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Bosutinib Dosage

Medically reviewed by Drugs.com. Last updated on Nov 7, 2018.

Applies to the following strengths: 100 mg; 500 mg; 400 mg

Usual Adult Dose for Chronic Myelogenous Leukemia

Newly-diagnosed:
400 mg orally once daily
Duration of therapy: Until disease progression or patient intolerance

Chronic/accelerated/blast phase:
500 mg orally once daily
Duration of therapy: Until disease progression or patient intolerance

Comments:
-Take this drug with food.
-If a dose is missed beyond 12 hours, the patient should skip the dose and take the usual prescribed dose on the following day.

Uses:
-For newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)
-For chronic phase, accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy

Renal Dose Adjustments

-Moderate (CrCl 30 to 50 mL/min) and severe (CrCl less than 30 mL/min: Reduce the starting dose.
-Severe (CrCl less than 30 mL/min) renal impairment: For patients who have declining renal function who cannot tolerate the starting dose, follow dose adjustment recommendations for toxicity (see Dose Adjustments).

Liver Dose Adjustments

Mild, moderate, or severe (Child-Pugh A, B, or C) hepatic impairment: Reduce the dose (see Dose Adjustments).

Dose Adjustments

DOSE ESCALATION:
-The dose can be escalated by increments of 100 mg once daily to a maximum of 600 mg once daily 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.

NON-HEMATOLOGIC ADVERSE REACTIONS:
Liver Impairment Adjustments:
-Liver transaminases greater than 5 times the upper limit of normal (5 x ULN): Withhold therapy until recovery to less than or equal to 2.5 x ULN and resume at 400 mg once daily thereafter. If recovery takes longer than 4 weeks, discontinue therapy.
-Liver transaminases greater than or equal to 3 x ULN concurrently with bilirubin greater than 2 x ULN and alkaline phosphatase less than 2 x ULN (Hy's law case definition): Discontinue therapy
Diarrhea:
-For NCI CTCAE Grade 3 to 4 diarrhea (increase of greater than or equal to 7 stools/day over baseline/pretreatment): Withhold drug until recovery to Grade 1 or less; resume at 400 mg once a day.
Other Moderate or Severe Non-Hematologic Adverse Reactions:
-Withhold therapy until resolved, then consider resuming therapy at a dose 100 mg less once daily.
-If appropriate, consider re-escalating the dose to the starting dose once a day.
-Doses less than 300 mg/day have been used in patients; however, efficacy has not been established

MYELOSUPPRESSION:
-Absolute neutrophil count (ANC less than 1000 x 10(6)/L OR platelets less than 50,000 x 10(6)/L: Withhold therapy until ANC is greater than or equal to 1000 x 10(6)/L and platelets are greater than or equal to 50,000 x 10(6)/L. Resume therapy at the same dose if recovery occurs within 2 weeks. If blood counts remain low for more than 2 weeks, upon recovery, reduce dose by 100 mg and resume therapy. If cytopenia recurs, reduce dose by an additional 100 mg upon recovery and resume therapy. Doses less than 300 mg/day have been used in patients; however, efficacy has not been established.

RECOMMENDED STARTING DOSE for newly-diagnosed chronic phase PH+ CML:
-Normal renal and hepatic function: 400 mg orally daily
-Renal impairment of CrCl 30 to 50 mL/min: 300 mg orally daily
-Renal impairment of CrCl less than 30 mL/min: 200 mg orally once daily
-Hepatic impairment of mild (Child-Pugh A), moderate (Child-Pugh B) or severe (Child-Pugh C): 200 mg orally daily
RECOMMENDED STARTING DOSE for Chronic, accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy:
-Normal renal and hepatic function: 500 mg orally daily
-Renal impairment of CrCl 30 to 50 mL/min: 400 mg orally daily
-Renal impairment of CrCl less than 30 mL/min: 300 mg orally once daily
-Hepatic impairment of mild (Child-Pugh A), moderate (Child-Pugh B) or severe (Child-Pugh C): 200 mg orally daily

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be taken with food.
-Tablets should be swallowed whole and not be broken or cut.

Storage requirements:
-Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

General:
-Procedures for proper disposal of anticancer drugs should be considered.
-Touching or handling crushed or broken tablets should be avoided.
-Any unused product or waste material should be disposed of in accordance with local requirements, or drug take back programs.

Patient advice:
-This drug may cause dizziness, fatigue, visual impairment, and other adverse effects which may impair ability to drive or operate machinery. If affected, avoid such tasks for as long as the side effects persist.
-Due to nausea and vomiting the efficacy of oral contraceptives may be reduced because of inadequate absorption.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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