Usual Adult Dose for HIV Infection

1250 mg orally twice a day or 750 mg orally 3 times a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Adult Dose for Nonoccupational Exposure

US CDC recommendations: 1250 mg orally twice a day or 750 mg orally 3 times a day
Duration of therapy: 28 days

Comments:

• Recommended as part of an alternative regimen for nonoccupational postexposure prophylaxis of HIV infection
• This drug should be used with (lamivudine or emtricitabine) plus (zidovudine or stavudine or abacavir or tenofovir or didanosine).
• Prophylaxis should be started as soon as possible, within 72 hours of exposure.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

2 to less than 13 years: 45 to 55 mg/kg orally twice a day or 25 to 35 mg/kg orally 3 times a day
Maximum dose: 2500 mg/day

• Oral powder (50 mg/g):

9 to less than 10.5 kg: 500 mg orally twice a day or 300 mg orally 3 times a day
10.5 to less than 12 kg: 550 mg orally twice a day or 350 mg orally 3 times a day
12 to less than 14 kg: 650 mg orally twice a day or 400 mg orally 3 times a day
14 to less than 16 kg: 750 mg orally twice a day or 450 mg orally 3 times a day
16 to less than 18 kg: 500 mg orally 3 times a day
18 to less than 23 kg: 600 mg orally 3 times a day
23 kg or more: 750 mg orally 3 times a day

• Tablets (250 mg):

10 to 12 kg: 500 mg orally twice a day or 250 mg orally 3 times a day
13 to 18 kg: 750 mg orally twice a day or 500 mg orally 3 times a day
19 to 20 kg: 1000 mg orally twice a day or 500 mg orally 3 times a day
21 kg or more: 1000 to 1250 mg orally twice a day or 750 mg orally 3 times a day

13 years or older:

• Tablets: 1250 mg orally twice a day or 750 mg orally 3 times a day

Comments: For twice-daily dosing, the 250 mg tablets are recommended for children weighing 16 kg or more.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A, score 5 to 6): No adjustment recommended.
Moderate or severe liver dysfunction (Child-Pugh B or C, score at least 7): Not recommended.

Precautions

In pediatric patients less than 2 years of age, this drug was found to be safe at the doses studied; however, a reliably effective dose could not be established.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments: Significant removal via dialysis is not likely (highly protein bound)

Other Comments

Administration advice:

• Administer all doses with a meal (for optimal absorption).
• For patients unable to swallow the tablets: Place tablet(s) in small amount of water; once dissolved, mix the cloudy liquid well, then consume immediately; rinse the glass with water and swallow the rinse to ensure the entire dose is consumed.
• Mix the measured dose of the oral powder with a small amount of water, milk, formula, soy formula, soy milk, or dietary supplements; once mixed, consume the entire contents 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.
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Store at 15C to 30C (59F to 86F).
• Store in original bottle and keep tightly closed.

Reconstitution/preparation techniques:

• Acidic foods or juices (e.g., orange juice, apple juice, apple sauce) should not be mixed with the oral powder as a bitter taste may result.
• The oral powder should not be reconstituted with water in its original container.

General:

• The oral powder contains 50 mg (as nelfinavir free base) in each level scoopful (1 g).
• If a teaspoon is used to measure the oral powder, 1 level teaspoon contains 200 mg of nelfinavir (4 level scoops equals 1 level teaspoon).

Monitoring:

• Hematologic: Bleeding in hemophiliacs