Usual Adult Dose for HIV Infection

90 mg subcutaneously twice daily administered into the upper arm, abdomen, or anterior thigh

Usual Pediatric Dose for HIV Infection

6 years through 16 years: 2 mg/kg subcutaneously twice daily administered into the upper arm, abdomen, or anterior thigh
Maximum dose: 90 mg subcutaneously twice daily

17 years or older: 90 mg subcutaneously twice daily administered into the upper arm, abdomen, or anterior thigh

Renal Dose Adjustments

CrCl 35 mL/min or more: No adjustment recommended
CrCl 34 mL/min or less: Data not available

Liver Dose Adjustments

Data not available

Precautions

An increased incidence of pneumonia has been reported in clinical trials. Patients should be closely monitored for signs and symptoms of pneumonia, especially if they have any predisposing risk factors (low initial CD4 cell count, high initial viral load, intravenous drug use, smoking, and a previous history of lung disease). Patients should be advised to immediately seek medical assistance if they develop possible signs of pneumonia (e.g., cough with fever, rapid breathing, shortness of breath).

Hypersensitivity reaction have occurred and may recur on rechallenge. Immediate medical evaluation is recommended for patients who develop signs of a systemic hypersensitivity reaction (e.g., rash, fever, nausea, vomiting, chills, rigors, hypotension, elevated liver transaminases, primary immune complex reaction, respiratory distress, glomerulonephritis, Guillain-Barre syndrome).

Immune reconstitution syndrome has occurred during combination antiretroviral therapy. Patients responding to therapy may develop an inflammatory response to indolent or residual opportunistic infections and require evaluation and treatment.

Enfuvirtide must be taken as part of a combination antiretroviral regimen. Monotherapy may lead to rapid development of viral resistance.

Safety and efficacy have not been established in pediatric patients under the age of 6 years.

Dialysis

Data not available
Due to its high molecular weight, enfuvirtide is not likely to be cleared by conventional hemodialysis methods.

Other Comments

After reconstitution with sterile water, the vial should be gently tapped for 10 seconds and then gently rolled between the hands to avoid foaming and to ensure all particles of drug are in contact with the liquid. The vial should then be allowed to stand until the powder goes completely into solution, up to 45 minutes. This time may be reduced by gently rolling the vial between the hands until the product is completely dissolved. The solution should be clear, colorless, and without bubbles or particulate matter.

Enfuvirtide does not contain preservatives. Reconstituted solution should be used immediately or kept refrigerated and used within 24 hours. Refrigerated solution should be brought to room temperature and inspected visually before injection.

The solution should be injected subcutaneously in the upper arm, abdomen, or anterior thigh using aseptic technique. It should be given at a different site from the previous site and where there is no current injection site reaction. It should not be injected near any sites where large nerves run close to the skin (e.g. near the elbow, knee, groin, or inferior or medial sections of the buttocks), skin abnormalities, including directly over a blood vessel, into moles, scar tissue, bruises, or near the navel, surgical scars, burn sites, or tattoos. Unused solution should be discarded.

Patients should be instructed on proper reconstitution and injection techniques, how to recognized injection site reactions, and when to contact their caregiver about these reactions.