Enfuvirtide

Enfuvirtide is a prescription medication used for the treatment of HIV infection.

• Enfuvirtide is available under the following different brand names: Fuzeon

Common side effects of Enfuvirtide include:

• fever,
• night sweats,
• swollen glands,
• cold sores,
• cough,
• wheezing,
• diarrhea,
• weight loss,
• trouble speaking,
• difficulty swallowing,
• problems with balance or eye movement,
• weakness,
• prickly feeling,
• swelling in the neck or throat (enlarged thyroid),
• menstrual changes, and
• impotence

Serious side effects of Enfuvirtide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• skin rash,
• fever with or without vomiting,
• blood in the urine,
• fainting,
• shortness of breath,  
• chills,
• chest congestion,
• cough with yellow or green mucus,
• stabbing chest pain,
• wheezing,
• severe pain in your upper stomach spreading to the back,
• nausea,
• vomiting,
• blood in the urine,
• swelling in the feet,
• skin reaction (itching, redness, swelling, pain or a hard lump) where the medicine is injected, and
• pain, warmth, oozing, or redness where an injection was given

Rare side effects of Enfuvirtide include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection, powder for reconstitution

• 90 mg/mL (reconstituted)
• NOTE: 108 mg vial reconstituted with 1.1 mL sterile water delivers 90 mg/mL

HIV Infection

Adult dosage

• 90 mg SC every 12 hours

Pediatric dosage

• Aged below 6 years: Safety and efficacy not established
• 6-16 years: 2 mg/kg SC every 12 hours; not to exceed 90 mg every 12 hours 
• Aged above 16 years: 90 mg SC every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Enfuvirtide has severe interactions with the following drug:
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
• Enfuvirtide has serious interactions with the following drugs:
  • betibeglogene autotemcel
  • cabotegravir
  • elivaldogene autotemcel
• Enfuvirtide has serious interactions with at least 18 other drugs.
• Enfuvirtide has serious interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Enfuvirtide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Enfuvirtide?”

Cautions

• Use only in combination with other antiretrovirals
• Each injection should be in a different site than the previous one (upper arm, anterior thigh, abdomen)
• Monitor for signs and symptoms of pneumonia
• Low initial CD4+ T-cell count and high initial viral load
• Pulmonary disease, smoking
• If pt becomes pregnant, call the Antiretroviral Pregnancy Registry at 1-800-258-4263
• The possibility exists that this drug could result in a false-positive HIV test using (ELISA); the use of a confirmatory test (Western blot) is advised
• Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs; patients may develop an inflammatory response to indolent or residual opportunistic infection

Pregnancy and Lactation

• May be acceptable during pregnancy.
• Lactation
  • Unknown whether enfuvirtide is excreted in milk; avoid in breastfeeding women; the CDC advises HIV-infected women not to breast-feed to avoid postnatal transmission of HIV