2 The technology
Marketing authorisation indication
2.1 Kyprolis 'in combination with either lenalidomide and dexamethasone or dexamethasone alone, is indicated for the treatment of adult patients with multiple myeloma who have had at least 1 prior therapy'. [2017]
Adverse reactions
2.2 The most common adverse reactions (in more than 20% of patients) were: anaemia, fatigue, diarrhoea, thrombocytopenia, nausea, pyrexia, dyspnoea, respiratory tract infection, cough and peripheral oedema. For full details of adverse reactions and contraindications, see the summary of product characteristics. [2017]
Dosage in the marketing authorisation
2.3 One cycle of carfilzomib is 28 days. [2017]
In combination with lenalidomide and dexamethasone
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Carfilzomib is given on 2 consecutive days each week for 3 weeks (days 1, 2, 8, 9, 15, and 16), followed by a 12-day rest period (days 17 to 28) for the first 12 cycles.
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From cycle 13, the day 8 and 9 doses of carfilzomib are omitted.
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Carfilzomib is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2.
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If tolerated, the dose should be increased to 27 mg/m2 (maximum dose 60 mg) from day 8 of cycle 1. [2017]
In combination with dexamethasone alone
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Carfilzomib is given on 2 consecutive days each week for 3 weeks (days 1, 2, 8, 9, 15, and 16) followed by a 12-day rest period (days 17 to 28).
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Carfilzomib is administered at a starting dose of 20 mg/m2 (maximum dose 44 mg) in cycle 1 on days 1 and 2.
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If tolerated, the dose should be increased to 56 mg/m2 (maximum dose 123 mg) from day 8 of cycle 1.
For further details, see the summary of product characteristics. [2017]
Price
2.4 The list price of carfilzomib is £1,056 for a 60-mg vial (excluding VAT; Monthly Index of Monthly Specialties online, accessed October 2016). [2017]
In combination with lenalidomide and dexamethasone
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From cycle 1 to 12: £5,127 (no wastage), £6,336 (wastage).
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From cycle 13: £3,418 (no wastage), £4,220 (wastage). [2017]
In combination with dexamethasone alone
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£10,644 (no wastage), £12,627 (wastage).
The company has a commercial arrangement. This makes carfilzomib available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount. [2017]