NEW FDA Approved Bosulif Side Effects

The U.S. Food and Drug Administration (FDA) has approved Bosulif (bosutinib), an Abl and Src kinase inhibitor, for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance, or intolerance to prior therapy.

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.

  • 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 while taking 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 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.
  • 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, or vomiting. Tell your doctor about 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.
  • 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 Bosulif:
    • 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 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.