HIV/AIDS Update - Changes to the Prezista (darunavir) label

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On April 7, 2014, FDA approved new changes to the Prezista (darunavir) label to update the following sections:

  • WARNING AND PRECAUTIONS, Severe Skin Reactions,  ADVERSE REACTIONS, Postmarketing Experience, and PATIENT COUNSELING INFORMATION sections of the labeling were updated with information regarding rash with eosinophilia and systemic symptoms.
  • DRUG INTERACTIONS, Established and Other Potentially Significant Drug Interaction and CLINICAL PHARMACOLOGY, Table 15 subsections of the labeling were updated with information regarding dolutegravir. Specifically, the following text was added.

Using cross-trial comparisons to historical pharmacokinetic data, dolutegravir did not appear to affect the pharmacokinetics of darunavir. Darunavir/ritonavir had no clinically significant effect on the pharmacokinetics of dolutegravir.

Additionally results from the drug-drug interaction studies were included.


Table 15:     Drug Interactions: Pharmacokinetic Parameters for Co-administered Drugs in the Presence of Darunavir/Ritonavir

Co‑Administered Drug

Dose/Schedule

N

PK

LS Mean Ratio (90% CI) of
Co-Administered Drug
Pharmacokinetic Parameters
With/Without Darunavir
No effect =1.00

Co‑Administered Drug

Darunavir/
ritonavir

Cmax

AUC

Cmin

Co‑Administration With Other HIV Protease Inhibitors

Dolutegravir

30 mg q.d

600/100 mg b.i.d.

15

¯

0.89
(0.83-0.97)

0.78
(0.72-0.85)

0.62Ω
(0.56-0.69)

Dolutegravir

 

50 mg q.d.

 

600/100 mg b.i.d. with 200 mg b.i.d. etravirine

9

¯

0.88
(0.78-1.00)

0.75
(0.69-0.81)

0.63 Ω
(0.52-0.76)

  • CLINICAL PHARMACOLOGY, Microbiology subsection of labeling was updated to rilipivirine to the list of drugs that did not show antagonism with darunavir.
  • Prezista 400 mg tablets were removed from the HOW SUPPLIED/STORAGE AND HANDLING section because this dosage strength is no longer marketed in the US.

The complete revised label can be viewed on line at Drugs@FDA.

Prezista, a protease inhibitor, is a product of Tibotec.

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration


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