Generic Name

Enfuvirtide

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Classification

FDA Approved Indications

• Treatment of HIV-1 infection in combination with other antiretroviral agents in treatment-experienced patients

Mechanism of Action

Enfuvirtide is a synthetic peptide that inhibits HIV-1 fusion by binding to the gp41 subunit of the viral envelope glycoprotein, preventing the conformational changes required for viral entry into the host CD4+ T cells.

Dosage and Administration

Adult: 90 mg subcutaneously twice daily; administer on an empty stomach or with food if tolerated

Pediatric: Not approved for pediatric use

Geriatric: No specific dosage adjustment recommended, but caution due to limited data

Renal Impairment: No dose adjustment required

Hepatic Impairment: No specific data; use with caution

Pharmacokinetics

Absorption: Administered subcutaneously, well-absorbed with peak plasma concentrations in 2-4 hours

Distribution: Limited data; binds minimally to plasma proteins

Metabolism: Not metabolized by cytochrome P450 enzymes; degraded by proteolytic enzymes

Excretion: Primarily degraded locally at injection site and via renal proteolytic enzymes

Half Life: 3.8 hours

Contraindications

• Hypersensitivity to enfuvirtide or any component of the formulation

Precautions

• Use with caution in patients with active or history of pulmonary diseases, including pneumonia
• Monitor for immune reconstitution inflammatory syndrome (IRIS)
• Potential for injection site reactions

Adverse Reactions - Common

• Injection site reactions (pain, erythema, nodules, pruritus, cysts, inflammation) (Very common)
• Eosinophilia (Common)

Adverse Reactions - Serious

• Hypersensitivity reactions, including rash, urticaria, dyspnea (Rare)
• Pulmonary infections, including pneumonia (Uncommon)

Drug-Drug Interactions

N/A

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Inject medication exactly as prescribed, rotating sites to minimize skin reactions
• Report any signs of allergic reactions, difficulty breathing, or chest pain
• Maintain regular follow-up appointments for viral load and CD4 count monitoring
• Use caution with other injectable medications or substances

Special Considerations

Black Box Warnings:

• Potential for hypersensitivity reactions which can be severe

Genetic Factors: No pharmacogenetic considerations established

Lab Test Interference: No known interference

Overdose Management

Signs/Symptoms: Localized injection site reactions or hypersensitivity symptoms

Treatment: Supportive care; discontinue use; provide antihistamines or corticosteroids for hypersensitivity as needed

Storage and Handling

Storage: Store vials refrigerated at 2-8°C; protect from light; do not freeze

Stability: Stable until expiration date when refrigerated; after reconstitution, use within 24 hours if stored refrigerated