VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.

VIRACEPT should not be used in patients with either moderate or severe hepatic impairment (Child-Pugh B or C, score greater than or equal to 7).

The safety and efficacy of VIRACEPT have not been established in patients with renal impairment.

VIRACEPT Oral Powder contains phenylalanine, a component of aspartame. Phenylalanine can be harmful to patients with phenylketonuria.

New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported during postmarketing surveillance in HIV-infected patients receiving protease inhibitor therapy.

There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with protease inhibitors.

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (“buffalo hump”), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including VIRACEPT. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PCP), or tuberculosis], which may necessitate further evaluation and treatment. 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.

Co-administration 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 including the following:

• Alpha 1-adrenoreceptor antagonists (e.g., alfuzosin)
• Antiarrhythmics (e.g., amiodarone, quinidine)
• Antimycobacterial agents (e.g., rifampin)
• Antipsychotics (e.g., lurasidone, pimozide)
• Ergot Derivatives (e.g., dihydroergotamine, ergotamine, methylergonovine)
• GI Motility Agents (e.g., cisapride)
• Herbal products (e.g., St. John’s wort)
• HMG-CoA Reductase Inhibitors (lovastatin, simvastatin)
• PDE5 Inhibitors  (e.g., sildenafil/revatio for treatment of pulmonary arterial hypertension)
• Sedative/Hypnotics (e.g.,triazolam, oral midazolam)

Patients with renal or hepatic impairment should not be given colchicine with VIRACEPT due to the risk of colchicine toxicity.

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.

Initiation of VIRACEPT, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving VIRACEPT, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of VIRACEPT, respectively. These interactions may lead to:

• Clinically significant adverse reactions, potentially leading to severe, life threatening, or fatal events from greater exposures of concomitant medications
• Clinically significant adverse reactions from greater exposures of VIRACEPT
• Loss of therapeutic effect of VIRACEPT and possible development of resistance

Concentrations of nelfinavir were increased while concentrations of delavirdine were decreased when the  two agents were co-administered.

Concentrations of nelfinavir were decreased when co-administered with nevirapine.

Concentrations of both indinavir and nelfinavir were increased when the two agents were co-administered. Appropriate doses for these combinations, with respect to safety and efficacy, have not been established.

Concentrations of nelfinavir were increased when co-administered with ritonavir. An appropriate dose of nelfinavir for this combination, with respect to safety and efficacy, has not been established.

Concentrations of both saquinavir and nelfinavir were increased when the two agents were co-administered. Appropriate doses for these combinations, with respect to safety and efficacy, have not been established.

Co-administration 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.

Use with anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin) may decrease concentrations of nelfinavir. VIRACEPT may not be effective due to decreased nelfinavir plasma concentrations in patients taking these agents concomitantly.

Concomitant use of trazodone and VIRACEPT may increase plasma concentrations of trazodone. Adverse events of nausea, dizziness, hypotension and syncope have been observed following co-administration of trazodone and ritonavir. If trazodone is used with a CYP3A4 inhibitor such as VIRACEPT, the combination should be used with caution and a lower dose of trazodone should be considered.

It is recommended that the dose of rifabutin be reduced to one-half the usual dose when administered with VIRACEPT; 1250 mg BID is the preferred dose of VIRACEPT when co-administered with rifabutin.

Concentrations of bosentan may be increased when co-administered with VIRACEPT.

Concentrations of immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus) and nelfinavir may be increased by co-administration of these agents with nelfinavir.

Concomitant use of fluticasone propionate and VIRACEPT may increase plasma concentrations of fluticasone propionate. Consider alternatives to fluticasone propionate, particularly for long-term use.

Dose adjustment of azithromycin is not recommended, but close monitoring for known side effects such as liver enzyme abnormalities and hearing impairment is warranted.

Concentrations of methadone were decreased when co-administered with VIRACEPT. Dosage of methadone may need to be increased when co-administered with VIRACEPT.

Concentrations of ethinyl estradiol and norethindrone were decreased when co-administered with VIRACEPT. Alternative or additional contraceptive measures should be used when oral contraceptives containing ethinyl estradiol or norethindrone and VIRACEPT are co-administered.

Concomitant use of PDE5 inhibitors and VIRACEPT should be undertaken with caution.

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.

Initiation of VIRACEPT in patients taking quetiapine: Consider alternative antiretroviral therapy to avoid increases in quetiapine drug exposures. If co-administration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reaction.

There are no adequate and well-controlled studies in pregnant women taking VIRACEPT.

The Centers for Disease Control and Prevention recommends that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV.

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• Use in patients under the age of 2. GoToSource

• Refractory multiple myeloma. GoToSource

• Squamous cell carcinoma of the larynx. GoToSource

• Adjunctive treatment for glioblastoma multiforme. GoToSource

• Melanoma, lung cancer, or kidney cancer. GoToSource

• Advanced rectal cancer. GoToSource

• Refractory pediatric leukemia. GoToSource

• Cutaneous and mucosal kaposi’s sarcoma. GoToSource 

Lipodystrophy (abnormal distribution of fat). GoToSource

Insulin resistance. GoToSource

Hyperlipidemia (high concentration of fats or lipids in the blood). GoToSource

Liver injury. GoToSource

Bleeding in hemophiliac patients. GoToSource

Immune reconstitution syndrome (flare-up of underlying undiagnosed infection or worsening of a previously treated infection after ART is started). GoToSource

Lawsuits filed for birth defects.