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Overview: Bosulif is used to treat certain cancers. Common side effects include diarrhea, stomach pain, nausea, and vomiting. Call your health care provider right away if you get any of the common side effects or have fever, swelling in your arms or legs, unusual bleeding or bruising, or shortness of breath. Keep all appointments to have your blood checked.

Uses

What is Bosulif used for?

Bosulif (bosutinib) is commonly used to treat certain types of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), which is a form of blood cancer.

Bosulif may also be used for other conditions as determined by your health care provider.

How does Bosulif work (mechanism of action)?

Bosulif is a type of medicine known as a tyrosine kinase inhibitor. It works by blocking a certain protein that occurs in Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). By blocking this protein, it helps to prevent or limit changes in the bone marrow that can lead to abnormal white blood cells that cause CML. 

How is Bosulif supplied (dosage forms)?

Brands and other names

  • Bosulif

Dosage forms and strengths

  • 50 mg, 100 mg oral capsules
  • 100 mg, 400 mg, 500 mg oral tablets

How should I store Bosulif?

Bosulif should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place and keep Bosulif in the original bottle. Bosulif will come with a packet in the bottle called a desiccant. The packet will help to keep the medicine dry. Keep the packet in the bottle and do not eat it. 

Side Effects

What are the most common side effects of Bosulif?

The most common side effects of Bosulif are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Stomach problems (see below)
  • Rash
  • Tiredness
  • Liver damage (see below)
  • Headache
  • Fever
  • Loss of appetite
  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Constipation
  • Blood disorders (see below)

There may be other side effects of Bosulif that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Bosulif?

While less common, the most serious side effects of Bosulif are described below, along with what to do if they happen.

Severe Allergic Reactions. Bosulif may cause allergic reactions, which can be serious. Stop taking Bosulif and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Stomach Problems. Diarrhea, stomach pain, nausea, and vomiting are common with Bosulif but can be severe. Get medical help right away if you have any of the following.

  • Diarrhea
  • Stomach pain
  • Nausea or vomiting
  • Blood in your stools or black or tarry poop

Blood Disorders. Bosulif can cause blood disorders, such as low red blood cells (anemia), low platelet levels (thrombocytopenia), and low neutrophil levels (neutropenia). Keep all of your appointments with your health care provider to have your blood cell counts checked. Call your health care provider right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Bosulif. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Heart Problems. Bosulif may cause or worsen heart problems, including heart failure and heart attacks. Get emergency help if you have any of the following symptoms.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness
  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness

Fluid Retention (Edema). Bosulif can cause fluid retention in many parts of your body. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. You may have pulmonary edema or get a pleural effusion or a pericardial effusion. Get emergency help if you have any of the following symptoms.

  • Chest pain
  • Irregular heartbeat
  • Shortness of breath and cough
  • Stretched or shiny skin
  • Swollen body parts, such as the belly or ankles
  • Weight gain

Kidney Damage. Kidney damage can happen when taking Bosulif. Call your health care provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee or frequently peeing
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • Difficulty catching your breath or chest pain/pressure
  • Confusion
  • Nausea
  • Seizures

Warnings & Precautions

Who should not use Bosulif?

Allergies to Ingredients. People who are allergic to any of the following should not take Bosulif.

  • Bosulif
  • Bosutinib
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Bosulif.

What should I know about Bosulif before using it?

Do not take Bosulif unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Bosulif with other people, even if they have the same condition as you. It may harm them.

Keep Bosulif out of the reach of children.

Take Bosulif with food.

Swallow Bosulif tablets whole. Do not crush, break, chew, or cut the tablets. Do not touch any tablets that may be broken.

Swallow Bosulif capsules whole. If you cannot swallow capsules, talk to your health care provider about how to open the capsule and mix it with applesauce or yogurt. 

Bosulif may make it difficult for you to get pregnant or get your partner pregnant. If you have concerns, talk to your health care provider.

What should I tell my health care provider before using Bosulif?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Bosulif is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Diabetes
  • High blood pressure
  • History of blood clots, including a previous stroke, heart attack, or changes in vision
  • Heart problems, including heart failure
  • Stomach or digestion problems
  • Blood cell count problems
  • Swelling problems
  • Liver problems
  • Kidney problems

Other Medicines and Supplements. Bosulif may interact with other medicines and supplements. Before taking Bosulif, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Bosulif may cause harm to a fetus. Your health care provider will give you a test to make sure you are not pregnant before you start taking Bosulif. If you can get pregnant, you should use birth control while taking Bosulif and for 2 weeks after your last dose. Tell your health care provider if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Bosulif passes into breast milk. You should not breastfeed while taking Bosulif and for 2 weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Bosulif?

For more information about Bosulif, you can visit the drugmaker’s website at www.bosulif.com or call them at 800-438-1985.

Interactions

Does Bosulif interact with foods or drinks?

Take Bosulif with food.

Grapefruit interacts with Bosulif. Do not eat grapefruit or drink grapefruit juice while taking Bosulif. Grapefruit can interfere with your body’s ability to break down Bosulif, which can lead to high levels of the medicine and an increased risk of side effects. 

It is unknown if drinking alcohol will affect Bosulif, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Bosulif interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Bosulif.

  • St. John’s wort, which is a supplement that may be used for depression
  • An antacid containing aluminum, calcium, iron, or magnesium
  • A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
  • An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid, Zantac), or nizatidine (Axid)
  • Ketoconazole, which is a medicine used for fungal infections
  • Aprepitant (Emend), which is a medicine used to prevent nausea and vomiting
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Any product that contains grapefruit extract

Many other medicines may alter the blood levels of Bosulif. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Bosulif. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Bosulif?

If you or someone else has used too much Bosulif, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Bosulif?

If you miss a dose, take it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.