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Label Changes for:

Norvir (ritonavir) Soft Gel capsules, tablets, and oral solution

December 2011

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011




  • hypersensitivity...(e.g. toxic epidermal necrolysis (TEN) or Stevens Johnson syndrome)



Drug Interactions
  • Information regarding coadministration with CYP3A inhibitors...Norvir is a CYP3A4 inhibitor. Initiating treatment with Norvir in patients receiving medications metabolized by CYP3A4 or initiating medications metabolized by CYP3A4 in patients already maintained on Norvir may result in increased plasma concentrations...



  • Table 6 section of the PI with new information on drug interactions with fentanyl, dasatinib and nilotinib
  • A decrease in the dosage or an adjustment of the dosing interval of nilotinib and dasatinib may be necessary for patients requiring co-administration with strong CYP3A inhibitors such as Norvir. Please refer to the nilotinib and dasatinib prescribing information for dosing instructions.
  • Concentrations of fentanyl are expected to increase. Careful monitoring of therapeutic and adverse effects (including potentially fatal respiratory depression) is recommended when fentanyl is concomitantly administered with Norvir.



  • toxic epidermal necrolyis (TEN)
  • and drug interactions with fentanyl, dasatinib and nilotinib



What should I tell my doctor before taking Norvir?
  • new information on drug interactions with fentanyl, dasatinib and nilotinib