Label Changes for:

Reyataz (atazanavir sulfate) Capsules

February 2012

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

February 2012

 

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

 

DRUG INTERACTIONS

Established and Other Potentially Significant Drug Interactions (Table)

  • Protease Inhibitors: telaprevir, atazanavir:Concomitant administration of telaprevir and atazanavir/ritonavir resulted in reduced steady-state telaprevir exposure, while steady-state atazanavir exposure was increase.
  • HMG-CoA reductase inhibitors: atorvastatin, rosuvastatin: Titrate atorvastatin dose carefully and use the lowest necessary dose. Rosuvastatin dose should not exceed 10 mg/day.

 

PATIENT COUNSELING INFORMATION

  • Reyataz is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using Reyataz.
  • Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
  • Do not share needles or other injection equipment…

 

Patient Information

Does Reyataz cure HIV or AIDS?

  • Reyataz does not cure HIV infection or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. You should remain under the care of a doctor when using Reyataz.
  • Avoid doing things that can spread HIV-1 infection.
  • Do not share needles or other injection equipment…

 

What should I tell my healthcare provider before I take Reyataz?

Tell your healthcare provider:

  • If you are breastfeeding. Do not breastfeed. It is not known if REYATAZ can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
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