Brand Name
Fuzeon
Generic Name
Enfuvirtide
View Brand Information FDA approval date: April 10, 2012
Form: Kit
What is Fuzeon (Enfuvirtide)?
FUZEON ® in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. FUZEON is an HIV-1 gp41 fusion inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with HIV-1 replication despite ongoing antiretroviral therapy.
Approved To Treat
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Brand Information
FUZEON (Enfuvirtide)
1INDICATIONS AND USAGE
FUZEON
2DOSAGE FORMS AND STRENGTHS
Lyophilized powder for injection: 108 mg enfuvirtide per single-dose vial
3CONTRAINDICATIONS
FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections:
- Administration with Biojector
- Hypersensitivity Reactions
- Pneumonia
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The overall safety profile of FUZEON is based on 2131 subjects who received at least 1 dose of FUZEON during various clinical trials. This includes 2051 adults, 658 of whom received the recommended dose for greater than 48 weeks, and 63 pediatric subjects.
Assessment of treatment-emergent adverse events is based on the pooled data from the two randomized, controlled, open-label, multicenter trials in treatment-experienced subjects, T20-301 (TORO 1) and T20-302 (TORO 2).
4.2Postmarketing Experience
The following adverse reaction has been identified during post approval use of FUZEON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5OVERDOSAGE
There are no reports of human experience of acute overdose with FUZEON. The highest dose administered to 12 subjects in a clinical trial was 180 mg as a single-dose subcutaneously. There is no specific antidote for overdose with FUZEON. Treatment of overdose should consist of general supportive measures.
6DESCRIPTION
FUZEON (enfuvirtide) is an inhibitor of the fusion of HIV-1 with CD4 cells. Enfuvirtide is a linear 36-amino acid synthetic peptide with the N-terminus acetylated and the C-terminus is a carboxamide. It is composed of naturally occurring L-amino acid residues.
Enfuvirtide is a white to off-white amorphous solid. It has negligible solubility in pure water and the solubility increases in aqueous buffers (pH 7.5) to 85-142 g/100 mL. The empirical formula of enfuvirtide is C
CH
The drug product, FUZEON (enfuvirtide) for Injection, is a white to off-white, sterile, lyophilized powder. Each single-dose vial contains 108 mg of enfuvirtide for the delivery of 90 mg. Prior to subcutaneous administration, the contents of the vial are reconstituted with 1 mL of Sterile Water for Injection to provide the delivery of 1 mL of the solution. Each 1 mL of the reconstituted solution contains approximately 90 mg of enfuvirtide with approximate amounts of the following excipients: 22.55 mg of mannitol, 2.39 mg of sodium carbonate (anhydrous), and sodium hydroxide and hydrochloric acid for pH adjustment as needed. The reconstituted solution has an approximate pH of 9.0.
7PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (
To assure safe and effective use of FUZEON, the following information and instructions should be given to patients:
8PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 0004-0381-40
Fuzeon
(enfuvirtide) for Injection
(enfuvirtide) for Injection
90 mg
For Subcutaneous use after reconstitution.
GTIN 00300040381405
Rx only
Package Contains:
Monthly Convenience Kit
60 Vials, FUZEON® 90 mg vial, NDC 0004-0380-01
60 Vials, Sterile Water for Injection 1 mL per vial
60 1cc Syringes (for administration)
60 3cc Syringes (for reconstitution)
Monthly Convenience Kit
60 Vials, FUZEON® 90 mg vial, NDC 0004-0380-01
60 Vials, Sterile Water for Injection 1 mL per vial
60 1cc Syringes (for administration)
60 3cc Syringes (for reconstitution)
Genentech
10213953
