Drug Action
Palbociclib is a highly selective inhibitor of cyclin-dependent kinases 4 and 6, which leads to disruption of cancer cell proliferation.
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Drug reference
Palbociclib is a highly selective inhibitor of cyclin-dependent kinases 4 and 6, which leads to disruption of cancer cell proliferation.
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Locally advanced or metastatic breast cancer (initiated by a specialist) ▶BY MOUTH ▶Adult: 125 mg once daily for 21 consecutive days of repeated 28 day cycles, for dose adjustments due to side-effects—consult product literature Immune system and malignant disease
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DUE TO INTERACTIONS ▶Manufacturer advises if concomitant use with potent CYP3A4 inhibitors is unavoidable, reduce palbociclib dose to 75 mg once daily. If the CYP3A4 inhibitor is stopped, increase the palbociclib dose (after 3–5 half lives of the inhibitor) to the dose used before starting the CYP3A4 inhibitor.
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NICE decisions ▶Palbociclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer (December 2017) NICE TA495 Palbociclib (Ibrance ®), 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. Palbociclib is recommended only if the manufacturer provides it with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta495 ▶Palbociclib with fulvestrant for treating hormone receptor- positive, HER2-negative, advanced breast cancer (January 2020) NICE TA619 Palbociclib (Ibrance ®) 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 people 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 palbociclib 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/ta619 Scottish Medicines Consortium (SMC) decisions SMC No. 1276/17 The Scottish Medicines Consortium has advised (December 2017) that palbociclib (Ibrance ®) is accepted for restricted use within NHS Scotland in combination with an aromatase inhibitor for the first-line treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic 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. SMC No. SMC2149 The Scottish Medicines Consortium has advised (July 2019) that palbociclib (Ibrance ®) is accepted for use within NHS Scotland in combination with fulvestrant in women who have received prior endocrine therapy for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic 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: palbociclib
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▶Common or very common Alopecia. anaemia. appetite decreased. asthenia. diarrhoea. dry eye. epistaxis. excessive tearing. fever. infection. leucopenia. mucositis . nausea. neutropenia. oral disorders. oropharyngeal complaints. skin reactions. taste altered. thrombocytopenia. vision blurred. vomiting SIDE-EFFECTS, FURTHER INFORMATION Side-effects are reported when used in combination with letrozole or fulvestrant.
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Manufacturer advises effective contraception in women of childbearing potential during treatment and for at least 3 weeks after completing treatment. Male patients should use effective contraception during treatment and for at least 14 weeks after completing treatment if their partner is of childbearing potential. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available.
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Manufacturer advises caution in moderate to severe impairment (risk of increased exposure). Dose adjustments Manufacturer advises dose reduction to 75 mg once daily in severe impairment.
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Manufacturer advises caution and monitor closely for signs of toxicity in moderate-to-severe impairment.
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Manufacturer advises monitor full blood count prior to starting therapy, at the start of each cycle, on day 14 of the first 2 cycles and as clinically indicated.
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There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 1, 21, 25 ▶Ibrance (Pfizer Ltd) A Palbociclib 75 mg Ibrance 75mg capsules | 21 capsule P £2,950.00 (Hospital only) | 63 capsule P £8,850.00 (Hospital only) Palbociclib 100 mg Ibrance 100mg capsules | 21 capsule P £2,950.00 (Hospital only) | 63 capsule P £8,850.00 (Hospital only) Palbociclib 125 mg Ibrance 125mg capsules | 21 capsule P £2,950.00 (Hospital only) | 63 capsule P £8,850.00 (Hospital only)
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Missed doses Manufacturer advises to take palbociclib at the same time each day; if a dose is missed, the missed dose should not be taken and the next dose should be taken at the usual time.
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125 mg once daily for 21 consecutive days of
First-line fragment. Read the complete Indications and Dose section above.
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