Usual Adult Dose for HIV Infection

Less than 60 kg: 30 mg orally every 12 hours
At least 60 kg: 40 mg orally every 12 hours

Comments:

• Some experts (including the WHO) have recommended a maximum dose of 30 mg orally twice a day, regardless of weight.

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

Usual Adult Dose for Nonoccupational Exposure

US CDC Recommendations:

• Less than 60 kg: 30 mg orally every 12 hours
• At least 60 kg: 40 mg orally every 12 hours

Duration of therapy: 28 days

Comments:

• Only with expert consultation, as part of an alternative regimen for use as nonoccupational postexposure prophylaxis of HIV infection
• Prophylaxis should be started as soon as possible, within 72 hours of exposure.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Occupational Exposure

US Public Health Service Working Group Recommendations:

• Less than 60 kg: 30 mg orally twice a day
• At least 60 kg: 40 mg orally twice a day

Duration of therapy: 28 days, if tolerated

Comments:

• Only with expert consultation, as part of an alternative regimen for use as HIV postexposure prophylaxis
• Prophylaxis should be started as soon as possible, preferably within hours after exposure.
• The optimal duration of prophylaxis is unknown and may differ based on institution protocol.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

Birth to 13 days: 0.5 mg/kg orally every 12 hours

14 days or older:
Less than 30 kg: 1 mg/kg orally every 12 hours
30 to less than 60 kg: 30 mg orally every 12 hours
At least 60 kg: 40 mg orally every 12 hours

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

Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV Recommendations:

• Neonates/infants (birth to 13 days): 0.5 mg/kg orally twice a day
• Pediatrics (14 days or older, weighing less than 30 kg): 1 mg/kg orally twice a day
• Adolescents (at least 30 kg): 30 mg orally twice a day

Comments:

• This drug is not recommended due to higher risk of side effects associated with mitochondrial toxicity and higher rate of lipoatrophy than other NRTIs.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Adult Patients:
CrCl 26 to 50 mL/min:

• Less than 60 kg: 15 mg orally every 12 hours
• At least 60 kg: 20 mg orally every 12 hours

CrCl 10 to 25 mL/min:

• Less than 60 kg: 15 mg orally every 24 hours
• At least 60 kg: 20 mg orally every 24 hours

Pediatric Patients: Insufficient data to recommend specific dose adjustment.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with use of nucleoside analogs alone or in combination, including this drug and other antiretrovirals. Fatal lactic acidosis reported in pregnant women who received this drug plus didanosine with other antiretroviral agents. Coadministration of this drug with didanosine is contraindicated due to increased risk of serious and/or life-threatening events. Therapy should be suspended if clinical or laboratory findings suggest lactic acidosis or pronounced hepatotoxicity.
• PANCREATITIS: Fatal and nonfatal pancreatitis have occurred during therapy when this drug was part of a regimen that included didanosine in both therapy-naive and therapy-experienced patients (regardless of degree of immunosuppression).

CONTRAINDICATIONS:
Clinically significant hypersensitivity to the active component or any of the ingredients; coadministration with didanosine

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis:
Adult Patients:

• Less than 60 kg: 15 mg orally every 24 hours
• At least 60 kg: 20 mg orally every 24 hours

Pediatric Patients: Insufficient data to recommend specific dose adjustment.

Comments:

• Dose should be administered after hemodialysis on dialysis days and at the same time each day on non-dialysis days.

Other Comments

Administration advice:

• May administer without regard to food
• Oral solution: Shake well before measuring each dose; discard any unused portion after 30 days.

Storage requirements:

• Store in tightly-closed bottles.
• Capsules: Store at 25C (77F); excursions permitted between 15C and 30C (59F and 86F).
• Oral solution (prior to constitution): Store at 25C (77F); excursions permitted between 15C and 30C (59F and 86F); protect from excessive moisture.
• Oral solution (after constitution): Store in the refrigerator at 2C to 8C (36F to 46F) for up to 30 days.

Reconstitution/preparation techniques:

• Oral solution: The manufacturer product information should be consulted.

Monitoring:

• Hepatic: Liver function in patients with preexisting liver dysfunction (according to standard practice)
• Renal: Renal function in elderly patients (during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Seek medical attention at once if symptoms of symptomatic hyperlactatemia or lactic acidosis syndrome (including unexplained weight loss, abdominal discomfort, nausea, vomiting, fatigue, dyspnea, motor weakness) develop.
• Do not use this drug with didanosine and/or hydroxyurea.
• Report symptoms of peripheral neuropathy (e.g., numbness, tingling, pain in hands/feet) to physician.
• Avoid alcohol while using this drug as it may increase risk of pancreatitis or liver damage.
• If diabetic, be aware that the oral solution contains 50 mg sucrose/mL.