Kineret (anakinra)
Kineret 100 MG in 0.67 ML Prefilled Syringe
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Kineret FAQs
Is KINERET safe to use during pregnancy?The available data from retrospective studies and case reports on KINERET use in pregnant women are insufficient to identify a drug associated risk of major birth defects, miscarriage, or maternal and fetal adverse events. In animal reproduction studies, subcutaneous administration of anakinra to pregnant rats and rabbits during organogenesis demonstrated no evidence of fetal harm at doses up to 25 times the maximum recommended human dose (MRHD). However, there are risks to the mother and fetus associated with active rheumatoid arthritis or Cryopyrin-Associated Periodic Syndromes (CAPS). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
Are there any considerations to keep in mind when using KINERET during pregnancy?Published data suggest the risk of adverse pregnancy outcomes in women with rheumatoid arthritis or CAPS is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (<2500 grams), and small for gestational age at birth. Overall, these data cannot definitively establish or exclude any anakinra-associated risks during pregnancy. Methodological limitations of these data include small sample size and the inability to control for confounders such as the timing of drug exposure, underlying maternal disease, and concomitant medication use.
Is it safe to use KINERET while breastfeeding?There are no data on the presence of anakinra in either human or animal milk or the effects on milk production. Available published data from a small retrospective study and postmarketing case reports do not establish an association between maternal anakinra use during lactation and adverse effects on breastfed infants. The limited clinical data during lactation precludes a clear determination of the risk of KINERET to an infant during lactation. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KINERET and any potential adverse effects on the breastfed infant from KINERET or from the underlying maternal condition.
Can KINERET be used in pediatric patients?KINERET has been studied in Neonatal-Onset Multisystem Inflammatory Disease (NOMID) and Deficiency of Interleukin-1 Receptor Antagonist (DIRA) patients. In the NOMID study, KINERET was administered to 36 pediatric patients, with an average maintenance dose of 3–4 mg/kg/day. In the DIRA study, KINERET was administered to 9 pediatric patients, with starting doses of 1 to 2 mg/kg/day and doses up to 7.5 mg/kg/day. However, the safety and effectiveness of KINERET in the treatment of pediatric patients with Juvenile Rheumatoid Arthritis (JRA) have not been established.
Is KINERET safe for use in elderly patients?A total of 752 RA 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.
What are the risks for patients with 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. Therefore, caution should be used when administering KINERET to patients with renal impairment.
Have there been any studies on the use of KINERET in patients with hepatic impairment?No formal studies have been conducted examining the pharmacokinetics of KINERET administered subcutaneously in patients with hepatic impairment.
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