Peptide LibraryEnfuvirtide dosage in published studies and labels
These are the doses used for Enfuvirtide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Enfuvirtide has an FDA-approved human dosage, as Fuzeon, for treatment-experienced people with HIV-1 who still have detectable virus despite ongoing antiretroviral therapy, always combined with other antiretrovirals. The label's adult dose is 90 mg (1 mL) injected under the skin twice daily; children weighing at least 11 kg receive 2 mg/kg twice daily, up to 90 mg twice daily.
| Human dosing established | Yes |
|---|---|
| Route | Subcutaneous |
| Frequency | Twice daily |
| Duration studied | Long-term, as part of combination antiretroviral therapy |
| Half-life | About 3.8 hours after a 90 mg subcutaneous dose |
| Evidence level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — Fuzeon, adultsFDA-approved label · FDA prescribing information | Treatment-experienced adults with HIV-1 replication despite ongoing antiretroviral therapy | 90 mg (1 mL) | Subcutaneous (upper arm, front of thigh or abdomen) | Twice daily | Ongoing, with other antiretrovirals | Treatment of HIV-1 infection | FUZEON (enfuvirtide) for injection — FDA prescribing information, revised 8/2019 (Drugs@FDA) |
| FDA label — Fuzeon, childrenFDA-approved label · FDA prescribing information | Treatment-experienced children with HIV-1 weighing at least 11 kg | 2 mg/kg, up to 90 mg; the label's weight table runs from 27 mg (11–15.5 kg) to 90 mg (42.6 kg and over) | Subcutaneous | Twice daily | Ongoing, with weight checked and the dose adjusted periodically | Treatment of HIV-1 infection | FUZEON (enfuvirtide) for injection — FDA prescribing information, revised 8/2019 (Drugs@FDA) |
| TORO 1 — phase 3, NEJM 2003Clinical trial · Randomised, open-label phase 3 trial | Adults with multidrug-resistant HIV-1 after at least six months of three drug classes (501 randomised) | Enfuvirtide with an optimised background regimen of three to five antiretrovirals, or the background regimen alone (dose not stated in the indexed abstract) | Not stated in the indexed abstract | Not stated in the indexed abstract | 24 weeks to the primary endpoint | Mean viral load fell by 1.696 log10 copies/mL with enfuvirtide versus 0.764 with the background regimen alone; injection-site reactions in 98% of patients and more pneumonia with enfuvirtide | Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med. 2003. |
Where sources disagree
- Fuzeon has no current label on DailyMed, and Drugs@FDA lists the product as discontinued; the dosing above is from its last FDA prescribing information (August 2019) on Drugs@FDA.
- The label reports local injection-site reactions in 98% of trial participants and an increased rate of bacterial pneumonia compared with the control arm; it also warns about hypersensitivity reactions and post-injection bleeding.
- The label says each single-dose vial must be reconstituted only with the 1 mL of Sterile Water for Injection provided in its kit.