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The absolute bioavailability of niraparib is approximately 73%. Following oral administration of niraparib, peak plasma concentration, C max , is reached within 3 hours. Concomitant administration of a high-fat meal (800 to 1,000 calories with approximately 50% of total caloric content of the meal from fat) did not significantly affect the pharmacokinetics of niraparib. The average (‘SD) apparent volume of distribution (Vd/F) was 1,220 (‘1,114) L. In a population pharmacokinetic analysis, the Vd/F of niraparib was 1,074 L in patients with cancer. Following multiple daily doses of 300 mg of niraparib, the mean half-life (t 1/2 ) is 36 hours. In a population pharmacokinetic analysis, the apparent total clearance (CL/F) of niraparib was 16. Metabolism: Niraparib is metabolized by carboxylesterases (CEs) to form a major inactive metabolite, which subsequently undergoes glucuronidation. Excretion: Following administration of a single oral 300-mg dose of radio-labeled niraparib, the average percent recovery of the administered dose over 21 days was 47. In pooled samples collected over 6 days, unchanged niraparib accounted for 11% and 19% of the administered dose recovered in urine and feces, respectively. Age (18 to 65 years), race/ethnicity, and mild to moderate renal impairment (CLcr ?30 to 90 mL/min) had no clinically significant effect on the pharmacokinetics of niraparib. The effect of severe renal impairment (CLcr Patients with Hepatic Impairment: Mild hepatic impairment (total bilirubin ULN) had no clinically significant effect on the pharmacokinetics of niraparib. In a trial of patients with moderate hepatic impairment (total bilirubin ?1. Niraparib dosage reduction is recommended for patients with moderate hepatic impairment [see Dosage and Administration (2. Moderate hepatic impairment did not have an effect on niraparib C max or on niraparib protein binding. The effect of severe hepatic impairment (total bilirubin >3. No clinical drug interaction studies have been performed with Zejula. In Vitro Studies: Inhibition of Cytochrome P450 ( CYP) Enzymes: Neither niraparib nor the major primary metabolite M1 is an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Induction of CYP Enzymes: Neither niraparib nor M1 is a CYP3A4 inducer. Niraparib weakly induces CYP1A2 in vitro. Substrate of CYP Enzymes: Niraparib is a substrate of CEs and the resulting M1 is further metabolized through the formation of glucuronides in vivo. Inhibition of Uridine 5’-Diphospho-Glucuronosyltransferases (UGTs): Niraparib did not exhibit inhibitory effect against the UGT isoforms (UGT1A1, UGT1A4, UGT1A9, and UGT2B7) up to 200 microM in vitro, online steroids 4 u. Therefore, the potential for a clinically relevant inhibition of UGTs by niraparib is minimal. Inhibition of Transporter Systems: Niraparib is a weak inhibitor of breast cancer resistance protein (BCRP), but does not inhibit P-glycoprotein (P-gp), bile salt export pump (BSEP), or multidrug resistance-associated protein 2 (MRP2). Niraparib is an inhibitor of multidrug and toxin extrusion (MATE) 1 and 2 with IC 50 of 0.
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