mg of bosutinib.

Bosutinib protein binding is 94% in vitro and 96% ex vivo, and is independent of concentration. Elimination The mean (SD) bosutinib terminal phase elimination half-life (t ½ ) was 22.5 (1.7) hours, and the mean (SD) apparent clearance was 189 (48) L/h following a single oral dose of bosutinib tablets. Metabolism Bosutinib is primarily metabolized by CYP3A4.

Excretion Following a single oral dose of [ 14 C] radiolabeled bosutinib without food, 91.3% of the dose was recovered in feces and 3.3% of the dose recovered in urine. Specific Populations Patients with Renal Impairment Bosutinib AUC increased 1.4-fold in subjects with moderate renal impairment (CL cr : 30 to 50 mL/min, estimated by Cockcroft-Gault (C-G)) and increased 1.6-fold in subjects with severe renal impairment (CL cr less than 30 mL/min) following a single oral dose of bosutinib tablets 200 mg (0.33 times the maximum approved recommended dosage of 600 mg).

No clinically significant difference in the pharmacokinetics of bosutinib was observed in subjects with mild renal impairment (CL cr : 51 to 80 mL/min, C-G). Bosutinib tablets has not been studied in patients undergoing hemodialysis. Patients with Hepatic Impairment Bosutinib C max increased 2.4-fold, 2-fold, and 1.5-fold, and AUC increased 2.3-fold, 2-fold, and 1.9-fold in hepatic impairment Child-Pugh A, B, and C, respectively, following a single oral dose of bosutinib tablet 200 mg (0.33 times the maximum approved recommended dosage of 600 mg).

Drug Interaction Studies Clinical Studi… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 54 words ▾

12.1Mechanism of Action Bosutinib is a TKI. Bosutinib inhibits the BCR-ABLkinase that promotes CML; it is also an inhibitor of Src-family kinases including Src, Lyn, and Hck. Bosutinib inhibited 16 of 18 imatinib-resistant forms of BCR-ABL kinase expressed in murine myeloid cell lines. Bosutinib did not inhibit the T315I and V299L mutant cells.

📦 How Supplied / Storage and Handling 151 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Bosutinib tablets are available in the following packaging configurations with a child-resistant (CR) closure. Bottle contains desiccants. Bosutinib tablets 100 mg are yellow colored, oval shaped, biconvex, film coated tablet, debossed with L603 on one side and plain on other side.

NDC 62332-311-35 bottle of 120 tablets Bosutinib tablets 500 mg are red colored, oval shaped, biconvex, film coated tablet debossed with L604 on one side and plain on the other. NDC 62332-312-30 bottle of 30 tablets Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Handling and Disposal Procedures for proper disposal of anticancer drugs should be considered.

Touching or handling crushed or broken tablets is to be avoided. Any unused product or waste material should be disposed of in accordance with local requirements, or drug take back programs.

📋 Description 188 words ▾

11 DESCRIPTION Bosutinib tablet contains bosutinib, a kinase inhibitor. The chemical name for bosutinib is 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]. Its chemical formula is C 26 H 29 Cl 2 N 5 O 3 ; its molecular weight is 530.45.

Bosutinib has the following chemical structure: Bosutinib is a white to yellowish-tan powder. Bosutinib is freely soluble in dimethyl sulfoxide, very slightly soluble in ethyl acetate and practically insoluble in water. Bosutinib tablets are supplied for oral administration in two strengths: a 100 mg yellow colored, oval shaped, biconvex, film coated tablet, debossed with L603 on one side and plain on other side; and a 500 mg red colored, oval shaped, biconvex, film coated tablet debossed with L604 on one side and plain on the other.

Each 100 mg bosutinib tablet contains 100 mg of bosutinib; each 500 mg bosutinib tablet contains 500 mg of bosutinib. The following inactive ingredients are included in the tablets: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol 6000, povidone K-25, titanium dioxide. Additionally 100 mg tablet contain iron oxide yellow and 500 mg tablet contains iron oxide red and talc. bosutinib-structure.jpg

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). • Dosage and Administration Instruct patients to take bosutinib tablets exactly as prescribed, not to change their dose or to stop taking bosutinib tablets unless they are told to do so by their doctor. If patients miss a dose beyond 12 hours, they should be advised to take the next scheduled dose at its regular time. A double dose should not be taken to make up for any missed dose.

Advise patients to take bosutinib tablets with food. Patients should be advised: “Swallow tablets whole. Do not crush, break, or cut tablet.

Do not touch or handle crushed or broken tablets.” • Gastrointestinal Toxicity Advise patients that they may experience diarrhea, nausea, vomiting, abdominal pain, or blood in their stools with bosutinib tablets and to seek medical attention promptly for these symptoms [see Warnings and Precautions (5.1)]. • Myelosuppression Advise patients of the possibility of developing low blood cell counts and to immediately report fever, any suggestion of infection, or signs or symptoms suggestive of bleeding or easy bruising [see Warnings and Precautions (5.2)]. • Hepatic Toxicity Advise patients of the possibility of developing liver function abnormalities and to immediately report jaundice [see Warnings and Precautions (5.3)]. • Cardiovascular Toxicity Advise patients that cardiac failure, left ventricular dysfunction, and cardiac ischemic events have been reported.

Advise patients to seek immediate medical attention if any symptoms suggestive of cardiac failure and cardiac ischemia occur, such as shortness of breath, weight gain, or fluid retention [see Warnings and Precautions (5.4)]. • Fluid Retention Advise patients of the possibility of developing fluid retention (swelling, weight gain, or shortness of breath) and to seek medical attention promptly if these symptoms arise [see Warnings and Precautions (5.5)]. • Renal Toxicity Advise patients of the possibility of developing renal problems and to immediately report frequent urination, polyuria or oliguria [see Warnings and Precautions (5.6)]. • Adverse Reactions Advise patients that they may experience other adverse reactions such as respiratory tract infections, rash, fatigue, headache, dizziness, back pain, arthralgia, or pruritus with bosutinib tablets and to seek medical attention if symptoms are significant.

There is a possibility of anaphylactic shock [see Contraindications (4) and Adverse Reactions (6)]. • Embryo-Fetal Toxicity Advise females to inform their healthcare provider if they are pregnant or become pregnant. Advise female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)] . Advise females of reproductive potential, to use effective contraception during treatment and for 2 weeks after receiving the last dose of bosutinib tablets [see Warnings and Precautions (5.7) and Use in Specific Populations (8.1, 8.3)].

Advise lactating women not to breastfeed during treatment with bosutinib tablets and for 2 weeks after the last dose [see Use in Specific Populations (8.2)]. • Drug Interactions Advise patients that bosutinib tablets and certain other medicines, including over the counter medications or herbal supplements (such as St. John’s wort) can interact with each other and may alter the effects of bosutinib tablets [see Drug Interactions (7)].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Bosutinib pharmacokinetics were assessed following oral dosing with food in adult patients with CML and were presented as geometric mean (CV%), unless otherwise specified. Bosutinib exhibits dose proportional increases in C max and AUC over the oral dose range of 200 to 800 mg (0.33 to 1.3 times the maximum approved recommended dosage of 600 mg). Bosutinib steady state C max was 127 ng/mL (31%), C trough was 68 ng/mL (39%) and AUC was 2370 ng•h/mL (34%) following multiple oral doses of bosutinib tablets 400 mg; Bosutinib steady state C max was 171 ng/mL (38%),C trough was 91 ng/mL (42%) and AUC was 3150 ng•h/mL (38%) following multiple oral doses of bosutinib tablets 500 mg.

No clinically significant differences in the pharmacokinetics of bosutinib were observed following administration of either the tablet or capsule dosage forms of bosutinib at the same dose, under fed conditions. Absorption The median bosutinib (minimum, maximum) time-to-C max (t max ) was 6 (6, 6) hours following oral administration of a single oral dose of bosutinib tablets 500 mg with food. The absolute bioavailability was 34% in healthy subjects.

Effect of Food Bosutinib C max increased 1.8-fold and AUC increased 1.7-fold when bosutinib tablets were given with a high fat meal to healthy subjects compared to administration under fasted condition. The high-fat meal (800 to 1000 total calories) consisted of approximately 150 protein calories, 250 carbohydrate calories, and 500 to 600 fat calories. Distribution The mean (SD) apparent bosutinib volume of distribution is 6080 (1230) L after an oral dose of 500 mg of bosutinib.

Bosutinib protein binding is 94% in vitro and 96% ex vivo, and is independent of concentration. Elimination The mean (SD) bosutinib terminal phase elimination half-life (t ½ ) was 22.5 (1.7) hours, and the mean (SD) apparent clearance was 189 (48) L/h following a single oral dose of bosutinib tablets. Metabolism Bosutinib is primarily metabolized by CYP3A4.

Excretion Following a single oral dose of [ 14 C] radiolabeled bosutinib without food, 91.3% of the dose was recovered in feces and 3.3% of the dose recovered in urine. Specific Populations Patients with Renal Impairment Bosutinib AUC increased 1.4-fold in subjects with moderate renal impairment (CL cr : 30 to 50 mL/min, estimated by Cockcroft-Gault (C-G)) and increased 1.6-fold in subjects with severe renal impairment (CL cr less than 30 mL/min) following a single oral dose of bosutinib tablets 200 mg (0.33 times the maximum approved recommended dosage of 600 mg).

No clinically significant difference in the pharmacokinetics of bosutinib was observed in subjects with mild renal impairment (CL cr : 51 to 80 mL/min, C-G). Bosutinib tablets has not been studied in patients undergoing hemodialysis. Patients with Hepatic Impairment Bosutinib C max increased 2.4-fold, 2-fold, and 1.5-fold, and AUC increased 2.3-fold, 2-fold, and 1.9-fold in hepatic impairment Child-Pugh A, B, and C, respectively, following a single oral dose of bosutinib tablet 200 mg (0.33 times the maximum approved recommended dosage of 600 mg).

Drug Interaction Studies Clinical Studies Strong CYP3A Inhibitors: Bosutinib C max increased 5.2-fold and AUC increased 8.6-fold following a single dose of bosutinib tablets 100 mg (0.17 times the maximum approved recommended dosage) without food when used concomitantly with 400 mg ketoconazole (a strong CYP3A inhibitor) administered over multiple daily doses. Moderate CYP3A Inhibitors: Bosutinib C max increased 1.5-fold and AUC increased 2.0-fold following a single dose of bosutinib tablet 500 mg with food when administered concomitantly with 125 mg aprepitant (a moderate CYP3A inhibitor).

Strong CYP3A Inducers: Bosutinib C max decreased by 86% and AUC decreased by 94% following a single dose of bosutinib tablet 500 mg with food administered concomitantly with multiple daily doses of 600 mg of rifampin (a strong CYP3A inducer). Proton Pump Inhibitors : Lans… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 66 words ▾

12.2Pharmacodynamics A greater likelihood of response and a greater likelihood of safety events were observed with higher bosutinib exposure in clinical studies. The time course of bosutinib pharmacodynamic response has not been fully characterized. Cardiac Electrophysiology At a single oral dose of 500 mg bosutinib tablet with ketoconazole (a strong CYP3A inhibitor), bosutinib tablets does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.2Adult Patients with Imatinib-Resistant or -Intolerant Ph+ CP, AP, and BP CML Study 200 (NCT00261846), a single-arm open-label, multicenter study in patients with CML who were resistant or intolerant to prior therapy was conducted to evaluate the efficacy and safety of bosutinib tablets 500 mg once daily in patients with imatinib-resistant or -intolerant CML with separate cohorts for CP, AP, and BP disease previously treated with 1 prior TKI (imatinib) or more than 1 TKI (imatinib followed by dasatinib and/or nilotinib) .

The definition of imatinib resistance included (1) failure to achieve or maintain any hematologic improvement within 4 weeks; (2) failure to achieve a CHR by 3 months, cytogenetic response by 6 months or major cytogenetic response (MCyR) by 12 months; (3) progression of disease after a previous cytogenetic or hematologic response; or (4) presence of a genetic mutation in the BCR-ABL gene associated with imatinib resistance. Imatinib intolerance was defined as inability to tolerate imatinib due to toxicity, or progression on imatinib and inability to receive a higher dose due to toxicity.

The definitions of resistance and intolerance to both dasatinib and nilotinib were similar to those for imatinib. The protocol was amended to exclude patients with a known history of the T315I mutation after 396 patients were enrolled in the trial. The efficacy endpoints for patients with CP CML previously treated with 1 prior TKI (imatinib) were the rate of attaining MCyR by Week 24 and the duration of MCyR.

The efficacy endpoints for patients with CP CML previously treated with both imatinib and at least 1 additional TKI were the cumulative rate of attaining MCyR by Week 24 and the duration of MCyR. The efficacy endpoints for patients with previously treated AP and BP CML were confirmed CHR and overall hematologic response (OHR). The study enrolled 546 patients with CP, AP or BP CML.

Of the total patient population 73% were imatinib resistant and 27% were imatinib intolerant . In this trial, 53% of patients were males, 65% were Caucasian, and 20% were 65 years old or older . Of the 546 treated patients, 506 were considered evaluable for cytogenetic or hematologic efficacy assessment.

Patients were evaluable for efficacy if they had received at least 1 dose of bosutinib tablets and had a valid baseline efficacy assessment. Among evaluable patients, there were 262 patients with CP CML previously treated with 1 prior TKI (imatinib), 112 patients with CP CML previously treated with both imatinib and at least 1 additional TKI, and 132 patients with advanced phase CML previously treated with at least 1 TKI. Median duration of bosutinib tablets treatment was 26 months in patients with CP CML previously treated with 1 TKI (imatinib), 9 months in patients with CP CML previously treated with imatinib and at least 1 additional TKI, 10 months in patients with AP CML previously treated with at least imatinib, and 3 months in patients with BP CML previously treated with at least imatinib.

The 24 week efficacy and MCyR at any time results are summarized in Table 14. Table 14: Efficacy Results in Patients with Ph+ CP CML With Resistance to or Intolerance to Imatinib Prior Treatment With Imatinib Only (N=262 evaluable) n (%) Prior Treatment With Imatinib and Dasatinib or Nilotinib (N=112 evaluable) n (%) By Week 24 MCyR (95% CI) 105 (40.1) (34.1, 46.3) 29 (25.9) (18.1, 35) MCyR any time 156 (59.5) (53.3, 65.5) 45 (40.2) (31, 49.9) Abbreviations: CI=confidence interval; CML=chronic myelogenous leukemia; CP=chronic phase; MCyR=major cytogenetic response; N/n=number of patients; Ph+=Philadelphia chromosome positive.

The long-term follow-up data analysis was based on a minimum of 60 months for patients with CP CML treated with 1 prior TKI (imatinib) and a minimum of 48 months for patients with CP CML treated with imatinib and at least 1 additional TKI. For the 59.5% of patients with CP CML treated with 1 prior TKI (imati… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Bosutinib was not carcinogenic in rats or transgenic mice. The rat 2-year carcinogenicity study was conducted at bosutinib oral doses up to 25 mg/kg in males and 15 mg/kg in females. Exposures at these doses were approximately 1.5 times (males) and 3.1 times (females) the human exposure at the 400 mg dose and 1.2 times (males) and 2.4 times (females) exposure in humans at the 500 mg dose.

The 6-month RasH2 transgenic mouse carcinogenicity study was conducted at bosutinib oral doses up to 60 mg/kg. Bosutinib was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames Test), the in vitro assay using human peripheral blood lymphocytes and the micronucleus test in orally treated male mice. In a rat fertility study, drug-treated males were mated with untreated females, or untreated males were mated with drug-treated females.

Females were administered the drug from pre-mating through early embryonic development. The dose of 70 mg/kg/day of bosutinib resulted in reduced fertility in males as demonstrated by 16% reduction in the number of pregnancies. There were no lesions in the male reproductive organs at this dose.

This dose of 70 mg/kg/day resulted in exposure (AUC) in male rats approximately 1.5 times and equal to the human exposure at the recommended doses of 400 and 500 mg/day, respectively. Fertility (number of pregnancies) was not affected when female rats were treated with bosutinib. However, there were increased embryonic resorptions at greater than or equal to 10 mg/kg/day of bosutinib (1.6 and 1.2 times the human exposure at the recommended doses of 400 and 500 mg/day, respectively), and decreased implantations and reduced number of viable embryos at 30 mg/kg/day of bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively).

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

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Bosutinib was not carcinogenic in rats or transgenic mice. The rat 2-year carcinogenicity study was conducted at bosutinib oral doses up to 25 mg/kg in males and 15 mg/kg in females. Exposures at these doses were approximately 1.5 times (males) and 3.1 times (females) the human exposure at the 400 mg dose and 1.2 times (males) and 2.4 times (females) exposure in humans at the 500 mg dose.

The 6-month RasH2 transgenic mouse carcinogenicity study was conducted at bosutinib oral doses up to 60 mg/kg. Bosutinib was not mutagenic or clastogenic in a battery of tests, including the bacteria reverse mutation assay (Ames Test), the in vitro assay using human peripheral blood lymphocytes and the micronucleus test in orally treated male mice. In a rat fertility study, drug-treated males were mated with untreated females, or untreated males were mated with drug-treated females.

Females were administered the drug from pre-mating through early embryonic development. The dose of 70 mg/kg/day of bosutinib resulted in reduced fertility in males as demonstrated by 16% reduction in the number of pregnancies. There were no lesions in the male reproductive organs at this dose.

This dose of 70 mg/kg/day resulted in exposure (AUC) in male rats approximately 1.5 times and equal to the human exposure at the recommended doses of 400 and 500 mg/day, respectively. Fertility (number of pregnancies) was not affected when female rats were treated with bosutinib. However, there were increased embryonic resorptions at greater than or equal to 10 mg/kg/day of bosutinib (1.6 and 1.2 times the human exposure at the recommended doses of 400 and 500 mg/day, respectively), and decreased implantations and reduced number of viable embryos at 30 mg/kg/day of bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively).

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION BOSUTINIB (boe sue' ti nib) TABLETS What is bosutinib tablet? Bosutinib tablet is a prescription medicine used to treat: • adults who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who no longer benefit from or did not tolerate other treatment. • adults with accelerated phase (AP), or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment. It is not known if bosutinib tablets are safe and effective in children less than 1 year of age with CP Ph+ CML who are newly-diagnosed or no longer benefit from or did not tolerate other treatment or in children with AP Ph+ CML or BP Ph+ CML.

Do not take bosutinib tablets if you are allergic to bosutinib or any of the ingredients in bosutinib tablets. See the end of this leaflet for a complete list of ingredients of bosutinib tablets. Before taking bosutinib tablets, tell your doctor about all of your medical conditions, including if you: • have liver problems • have heart problems • have kidney problems • have high blood pressure • have diabetes • are pregnant or plan to become pregnant.

Bosutinib tablets can harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with bosutinib tablets. Tell your doctor right away if you become pregnant during treatment with bosutinib tablets. o Females who are able to become pregnant should use effective birth control (contraception) during treatment with bosutinib tablets and for 2 weeks after the last dose.

Talk to your doctor about birth control methods that may be right for you. • are breastfeeding or plan to breastfeed. It is not known if bosutinib passes into your breast milk or if it can harm your baby. Do not breastfeed during treatment with bosutinib tablets and for 2 weeks after the last dose.

Tell your doctor about all the medicines you take , including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. When taken together, bosutinib tablets and certain other medicines can affect each other. Know the medicines you take.

Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take bosutinib tablets? • Take bosutinib tablets exactly as prescribed by your doctor. • Do not change your dose or stop taking bosutinib tablets without first talking with your doctor. • Take bosutinib tablets with food. • Swallow bosutinib tablets whole. Do not crush, break, chew or cut bosutinib tablets.

Do not touch or handle crushed or broken bosutinib tablets. • If you take an antacid or H2 blocker medicine, take it at least 2 hours before or 2 hours after bosutinib tablets. If you take a Proton Pump Inhibitor (PPI) medicine, talk to your doctor or pharmacist. • You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract during treatment with bosutinib tablets. Grapefruit products increase the amount of bosutinib tablets in your body. • If you miss a dose of bosutinib tablets, take it as soon as you remember.

If you miss a dose by more than 12 hours, skip that dose and take your next dose at your regular time. Do not take 2 doses at the same time. • If you take too much bosutinib tablets, call your doctor or go to the nearest hospital emergency room right away. What are the possible side effects of bosutinib tablets?

Bosutinib tablets may cause serious side effects, including: • Stomach problems. Bosutinib tablets may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for any stomach problems. • Low blood cell counts .

Bosutinib tablets may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with bosutinib tablets… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 58 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg NDC 62332-311-35 Bosutinib Tablets 100 mg Do not crush or cut tablet For Oncology Use Only Rx only 120 Tablets Alembic 120 tablets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 500 mg NDC 62332-312-30 Bosutinib Tablets 500 mg Do not crush or cut tablet For Oncology Use Only Rx only 30 Tablets Alembic 30 tablets

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

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

Medicare Part D (outpatient prescription) spending for Bosulif (matched by generic name) — the program that covers self-administered drugs. 2 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 Bosulif. 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
$85.42M
Claims incl. refills
5.2K
Beneficiaries
2.1K
Spend / beneficiary
$41,527.89
Spend / claim
$16,529.19
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alembic Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 62332-0280-30 · Alembic 62332-0312-30 · Alembic →
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.