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Label Changes for:

Crixivan (indinavir sulfate) Capsules

March 2015

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

*Risk of significant adverse drug-drug interactions between the psychotropic medication, quetiapine (Seroquel), and HIV protease inhibitors

Aptivus (tipranavir) Capsules, Oral Solution
Crixivan (indinavir sulfate) Capsules
Invirase (saquinavir mesylate) Capsules, Tablets
Kaletra (lopinavir/ritonavir) Oral Solution, Tablets, Capsules
Lexiva (fosamprenavir calcium) Tablets, Oral Suspension
Norvir (ritonavir) Capsules, Oral Solution, Tablets
Prezista (darunavir) Tablets, Oral Suspension
Reyataz (atazanavir) Capsules, Oral Powder
Viracept (nelfinavir mesylate) Oral Powder, Tablets


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

March 2015


Risk of Serious Adverse Reactions Due to Drug Interactions
  • Initiation of <PRODUCT>, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving <PRODUCT>, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of <PRODUCT>, respectively.

These interactions may lead to:

  • Clinically significant adverse reactions, potentially leading to severe, life threatening, or fatal events from greater exposures of concomitant medications.
  • Clinically significant adverse reactions from greater exposures of <PRODUCT>.
  • Loss of therapeutic effect of <PRODUCT> and possible development of resistance.

See Table for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations [see Drug Interactions (7)]. Consider the potential for drug interactions prior to and during <PRODUCT> therapy; review concomitant medications during <PRODUCT> therapy; and monitor for the adverse reactions associated with the concomitant medications [see Contraindications (4) and Drug Interactions (7)].