Kineret^® is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). kineret^® can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents (see WARNINGS).

The recommended dose of Kineret^® for the treatment of patients with rheumatoid arthritis is 100 mg/day administered daily by subcutaneous injection. Higher doses did not result in a higher response. The dose should be administered at approximately the same time every day.

Physicians should consider a dose of 100 mg of Kineret^® administered every other day for RA patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance <30 mL/min, as estimated from serum creatinine levels). See CLINICAL PHARCOLOGY, Pharmacokinetics: Patients with Renal Impairment.

Kineret^® is provided in single-use prefilled glass syringes. The needle cover contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance. Instructions on appropriate use should be given by the healthcare provider to the patient or caregiver. Patients or caregivers should not be allowed to administer Kineret^® until the patient or caregiver has demonstrated a thorough understanding of procedures and an ability to inject the product. Afer administration of kineret^® , it is essential to follow the proper procedure for disposal of syringes and needles. See the †?Information for Patients†� insert for detailed instrctions on the handling and injection of Kineret^®

Do not use Kineret^® beyond the expiration date shown on the carton. Visually inspect the solution for particulate matter and discoloration before administration. If particulates or discoloration are observed, the prefilled syringe should not be used.

Administer only one dose (the entire contents of one prefilled glass syringe) per day. Discard any unused portions.

Kineret^® is supplied in single-use preservative free, prefilled glass syringes with 27 gauge needles. Each prefilled glass syringe contains 0.67 mL (100 mg) of anakinra. Kineret^® is dispensed in a 4 x 7 syringe dispensing pack containg 28 syringes (NDC 55513-177- 28).

Storage

Kineret^® should be stored in the refrigerator at 2° to 8° C (36° to 46°F). DO NOT FREZE OR SHAKE. Protect from light.

REFERENCES

1.    Hannum CH, Wilcox CJ, Arend WP, et al. Interleukin- l receptor antagonist activity of a human interleukin- l inhibitor. Nature. 1990; 343:336-40.

2. Van Lent PLEM, Fons AJ, Van De Loo AEM, et al, Major role for interleukin- 1 but not for tumor necrosis factor in early cartilage damage in immune     complex in mice. J Rheumatol. 1995; 22:2250-2258.

3. Deleuran BW, Shu CQ, Field M, et al. Localization of interleukin- l alpha, type 1 interleukin- l receptor and interleukin- l receptor antagonist in the synovial     membrane and cartilage/pannus junction in rheumatoid arthritis. Br J Rheumatol. 1992; 31:801-809.

4. Chomarat P, Vannier E, Dechanet J, et al. Balance of IL- l receptor antagonist/IL-lB in rheumatoid synovium ard its regulation by IL-4 and IL- l0. J     Immunol. 1995; 1432-1439.

5. Firestein GS, Boyle DL, Yu C, et al. Synovial interleukin- l receptor antagonist and interleukin- l balance in rheumatoid arthritis. Arthritis Rheum. 1994;     37:644-652.

7. Bresnihan B, Alvaro-Gracia JM, Cobby M, et al. Treatment of rheumatoid arthritis with recombinant human interleukin-l receptor antagonist. Arthritis     Rheum. 1998; 41:2196-2204.

8. Sharp JT, Young DY, Bluhm GB, et al. How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess     rheumatoid arthritis? Arthritis Rheum. 1985; 28:1326- 1335.

9. National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 11 Registries, 1992-1999.

This product, its production, and/or its use may be covered by one or more U. S. Patents, including U.S. Patent Nos. 6 ,599,873 and 5,075 222 as well as other patents or patents pending.

AMGN^® Manufactured by: Amgen Manufactung, Limited a subsidiar of Amgen Inc One Amgen Center Drive Thousand Oaks, CA 91320-1799 ©2001 Amgen.
Rev. 4/23/04

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