VIRACEPT Highlights

(nelfinavir mesylate)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VIRACEPT safely and effectively. See full prescribing information for VIRACEPT.

VIRACEPT (nelfinavir mesylate) Tablets, for oral use
VIRACEPT (nelfinavir mesylate) Oral Powder, for oral use
Initial U.S. Approval: 1997

INDICATIONS AND USAGE

VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. (1)

DOSAGE AND ADMINISTRATION

•
See full prescribing information for administration instructions (2)
•
Adults and adolescents 13 years and older (tablets): 1250 mg twice daily or 750 mg three times daily with a meal (2.1)
•
Children 2 to less than 13 years (oral powder or 250 mg tablets): 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily with a meal. Refer to Tables 1 and 2 of the full prescribing information for specific dosing guidelines based on age and body weight (2.2)

DOSAGE FORMS AND STRENGTHS

•
Tablet: 250 mg, 625 mg nelfinavir free base (3)
•
Oral Powder: 50 mg/g nelfinavir free base (3)

CONTRAINDICATIONS

•
Coadministration with drugs that are highly dependent on CYP3A for clearance and which elevated concentrations are associated with serious and/or life-threatening events (4)

WARNINGS AND PRECAUTIONS

ALERT: Find out about medicines that should not be taken with VIRACEPT.

•
The concomitant use of VIRACEPT and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions (5.1, 7.3)
•
Hepatic impairment: should not be used in patients with either moderate or severe hepatic impairment (2.4, 5.2)
•
Phenylketonuria: the oral powder contains 11.2 mg phenylalanine per gram of powder (5.3)
•
Diabetes mellitus/hyperglycemia: new onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia reported with protease inhibitors. In some cases after treatment discontinuation, hyperglycemia persisted (5.4)
•
Hemophilia: increased bleeding, including spontaneous skin hematomas and hemarthrosis reported with protease inhibitors. In more than half of the cases, protease inhibitors was continued or reintroduced (5.5)
•
Fat redistribution: observed with antiretroviral therapy (5.6)
•
Immune reconstitution syndrome: reported with combination antiretroviral therapy, including VIRACEPT. Patients may develop an inflammatory response to indolent or residual opportunistic infections (5.7)

ADVERSE REACTIONS

•
Most common adverse reactions (≥2%) of moderate or severe intensity in adults and adolescents (13 years and older) are diarrhea, nausea, rash, and flatulence (6.1)
•
Most common adverse reactions in pediatric patients (2 to less than 13 years) are diarrhea, leukopenia/neutropenia, rash, anorexia, and abdominal pain. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Coadministration of VIRACEPT with other drugs (CYP3A substrates) can alter the concentration of these other drugs, and other drugs (inhibitors and/or inducers of CYP3A or CYP2C19) may alter the concentrations of nelfinavir. The potential drug-drug concentrations must be considered prior to and during therapy (4, 7, 12.3)
•
VIRACEPT should be given with food one hour after or more than 2 hours before didanosine (7)

USE IN SPECIFIC POPULATIONS

•
Use during pregnancy if the potential benefit justifies the potential risk to the fetus (8.1)
•
Lactation: Patients infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use VIRACEPT safely and effectively. See full prescribing information for VIRACEPT.

VIRACEPT (nelfinavir mesylate) Tablets, for oral use
VIRACEPT (nelfinavir mesylate) Oral Powder, for oral use
Initial U.S. Approval: 1997

INDICATIONS AND USAGE

VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. (1)

DOSAGE AND ADMINISTRATION

•
See full prescribing information for administration instructions (2)
•
Adults and adolescents 13 years and older (tablets): 1250 mg twice daily or 750 mg three times daily with a meal (2.1)
•
Children 2 to less than 13 years (oral powder or 250 mg tablets): 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily with a meal. Refer to Tables 1 and 2 of the full prescribing information for specific dosing guidelines based on age and body weight (2.2)

DOSAGE FORMS AND STRENGTHS

•
Tablet: 250 mg, 625 mg nelfinavir free base (3)
•
Oral Powder: 50 mg/g nelfinavir free base (3)

CONTRAINDICATIONS

•
Coadministration with drugs that are highly dependent on CYP3A for clearance and which elevated concentrations are associated with serious and/or life-threatening events (4)

WARNINGS AND PRECAUTIONS

ALERT: Find out about medicines that should not be taken with VIRACEPT.

•
The concomitant use of VIRACEPT and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions (5.1, 7.3)
•
Hepatic impairment: should not be used in patients with either moderate or severe hepatic impairment (2.4, 5.2)
•
Phenylketonuria: the oral powder contains 11.2 mg phenylalanine per gram of powder (5.3)
•
Diabetes mellitus/hyperglycemia: new onset or exacerbation of pre-existing diabetes mellitus and hyperglycemia reported with protease inhibitors. In some cases after treatment discontinuation, hyperglycemia persisted (5.4)
•
Hemophilia: increased bleeding, including spontaneous skin hematomas and hemarthrosis reported with protease inhibitors. In more than half of the cases, protease inhibitors was continued or reintroduced (5.5)
•
Fat redistribution: observed with antiretroviral therapy (5.6)
•
Immune reconstitution syndrome: reported with combination antiretroviral therapy, including VIRACEPT. Patients may develop an inflammatory response to indolent or residual opportunistic infections (5.7)

ADVERSE REACTIONS

•
Most common adverse reactions (≥2%) of moderate or severe intensity in adults and adolescents (13 years and older) are diarrhea, nausea, rash, and flatulence (6.1)
•
Most common adverse reactions in pediatric patients (2 to less than 13 years) are diarrhea, leukopenia/neutropenia, rash, anorexia, and abdominal pain. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Coadministration of VIRACEPT with other drugs (CYP3A substrates) can alter the concentration of these other drugs, and other drugs (inhibitors and/or inducers of CYP3A or CYP2C19) may alter the concentrations of nelfinavir. The potential drug-drug concentrations must be considered prior to and during therapy (4, 7, 12.3)
•
VIRACEPT should be given with food one hour after or more than 2 hours before didanosine (7)

USE IN SPECIFIC POPULATIONS

•
Use during pregnancy if the potential benefit justifies the potential risk to the fetus (8.1)
•
Lactation: Patients infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission (8.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 10/2023
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