Pharmacy & Therapeutics - March 2009 - (Page 140) DRUG FORECAST DOSAGE AND ADMINISTRATION Rilonacept is being distributed through two specialty pharmacies, which plan to mail patients a monthly shipment of the drug and the supplies needed for selfinjection. The pharmacies will also provide access to self-injection training and adherence counseling to patients who need those services. Information is available to patients and physicians toll-free at 1-877-REGN-777 (1-877-734-6777). Rilonacept injections should be administered via subcutaneous (SQ) injection. After reconstitution, the final concentration is 80 mg/mL with a volume of 2 mL. The recommended dose, up to 2 mL (160 mg), should be drawn using a 3-mL syringe for SQ injection. Each vial should be used for a single dose only and should be discarded after withdrawal of the drug. Before reconstitution, rilonacept should be refrigerated at 36° to 46°F and stored in the original carton to protect the product from light. After the drug is reconstituted, it may be kept at room temperature. It should be protected from light, and it must be used within three hours.8 In patients 18 years of age and older, rilonacept therapy should be started with a loading dose of 320 mg, delivered as two separate 2-mL (160-mg) injections. These SQ injections are given on the same day at two dif ferent injection sites. Dosing should then be continued with SQ onceweekly injections of 2 mL (160 mg). No dosage adjustments are necessary based on the patient’s sex or advanced age. In pediatric patients 12 to 17 years of age, rilonacept should be started with a loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as one or two SQ injections. If the loading dose is given as two injections, they should be given on the same day at different injection sites. Dosing should be continued with a onceweekly SQ injection of 2.2 mg/kg, up to a maximum of 160 mg (2 mL). Rilonacept should not be given more often than once weekly in either adult or pediatric patients.8 Rilonacept is classified as a Pregnancy Category C agent and should be used during pregnancy only if expected benefits outweigh potential risks to the fetus.8 in one case study of a pediatric patient with FCAS,16 a 50-mg/day SQ dose of anakinra was successful in achieving sustained clinical improvement and a reduction in serum amyloid A and CRP levels. In various studies evaluating anakinra in the treatment of FCAS or Muckle–Wells syndrome, adults were given a dose of 100 mg/day subcutaneously (the recommended dose and schedule for rheumatoid arthritis).13–15 Although anakinra is approved only for rheumatoid arthritis, these studies demonstrated the efficacy of the drug in treating auto-inflammatory diseases. Table 2 shows a cost comparison of rilonacept and anakinra. ALTERNATIVE THERAPIES Colchicine, 1 to 2 mg/day orally, and TNF-α blockers, such as SQ etanercept (Enbrel, Amgen/Wyeth) 25 mg twice weekly, have been ineffective for FCAS and Muckle–Wells syndrome.1 Treatment with high-dose corticosteroids can be beneficial in managing these dis orders, but their long-term use is limited by the adverse effects of these agents. Nonsteroidal anti-inflammatory medications (NSAIDs) can be used to alleviate arthralgias associated with FCAS and Muckle–Wells syndrome, but they do not help with other clinical manifestations.4 Anakinra (Kineret, Biovitrum; formerly, Amgen), an IL-1 receptor antagonist, has been shown to be effective in preventing and decreasing heightened inflammatory response in studies evaluating patients with FCAS or Muckle– Wells syndrome.13–16 This use of anakinra is an off-label treatment option for CAPS disorders.17 Anakinra is not approved for children younger than 18 years of age. However, IMPLICATIONS FOR MANAGED CARE Regeneron has created the Arcalyst Resource Center (ARC) program to support patients throughout the entire reimbursement process.18 Services include finding physicians familiar with diagnosing and treating CAPS, contacting the patient’s insurance companies to conduct benefit investigations to determine coverage, working with physicians to obtain and assist with prior authorization requests and appeals, referring patients to foundations that may assist with high copayments, and helping uninsured patients by evaluating their eligibility for the company’s assistance program that offers the drug free of charge to qualifying patients or by finding alternative coverage for nonqualifying patients. Patients with Medicare prescription drug coverage or other government insurance may also receive assistance, but coverage is specific for each plan.18 Table 2 Cost Comparison of Rilonacept and Anakinra* Agent Rilonacept (Arcalyst) Strength 80-mg/mL vial Recommended Dose Adults: 320-mg loading dose, followed by 160 mg/week subcutaneously Pediatric patients: 4.4 mg/kg loading dose, followed by 2.2 mg/kg per week subcutaneously Anakinra (Kineret) 100-mg/0.67-mL prefilled syringe Adults: 100 mg/day subcutaneously Pediatric patients: not approved in pediatric patients younger than 18 years of age $54 $1,515 AWP (Unit Price) $6,000 Monthly Cost (Adult Dose) $30,000 AWP = average wholesale price. * Unlabeled indication; anakinra is not approved for use in cryopyrin-associated periodic syndromes. Adapted from references 8, 13–16, and 19. 140 P&T® • March 2009 • Vol. 34 No. 3
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