Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Entry and Fusion Inhibitors

Enfuvirtide

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/
Formulations
Lyophilized Powder for Injection:
  • 108-mg vial of enfuvirtide. Reconstitution with 1.1 mL sterile water will deliver 90 mg/mL.
Convenience Kit:
  • 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
Dosing Recommendations Selected Adverse Events
Pediatric and Adolescent Dose (Aged 6–16 Years)
Children Aged <6 Years:
  • Not approved for use in children aged <6 years
Children Aged ≥6 Years:
  • 2 mg/kg (maximum dose 90 mg [1 mL]) twice daily injected subcutaneously (SQ) into the upper arm, anterior thigh, or abdomen
Adolescent (Aged >16 Years) and Adult Dose:
  • 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.
Special Instructions
  • 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.
Metabolism/Elimination
  • Catabolism to constituent amino acids.

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