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U.S. Department of Health and Human Services

Safety

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Invirase (saquinavir mesylate) capsules and tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2010 and February 2012


 

February 2012

Summary View

 

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: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interactions with Invirase/ritonavir (TABLE)
HMG-CoA reductase inhibitors: Atorvastatin
  • Titrate atorvastatin dose carefully and use the lowest dose necessary; do not exceed atorvastatin 20 mg/day.
 

PATIENT COUNSELING INFORMATION

  • Invirase 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 Invirase.
  • 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…Do not breastfeed…
 

MEDICATION GUIDE

What should I tell my healthcare provider before taking Invirase?
  • are breast-feeding or plan to breastfeed…Do not breastfeed…
 
General information about Invirase
  • Invirase is not a cure for HIV-1 infection 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 Invirase.
  • Avoid doing things that can spread HIV-1 infection.
  • 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 to lower the chance of sexual contact with semen, vaginal secretions, or blood.

 

January 2010 

Summary View

 

CONTRAINDICTIONS

  • Invirase is contraindicated in patients with clinically significant hypersensitivity (e.g. anaphylactic reaction, Stevens-Johnson syndrome) to saquinavir, saquinavir mesylateor to any of its ingredients including ritonavir.
  • Table 4: Drugs That Are Contraindicated With Invirase/Ritonavir, content has been updated

WARNINGS

Invirase must be used in combination with ritonavir.

PRECAUTIONS

Drug Interactions
  • Table 5: Established and Other Potentially Significant Drug Interactions; Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or on Predicted Interaction, content updated

ADVERSE REACTIONS

Clinical Trials Experience
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Additional Adverse Reactions Reported with Saquinavir
  • Infections and Infestations: abscess, angina tonsillaris, candidiasis, cellulitis, herpes simplex, herpes zoster, infection bacterial, infection mycotic, infection staphylococcal, influenza, moniliasis,

PATIENT PACKAGE INSERT

  • Medicines/interactions with Invirase/Norvir content updated.