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Absorption, Distribution, and Excretion
Anakinra, the active ingredient in Kineret®, has an absolute bioavailability of 95% for healthy patients (n = 11) after a 70 mg subcutaneous (SC) bolus injection. The maximum plasma concentrations of Kineret® generally occurred 3 to 7 hours after SC administration of clinically relevant doses (1 to 2 mg/kg: n = 18) for patients with rheumatoid arthritis (RA). The terminal half-life ranged from 4 to 6 hours. After daily SC dosing for up to 24 weeks, no unexpected accumulations of Kineret® were observed in the plasma samples of RA patients.1 Dosage Within Special Patient Populations Renal Insufficiency Kineret® is known to be excreted by the kidney.1 Subjects with mild (creatinine clearance 50–80 mL/min) renal insufficiency experienced a 16% decrease in mean plasma clearance. Mean plasma clearance for patients with moderate (creatinine clearance 30–49 mL/min) renal insufficiency was reduced by 50%. Severe (creatinine clearance < 30 mL/min) renal insufficiency resulted in a 70% decrease in mean plasma clearance, and end-stage renal disease resulted in a 75% decrease.1 Hemodialysis and continuous ambulatory peritoneal dialysis removed less than 2.5% of the Kineret® dosage.1 Given these findings, a change in dosage scheduling to 100 mg administered subcutaneously once every other day, should be considered for patients with severe renal insufficiency or end-stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels).1 Hepatic Insufficiency No formal investigations of the pharmacokinetics of subcutaneously injected Kineret® in RA patients with hepatic impairment have been conducted.1 Pregnant and Nursing Women Kineret® should be used during pregnancy only if clearly needed.1 Many drugs are secreted in human milk and, while it is unknown if Kineret® exhibits this behavior, caution should be exercised if Kineret® is administered to nursing women.1 Pediatric Use The safety and efficacy of Kineret® in patients with juvenile rheumatoid arthritis (JRA) have not been established.1 Geriatric Use Clinical trials were executed that consisted of 752 patients of at least 65 years of age and 163 of these patients were in excess of 75 years of age. While there were no differences in safety and efficacy when these patients were compared to younger patients, the greater sensitivity of older patients to Kineret® should not be dismissed without careful consideration. Caution should be used when treating the elderly due to the higher incidence of infection in this population.1
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ABOUT KINERET® ABOUT IL-1 PROFESSIONAL RESOURCES REIMBURSEMENT IMPORTANT PRODUCT SAFETY INFORMATION GLOSSARY |
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