SubcutaneousRheumatoid arthritisAdult: For moderately to severely active cases in patients who have inadequate response or intolerance to 1 or more DMARDs: As monotherapy or in combination with methotrexate or nonbiologic DMARDs: 200 mg once every 2 weeks. Do not start the therapy if the baseline ANC is <2,000 cells/mm3; platelets <150,000 cells/mm3; ALT/AST >1.5 times the ULN. Dose reduction, dosing interruption or discontinuation may be required according to individual safety or tolerability (refer to detailed product guideline).
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Active infections, including localised infections. Concurrent administration of live vaccines, and use in combination with biologic DMARDs (e.g. etanercept, anakinra, rituximab).
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Patient with chronic or recurrent infections, history of serious or opportunistic infection, underlying conditions predisposing to infection, HIV infection; history of diverticulitis or gastrointestinal ulceration. Patients exposed to TB and those who resided in or travelled to areas with endemic TB or mycoses. Hepatic impairment. Elderly. Pregnancy and lactation.
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Significant: Gastrointestinal perforation, haematological effects (e.g. neutropenia, thrombocytopenia), viral reactivation (e.g. herpes zoster), increased risk of malignancy; increased hepatic transaminase levels; increased triglycerides, LDL and HDL levels; hypersensitivity reactions, including anaphylaxis, rash, urticaria, and inj site rash.
Blood and lymphatic system disorders: Leucopenia.
Gastrointestinal disorders: Oral herpes simplex infection.
General disorders and administration site conditions: Inj site reactions (e.g. pruritus, erythema).
Immune system disorders: Antibody development.
Renal and urinary disorders: UTI.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, URTI.
Potentially Fatal: Serious infections (e.g. active pulmonary or extrapulmonary TB [including reactivation of latent TB], invasive fungal infections [e.g. candidiasis, pneumocystis], bacterial [e.g. pneumonia, cellulitis], viral, and other opportunistic infections).
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Women of childbearing potential must use proven birth control methods during therapy and up to 3 months after stopping the treatment. Consider using other reliable contraceptive methods recommended by the doctor as oral contraceptives may be ineffective.
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Assess for TB risk factors and perform latent TB screening prior to initiation of therapy. Monitor neutrophils, platelets, ALT/AST prior to therapy, then 4-8 weeks after treatment initiation, and every 3 months thereafter; LFT, serum bilirubin (as clinically necessary); lipid panel (4-8 weeks after initiation and approx every 6 months during therapy). Monitor for signs or symptoms of infection (including TB) before, during, and after therapy; hypersensitivity reaction, and gastrointestinal perforation.
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May alter the serum concentrations of CYP substrates with narrow therapeutic index (e.g. warfarin, theophylline). May reduce the exposure and effectiveness of oral contraceptives and statins (e.g. simvastatin, atorvastatin, lovastatin). May increase the risk of gastrointestinal perforation when given with NSAIDs or corticosteroids.
Potentially Fatal: Increased risk of immunosuppression and infection with biologic DMARDs (e.g. etanercept, anakinra, rituximab). Increased risk of infections with concurrent administration of live vaccines.
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Description:
Mechanism of Action: Sarilumab is a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody which specifically binds to both soluble and membrane-bound interleukin-6 (IL-6) receptors, thereby inhibiting pro-inflammatory cytokine IL-6 signalling pathway leading to a reduction in inflammatory mediator production.
Pharmacokinetics:
Absorption: Absolute bioavailability: Approx 80% (SC). Time to peak plasma concentration: 2-4 days.
Distribution: Crosses the placenta.
Excretion: Via linear, non-saturable proteolytic pathway at high concentrations; non-linear saturable proteolytic pathway predominates at low concentrations. Parallel elimination half-life: 8-10 days (initial half-life); 21 days (effective half-life).
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Store between 2-8°C. Do not freeze or shake. Protect from light. May store below 25°C for up to 14 days, if necessary.
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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 01/02/2023. Anon. Sarilumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/02/2023. Buckingham R (ed). Sarilumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/02/2023. Joint Formulary Committee. Sarilumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/02/2023. Kevzara 150 mg Solution for Injection in Pre-filled Pen (Aventis Pharma Ltd, Trading as Sanofi Genzyme). MHRA. https://products.mhra.gov.uk. Accessed 01/02/2023. Kevzara 200 mg Solution for Injection in Pre-filled Syringe (Aventis Pharma Ltd, Trading as Sanofi Genzyme). MHRA. https://products.mhra.gov.uk. Accessed 01/02/2023. Kevzara Injection, Solution (Sanofi-Aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/02/2023.
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