Sarilumab


Concise Prescribing Info
Indications/Uses
Rheumatoid arthritis.
Dosage/Direction for Use
Adult : SC Rheumatoid arthritis As monotherapy or adjunctive therapy with methotrexate or nonbiologic antirheumatics: 200 mg once every 2 weeks.
Dosage Details
Subcutaneous
Rheumatoid arthritis
Adult: 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.
Contraindications
Active severe infections, including localised infections. Combination with biologic antirheumatics (e.g. anakinra, etanercept, rituximab) and concurrent administration of live vaccines.
Special Precautions
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.
Adverse Reactions
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).
MonitoringParameters
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.
Drug Interactions
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.
Action
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.
Storage
Store between 2-8°C. Do not freeze. Protect from light.
MIMS Class
ATC Classification
L04AC14 - sarilumab ; Belongs to the class of interleukin inhibitors. Used as immunosuppressants.
References
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.

Disclaimer: This information is independently developed by MIMS based on Sarilumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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