Label Changes for:

Viracept (nelfinavir mesylate) tablets and oral powder

April 2010

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

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

CONTRAINDICATIONS

Table 9: Drugs That Are Contraindicated With Viracept
  • Alpha 1-adrenoreceptor antagonist: alfuzosin
  • PDE5 Inhibitors: Revatio (sildenafil) [for treatment of pulmonary arterial hypertension]

PRECAUTIONS

Drug Interactions

Table 11 Established and Other Potentially Significant Drug Interactions

  • Inhaled beta agonist- salmeterol: Concurrent administration of salmeterol with Viracept is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations and sinus tachycardia.
  • Bosentan: Co-administration of bosentan in patients on Viracept or coadministration of Viracept in patients on bosentan: Start at or adjust bosentan to 62.5 mg once daily or every other day based upon individual tolerability.
  • PDE5 Inhibitors:Use of sildenafil (Revatio) is contraindicated when used for the treatment of pulmonary arterial hypertension (PAH). Tadalafil: Use of tadalafil for pulmonary arterial hypertension (PAH), the following dose adjustments are recommended for use of Adcirca (tadalafil) with Viracept: Co-administration of Adcirca in patients on Viracept or coadministration of Viracept in patients on Adcirca: Start at or adjust Adcirca to 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability.
  • Colchicine: The addition of new dosing recommendations when prescribed for the treatment of familial Mediterranean fever or gout.  Addition of new dosing recommendations for colchicine when prescribed for the prophylaxis of gout and the addition of the recommendation that colchicine should not be coadministered with Viracept in patients with hepatic or renal impairment.
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