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U.S. Department of Health and Human Services

Safety

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Viracept (nelfinavir mesylate) Tablets, Oral Powder

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

 

May 2013

Summary View

7 DRUG INTERACTIONS

7.3 Established and Potentially Significant Drug Interactions
  • added.........omeprazole: Omeprazole decreases the plasma concentrations of nelfinavir.Concomitant use of proton pump inhibitors and VIRACEPT may lead to a loss of virologic response and development of resistance

 

April 2012

Summary View

 

CONTRAINDICATIONS

Table 3
Antimycobacterial Agents - Rifampin (new)
  • Plasma concentrations of nelfinavir can be reduced by concomitant use of rifampin. This may lead to loss of therapeutic effect and possible development of resistance to Viracept or other coadministered antiretroviral agents.
 
Ergot Derivatives – Ergonovine (new)
  • Potential for serious and/or life threatening reactions such as ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
 
GI Motility Agent- Cisapride (new)
  • Potential for serious and/or life threatening reactions such as cardiac arrhythmias
 
Sedative/Hypnotics – Oral Midazolam
  • Potential for serious and/or life threatening reactions such as prolonged or increased sedation or respiratory depression.
 

WARNINGS AND PRECAUTIONS

Drug Interactions
  • See Table 3 for listing of drugs that are contraindicated for use with Viracept due to potentially life-threatening adverse events or potential loss of therapeutic effects…
 
Immune Reconstitution Syndrome
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Viracept…
     

PATIENT INFORMATION

Who should not take Viracept?
  • Do not take VIRACEPT if you take any of the following medicines…..