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Bosutinib (Bosulif): Uses, Side Effects and Dosage

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100 mg, 500 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Bosutinib

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.

  • 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. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection.
  • Liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with bosutinib tablets. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark “tea color” urine.
  • Heart problems. Bosutinib tablets may cause heart problems, including heart failure and decreased blood flow to the heart which can lead to heart attack. Get medical help right away if you get shortness of breath, weight gain, chest pain, or swelling in your hands, ankles or feet.
  • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Get medical help right away if you get any of the following symptoms during your treatment with bosutinib tablets:
  • shortness of breath and cough o swelling all over your body
  • chest pain o weight gain
  • swelling in your hands, ankles, or feet
  • Kidney problems. Your doctor should do tests to check your kidney function when you start treatment with bosutinib tablets and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with bosutinib tablets:
  • you urinate more often than normal
  • you urinate less often than normal
  • you make a much larger amount of urine than normal
  • you make a much smaller amount of urine than normal

The most common side effects of bosutinib tablets in adults with CML include:

  • diarrhea • headache
  • stomach (abdominal) pain • fever
  • vomiting
  • nausea • respiratory tract infections (infections in nose, throat or lungs)
  • rash
  • tiredness • changes in certain blood tests. Your
  • liver problems doctor may do blood tests during treatment

with bosutinib tablets to check for changes

Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, rash or itching while taking bosutinib tablets. These may be symptoms of a severe allergic reaction.

Your doctor may change your dose, temporarily stop, or permanently stop treatment with bosutinib tablets if you have certain side effects.

Bosutinib tablets may cause fertility problems in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of bosutinib tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store bosutinib tablets?

  • Store bosutinib tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  • The bosutinib tablets bottle has a child-resistant closure.
  • The bosutinib tablets bottle contain desiccants to help keep your medicine dry (protect it from moisture). Keep the desiccants in the bottle. Do not eat the desiccant.
  • Ask your doctor or pharmacist about the right way to throw away outdated or unused bosutinib tablets.

Keep bosutinib tablets and all medicines out of the reach of children.

General information about the safe and effective use of bosutinib tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use bosutinib tablets for a condition for which it is not prescribed. Do not give bosutinib tablets to other people even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about bosutinib tablets that is written for health professionals.

What are the ingredients in bosutinib tablets?

Active ingredient: bosutinib.

Inactive ingredients: croscarmellose sodium, hypromellose, iron oxide red (for 500 mg tablet), iron oxide yellow (for 100 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol 6000, povidone K-25, talc (for 500 mg tablet) and titanium dioxide.

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.

Manufactured by:

Alembic Pharmaceuticals Limited

Formulations Division II,

Panelav 389350, Gujarat, India

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 05/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 209543 · View the label on DailyMed

Revision date stated in the text: May 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Bosutinib

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Kinase Inhibitor
Active ingredient Bosutinib
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) ALEMBIC
FDA approval ANDA 209543Abbreviated New Drug Application (ANDA) – generic drug Approved May 23, 2025
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Bosulif with the same TE code
Manufacturers 3 labelers list this drug on DailyMed
Packages (NDC)
Package
100 mg – 120 in 1 bottle NDC 46708-311-35
500 mg – 30 in 1 bottle NDC 46708-312-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.