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BOSULIF®Highlights (bosutinib)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BOSULIF safely and effectively. See full prescribing information for BOSULIF.

BOSULIF® (bosutinib) tablets, for oral use
Initial U.S. Approval: 2012

RECENT MAJOR CHANGES

Warnings and Precautions, Embryo-Fetal Toxicity (5.7)8/2019
Warnings and Precautions, Cardiac Failure (5.4)10/2019

INDICATIONS AND USAGE

BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with

  • Newly-diagnosed chronic phase Ph+ chronic myelogenous leukemia (CML). This indication is approved under accelerated approval based on molecular and cytogenetic response rates. Continued approval for this indication may be contingent upon verification and confirmation of clinical benefit in an ongoing long-term follow up trial. (1, 14)
  • Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. (1)

DOSAGE AND ADMINISTRATION

  • Newly-diagnosed chronic phase Ph+ CML: 400 mg orally once daily with food. (2.1)
  • Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy: 500 mg orally once daily with food. (2.1)
  • Consider dose escalation by increments of 100 mg once daily to a maximum of 600 mg daily in patients who do not reach complete hematologic, cytogenetic, or molecular response and do not have Grade 3 or greater adverse reactions. (2.2)
  • Adjust dosage for toxicity and organ impairment (2)

DOSAGE FORMS AND STRENGTHS

Tablets: 100 mg, 400 mg, and 500 mg. (3)

CONTRAINDICATIONS

Hypersensitivity to BOSULIF. (4)

WARNINGS AND PRECAUTIONS

  • Gastrointestinal Toxicity: Monitor and manage as necessary. Withhold, dose reduce, or discontinue BOSULIF. (2.3, 5.1)
  • Myelosuppression: Monitor blood counts and manage as necessary. (2.4, 5.2)
  • Hepatic Toxicity: Monitor liver enzymes at least monthly for the first 3 months and as needed. Withhold, dose reduce, or discontinue BOSULIF. (2.3, 5.3)
  • Cardiac Failure: Monitor and manage as necessary. (5.4)
  • Fluid Retention: Monitor patients and manage using standard of care treatment. Withhold, dose reduce, or discontinue BOSULIF. (2.3, 5.5)
  • Renal Toxicity: Monitor patients for renal function at baseline and during therapy with BOSULIF. (5.6)
  • Embryo-Fetal Toxicity: BOSULIF can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.7)

ADVERSE REACTIONS

Most common adverse reactions in patients with newly-diagnosed CML (incidence ≥20%) are diarrhea, nausea, thrombocytopenia, rash, increased alanine aminotransferase, abdominal pain, increased aspartate aminotransferase. (6)

Most common adverse reactions in patients with CML who were resistant or intolerant to prior therapy (incidence ≥20%) are diarrhea, nausea, abdominal pain, rash, thrombocytopenia, vomiting, anemia, fatigue, pyrexia, cough, headache, alanine aminotransferase, and edema. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Strong and Moderate CYP3A Inhibitors: Avoid concomitant use with BOSULIF. (7.1)
  • Strong CYP3A Inducers: Avoid concomitant use with BOSULIF. (7.1)
  • Proton Pump Inhibitors: Use short-acting antacids or H2 blockers as an alternative to proton pump inhibitors. (7.1)

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise women not to breastfeed. (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 6/2020

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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch