enfuvirtide

en-FOO-veer-tide

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: fusion inhibitors

REMS

Management of HIV infection in combination with other antiretrovirals in patients with evidence of progressive HIV-1 replication despite ongoing treatment.

Prevents entry of HIV-1 into cells by interfering with the fusion of the virus with cellular membranes.

Therapeutic effects:

Decreased replication of the HIV virus.
Slowed progression of HIV infection with decreased occurrence of sequelae.
Improved CD4 cell count.

Absorption: 84% absorbed following SUBQ administration.

Distribution: 5.5 L.

Protein Binding: 92% bound to plasma proteins.

Metabolism/Excretion: Broken down into component amino acids and then recycled in body pool.

Half-Life: 3.8 hr.

(blood levels)

ROUTE	ONSET	PEAK	DURATION
SUBQ	Unknown	8 hr	12 hr

Contraindicated in:

Hypersensitivity;
Lactation: Breastfeeding not recommended for HIV-infected mothers.

Use Cautiously in:

OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Pedi: Children 6 yr (safety and effectiveness not established).

EENT: conjunctivitis

GI: diarrhea, nausea, abdominal pain, anorexia, dry mouth, PANCREATITIS, weight loss

Local: injection site reactions

MS: limb pain, myalgia

Neuro: fatigue

Resp: cough, pneumonia, sinusitis

Misc: herpes simplex, hypersensitivity reactions, immune reconstitution syndrome

Drug-drug:

None noted.

SC (Adults and Children ≥6 yr and ≥42.6 kg): 90 mg twice daily.
SC (Children ≥6 yr and 38.1–42.5 kg): 81 mg twice daily.
SC (Children ≥6 yr and 33.6–38 kg): 72 mg twice daily.
SC (Children ≥6 yr and 29.1–33.5 kg): 63 mg twice daily.
SC (Children ≥6 yr and 24.6–29 kg): 54 mg twice daily.
SC (Children ≥6 yr and 20.1–24.5 kg): 45 mg twice daily.
SC (Children ≥6 yr and 15.6–20 kg): 36 mg twice daily.
SC (Children ≥6 yr and 11–15.5 kg): 27 mg twice daily.

Lyophilized powder for injection: 108 mg/vial

Assess patient for change in severity of HIV symptoms and for symptoms of opportunistic infections throughout therapy.
Assess patient for injection site reactions (pain, discomfort, induration, erythema, nodules and cysts, pruritus, ecchymosis). These are common, may require analgesics and limitation of physical activities.
Assess patient for signs and symptoms of pneumonia (cough with fever, rapid breathing, dyspnea) during therapy. Notify health care professional immediately if these appear. Patients at higher risk for pneumonia include patients with low initial CD4 cell count, high initial viral load, IV drug use, smoking, and prior history of lung disease.
Monitor patient for signs of hypersensitivity reactions (rash, fever, nausea and vomiting, chills, rigors, hypotension, elevated serum liver transaminases). If these occur, discontinue and do not restart enfuvirtide.

Lab Test Considerations:

Monitor viral load and CD4 cell count regularly during therapy.
- May cause eosinophilia, ↑ serum amylase, lipase, triglycerides, ALT, AST, creatine kinase, and GGT.

Reconstitute vial with 1.1 mL of Sterile Water for Injection and gently tap vial for 10 sec and roll between hands to avoid foaming and ensure all particles come in contact with the liquid and no drug remains on vial wall. Allow vial to stand until powder goes completely into solution; may take up to 45 min or roll vial gently between hands until completely dissolved. Solutions should be clear and colorless; do not administer solutions that are discolored or contain bubbles or particulate matter. Inject immediately or refrigerate for up to 24 hr after reconstitution. Bring to room temperature and inspect solution before administering. Discard any unused drug.
SC: Administer in the upper arm, abdomen, or anterior thigh. Rotate sites; do not inject into sites with previous injection site reactions, moles, scars, bruises, or within 2 inches of the navel.
Do not mix other medications in the same syringe.

Instruct patient on the correct technique for administering enfuvirtide. Review patient information sheet, preparation of dose, administration sites and technique, and disposal of equipment into a puncture-resistant container. First injection should be administered under supervision of a health care professional and technique re-evaluate periodically. Instruct patient to contact www.FUZEON.com or 1-877-4-FUZEON (1-877-438-9366) for more information.
Emphasize the importance of administering enfuvirtide exactly as directed. It must always be used in combination with other antiretrovirals. Do not take more than prescribed amount and do not stop taking without consulting health care professional. If a dose is missed, take as soon as remembered then return to regular schedule. If close to time for the next dose, wait and administer next dose as regularly scheduled; do not administer two doses at same time. If too much is administered, notify health care professional promptly.
Instruct patient that enfuvirtide should not be shared with others.
Inform patient that enfuvirtide does not cure AIDS or prevent opportunistic infections. Enfuvirtide does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood. Advise patient that the long-term effects of enfuvirtide are unknown at this time.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional immediately if signs and symptoms of hypersensitivity reaction (rash; hives; fever; nausea; vomiting; chills; trouble breathing; swelling of face, eyes, lips or mouth; low blood pressure), or signs of immune reconstitution syndrome (signs and symptoms of an infection or inflammation), or pneumonia occur.
Instruct patient to notify health care professional if signs of injection site infection (oozing, increasing heat, swelling, redness, or pain), pneumonia, or hypersensitivity occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected. Encourage pregnant women to enroll in the Antiretroviral Pregnancy Registry by calling 1-800-258-4263. Advise female patient to avoid breast feeding during therapy.
Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.

Decreased replication of the HIV virus.
Slowed progression of HIV infection with decreased occurrence of sequelae.
Improved CD4 count.

Fuzeon

NDC Code

0004- Genentech, Inc.
- 0004-0381- FUZEON
  - 0004-0381-40- 1 KIT in 1 CARTON (0004-0381-40) * 1 mL in 1 VIAL, SINGLE-USE * 1 mL in 1 VIAL, SINGLE-DOSE

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