Bosulif® is the trade for the generic chemotherapy drug Bosutinib. In some cases, health care professionals may use the generic name Bosutinib when referring to the trade name Bosulif®.
For the treatment of adult Philadelphia chromosome-positive chronic myelogenous leukemia.
You should not use Bosulif if you are allergic to bosutinib.
To make sure Bosulif is safe for you, tell your doctor if you have:
You may need to have a negative pregnancy test before starting this treatment.
Do not use Bosulif if you are pregnant. It could harm the unborn baby. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication and for at least 1 month after your last dose.
You should not breastfeed while using this medicine and for at least 1 month after your last dose.
Important things to remember about the side effects of Bosulif®:
The following side effects are common (occurring in greater than 30%) for patients taking Bosulif®:
These side effects are less common side effects (occurring in about 10-29%) of patients receiving Bosulif®:
The recommended dose is taken orally once daily with food. The tablet is to be swallowed whole and should not be broken or cut. Continue treatment with BOSULIF until disease progression or intolerance to therapy.
If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.
Newly-Diagnosed CP Ph+ CML
The recommended dose of BOSULIF is 400 mg orally once daily with food.
CP, AP, or BP Ph+ CML with Resistance or Intolerance to Prior Therapy
The recommended dose and schedule of BOSULIF is 500 mg orally once daily with food.
In clinical studies of adult Ph+ CML patients, dose escalation by increments of 100 mg once daily to a maximum of 600 mg once daily was allowed in patients who did not achieve or maintain a hematologic, cytogenetic, or molecular response and who did not have Grade 3 or higher adverse reactions at the recommended starting dosage.
Elevated liver transaminases: If elevations in liver transaminases greater than 5×institutional upper limit of normal (ULN) occur, withhold BOSULIF until recovery to less than or equal to 2.5×ULN and resume at 400 mg once daily thereafter. If recovery takes longer than 4 weeks, discontinue BOSULIF. If transaminase elevations greater than or equal to 3×ULN occur concurrently with bilirubin elevations greater than 2×ULN and alkaline phosphatase less than 2×ULN (Hy’s law case definition), discontinue BOSULIF [see Warnings and Precautions (5.3)].
Diarrhea: For National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3–4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment), withhold BOSULIF until recovery to Grade less than or equal to 1. BOSULIF may be resumed at 400 mg once daily [see Warnings and Precautions (5.1)].
For other clinically significant, moderate or severe non-hematological toxicity, withhold BOSULIF until the toxicity has resolved, then consider resuming BOSULIF at a dose reduced by 100 mg taken once daily. If clinically appropriate, consider re-escalating the dose of BOSULIF to the starting dose taken once daily. Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.
What is the Generic Name for the trade name drug Bosulif® ?
Bosutinib is Generic Name for the trade name drug Bosulif®
What is the Manufacturer Name of Bosulif®?
Bosulif® is manufactured by PFIZER.
Is Bosulif® approved by FDA?
Yes, Bosulif® is approved by FDA. Date of approval: January 2012
What is the dosage and form of Bosulif® is available?
Bosulif® is available as 100 mg and 500 mg Tablets.
What is the Highlights of prescribing information of Bosulif®?
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