VIRACEPT Contraindications

(nelfinavir mesylate)

4 CONTRAINDICATIONS

Coadministration of VIRACEPT is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of nelfinavir) are listed in Table 3 [also see Drug Interactions (7), Table 6].

Table 3: Drugs That Are Contraindicated With VIRACEPT
Drug ClassDrugs Within Class That Are Contraindicated With VIRACEPTClinical Comment
*
See Drug Interactions, Table 6 for coadministration of sildenafil and tadalafil when dosed for erectile dysfunction.

Alpha 1-adrenoreceptor antagonist

Alfuzosin

Potentially increased alfuzosin concentrations can result in hypotension.

Antiarrhythmics

Amiodarone, quinidine

Potential for serious and/or life-threatening cardiac arrhythmia.

Antimycobacterial Agents

Rifampin

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.

Antipsychotics

Lurasidone


Pimozide

Potential for serious and/or life-threatening reactions.

Potential for serious and/or life threatening reactions such as cardiac arrhythmias.

Ergot Derivatives

Dihydroergotamine, ergotamine, methylergonovine

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

Potential for serious and/or life threatening reactions such as cardiac arrhythmias.

Herbal products

St. John's wort (Hypericum perforatum)

Plasma concentrations of nelfinavir can be reduced by concomitant use of the herbal preparation St. John's wort. This may lead to loss of therapeutic effect and possible development of resistance to VIRACEPT or other coadministered antiretroviral agents.

HMG-CoA Reductase Inhibitors

Lovastatin, Simvastatin

Potential for serious reactions such as myopathy including rhabdomyolysis.

PDE5 Inhibitors

Sildenafil (Revatio) [for treatment of pulmonary arterial hypertension]*

A safe and effective dose has not been established when used with nelfinavir. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

Sedative/Hypnotics

Triazolam, oral midazolam

Potential for serious and/or life threatening reactions such as prolonged or increased sedation or respiratory depression.

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Contraindications

4 CONTRAINDICATIONS

Coadministration of VIRACEPT is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of nelfinavir) are listed in Table 3 [also see Drug Interactions (7), Table 6].

Table 3: Drugs That Are Contraindicated With VIRACEPT
Drug ClassDrugs Within Class That Are Contraindicated With VIRACEPTClinical Comment
*
See Drug Interactions, Table 6 for coadministration of sildenafil and tadalafil when dosed for erectile dysfunction.

Alpha 1-adrenoreceptor antagonist

Alfuzosin

Potentially increased alfuzosin concentrations can result in hypotension.

Antiarrhythmics

Amiodarone, quinidine

Potential for serious and/or life-threatening cardiac arrhythmia.

Antimycobacterial Agents

Rifampin

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.

Antipsychotics

Lurasidone


Pimozide

Potential for serious and/or life-threatening reactions.

Potential for serious and/or life threatening reactions such as cardiac arrhythmias.

Ergot Derivatives

Dihydroergotamine, ergotamine, methylergonovine

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

Potential for serious and/or life threatening reactions such as cardiac arrhythmias.

Herbal products

St. John's wort (Hypericum perforatum)

Plasma concentrations of nelfinavir can be reduced by concomitant use of the herbal preparation St. John's wort. This may lead to loss of therapeutic effect and possible development of resistance to VIRACEPT or other coadministered antiretroviral agents.

HMG-CoA Reductase Inhibitors

Lovastatin, Simvastatin

Potential for serious reactions such as myopathy including rhabdomyolysis.

PDE5 Inhibitors

Sildenafil (Revatio) [for treatment of pulmonary arterial hypertension]*

A safe and effective dose has not been established when used with nelfinavir. There is increased potential for sildenafil-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope).

Sedative/Hypnotics

Triazolam, oral midazolam

Potential for serious and/or life threatening reactions such as prolonged or increased sedation or respiratory depression.

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