Bosulif

Generic name: Bosutinib
Dosage form: oral capsules, oral tablets
Drug class: BCR-ABL tyrosine kinase inhibitors

Usage of Bosulif

Bosulif is a kinase inhibitor that may be used to treat adults and some children aged 1 year and older with a type of cancer called chronic myelogenous leukemia (CML; also called chronic myeloid leukemia).

Bosulif is approved to treat:

Adults and children aged 1 year and older with Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in chronic phase (CP) that is newly diagnosed, resistant, or intolerant to other treatments

Adults with accelerated, or blast phase Ph+ CML that is resistant or intolerant to prior treatment.

Bosulif is a targeted treatment that works by inhibiting the action of BCR-ABL kinase—a protein typically overproduced by CML cells, stopping, or slowing the growth of CML cells. In addition to its role in targeting BCR-ABL, it also inhibits Src, Lyn, and Hck, which are part of the Src family of kinases. Bosulif belongs to the class of medicines known as tyrosine kinase inhibitors.

Bosulif was first FDA-approved on September 4, 2012.

Bosulif side effects

Get emergency medical help if you have signs of an allergic reaction to Bosulif: hives, itching; dizziness; back pain, joint pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Bosulif and call your doctor at once if you have:

severe or ongoing nausea, vomiting, stomach pain, or diarrhea

blood in your stools

urinating more or less than usual

feeling light-headed or short of breath

heart problems - swelling, rapid weight gain, feeling short of breath

low blood cell counts - fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet

liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes) or

swelling or fluid build-up in the lungs - anxiety, sweating, pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

The most common Bosulif side effects reported in 20% or more patients include:

diarrhea

stomach pain

vomiting

nausea

rash

fatigue

liver dysfunction

headache

fever

decreased appetite

respiratory tract infection

constipation

laboratory abnormalities.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Bosulif

You should not use Bosulif if you are allergic to Bosutinib or any of the inactive ingredients in the tablets or capsules.

To make sure Bosulif is safe for you, tell your doctor if you have ever had:

heart disease

high blood pressure

diabetes

liver disease

kidney disease

are pregnant or intend to become pregnant

are breastfeeding.

Pregnancy and breastfeeding

Bosulif can harm your unborn baby. Females who can become pregnant should have a pregnancy test before starting treatment and use effective birth control (contraception) during treatment and for 2 weeks after the last dose. Talk to your doctor about suitable birth control methods. Tell your doctor right away if you inadvertently become pregnant during treatment.

Do not breastfeed during treatment with Bosulif and for 2 weeks after the last dose.

Relate drugs

How to use Bosulif

Usual adult dose

Newly-diagnosed: 400 mg orally once daily.

Chronic/accelerated/blast phase: 500 mg orally once daily

Usual child dose

Newly diagnosed: 300 mg/m2 orally once daily.

Chronic phase with resistance or intolerance to prior therapy: 400 mg/m2 orally once daily.

Warnings

May cause severe diarrhea and other gastrointestinal side effects. Tell your doctor if you develop any intolerable gastrointestinal side effects. They may need to withhold, reduce the dose, or discontinue Bosulif.

Bosulif can cause myelosuppression and lower blood cells that can help your body fight infections and help your blood clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

May increase the risk of liver problems. Stop using Bosulif and call your doctor at once if you have a fever, easy bruising or bleeding, shortness of breath, jaundice (yellowing of the skin or eyes), swelling or rapid weight gain, blood in your stools, or severe and ongoing vomiting, stomach pain, or diarrhea. Your doctor will monitor your liver enzymes at least monthly for the first 3 months and as needed.

May increase the risk of fluid retention or heart problems. Tell your doctor if you have swelling or rapid weight gain, shortness of breath, fast or slow heart rate, weak pulse, or fainting. There is also an increased risk of kidney toxicity, your doctor will measure your kidney function before you start treatment and while you are taking Bosulif.

Bosulif can cause harm to an unborn baby and should not be used during pregnancy. Your doctor should conduct a pregnancy test if you are a woman of childbearing age before prescribing Bosulif and you should use adequate contraception during treatment. Do not breastfeed.

Do not break or crush a Bosulif tablet. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

What other drugs will affect Bosulif

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Interactions include:

Antacids or stomach acid reducers (such as famotidine or cimetidine)

Proton pump inhibitors (such as omeprazole)

Strong and moderate CYP3A inhibitors such as clarithromycin, diltiazem, erythromycin, itraconazole, ketoconazole, ritonavir, and verapamil

Strong CYP3A inducers such as glucocorticoids, rifampin, Carbamazepine, phenobarbital, and phenytoin.

Avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract.

Many other drugs can interact with bosutinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

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