miércoles, 31 de enero de 2018

Prezista Label Revised

U.S. Food and Drug Administration Header

The Prezista (darunavir) label was recently revised:

To update DRUG INTERACTIONS, subsection 7.3, Table 11 with information about anticonvulsants, antifungals, antipsychotics, narcotic analgesics metabolized by CYP3A, and platelet aggregation inhibitor as follows:
  • Clonazepam: Clinical monitoring of anticonvulsants that are metabolized by CYP3A is recommended
  • Perphenazine: A decrease in the dose of antipsychotics that are metabolized by CYP3A or CYP2D6 may be needed when co-administered with PREZISTA/ritonavir.
  • Narcotic analgesics metabolized by CYP3A: e.g. fentanyl, oxycodone: Careful monitoring of therapeutic effects and adverse reactions associated with CYP3A-metabolized narcotic analgesics (including potentially fatal respiratory depression) is recommended with co-administration.
  • Tramadol: A dose decrease may be needed for tramadol with concomitant use.
  • Platelet aggregation inhibitor:
  • Ticagrelor: Co administration of PREZISTA/ritonavir and ticagrelor is not recommended
To update USE IN SPECIFIC POPULATIONS, Pregnancy subsection with information from a clinical trial as follows:

Human Data

PREZISTA/ritonavir (600/100 mg twice daily or 800/100 mg once daily) in combination with a background regimen was evaluated in a clinical trial of 34 pregnant women during the second and third trimesters, and postpartum. Seventeen subjects were enrolled in each BID and QD treatment arms. Twenty-seven subjects completed the trial through the postpartum period (6 12 weeks after delivery) and 7 subjects discontinued before trial completion, 5 subjects in the BID arm and 2 subjects in the QD arm.

The pharmacokinetic data demonstrate that exposure to darunavir and ritonavir as part of an antiretroviral regimen was lower during pregnancy compared with postpartum (6-12 weeks). Exposure reductions during pregnancy were greater for the once daily regimen as compared to the twice daily regimen [see Clinical Pharmacology (12.3)].

Virologic response was preserved. In the BID arm, the proportion of subjects with HIV 1 RNA < 50 copies/mL were 35% (6/17) at baseline, 59% (10/17) through the third trimester visit, and 59% (10/17) through the 6-12 week postpartum visit. Virologic outcomes during the third trimester visit showed HIV-1 RNA ≥50 copies/mL for 12% (2/17) of subjects and were missing for 5 subjects (1 subject discontinued prematurely due to virologic failure). In the QD arm, the proportion of subjects with HIV-1 RNA < 50 copies/mL were 59% (10/17) at baseline, 82% (14/17) through the third trimester visit, and 82% (14/17) through the 6 12 week postpartum visit. Virologic outcomes during the third trimester visit showed HIV-1 RNA ≥50 copies/mL for none of the subjects and were missing for 3 subjects (1 subject discontinued prematurely due to virologic failure).

PREZISTA/ritonavir was well tolerated during pregnancy and postpartum. There were no new clinically relevant safety findings compared with the known safety profile of PREZISTA/ritonavir in HIV-1-infected adults.

Among the 29 infants with HIV test results available data, born to the 29 HIV-infected pregnant women who completed trial through delivery or postpartum period, all 29 infants had test results that were negative for HIV-1 at the time of delivery and/or through 16 weeks postpartum. All 29 infants received antiretroviral prophylactic treatment containing zidovudine.
The updated label will soon be available at drugs@fda or DailyMed
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
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