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U.S. Department of Health and Human Services

Safety

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Viracept (nelfinavir mesylate) Oral Powder and Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2011 and February 2012

 

February 2012

Summary View

 

CONTRAINDICATIONS

Drugs Within Class That Are Contraindicated With Viracept (Table)
  • HMG-CoA reductase inhibitors: Lovastatin, Simvastatin

 

WARNINGS

Drug Interactions
  • Concomitant use of Viracept with lovastatin or simvastatin is contraindicated.
  • Titrate atorvastatin dose carefully and use the lowest necessary dose; do not exceed a total atorvastatin dose of 40 mg/day during coadministration with Viracept.

 

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
  • Viracept 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 Viracept.
  • 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

Drugs That Should Not Be Coadministered With Viracept (Table)

  • Alpha 1-adrenoreceptor antagonist:alfuzosin: CONTRAINDICATED due to potentially increased alfuzosin concentrations can result in hypotension…

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

  • HMG-CoA Reductase Inhibitor: atorvastatin, rosuvastatin: Titrate atorvastatin dose carefully and use the lowest necessary dose; do not exceed atorvastatin 40 mg/day.

 

Patient Prescribing Information:

Does Viracept cure HIV or AIDS?

  • Viracept 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 Viracept.
  • Avoid doing things that can spread HIV-1 infection…

Who should not take Viracept?

  • Do not breastfeed. We do not know if Viracept 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.

 

MEDICINES YOU SHOULD NOT TAKE WITH VIRACEP

Do not take the following drugs because they can cause serious problems or death if taken with Viracept
  • Mevacor(lovastatin) (for lowering cholesterol)
  • Zocor(simvastatin) (for lowering cholesterol)
  • Do not take Viracept with Serevent(salmeterol) because of possible serious reactions.

 

February 2011

Summary View

 

PRECAUTIONS

Drug Interactions
  • Coadministration of warfarin and Viracept may affect concentrations of warfarin. It is recommended that the INR (international normalized ratio) be monitored carefully during treatment with Viracept , especially when commencing therapy.

PATIENT PACKAGE INSERT

  • Before you take warfarin (Coumadin) with ,Viracept talk to your healthcare provider since Viracept may affect the amount of warfarin in your blood.