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:

Data
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
 
Visit the FDA Patient Network for more Information about the HIV Liaison Program 

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