Bosutinib

Bosutinib is a prescription medication used to treat a certain type of leukemia in adults. Bosutinib belongs to a group of drugs called tyrosine kinase inhibitors, which prevent cancer cells from growing and multiplying. 

This medication comes in tablet form and should be taken as directed by your doctor, with food.

Common side effects of bosutinib include stomach problems including diarrhea, nausea and vomiting.  

Leukemia is a type of cancer found when blood cells divide rapidly. Some patients who have chronic myelogenous leukemia have Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). Bosutunib is approved for treatment of Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). It works by targeting the Bcr-Abl protein found on leukemia cells. By binding to the Bcr-Abl protein, bosutinib prevents the growth of cancer cells.  

The Philadelphia chromosome contains a gene that codes for a protein called Bcr-Abl. Bcr-Abl makes leukemia cells divide more rapidly. This gene can also make leukemia cells resistant to certain types of treatment. 

Testing for the Philadelphia chromosome is done to see whether treatment with bosutinib is likely to be effective in treating acute myelogenous leukemia. If testing is not done, treatment with bosutinib may not be effective.

Bosutinib is a prescription medicine used to treat adults who have a certain type of leukemia called Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who no longer benefit from or did not tolerate other treatment.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Bosutinib may be found in some form under the following brand names:

• Bosulif

Bosutinib may cause serious side effects, including:

• Stomach problems. Bosutinib may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about any stomach problems.
• Low blood cell counts. Bosutinib 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. 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. Bosutinib may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with bosutinib. 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.
• 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. Call your doctor right away if you get any of the following symptoms during your treatment with bosutinib:
  • shortness of breath and cough
  • chest pain
  • swelling in your hands, ankles, or feet
  • swelling all over your body
  • weight gain
• The other common side effects of bosutinib include:
  • rash
  • fever
  • tiredness or weakness

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

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. For more information, ask your doctor or pharmacist.

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

Tell your doctor about the medicines you take, including prescription medicines, non-prescription medicines, vitamins, and herbal supplements. Bosutinib and certain other medicines can affect each other.

Especially tell your doctor if you take:

• medicines that increase the amount of bosutinib in your blood stream, such as:
  • amprenavir (Agenerase)
  • aprepitant (Emend)
  • atazanavir (Reyataz)
  • boceprevir (Victrelis)
  • ciprofloxacin (Cipro, Proquin XR)
  • clarithromycin (Biaxin, Prevpac)
  • conivaptan (Vaprisol)
  • crizotinib (Xalkori)
  • darunavir (Prezista)
  • digoxin (Lanoxin)
  • diltiazem (Cardizem, Dilacor XR, Tiazac)
  • erythromycin (Ery-tab)
  • fluconazole (Diflucan)
  • fosamprenavir (Lexiva)
  • imatinib (Gleevec)
  • indinavir (Crixivan)
  • itraconazole (Onmel, Sporanox)
  • ketoconazole (Nizoral)
  • nefazodone (Serzone)
  • nelfinavir (Viracept)
  • posaconazole (Noxafil)
  • ritonavir (Kaletra, Norvir)
  • saquinavir (Invirase, Fortovase)
  • telaprevir (Incivek)
  • telithromycin (Ketek)
  • verapamil (Calan, Covera-HS, Tarka, Verelan PM)
  • voriconazole (Vfend)
• medicines that decrease the amount of bosutinib in your blood stream, such as:
  • bosentan (Tracleer)
  • carbamazepine (Carbatrol, Equetro, Tegretol)
  • efavirenz (Sustiva)
  • etravirine (Intelence)
  • modafinil (Provigil)
  • nafcillin (Unipen, Nallpen)
  • phenobarbital (Solfoton)
  • phenytoin (Dilantin)
  • rifabutin (Mycobutin)
  • rifampin (Rifamate, Rifater, Rifadin)
  • St. John's wort

Bosutinib is best absorbed from your stomach into your blood stream in the presence of stomach acid. You should avoid taking bosutinib with medicines that reduce stomach acid, such as:

• esomeprazole (Nexium)
• dexlansoprazole (Dexilant)
• lansoprazole (Prevacid)
• omeprazole (Prilosec, Vimovo, Zegerid)
• pantoprazole sodium (Protonix)
• rabeprazole (AcipHex)

Medicines that neutralize stomach acid, such as: cimetidine (Tagamet), famotidine (Pepcid), ranitidine (Zantac), aluminum hydroxide/magnesium hydroxide (Maalox), calcium carbonate (Tums), or calcium carbonate and magnesia (Rolaids) may be taken up to 2 hours before or 2 hours after bosutinib.

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.

Do not take bosutinib if you are allergic to bosutinib or any of the ingredients in bosutinib.

You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract while taking bosutinib. Grapefruit products increase the amount of bosutinib in your body.

Before you take bosutinib, tell your doctor if you:

• have liver problems
• have heart problems
• have any other medical conditions
• are pregnant or plan to become pregnant. Bosutinib can harm your unborn baby. You should not become pregnant while taking bosutinib. Tell your doctor right away if you become pregnant while taking bosutinib.
• are a woman who may become pregnant. Use effective contraception (birth control) during and for at least 30 days after completing treatment with bosutinib. Talk to your doctor about forms of birth control.
• are breastfeeding or plan to breastfeed. It is not known if bosutinib passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take bosutinib or breastfeed. You should not do both.

Tell your doctor about the medicines you take, including prescription medicines, non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Bosutinib can harm your unborn baby. You should not become pregnant while taking bosutinib. Tell your doctor right away if you become pregnant while taking bosutinib.

Use effective contraception (birth control) during and for at least 30 days after completing treatment with bosutinib. Talk to your doctor about forms of birth control.

Tell your doctor if 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. You and your doctor should decide if you will take bosutinib or breastfeed. You should not do both.

• Take bosutinib exactly as prescribed by your doctor.
• Do not change your dose or stop taking bosutinib without first talking with your doctor.
• Take bosutinib with food.
• Swallow bosutinib tablets whole. Do not crush or cut bosutinib tablets. Do not touch or handle crushed or broken bosutinib tablets.
• You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract while taking bosutinib. Grapefruit products increase the amount of bosutinib in your body.
• Your doctor may change your dose of bosutinib or tell you to stop taking bosutinib depending on how you respond to treatment.
• If you miss a dose of bosutinib, take it as soon as you remember. If it has been more than 12 hours since your last dose, take your next dose at your regular time. Do not take two doses at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of bosutinib is 500 mg by mouth once daily with food.

If you take too much bosutinib call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If bosutinib is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store bosutinib between 68°F to 77°F (20°C to 25°C).
• Ask your doctor or pharmacist about the right way to throw away outdated or unused bosutinib.
• Keep bosutinib and all medicines out of the reach of children.