Drug reference

Bosutinib

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1045, 1046

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

Previously treated chronic, accelerated and blast phase Immune system and malignant disease Philadelphia chromosome-positive chronic myeloid leukaemia (specialist use only) ▶BY MOUTH ▶Adult: 500 mg once daily, consult product literature for dose adjustment due to side-effects, or incomplete haematologic response by week 8, or incomplete cytogenetic response by week 12 Newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia (specialist use only) ▶BY MOUTH ▶Adult: 400 mg once daily, consult product literature for dose adjustment due to side-effects, or failure to demonstrate breakpoint cluster region-Abelson (BCR- ABL) transcripts 10% by month 3

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Cautions

Cardiac disease. hepatitis B infection. history of pancreatitis—withhold treatment if lipase elevated and abdominal symptoms occur. history of QT prolongation— monitor ECG and correct hypokalaemia and hypomagnesaemia before and during treatment. recent cardiac event—monitor ECG and correct hypokalaemia and hypomagnesaemia before and during treatment. risk factors for QT prolongation—monitor ECG and correct hypokalaemia and hypomagnesaemia before and during treatment. signiﬁcant gastrointestinal disorder CAUTIONS, FURTHER INFORMATION ▶Hepatitis B infection The MHRA advises that patients who are carriers of hepatitis B virus should be closely monitored for signs and symptoms of active infection throughout treatment and for several months after stopping treatment; expert advice should be sought for patients who test positive for hepatitis B virus and in those with active infection.

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National Funding Access Decisions

NICE decisions ▶Bosutinib for previously treated chronic myeloid leukaemia (August 2016) NICE TA401 Bosutinib (Bosulif ®) is recommended as a treatment option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia-chromosome- positive CML in adults, when: . they have previously been treated with 1 or more tyrosine kinase inhibitor, and . imatinib, nilotinib and dasatinib are not appropriate, and . the manufacturer provides bosutinib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta401

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Safety

Important Safety Information

RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938. MHRA/CHM ADVICE (MAY 2016): RISK OF HEPATITIS B VIRUS REACTIVATION WITH BCR-ABL TYROSINE KINASE INHIBITORS An EU wide review has concluded that bosutinib can cause hepatitis B reactivation; the MHRA recommends establishing hepatitis B virus status in all patients before initiation of treatment.

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Interactions

→Appendix 1: bosutinib

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Side Effects

▶Common or very common Anaemia. appetite decreased. arthralgia. asthenia. chest discomfort. cough. dehydration. diarrhoea. dizziness. dyspnoea. electrolyte imbalance. fever. gastritis. gastrointestinal discomfort. haemorrhage. headache. hepatic disorders. hyperbilirubinaemia. hyperlipasaemia. hypertension. increased risk of infection. leucopenia. long QT syndrome . malaise. myalgia. nausea. neutropenia. oedema. pain. pericardial effusion. QT interval prolongation. renal impairment. respiratory disorders. skin reactions. taste altered. thrombocytopenia. tinnitus. vomiting ▶Uncommon Pancreatitis. pericarditis. pulmonary hypertension. pulmonary oedema. tumour lysis syndrome ▶Frequency not known Hepatitis B reactivation. severe cutaneous adverse reactions (SCARs)

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Conception And Contraception

Effective contraception required during treatment in women.

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Pregnancy

Avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

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Breast Feeding

Manufacturer advises avoid—no information available.

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Hepatic Impairment

Manufacturer advises avoid. Immune system and malignant disease

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Renal Impairment

Dose adjustments For chronic, accelerated and blast phase Philadelphia chromosome-positive chronic myeloid leukaemia, manufacturer advises reduce dose to 400 mg in moderate impairment; reduce dose to 300 mg in severe impairment; consult product literature for dose adjustment due to side-effects, or incomplete haematological, cytogenetic, or molecular response. For newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia, manufacturer advises reduce dose to 300 mg in moderate impairment; reduce dose to 200 mg in severe impairment; consult product literature for dose adjustment due to side- effects, or incomplete haematological, cytogenetic, or molecular response.

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Monitoring Requirements

▶Manufacturer advises monitor liver function before treatment initiation, then monthly for the ﬁrst 3 months and thereafter as clinically indicated—consult product literature for management of raised transaminases. ▶Manufacturer advises monitor full blood count weekly for the ﬁrst month and then monthly thereafter or as clinically indicated. ▶Manufacturer advises monitor for signs and symptoms of ﬂuid retention (including pericardial effusion, pleural effusion and pulmonary oedema).

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Dose and formulations

Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ▶Bosulif (Pfizer Ltd) A Bosutinib 100 mg Bosulif 100mg tablets | 28 tablet P £859.17 (Hospital only) Bosutinib 400 mg Bosulif 400mg tablets | 28 tablet P £3,436.67 (Hospital only) Bosutinib 500 mg Bosulif 500mg tablets | 28 tablet P £3,436.67 (Hospital only)

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Dose text by age group

Adult

500 mg once daily, consult product literature for

First-line fragment. Read the complete Indications and Dose section above.

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Adult

400 mg once daily, consult product literature for

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1045

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Bosutinib

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1045, 1046

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 1045

Cautions

PDF page 1045

National Funding Access Decisions

PDF page 1046

Safety

Important Safety Information

PDF page 1045

Interactions

→Appendix 1: bosutinib

PDF page 1045

Side Effects

PDF pages 1045, 1046

Conception And Contraception

Effective contraception required during treatment in women.

PDF page 1046

Pregnancy

Avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.

PDF page 1046

Breast Feeding

Manufacturer advises avoid—no information available.

PDF page 1046

Hepatic Impairment

Manufacturer advises avoid. Immune system and malignant disease

PDF page 1046

Renal Impairment

PDF page 1046

Monitoring Requirements

PDF page 1046

Dose and formulations

Medicinal Forms

PDF page 1046

Dose text by age group

Adult

500 mg once daily, consult product literature for

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1045

Adult

400 mg once daily, consult product literature for

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1045

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.