KINERET^® HAS BEEN ASSOCIATED WITH AN INCREASED INCIDENCE OF SERIOUS INFECTIONS (2%) VS. PLACEBO (<1%). ADMINISTRATION OF KINERET^® SHOULD BE DISCONTINUED IF A PATIENT DEVELOPS A SERIOUS INFECTION. TREATMENT WITH KINERET^® SHOULD NOT BE INITIATED IN PATIENTS WITH ACTIVE INFECTIONS. THE SAFETY AND EFFICACY OF KINERET^® IN IMMUNOSUPPRESSED PATIENTS OR IN PATIENTS WITH CHRONIC INFECTIONS HAVE NOT BEEN EVALUATED.

IN A 24-WEEK STUDY OF CONCURRENT KINERET^® AND ETANERCEPT THERAY, THE RATE OF SERIOUS INFECTIONS IN THE COMBINATION ARM (7%) WAS HIGHER THAN WITH ETANERCEPT ALONE (0%). THE COMBINATION OF KINERET^® AND ETANERCEPT DID NOT RESULT IN HIGHER ACR RESPONSE RATES COMPARED TO ETANRCEPT ALONE. (see CLINICAL STUDIES). CONCURRENT THERAY WITH KINERET^® AND ETANERCKPT IS NOT RECOMMENDED.

General

Hypersensitivity reactions associated with Kineret^® administration are rare. If a severe hypersensitivity reaction occurs, administration of Kineret^® should be discontinued and appropriate therapy initiated.

Immunosuppression

The impact of treatment with Kineret^® on active and/or chronic infections and the development of malignancies is not known (see WARNINGS and ADVERSE REACTIONS: Infections and Malignancies).

Immunizations

No data are available on the effects of vaccination in patients receiving kineret^®. Live vaccines should not be given concurrently with Kineret^®. No data are available on the secondary transmission of infection by live vaccines in patients receiving kineret^® (see PRECAUTIONS: Immunosuppression). Since Kineret^® interferes with normal immune response mechanisms to new antigens such as vaccines, vaccination may not be effective in patients receiving kineret^®.

Laboratory Tests

Patients receiving Kineret^® may experience a decrease in neutrophil counts. In the placebo-controlled studies, 8% of patients receiving kineret^® had decreases in neutrophil counts of at least 1 World Health Organization (WHO) toxicity grade compared with 2% in the placebo control group. Nine kineret^®- treated patients (0.4%) experienced neutropenia (ANC <1 x 10⁹/L). This is discussed in more detail in the ADVERSE REACTIONS: Hematologic Events section.Neutrophil counts should be assessed prior to initiating Kineret^® treatment, and while receiving Kineret^® , monthly for 3 months, and thereafter quarterly for a period up to 1 year.

Carcinogenesis, Mutagenesis, and Impairment of Fertilty

Kineret^® has not been evaluated for its carcinogenic potential in animals. Using a standard in vivo and in vitro battery of mutagenesis assays, Kineret^® did not induce gene mutations in either bacteria or mammalian cells. In rats and rabbits, kineret^® at doses of up to 100- fold greater than the human dose had no adverse effects on male or female fertility.

Pregnancy Category B

Reproductive studies have been conducted with Kineret^® on rats and rabbits at doses up to 100 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Kineret^® should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether Kineret^® is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised if Kineret^® is administered to nursing women.

Pediatric Use

The safety and efficacy of Kineret^® in patients with juvenile rheumatoid arthritis (JRA) have not been established.

Geriatric Use

A total of 752 patients ≥65 years of age, including 163 patients ≥75 years of age, were studied in clinical trials. No differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

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