Drug Action
Cemiplimab is a human immunoglobulin G4 monoclonal antibody, which binds to the programmed death-1 (PD-1) receptor thereby potentiating an immune response to tumour cells.
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Drug reference
Cemiplimab is a human immunoglobulin G4 monoclonal antibody, which binds to the programmed death-1 (PD-1) receptor thereby potentiating an immune response to tumour cells.
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Cutaneous squamous cell carcinoma (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 350 mg every 3 weeks, for dose interruption or discontinuation of treatment due to side-effects or infusion-related reactions—consult product literature
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For full details consult product literature.
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Cemiplimab is a biological medicine. Biological medicines must be prescribed and dispensed by brand name, see Biological medicines and Biosimilar medicines, under Guidance on prescribing p. 1; manufacturer advises to record the brand name and batch number after each administration. The manufacturer of Libtayo ® has provided a Risk minimisation materials document for healthcare professionals. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C) and protect from light—consult product literature about storage after preparation of the infusion.
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NICE decisions ▶Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma (August 2019) NICE TA592 Cemiplimab (Libtayo ®) is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced or metastatic cutaneous squamous cell carcinoma in adults when curative surgery or curative radiotherapy is not appropriate. It is recommended only if the conditions in the managed access agreement are followed. Treatment with cemiplimab should be continued until disease progression or for up to 24 months (whichever is sooner). 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/ta592 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2216 The Scottish Medicines Consortium has advised (February 2020) that cemiplimab (Libtayo ®) is accepted for use within NHS Scotland on an interim basis subject to ongoing evaluation and future reassessment. It is used as monotherapy for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. 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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→Appendix 1: monoclonal antibodies
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▶Common or very common Arthralgia. arthritis. asthenia. colitis. diarrhoea. hepatic disorders. hyperthyroidism. hypothyroidism. infusion related reaction. myalgia. pain. pneumonitis. skin reactions. stomatitis ▶Uncommon Adrenal insufficiency. cardiac inflammation. diabetic ketoacidosis. encephalitis. hypophysitis. immune thrombocytopenic purpura. keratitis. meningitis. muscle weakness. myasthenia gravis. nephritis. nerve disorders. nervous system disorders. Sjögren’s syndrome. thyroiditis . type 1 diabetes mellitus. vasculitis ▶Frequency not known Encephalitis non-infective. severe cutaneous adverse reactions (SCARs)
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Manufacturer advises females of childbearing potential should use effective contraception during treatment and for at least 4 months after the last dose. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless potential benefit outweighs risk—no information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises discontinue breast-feeding during treatment and for at least 4 months after stopping—no information available.
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Manufacturer advises monitor for signs and symptoms of infusion- and immune- related side-effects—consult product literature.
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Manufacturer advises for intermittent intravenous infusion, dilute to a concentration between 1 mg/mL and 20 mg/mL with Glucose 5% or Sodium Chloride 0.9%; give over 30 minutes through a low-protein binding in-line or add-on filter (pore size 0.2–5 micron).
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion EXCIPIENTS: May contain L-proline, polysorbates, sucrose A ▶Libtayo (Sanofi) Cemiplimab 50 mg per 1 ml Libtayo 350mg/7ml concentrate for solution for infusion vials | 1 vial P £4,650.00 (Hospital only)
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Risk of immune-related side-effects A patient alert card and patient guide should be provided. Immune system and malignant disease
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350 mg every 3 weeks, for dose interruption or
First-line fragment. Read the complete Indications and Dose section above.
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