Drug Action
Ipilimumab is a monoclonal antibody which causes T-cell activation resulting in tumour cell death.
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Drug reference
Ipilimumab is a monoclonal antibody which causes T-cell activation resulting in tumour cell death.
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Melanoma (as monotherapy) (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: 3 mg/kg every 3 weeks for 4 doses, for dose interruption or discontinuation of treatment due to immune-related side-effects—consult product literature Melanoma (in combination with nivolumab) (specialist use only) | Advanced renal cell carcinoma (in combination with nivolumab) (specialist use only) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature)
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For full details consult product literature.
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Infusion- related side-effects have been reported; premedication with paracetamol and an antihistamine is recommended. l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8 °C) and protect from light—consult product literature for further information regarding storage conditions outside refrigerator and after preparation of the infusion.
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NICE decisions ▶Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma (December 2012) NICE TA268 Ipilimumab (Yervoy ®) is recommended as an option for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta268 ▶Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma (July 2014) NICE TA319 Ipilimumab (Yervoy ®) is recommended, within its marketing authorisation, as an option for treating adults with previously untreated advanced (unresectable or metastatic) melanoma, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta319 ▶Nivolumab in combination with ipilimumab for treating advanced melanoma (July 2016) NICE TA400 Nivolumab in combination with ipilimumab (Yervoy ®) is recommended, within its marketing authorisation, as a treatment option for advanced (unresectable or metastatic) melanoma in adults, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta400 ▶Nivolumab with ipilimumab for untreated advanced renal cell carcinoma (May 2019) NICE TA581 Nivolumab in combination with ipilimumab (Yervoy ®) is recommended for use within the Cancer Drugs Fund as an option for adults with untreated advanced renal cell carcinoma that is intermediate- or poor-risk as defined in the International Metastatic Renal Cell Carcinoma Database Consortium criteria. It is recommended only if the conditions in the managed access agreement for nivolumab with ipilimumab are followed. Immune system and malignant disease 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/ta581 Scottish Medicines Consortium (SMC) decisions SMC No. 779/12 The Scottish Medicines Consortium has advised (April 2013) that ipilimumab (Yervoy ®) is accepted for use within NHS Scotland for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior 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. 997/14 The Scottish Medicines Consortium has advised (November 2014) that ipilimumab (Yervoy ®) is accepted for use within NHS Scotland for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults. 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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MHRA/CHM ADVICE: IPILIMUMAB (YERVOY ®): REPORTS OF CYTOMEGALOVIRUS (CMV) GASTROINTESTINAL INFECTION OR REACTIVATION (JANUARY 2019) There have been post-marketing cases of gastrointestinal CMV infection or reactivation in ipilimumab-treated patients reported to have corticosteroid-refractory immune-related colitis, including fatal cases. Patients should be advised to contact their healthcare professional immediately at the onset of symptoms of colitis. Possible causes, including infections, should be investigated; a stool infection work-up should be performed and patients screened for CMV. For patients with corticosteroid-refractory immune-related colitis, use of an additional immunosuppressive agent should only be considered if other causes are excluded using viral PCR on biopsy, and eliminating other viral, bacterial, and parasitic causes.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Alopecia. anaemia. appetite decreased. arthralgia. asthenia. cancer pain. chills. confusion. constipation. cough. dehydration. diarrhoea. dizziness. dyspnoea. electrolyte imbalance. eye discomfort. fever. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headache. hepatic disorders. hypophysitis. hypopituitarism. hypotension. hypothyroidism. influenza like illness. lethargy. lymphopenia. mucositis. muscle complaints. nausea. nerve disorders. night sweats. oedema. pain. skin reactions. vasodilation. vision disorders. vomiting. weight decreased ▶Uncommon Adrenal hypofunction. alkalosis. allergic rhinitis. amenorrhoea. arrhythmias. arthritis. brain oedema. depression. dysarthria. eosinophilia. eye inflammation. glomerulonephritis. haemolytic anaemia. hair colour changes. hypersensitivity. hyperthyroidism. hypogonadism. increased risk of infection. infusion related reaction. libido decreased. meningitis. movement disorders. multi organ failure. muscle weakness. myopathy. nephritis autoimmune. neutropenia. pancreatitis. paraneoplastic syndrome. peripheral ischaemia. polymyalgia rheumatica. psychiatric disorder. pulmonary oedema. renal failure. renal tubular acidosis. respiratory disorders. sepsis. severe cutaneous adverse reactions (SCARs). syncope. systemic inflammatory response syndrome. thrombocytopenia. tremor. tumour lysis syndrome. vascular disorders. vasculitis ▶Rare or very rare Myasthenia gravis. proteinuria. thyroiditis ▶Frequency not known Cytomegalovirus infection reactivation SIDE-EFFECTS, FURTHER INFORMATION A corticosteroid can be used after starting ipilimumab, to treat immune- related reactions.
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Use effective contraception.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution if bilirubin greater than 3 times upper limit of normal range or if transaminases equal to or greater than 5 times upper limit of normal range (limited information available).
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▶Manufacturer advises monitor liver function tests and thyroid function prior to initiation of treatment and before each dose. ▶Manufacturer advises monitor for signs or symptoms of immune-related side-effects and gastrointestinal perforation—consult product literature.
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Manufacturer advises for intravenous infusion, give undiluted or dilute to a concentration of 1–4 mg/mL with Glucose 5% or Sodium Chloride 0.9%; give over 90 minutes.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ELECTROLYTES: May contain Sodium ▶Yervoy (Bristol-Myers Squibb Pharmaceuticals Ltd) Ipilimumab 5 mg per 1 ml Yervoy 50mg/10ml concentrate for solution for infusion vials | 1 vial P £3,750.00 (Hospital only) Yervoy 200mg/40ml concentrate for solution for infusion vials | 1 vial P £15,000.00 (Hospital only)
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3 mg/kg every 3 weeks for 4 doses, for dose
First-line fragment. Read the complete Indications and Dose section above.
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(consult product literature)
First-line fragment. Read the complete Indications and Dose section above.
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