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However, only limited data were available in patients above the age of 65 year. Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16. This difference is not clinically relevant. Results from a mass balance study with 14 C-darunavir with ritonavir showed that approximately 7. Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 ml/min, n=20) (see sections 4, buy masteron 200 mg injectable steroids $87.00 masteron. Darunavir is primarily metabolised and eliminated by the liver. In a multiple dose study with PREZISTA co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (Child-Pugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects. However, unbound darunavir concentrations were approximately 55% (Child-Pugh Class A) and 100% (Child-Pugh Class B) higher, respectively. The clinical relevance of this increase is unknown therefore, PREZISTA should be used with caution. The effect of severe hepatic impairment on the pharmacokinetics of darunavir has not been studied (see sections 4. The exposure to total darunavir and ritonavir after intake of darunavir/ritonavir 600/100 mg twice daily and darunavir/ritonavir 800/100 mg once daily as part of an antiretroviral regimen was generally lower during pregnancy compared with postpartum. However, for unbound (i. Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 600/100 mg twice daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum. Pharmacokinetics of total darunavir. Second trimester of pregnancy. Third trimester of pregnancy. Postpartum (6-12 weeks) a n=11 for AUC 12h. Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 800/100 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum. Pharmacokinetics of total darunavir. Second trimester of pregnancy. Third Trimester of pregnancy. Postpartum (6-12 weeks) In women receiving darunavir/ritonavir 600/100 mg twice daily during the second trimester of pregnancy, mean intra-individual values for total darunavir C max , AUC 12h and C min were 28%, 26% and 26% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir C max , AUC 12h and C min values were 18%, 16% lower and 2% higher, respectively, as compared with postpartum. In women receiving darunavir/ritonavir 800/100 mg once daily during the second trimester of pregnancy, mean intra-individual values for total darunavir C max , AUC 24h and C min were 33%, 31% and 30% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir C max , AUC 24h and C min values were 29%, 32% and 50% lower, respectively, as compared with postpartum. Treatment with darunavir/cobicistat 800/150 mg once daily during pregnancy results in low darunavir exposure. In women receiving darunavir/cobicistat during the second trimester of pregnancy, mean intra-individual values for total darunavir C max , AUC 24h and C min were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir C max , AUC 24h and C min values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
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