SubcutaneousRheumatoid arthritisAdult: In moderately to severely active RA in patients who have inadequate response or intolerance to 1 or more DMARDs: As monotherapy or adjunctive therapy with methotrexate or nonbiologic DMARD: 200 mg once every 2 weeks. Delay therapy if absolute neutrophil count (ANC) <2,000 cells/mm3; platelet <150,000 cells/mm3; ALT/AST >1.5 times the upper limit of normal (ULN). Interrupt dosing if ANC 500-1,000 cells/mm3; platelet count 50,000-100,000 cells/mm3; ALT >3-5 times the ULN. Restart therapy with normalised values: Initially, 150 mg once every 2 weeks, may be titrated according to clinical response. Discontinue treatment if ANC <500 cells/mm3; platelet <50,000 cells/mm3; ALT >5 times the ULN.
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Active severe infections, including localised infections. Combination with biologic antirheumatics (e.g. anakinra, etanercept, rituximab) and concurrent administration of live vaccines.
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Patients with chronic or recurrent infections, opportunistic infection, history of exposure to latent or active TB, underlying conditions predisposing to infection, diverticulitis or gastrointestinal ulceration, significantly compromised immune system. Patients residing in or travelling to areas with endemic TB or endemic mycoses. Hepatic impairment. Pregnancy and lactation.
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Significant: Risk of malignancy, upper respiratory tract infection, UTI, oral herpes, neutropenia, leucopenia, thrombocytopenia, increased hepatic transaminases. Rarely, gastrointestinal perforation.
General disorders and admin site conditions: Injection site reactions (e.g. erythema, pruritus).
Immune system disorders: Hypersensitivity reactions.
Metabolism and nutrition disorders: Hypercholesterolaemia, hypertriglyceridaemia.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis.
Potentially Fatal: Serious infections (e.g. cellulitis, pneumonia, pulmonary or extrapulmonary TB, candidiasis, pneumocystis, herpes zoster). Rarely, progressive multifocal leukoencephalopathy (PML).
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Monitor neutrophils, platelets, ALT/AST (prior to therapy and periodically thereafter), serum bilirubin as clinically necessary; lipid panel (4-8 weeks after initiation and approx every 6 months during therapy). Conduct latent TB screening prior to and periodically after therapy initiation. Monitor closely for signs or symptoms of infection. Assess for signs of allergic, infusion-related or cytokine-release reactions, and gastrointestinal perforation.
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May alter the serum concentration of CYP3A4 substrates with narrow therapeutic index (e.g. warfarin, theophylline). May reduce therapeutic efficacy of oral contraceptives, and statins (e.g. atorvastatin, lovastatin, simvastatin). Concomitant use with NSAIDs or corticosteroids may increase risk for gastrointestinal perforation.
Potentially Fatal: Combination with biologic antirheumatics (e.g. anakinra, etanercept, rituximab) may increase immunosuppression and risk of serious infection (e.g. aspergillosis, histoplasmosis, cryptococcus). Increased risk of infections with concurrent administration of live vaccines.
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Description: Sarilumab is a recombinant human immunoglobulin G1 kappa (IgG1k) monoclonal antibody that specifically binds to both soluble and membrane-bound cytokine interleukin-6 receptors (IL-6Rα), thereby inhibiting IL-6-mediated signalling that leads to a reduction in inflammatory mediator production.
Pharmacokinetics:
Absorption: Bioavailability: Approx 80%. Time to peak plasma concentration: 2-4 days.
Distribution: Crosses placenta.
Excretion: Undergoes biphasic elimination (parallel linear and non-linear) from the circulation. Parallel linear elimination: Initial half-life: 8-10 days. Effective half-life: 21 days.
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Store between 2-8°C. Do not freeze. Protect from light.
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L04AC14 - sarilumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
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Anon. Sarilumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 07/03/2019. Anon. Sarilumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/03/2019. Buckingham R (ed). Sarilumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2019. Joint Formulary Committee. Sarilumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/03/2019. KEVZARA Injection, Solution (Sanofi-aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/03/2019.
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