Label Changes for:

Norvir (ritonavir) oral solution and tablets

February 2012

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – 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 Updates to HMG-CoA Reductase Inhibitor: atorvastatin and rosuvastatin

 

PATIENT COUNSELING INFORMATION

Information For Patients
  • Norvir 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 Norvir.
  • Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
  • Do not share needles or other injection equipment.
  • Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
  • Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  • Do not breastfeed. We do not know if Norvir can be passed to the baby through breast milk and whether it could harm the baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.
What is Norvir?
  • Norvir 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…
What Should I Tell My Doctor Before Taking Norvir?
  • Do not breastfeed. We do not know if Norvir can be passed to your the baby in through your breast milk and whether it could harm your the 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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