VIRACEPT Patient Counseling Information

(nelfinavir mesylate)

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

A statement to patients and healthcare providers is included on the product's bottle label: ALERT: Find out about medicines that should NOT be taken with VIRACEPT.

Instruction for Use

For optimal absorption, patients should be advised to take VIRACEPT with food.

Patients should be informed that VIRACEPT Tablets are film-coated and that this film-coating is intended to make the tablets easier to swallow.

If a dose of VIRACEPT is missed, patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped, the patient should not double the next dose.

Adult or pediatric patients unable to swallow the tablets may dissolve the tablets in a small amount of water:

Place VIRACEPT tablet(s) in small amount of water
Once dissolved, mix the cloudy liquid well, and consume it immediately.
The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed

Pediatric patients unable to swallow tablets can also use the powder formulation:

Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements
Once mixed, the entire contents must be consumed in order to obtain the full dose.
If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste.
VIRACEPT Oral Powder should not be reconstituted with water in its original container.

Drug Interactions

VIRACEPT may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription, non-prescription medication or herbal products, including St. John's wort [see Contraindications (4), Drug Interactions (7.3), and Use in Specific Populations (8.3)].

Hepatic Impairment

Patients should be informed that VIRACEPT should not be used if there is moderate or severe hepatic impairment.

Phenylketonuria

Physicians should alert patients with phenylketonuria that VIRACEPT Oral Powder contains phenylalanine

Fat Redistribution

Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including PREZISTA/ritonavir, and that the cause and long-term health effects of these conditions are not known at this time

The most frequent adverse event associated with VIRACEPT is diarrhea, which can usually be controlled with non-prescription drugs, such as loperamide, which slow gastrointestinal motility.

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VIRACEPT during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Instruct patients with HIV-1 infection not to breastfeed because HIV-1 can be passed to the infant in the breast milk [see Use in Specific Populations (8.2)].

Females and Males of Reproductive Potential

Advise females of reproductive potential that VIRACEPT may reduce the effectiveness of estrogen-based contraceptives, and to use alternative non-hormonal contraception [see Drug Interactions (7.3), Use in Specific Populations (8.3)].

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Prescribing Information
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Health Professional Information

Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

A statement to patients and healthcare providers is included on the product's bottle label: ALERT: Find out about medicines that should NOT be taken with VIRACEPT.

Instruction for Use

For optimal absorption, patients should be advised to take VIRACEPT with food.

Patients should be informed that VIRACEPT Tablets are film-coated and that this film-coating is intended to make the tablets easier to swallow.

If a dose of VIRACEPT is missed, patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped, the patient should not double the next dose.

Adult or pediatric patients unable to swallow the tablets may dissolve the tablets in a small amount of water:

Place VIRACEPT tablet(s) in small amount of water
Once dissolved, mix the cloudy liquid well, and consume it immediately.
The glass should be rinsed with water and the rinse swallowed to ensure the entire dose is consumed

Pediatric patients unable to swallow tablets can also use the powder formulation:

Mix VIRACEPT Oral Powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements
Once mixed, the entire contents must be consumed in order to obtain the full dose.
If the mixture is not consumed immediately, it must be stored under refrigeration, but storage must not exceed 6 hours.
Acidic food or juice (e.g., orange juice, apple juice, or apple sauce) are not recommended for mixing VIRACEPT Oral Powder because the combination may result in a bitter taste.
VIRACEPT Oral Powder should not be reconstituted with water in its original container.

Drug Interactions

VIRACEPT may interact with some drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription, non-prescription medication or herbal products, including St. John's wort [see Contraindications (4), Drug Interactions (7.3), and Use in Specific Populations (8.3)].

Hepatic Impairment

Patients should be informed that VIRACEPT should not be used if there is moderate or severe hepatic impairment.

Phenylketonuria

Physicians should alert patients with phenylketonuria that VIRACEPT Oral Powder contains phenylalanine

Fat Redistribution

Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, including PREZISTA/ritonavir, and that the cause and long-term health effects of these conditions are not known at this time

The most frequent adverse event associated with VIRACEPT is diarrhea, which can usually be controlled with non-prescription drugs, such as loperamide, which slow gastrointestinal motility.

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VIRACEPT during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Instruct patients with HIV-1 infection not to breastfeed because HIV-1 can be passed to the infant in the breast milk [see Use in Specific Populations (8.2)].

Females and Males of Reproductive Potential

Advise females of reproductive potential that VIRACEPT may reduce the effectiveness of estrogen-based contraceptives, and to use alternative non-hormonal contraception [see Drug Interactions (7.3), Use in Specific Populations (8.3)].

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