Adult Dosing
Human immunodeficiency virus type 1 (HIV-1)
- 90 mg (1 mL) SC bid into the upper arm, anterior thigh, or abdomen
Note: Should not be injected near any anatomical areas where large nerves course close to the skin
Pediatric Dosing
Human immunodeficiency virus type 1 (HIV-1)
- 6-16 yrs
- 2 mg/kg/dose SC bid; MAX 90 mg bid
- Note: Should not be injected near any anatomical areas where large nerves course close to the skin. Periodically monitor weight and adjust the dose accordingly
[Outline]
Renal Dose Adjustment (Based on CrCl)
- >35mL/min: No dose adjustments
- <35mL/min: Dose adjustments not defined
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
See Supplemental Patient Information
- Injection site reactions such as pain, discomfort, erythema, nodules and cysts, and ecchymosis have occurred
- Neuralgia, paresthesia, bruising and hematomas have occurred on administration of drug with biojector 2000. Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, are at higher risk of post-injection bleeding
- Risk of bacterial pneumonia increases in patients undergoing therapy; patients may require hospitalization. Monitor HIV-infected patients for signs and symptoms of pneumonia, especially those predisposed to pneumonia
- Systemic hypersensitivity reactions have occurred; may recur on re-challenge. Discontinue therapy on developing signs and symptoms suggestive of a systemic hypersensitivity reaction and immediately seek medical evaluation. Avoid restarting therapy
- Production of anti-enfuvirtide antibodies which cross react with HIV gp41 resulting in false positive HIV test with an ELISA assay can occur
- Safety and efficacy have not been established in non-HIV infected individuals
- Immune reconstitution syndrome requiring further evaluation and treatment has occurred in patients treated with combination antiretroviral therapy
- Autoimmune disorders including Graves disease, polymyositis, and Guillain-Barré syndrome may occur in the setting of immune reconstitution
Cautions: Use cautiously in:
- Pulmonary disease
- Prior history of lung disease
- Risk of pneumonia
- Low initial CD4 lymphocyte count
- High initial viral load
- Intravenous drug use
- Smoking
Supplemental Patient Information
- Advise patients to discontinue therapy and immediately seek medical evaluation if they develop signs or symptoms of systemic hypersensitivity
- Advise patients to communicate their healthcare provider if they are pregnant, plan to become pregnant or become pregnant while taking this medication, and also if they are breastfeeding
Pregnancy Category:B
Breastfeeding: Unsafe; unknown whether enfuvirtide is excreted in human milk. Manufacturer advises mothers to avoid breastfeeding if they are receiving therapy as potential for serious adverse reactions in nursing infants and potential for HIV transmission exists.
