Drug Action
Ribociclib is an inhibitor of cyclin- dependent kinases 4 and 6, which are involved in cancer cell proliferation; their inhibition results in prevention of cancer cell growth.
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Drug reference
Ribociclib is an inhibitor of cyclin- dependent kinases 4 and 6, which are involved in cancer cell proliferation; their inhibition results in prevention of cancer cell growth.
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Locally advanced or metastatic breast cancer (specialist use only) ▶BY MOUTH ▶Adult: 600 mg once daily for 21 consecutive days of repeated 28 day cycles, to be taken at approximately the same time each day, preferably in the morning, for dose adjustments due to side-effects—consult product literature
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DUE TO INTERACTIONS ▶Manufacturer advises if concurrent use of potent inhibitors of CYP3A4 is unavoidable, reduce dose to 400 mg once daily; in those already taking 400 mg once daily, reduce dose to 200 mg once daily.
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Pre-existing QTc prolongation. risk factors for QTc prolongation (including concomitant use of drugs known to prolong QTc interval)
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Contra-indicated in patients with hypersensitivity to peanut or soya products.
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NICE decisions ▶Ribociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (December 2017) NICE TA496 Ribociclib, with an aromatase inhibitor, is recommended within its marketing authorisation, as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in adults. Ribociclib is recommended only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta496 ▶Ribociclib with fulvestrant for treating hormone receptor- positive, HER2-negative, advanced breast cancer (August 2019) NICE TA593 Ribociclib (Kisqali ®) with fulvestrant is recommended for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in patients who have had previous endocrine therapy only if: . exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor, and . the conditions in the managed access agreement for ribociclib with fulvestrant are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta593 Scottish Medicines Consortium (SMC) decisions SMC No. 1295/18 The Scottish Medicines Consortium has advised (March 2018) that ribociclib (Kisqali ®) is accepted for use within NHS Scotland in combination with an aromatase inhibitor, for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer as initial endocrine-based therapy. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. SMC No. SMC2198 The Scottish Medicines Consortium has advised (November 2019) that ribociclib (Kisqali ®) in combination with fulvestrant, is accepted for restricted use within NHS Scotland for the treatment of hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, in women who have relapsed on or within 12 months of completing (neo) adjuvant endocrine therapy, or have progressed on first-line endocrine-based therapy for advanced breast cancer. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: ribociclib
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▶Common or very common Alopecia. anaemia. appetite decreased. asthenia. back pain. constipation. cough. decreased leucocytes. diarrhoea. dizziness. dry eye. dry mouth. dyspnoea. electrolyte imbalance. excessive tearing. fever. gastrointestinal discomfort. headache. hepatic disorders. increased risk of infection. nausea. neutropenia. oropharyngeal pain. peripheral oedema. QT interval prolongation. sepsis. skin reactions. stomatitis. syncope. taste altered. thrombocytopenia. vertigo. vomiting
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Manufacturer advises caution in moderate to severe impairment (risk of increased exposure). Dose adjustments Manufacturer advises initial dose reduction to 400 mg once daily in moderate to severe impairment.
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Manufacturer advises use with caution in severe renal impairment—limited information available.
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▶Manufacturer advises to perform full blood counts and liver function tests before initiating treatment, every 2 weeks for the first 2 cycles, at the beginning of the subsequent 4 cycles, and then as clinically indicated thereafter. ▶Manufacturer advises to assess ECG before initiating treatment (only initiate treatment in patients with QTcF values <450 milliseconds); ECG should be repeated at approx. day 14 of the first cycle and at the beginning of the second cycle, then as clinically indicated. ▶Manufacturer advises to monitor serum electrolytes (including potassium, calcium, phosphorus and magnesium) before initiating treatment, at the beginning of the first 6 cycles and then as clinically indicated; any abnormality should be corrected before initiating treatment.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 3, 25 ▶Kisqali (Novartis Pharmaceuticals UK Ltd) A Ribociclib (as Ribociclib succinate) 200 mg Kisqali 200mg tablets | 21 tablet P £983.33 | 42 tablet P £1,966.67 | 63 tablet P £2,950.00
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600 mg once daily for 21 consecutive days of
First-line fragment. Read the complete Indications and Dose section above.
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