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PharmaCare has Kineret^TM in stock and is prepared to assist you with paperwork and phone calls necessary to initiate appropriate therapy. For immediate pharmacy enrollment, please call 1-800-238-7828.

Full product information is available by calling toll-free 1-800-238-7828 or by visiting Amgen's site.

PRODUCT INFORMATION
The U.S. Food and Drug Administration has granted approval of Kineret (anakinra), an injection for the reduction in signs and symptoms of moderate to severe rheumatoid arthritis (RA) in patients who have failed one or more disease modifying anti-rheumatic drugs (DMARDs). Kineret can be used alone or in combination with other DMARDs, except for Tumor Necrosis Factor blocking agents. Kineret is the first direct and selective blocker of interleukin-1 (IL-1). By blocking IL-1, Kineret reduces the inflammatory response and tissue destruction in RA.

CLINICAL TRIALS

• The safety and efficacy of Kineret has been evaluated in three randomized, multi-center, double-blinded, placebo-controlled clinical trials in patients with active RA. Kineret's approval is based on improvements in signs and symptoms of RA, assessed by using the American College of Rheumatology (ACR) response criteria (ACR2₀, ACR₅₀ and ACR₇₀).
• In one study (n=501), patients had been stabilized on methotrexate therapy prior to initiation of either Kineret or placebo. Analysis showed an increase in the number of patients attaining an ACR₂₀, ACR₅₀ and ACR₇₀ response at 6 months with Kineret compared to placebo-treated patients (p<0.001, p<0.01 and p<0.05, respectively).
• In another trial (n=419), Kineret was evaluated in patients who received no DMARDs in the 6 weeks prior to study initiation or during the study. The results showed that more Kineret-treated patients attained an ACR₂₀ and ACR₅₀ response at 6 months compared to placebo-treated patients (p<0.05).

MECHANISM OF ACTION
Kineret is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1 Ra) that inhibits the activity of IL-1 by competitively inhibiting IL-1 binding to the IL-1 type 1 receptor found in many tissue types. IL-1 plays an important role in the pathophysiology of RA by causing cartilage destruction by inducing the loss of proteoglycans and stimulating bone resorption. Inhibition of IL-1 leads to the therapeutic effects of Kineret, namely reduced joint pain, swelling, bone erosion and cartilage damage.

DOSAGE AND ADMINISTRATION
The recommended dose of Kineret is 100 mg administered daily by subcutaneous injection at approximately the same time each day.

ADVERSE REACTIONS
The most commonly reported adverse events in patients receiving Kineret during clinical trials were mild injection site reactions such as erythema, ecchymosis, inflammation, and pain. Serious adverse reactions include serious infections and neutropenia, especially when combined with TNF blocking medication. Infections occurred in 40% of Kineret patients in two clinical trials combined versus 35% in placebo patients. Furthermore, serious infections occurred more often in patients receiving Kineret (1.8% in Kineret-treated patients compared to 0.6% in placebo-treated patients at 6 months) and consisted mostly of pneumonia, cellulitis, and bone and joint infections. Neutropenia (8% overall) occurred more often when Kineret was used in combination with etanercept (Enbrel®). It is recommended that Kineret only be used in combination with TNF-blocking agents with extreme caution and when no satisfactory alternatives exist.

AVAILABILITY AND STORAGE
Kineret is available in a sterile single-use preservative-free. 1 mL prefilled glass syringe with a 27 gauge needle. Each prefilled syringe contains 0.67 mL (100 mg) of anakinra. Kineret is dispensed in packs containing 7 syringes and is also available in a 4x7 syringe dispensing pack (28 syringes). Kineret should be stored in the refrigerator at 2° to 8° C (36°- 46° F). Do not freeze or shake Kineret.

PharmaCare understands the demand for this product in the marketplace. Helping to make the hard-to-find oral and injectable medications easily accessible and providing quality pharmacy care around new drug therapies are two extra ways that PharmaCare goes the extra mile to support your practice and patients. PharmaCare is the nation's leading specialty pharmaceutical provider with over 11,000 contracted insurance plans, clinically-trained pharmacists and nationwide delivery to your office or patient's home at no additional charge. Choose PharmaCare as the Kineret Pharmacy for your patients.

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