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Included as part of the PRECAUTIONS section.

Serious Infections

Kineret has been associated with an increased incidence of serious infections (2%) vs. Placebo ( < 1%) in clinical trials. 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.

Use With TNF Blocking Agents

In a 24-week study of concurrent Kineret and etanercept therapy, 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 etanercept alone [see clinical studies]. Use of Kineret in combination with TNF blocking agents is not recommended.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported with Kineret. If a severe hypersensitivity reaction occurs, administration of Kineret should be discontinued and appropriate therapy initiated.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.

Immunosuppression

The impact of treatment with Kineret on active and/or chronic infections and the development of malignancies is not known [see ADVERSE REACTIONS].

Immunizations

In a placebo-controlled clinical trial (n = 126), no difference was detected in anti-tetanus antibody response between the Kineret and placebo treatment groups when the tetanus/diphtheria toxoids vaccine was administered concurrently with Kineret. No data are available on the effects of vaccination with other inactivated antigens in patients receiving Kineret. No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving Kineret. Therefore, live vaccines should not be given concurrently with Kineret.

Neutrophil Count

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 one 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 (6): 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.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

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.

Use In Specific Populations

Pregnancy

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

Kineret was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course Juvenile Rheumatoid Arthritis (JRA; ages 2-17 years) receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg. The 50 patients who achieved a clinical response after a 12-week open-label run-in were randomized to Kineret (25 patients) or placebo (25 patients), administered daily for an additional 16 weeks. A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study. An adverse event profile similar to that seen in adult RA patients was observed in these studies. These study data are insufficient to demonstrate efficacy and the prefilled syringes do not permit accurate dosing lower than 100 mg. Therefore, Kineret is not recommended for pediatric use.

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.

Renal Impairment

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 [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

No formal studies have been conducted examining the pharmacokinetics of Kineret administered subcutaneously in rheumatoid arthritis patients with hepatic impairment.

Last reviewed on RxList: 10/7/2011
This monograph has been modified to include the generic and brand name in many instances.