Label Changes for:

Norvir (ritonavir) Soft Gelatin Capsules, Tablets and Oral Solution

November 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)

 

November 2012

WARNINGS AND PRECAUTIONS

Drug Interactions
  • avanafil, budesonide, raltegravir and rivaroxaban

PATIENT COUNSELING INFORMATION

What should I tell my doctor before taking NORVIR?

  • Before taking NORVIR, tell your doctor if you take:
    • Medicine such as rivaroxaban, budesonide and avanafil

 

 

February 2012

 

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.
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…

 

Drug Interactions

Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen Recommended Based on Drug Interaction Studies or Predicted Interaction (Table)

  • HMG-CoA Reductase Inhibitor: atorvastatin, rosuvastatin: Titrate atorvastatin and rosuvastatin dose carefully and use the lowest necessary dose. If Norvir is used with another protease inhibitor, see the complete prescribing information for the concomitant protease inhibitor for details on coadministration with atorvastatin and rosuvastatin.

 

Patient Information

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 Norvir.
  • Avoid doing things that can spread HIV-1 infection.
  • Do not share needles or other injection equipment…

Before taking Norvir, tell your doctor if you:

  • Do not breastfeed.
    • We do not know if Norvir can be passed to the baby through your 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.

 

April 2010

 

PRECAUTIONS- DRUG INTERACTIONS

Established and Other Potentially Significant Drug Interactions

Table 6. Established and Other Potentially Significant Drug Interactions: Alteration in Dose or Regimen Recommended Based on Drug Interaction Studies or Predicted Interaction

  • Bosentan: addition of new dosing recommendations for  and  when prescribed for the treatment of pulmonary arterial hypertension.
  • Tadalafil: addition of new dosing recommendations for when prescribed for the treatment of pulmonary arterial hypertension.
  • Colchicine: The addition of new dosing recommendations when prescribed for the treatment of familial Mediterranean fever or gout.  The addition of new dosing recommendations when prescribed for the prophylaxis of gout. The recommendation that colchicine should not be coadministered with Norvir (ritonavir) in patients with hepatic or renal impairment.

 

 

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