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BOSULIF
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

BOSULIF Rx

Generic Name and Formulations:
Bosutinib 100mg, 400mg, 500mg; tabs.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for BOSULIF:

Newly-diagnosed chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.

Adult:

Take with food. Swallow whole. Continue until disease progression or patient intolerance. Newly-diagnosed: 400mg once daily. Renal impairment (CrCl 30–50mL/min): initially 300mg daily; (CrCl <30mL/min): initially 200mg daily. With resistance/intolerance to prior therapy: 500mg once daily. Renal impairment (CrCl 30–50mL/min): initially 400mg daily; (CrCl <30mL/min): initially 300mg daily. Both: hepatic impairment: initially 200mg daily. Dose escalation or dose adjustments for toxicity: see full labeling.

Children:

<18yrs: not established.

Warnings/Precautions:

Monitor and manage GI toxicity, fluid retention; withhold, reduce dose, or discontinue as necessary. Perform CBC weekly for first month, then monthly; hepatic enzyme tests monthly for first 3 months (more frequently if transaminase elevations occur); withhold, reduce dose, or discontinue as necessary. Monitor renal function at baseline and during therapy; consider adjusting dose if renal impairment occurs. Dialysis: not studied. Embryo-fetal toxicity. Pregnancy; exclude status prior to initiation. Females of reproductive potential should use effective contraception during and for ≥1 month after last dose. Nursing mothers: not recommended (during and for ≥1 month after last dose).

Pharmacological Class:

Tyrosine kinase inhibitor.

Interactions:

Potentiated by concomitant strong or moderate CYP3A inhibitors (eg, ketoconazole, aprepitant, grapefruit products); avoid. Antagonized by concomitant strong or moderate CYP3A inducers (eg, rifampin, St. John’s wort); avoid. Antagonized by proton pump inhibitors (eg, lansoprazole); consider short-acting antacids or H2 blockers instead; separate dosing by ≥2hrs.

Adverse Reactions:

Diarrhea, nausea, thrombocytopenia, rash, vomiting, abdominal pain, anemia, pyrexia, abnormal LFTs, fatigue, cough, headache, edema; fluid retention, hepatic or renal toxicity.

Metabolism:

Hepatic (CYP3A4); 94% protein bound.

Elimination:

Fecal (primary), renal.

Generic Availability:

NO

How Supplied:

Tabs 100mg—120; 400mg, 500mg—30


Data provided by MPR.

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