Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 90mg/mL (reconstituted)
- NOTE: 108mg vial reconstituted with 1.1mL sterile water delivers 90mg/mL
HIV Infection
90 mg SC q12hr
Dosage Forms & Strengths
injection, powder for reconstitution
- 90mg/mL (reconstituted)
- NOTE: 108mg vial reconstituted with 1.1mL sterile water delivers 90mg/mL
HIV Infection
<6 years: Safety and efficacy not established
6-16 years: 2 mg/kg SC q12hr; not to exceed 90 mg q12hr
>16 years: 90 mg SC q12hr
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
enfuvirtide, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.
Serious - Use Alternative (1)
- cabotegravir
enfuvirtide, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
Monitor Closely (17)
- abacavir
abacavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- atazanavir
atazanavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- darunavir
darunavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- efavirenz
efavirenz and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- emtricitabine
emtricitabine and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- fosamprenavir
fosamprenavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- indinavir
indinavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- lamivudine
enfuvirtide and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nelfinavir
nelfinavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nevirapine
enfuvirtide and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- orlistat
orlistat will decrease the level or effect of enfuvirtide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.
- ritonavir
ritonavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- saquinavir
saquinavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- stavudine
enfuvirtide and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tenofovir DF
enfuvirtide and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tipranavir
tipranavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- zidovudine
enfuvirtide and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (0)
Adverse Effects
>10%
Difficult to separate from background regimen
Multiple inj site rxn (98%)
Pain & discomfort (96%)
Erythema (91%)
Induration (90%)
Nodules and cysts (80%)
Pruritis (65%)
Ecchymosis (52%)
Diarrhea (31%)
Nausea (22%)
Fatigue (20%)
Periph. neuropathy
Insomnia
1-10%
Difficult to separate from background regimen
Asthenia
Depression
Pruritis
Abdominal pain
Anorexia
Decreased appetite
Weight loss
Myalgia
Cough
Herpes simplex
Influenza-like illness
Pneumonia
Sinusitis
Lymphadenopathy
Pancreatitis
<1% (selected)
Unstable angina
Toxic hepatitis
Renal failure
Respiratory distress
Guillain-Barre syndrome
Hypersensitivity rxn
Primary immune complex reaction
Suicide attempt
Postmarketing Reports
Cutaneous amyloidosis at the injection site
Warnings
Contraindications
Hypersensitivity
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 Antiretroviral Pregnancy Registry 1-800-258-4263
The possibility exists that this drug could result in a false-positive HIV test using (ELISA); 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 & Lactation
Pregnancy Category: B
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Synthetic peptide; inhibits fusion of HIV-1 with CD4+ cell membrane
Combination use recommended
Pharmacokinetics
Half-Life: 3.8 hr
Peak Plasma Time: 4-8 hr
Peak Plasma Concentration: 4.59 +/- 1.5 mcg/mL
AUC: 55.8 +/- 12.1 mcg.hr/mL
Bioavailability: 84%
Vd: 5.5L
Protein Bound: 92%
Metabolism: Hydrolysis
Total Body Clearance: 21-29 mL/hr/kg
Administration
SC Administration
Inject SC into the upper arm, anterior thigh, or abdomen
Images
Patient Handout
enfuvirtide subcutaneous
ENFUVIRTIDE - INJECTION
(en-FUE-vir-tide)
COMMON BRAND NAME(S): Fuzeon
USES: This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life.Enfuvirtide is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using enfuvirtide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Inject this medication under the skin (subcutaneously) usually twice daily into the upper arm, thigh, or abdomen. Do not inject into the buttock or near the elbow, knee or groin. Rotate injection sites with each shot. Do not inject in or near bumps from past injections. Also, do not inject into moles, scars, bruises, tattoos, burn areas, or your belly button.For children, the dosage is based on their weight.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.It is very important to continue using this medication (and other anti-HIV medications) exactly as prescribed by your doctor. Do not skip any doses.For the best effect, use this medication at evenly spaced times. To help you remember, use this medication at the same times every day.If you have a very serious allergic reaction to enfuvirtide, do not use it again (see Side Effects section).
SIDE EFFECTS: Pain, redness, itching, bruising, hardened skin, or bumps at the injection site may occur. These types of reactions are common and may last up to 7 days. Runny nose may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes), signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).Tell your doctor right away if you have any serious side effects, including: anxiety, numbness/tingling/shooting nerve pain near injection site, signs of injection site infection (such as oozing, warmth, persistent pain and redness), abdominal pain, loss of appetite.An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing, fever, chills, nausea/vomiting.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using enfuvirtide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (e.g., hemophilia, coagulopathy), smoking, IV drug abuse, lung disease.During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and enfuvirtide may be part of that treatment. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (e.g., warfarin, heparin, enoxaparin), orlistat.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., blood test, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Before mixing, store the dry powder and mixing solution at room temperature. Once mixed, store the medication in the refrigerator and use within 24 hours. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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