compared with subjects without RA Blockade of IL-6 signaling by IL-6 antagonists (eg, sarilumab) might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to decreased drug concentrations Caution when initiating or discontinuing sarilumab if coadministered with CYP450 substrates, especially those with a narrow therapeutic index Biological DMARDs Avoid coadministering with biological DMARDs (eg, TNF antagonists, IL-1R antagonists, antiCD20 monoclonal antibodies, JAK inhibitors, selective costimulation modulators) because of increased risk for immunosuppression and infection Coadministration with biological DMARDs has not been studied Pregnancy Limited human data in pregnant women are not sufficient to inform drug-associated risk for major birth defects and miscarriage Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed in utero From the animal data, and consistent with the mechanism of action, levels of IgG, in response to antigen challenge, may be reduced in the fetus/infant of treated mothers Pregnancy registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to sarilumab during pregnancy Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972 Lactation Unknown if distributed in human breast milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Human monoclonal antibody that binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors IL-6 is produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes (eg, rheumatoid arthritis) IL-6 is a pleiotropic proinflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts IL-6 has been shown to be involved in diverse physiological processes (eg, T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute-phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation Absorption Peak plasma time: 2-4 days Peak plasma concentration: 20 mg/L (150 mg SC q2Weeks); 35.6 mg/L (200 mg SC q2Weeks) Minimum plasma concentration: 6.35 mg/L (150 mg SC q2Weeks); 16.5 mg/L (200 mg SC q2Weeks) AUC: 202 mg·day/L (150 mg SC q2Weeks); 395 mg·day/L (200 mg SC q2Weeks) Steady state: Reached in 14-16 weeks Distribution Vd: 7.3 L Metabolism Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG Elimination Half-life: 10 days (200 mg q2wk); 8 days (150 mg q2wk) Excretion: Monoclonal antibodies are not eliminated via renal or hepatic pathways SC Preparation Remove from refrigerator and allow to sit at room temperature for 30 minutes (prefilled syringes) or 60 minutes (prefilled pen) y Visually inspect syringe for particulate matter and discoloration prior to administration Solution should be clear and colorless to pale yellow; do not use if the solution is cloudy, discolored, or contains particles, or if any part of the prefilled syringe appears to be damaged SC Administration Patient may self-inject or the patient's caregiver may administer after properly instructed Instruct patients to inject the full amount in the syringe (1.14 mL), which provides 200 mg or 150 mg Rotate injection sites with each injection; do not inject into skin that is tender, damaged, or has bruises or scars Do not rub the injection site Storage Refrigerate at 36-46°F (2-8°C) in original carton to protect from light Do not freeze If needed, may store at room temperature up to 77°F (25°C) up to 14 days in the outer carton; do not store above 77°F (25°C) BRAND FORM. UNIT PRICE PILL IMAGE Kevzara subcutaneous- 200 mg/1.14 mL injectionCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. QL Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered. ST Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription. OR Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription. 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