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BOSULIF- bosutinib monohydrate tablet, film coated


  1. Patient Information
  2. Bosulif May Cause Serious Side Effects, Including:
  3. The Most Common Side Effects Of Bosulif In People With Newly-diagnosed Cml Include:
  4. The Most Common Side Effects Of Bosulif In People With Cml Who No Longer Benefit From Or Did Not Tolerate Other Treatment Include:
  5. How Should I Store Bosulif?
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. What Is Bosulif?
  9. Who Should Not Take Bosulif?
  10. Before You Take Bosulif, Tell Your Doctor If You:
  11. Medicines That Increase The Amount Of Bosulif In Your Blood Stream, Such As:
  12. Medicines That Decrease The Amount Of Bosulif In Your Blood Stream, Such As:
  13. Bosulif Is Best Absorbed From Your Stomach Into Your Blood Stream In The Presence Of Stomach Acid. You Should Avoid Taking Bosulif With Medicines That Reduce Stomach Acid, Such As:
  14. Medicines That Neutralize Stomach Acid, Such As:
  15. How Should I Take Bosulif?
  16. Other Common Side Effects Of Bosulif Include:
  17. How Do I Store Bosulif?

Patient Information 

Advise the patient to read the FDA-approved patient labeling(Patient Information).

  • Dosage and Administration

Instruct patients to take BOSULIF exactly as prescribed, not to change their dose or to stop taking BOSULIF 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 BOSULIF with food. Patients should be advised: "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 BOSULIF and to
BOSULIF 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 are newly-diagnosed or who no longer benefit from or did not tolerate other treatment.
It is not known if BOSULIF is safe and effective in children less than 18 years of age.Do not take BOSULIFif you are allergic to bosutinib or any of the ingredients in BOSULIF.

  • Take BOSULIF exactly as prescribed by your doctor.
  • Do not change your dose or stop taking BOSULIF without first talking with your doctor.
  • Take BOSULIF with food.
  • Swallow BOSULIF tablets whole. Do not crush, break, or cut BOSULIF tablets. Do not touch or handle crushed or broken BOSULIF tablets.
  • If you take an antacid or H2blocker medicine, take it at least 2 hours before or 2 hours after BOSULIF. 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 BOSULIF. Grapefruit products increase the amount of BOSULIF in your body.
  • If you miss a dose of BOSULIF, 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 BOSULIF, call your doctor or go to the nearest hospital emergency room right away.

Bosulif May Cause Serious Side Effects, Including: 

  • Stomach problems.BOSULIF 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. BOSULIF 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 BOSULIF. 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.BOSULIF may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. 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.BOSULIF may cause heart problems, including heart failure. Get medical help right away if you get shortness of breath, weight gain 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 BOSULIF:
  • shortness of breath and cough
  • chest pain
  • swelling in your hands, ankles, or feet
  • swelling all over your body
  • weight gain
  • Kidney problems.BOSULIF may cause kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • 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 Bosulif In People With Newly-diagnosed Cml Include: 

  • diarrhea
  • nausea
  • low platelet counts
  • rash
  • changes in liver function test
  • stomach (abdomen) pain

The Most Common Side Effects Of Bosulif In People With Cml Who No Longer Benefit From Or Did Not Tolerate Other Treatment Include: 

  • diarrhea
  • nausea
  • stomach (abdomen) pain
  • rash
  • low platelet counts
  • vomiting
  • low red blood cell counts
  • tiredness
  • fever
  • cough
  • headache
  • change in liver function test
  • swelling
Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, or itching while taking BOSULIF. These may be symptoms of a severe allergic reaction.
Your doctor may change your dose, temporarily stop, or permanently stop treatment with BOSULIF if you have certain side effects.
BOSULIF 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 BOSULIF. 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.

How Should I Store Bosulif? 

  • Store BOSULIF 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 BOSULIF.
Keep BOSULIF and all medicines out of the reach of children.General information about the safe and effective use of BOSULIF.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BOSULIF for a condition for which it is not prescribed. Do not give BOSULIF 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 BOSULIF that is written for health professionals.

Active Ingredient: 

bosutinib.

Inactive Ingredients: 

microcrystalline cellulose, croscarmellose sodium, poloxamer, povidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide yellow (for 100 mg and 400 mg tablets) and iron oxide red (for 400 mg and 500 mg tablets).

Logo

LAB-0639-10.0
For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985.

What Is Bosulif? 

BOSULIF 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.

It is not known if BOSULIF is safe and effective in children less than 18 years of age.

Who Should Not Take Bosulif? 

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

Before You Take Bosulif, Tell Your Doctor If You: 

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

Tell your doctor about all the medicines you take,including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. BOSULIF and certain other medicines can affect each other.

Medicines That Increase The Amount Of Bosulif 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 Bosulif 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

Bosulif Is Best Absorbed From Your Stomach Into Your Blood Stream In The Presence Of Stomach Acid. You Should Avoid Taking Bosulif With Medicines That Reduce Stomach Acid, Such As: 

  • esomeprazole (Nexium), esomeprazole strontium
  • 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 BOSULIF.

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 Bosulif? 

  • Take BOSULIF exactly as prescribed by your doctor.
  • Do not change your dose or stop taking BOSULIF without first talking with your doctor.
  • Take BOSULIF with food.
  • Swallow BOSULIF tablets whole. Do not crush or cut BOSULIF tablets. Do not touch or handle crushed or broken BOSULIF tablets.
  • You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract during treatment with BOSULIF. Grapefruit products increase the amount of BOSULIF in your body.
  • Your doctor may change your dose of BOSULIF or tell you to stop taking BOSULIF depending on how you respond to treatment.
  • If you miss a dose of BOSULIF, 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 two doses at the same time.
  • If you take too much BOSULIF, call your doctor or go to the nearest hospital emergency room right away.

Other Common Side Effects Of Bosulif 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 BOSULIF. 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 BOSULIF. 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.

How Do I Store Bosulif? 

  • Store BOSULIF 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 BOSULIF.

Keep BOSULIF and all medicines out of the reach of children.

General information about BOSULIF.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BOSULIF for a condition for which it is not prescribed. Do not give BOSULIF to other people even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about BOSULIF. If you would like more information, talk with your doctor. You may ask your doctor or pharmacist for information about BOSULIF that is written for healthcare professionals.

For more information, go towww.Bosulif.comorwww.pfizermedicalinformation.comor call1-800-438-1985.



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