Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
Enfuvirtide (T-20, Fuzeon)
|Enfuvirtide (T-20, Fuzeon)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
|Lyophilized Powder for Injection:
- 108-mg vial of enfuvirtide. Reconstitution with 1.1 mL sterile water will deliver 90 mg/mL.
- 60 single-use vials of enfuvirtide (108-mg vial reconstituted as 90 mg/mL), 60 vials of sterile water for injection, 60 reconstitution syringes (3 mL), 60 administration syringes (1 mL), alcohol wipes
||Selected Adverse Events
|Pediatric and Adolescent Dose (Aged 6–16 Years)
Children Aged <6 Years:
Children Aged ≥6 Years:
- Not approved for use in children aged <6 years
Adolescent (Aged >16 Years) and Adult Dose:
- 2 mg/kg (maximum dose 90 mg [1 mL]) twice daily injected subcutaneously (SQ) into the upper arm, anterior thigh, or abdomen
- 90 mg (1 mL) twice daily injected SQ into the upper arm, anterior thigh, or abdomen
- Local injection site reactions (e.g., pain, erythema, induration, nodules and cysts, pruritus, ecchymosis) in up to 98% of patients.
- Increased rate of bacterial pneumonia (unclear association).
- Hypersensitivity reaction (HSR)—symptoms may include rash, fever, nausea, vomiting, chills, rigors, hypotension, or elevated serum transaminases. Rechallenge is not recommended.
- Carefully instruct patient or caregiver in proper technique for drug reconstitution and administration of SQ injections. Enfuvirtide injection instructions are provided with convenience kits.
- Allow reconstituted vial to stand until the powder goes completely into solution, which could take up to 45 minutes. Do not shake.
- Once reconstituted, inject enfuvirtide immediately or keep refrigerated in the original vial until use. Reconstituted enfuvirtide must be used within 24 hours.
- Enfuvirtide must be given SQ; severity of reactions increases if given intramuscularly.
- Give each injection at a site different from the preceding injection site; do not inject into moles, scar tissue, bruises, or the navel. Both the patient/caregiver and health care provider should carefully monitor for signs and symptoms of local infection or cellulitis.
- To minimize local reactions, apply ice or heat after injection or gently massage injection site to better disperse the dose. There are reports of injection-associated neuralgia and paresthesia when alternative delivery systems, such as needle-free injection devices, are used.
- Advise patients/caregivers of the possibility of a HSR; instruct them to discontinue treatment and seek immediate medical attention if a patient develops signs and symptoms consistent with a HSR.
- Catabolism to constituent amino acids.