Drug Action
Sarilumab is a recombinant human monoclonal antibody that specifically binds to interleukin- 6 receptors and blocks the activity of pro-inflammatory cytokines.
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Drug reference
Sarilumab is a recombinant human monoclonal antibody that specifically binds to interleukin- 6 receptors and blocks the activity of pro-inflammatory cytokines.
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Moderate-to-severe active rheumatoid arthritis in patients who have had an inadequate response to, or are intolerant to one or more disease-modifying anti- rheumatic drugs (as monotherapy or in combination with methotrexate) (specialist use only) ▶BY SUBCUTANEOUS INJECTION ▶Adult: 200 mg every 2 weeks, for dose adjustments due to neutropenia, thrombocytopenia, or liver enzyme elevations—consult product literature
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Do not initiate if absolute neutrophil count less than 2 6 109/litre. do not initiate if platelet count less than 150 6 103/microlitre. do not initiate if serum transaminases (ALT or AST) greater than 1.5 times the upper limit of normal. severe active infection
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Chronic or recurrent infection. elderly (increased risk of infection). history of diverticulitis. history of intestinal ulceration. history of serious or opportunistic infection. predisposition to infection CAUTIONS, FURTHER INFORMATION ▶Infection Manufacturer advises caution in patients who have been exposed to tuberculosis, or who have lived in or travelled to areas of endemic tuberculosis or mycoses. Patients with latent tuberculosis should complete anti- tuberculosis therapy before initiation of sarilumab; consider anti-tuberculosis therapy before initiation of sarilumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for those with a negative test for latent tuberculosis but have risk factors for tuberculosis— consultation with a tuberculosis specialist may be appropriate. Manufacturer advises patients should be brought up-to- date with current immunisation schedule before initiating treatment.
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Manufacturer advises that patients should be evaluated for tuberculosis before treatment.
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Sarilumab 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. 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 outside refrigerator.
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NICE decisions ▶Sarilumab for moderate-to-severe rheumatoid arthritis (November 2017) NICE TA485 Sarilumab, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease- modifying antirheumatic drugs (DMARDs), only if: . disease is severe (a disease activity score [DAS28] of more than 5.1), and . the manufacturer provides sarilumab with the discount agreed in the patient access scheme. Sarilumab, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to or who cannot have other DMARDs, including at least 1 biological DMARD, only if: . disease is severe (a DAS28 of more than 5.1), and . they cannot have rituximab, and . the manufacturer provides sarilumab with the discount agreed in the patient access scheme. Sarilumab can be used as monotherapy for people who cannot take methotrexate because it is contra-indicated or because of intolerance, when the above criteria are met. Sarilumab, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has responded inadequately to rituximab and at least 1 biological DMARD, only if: . disease is severe (a DAS28 of more than 5.1), and . the manufacturer provides sarilumab with the discount agreed in the patient access scheme. Continue treatment only if there is a moderate response measured using European League Against Rheumatism (EULAR) criteria at 6 months after starting therapy. After an initial response within 6 months, withdraw treatment if at least a moderate EULAR response is not maintained. 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/ta485 Scottish Medicines Consortium (SMC) decisions SMC No. 1314/18 The Scottish Medicines Consortium has advised (April 2018) that sarilumab (Kevzara ®) is accepted for restricted use within NHS Scotland for treatment of severely active rheumatoid arthritis (a disease activity score [DAS28] greater than 5.1) that has not responded to intensive therapy with a combination of conventional disease- modifying anti-rheumatic drugs (DMARDs). In patients with severe disease inadequately controlled by a TNF antagonist, it may be used in patients ineligible to receive rituximab. 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 Dyslipidaemia. increased risk of infection. neutropenia. thrombocytopenia ▶Frequency not known Hypersensitivity. skin reactions
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Manufacturer advises effective contraception in women of childbearing potential during treatment and for up to 3 months after treatment.
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Manufacturer advises avoid unless essential—limited information available.
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Manufacturer advises avoid—no information available.
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Manufacturer advises avoid (no information available).
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▶Manufacturer advises monitor for signs and symptoms of infection; monitor neutrophil count 4 to 8 weeks after treatment initiation and according to clinical judgement thereafter—discontinue if absolute neutrophil count less than 0.5 6 109/litre. ▶Manufacturer advises monitor platelet count 4 to 8 weeks after treatment initiation and according to clinical judgement thereafter—discontinue if platelet count less than 50 6 103/microlitre. ▶Manufacturer advises monitor hepatic transaminases (ALT and AST) 4 to 8 weeks after treatment initiation and every 3 months thereafter, and consider other liver function tests if clinically indicated—discontinue if ALT is greater than 5 times the upper limit of normal. ▶Manufacturer advises monitor lipid profile approximately 4 to 8 weeks after treatment initiation and approximately every 6 months thereafter—hyperlipidaemia should be managed according to clinical guidelines.
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Manufacturer advises to avoid injecting into areas of the skin that are tender, damaged, or have bruises or scars; patients may self- administer Kevzara ®, after appropriate training in subcutaneous injection technique.
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There can be variation in the licensing of different medicines containing the same drug. Solution for injection CAUTIONARY AND ADVISORY LABELS 10 ▶Kevzara (Sanofi) A Sarilumab 131.6 mg per 1 ml Kevzara 150mg/1.14ml solution for injection pre-filled syringes | 2 pre-filled disposable injection P £912.25 Kevzara 150mg/1.14ml solution for injection pre-filled pens | 2 pre- filled disposable injection P £912.25 Sarilumab 175 mg per 1 ml Kevzara 200mg/1.14ml solution for injection pre-filled syringes | 2 pre-filled disposable injection P £912.25 Kevzara 200mg/1.14ml solution for injection pre-filled pens | 2 pre- Musculoskeletal system filled disposable injection P £912.25
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Manufacturer advises patients should be advised to seek immediate medical attention if symptoms of a hypersensitivity reaction occur. Self-administration Manufacturer advises patients and their carers should be given training in subcutaneous injection technique if appropriate. Alert card An alert card should be provided. Missed doses Manufacturer advises if a dose is more than 3 days late, the missed dose should not be taken and the next dose should be taken at the normal time.
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200 mg every 2 weeks, for dose adjustments due
First-line fragment. Read the complete Indications and Dose section above.
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