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Enfuvirtide (Fuzeon)

Trade Name : FUZEON

Genentech, Inc.

KIT

Strength

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Enfuvirtide (Fuzeon) which is also known as FUZEON and Manufactured by Genentech, Inc.. It is available in strength of per ml. Read more

Enfuvirtide (Fuzeon) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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. ()
  • No data
  • Adults: Recommended dosage of FUZEON is 90 mg (1 mL) twice daily injected subcutaneously into the upper arm, anterior thigh, or abdomen. ()
  • Pediatric Patients (weighing at least 11kg): Recommended dose of 2 mg/kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously. Weight should be monitored periodically and the FUZEON dose should be adjusted accordingly. ()
  • FUZEON must only be reconstituted with 1 mL of Sterile Water for Injection provided in the Convenience Kit. ()
  • Reconstituted FUZEON must be injected immediately or kept refrigerated in the original vial. It must be used within 24 hours. ()
  • Lyophilized powder for injection: 108 mg enfuvirtide per single-dose vial
  • Lyophilized powder: 108 mg of enfuvirtide per single-dose vial. ()
  • FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components .
  • Hypersensitivity to FUZEON or any of its components. ()
  • No data
  • Injection Site Reaction: 98% of subjects experienced at least one injection site reaction during FUZEON treatment in randomized, controlled, open-label, multicenter trials. Manifestations included pain and discomfort, erythema, nodules and cysts, and ecchymosis. ()
  • Biojector 2000: Administration of FUZEON with Biojector 2000 may result in neuralgia and/or paresthesia, bruising and hematomas. ()
  • Post-Injection Bleeding: Patients receiving anticoagulants or persons with hemophilia, or other coagulation disorders, may have a higher risk of post-injection bleeding. ()
  • Hypersensitivity: FUZEON should be discontinued immediately upon signs and symptoms of systemic hypersensitivity reactions. ()
  • Pneumonia: Monitor for signs and symptoms of pneumonia in HIV-infected patients, especially those predisposed to pneumonia (e.g., low initial CD4 cell count). ()
  • Immune Reconstitution: Patients treated with combination antiretroviral therapy, including FUZEON, may experience immune reconstitution syndrome requiring further evaluation and treatment. ()
  • The following adverse reactions are discussed in greater detail in other sections:
  • Most common adverse reactions are local injection site reactions, diarrhea, nausea, and fatigue. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Lactation: Breastfeeding is not recommended due to risk of HIV-1 transmission. ()
  • 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.
  • 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 CHNO, and the molecular weight is 4492. It has the following primary amino acid sequence:
  • CHCO-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH and the following structural formula:
  • 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.
  • No data
  • No data
  • No data
  • No data
  • See FDA-Approved Patient Labeling (, ) tttttt
  • To assure safe and effective use of FUZEON, the following information and instructions should be given to patients:
  • FUZEON is a trademark of Hoffmann-La Roche Inc.
  • FUZEON has been jointly developed by Alexion Pharmaceuticals, Inc. and Hoffmann-La Roche Inc. FUZEON is manufactured by Hoffmann-La Roche Inc.
  • Distributed by:n n A Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080
  • Arrayn- u00ae
  • Patient InformationFUZEON (few'-zee-on)(enfuvirtide) Injection
  • Instructions for UseFUZEONu2122 (few'-zee-on)(enfuvirtide)Injection, for subcutaneous use108 mg vial
  • 1 Before You Begin
  • Important Information:
  • How should I store FUZEON?
  • 2 Getting Started
  • 3 Prepare Your FUZEON Dose
  • 4 Mixing FUZEON
  • 5 Choose and prepare your injection site
  • 6 Inject FUZEON
  • Dispose of (throw away) your used FUZEON needle and syringe:
  • Rx only
  • FUZEON has been jointly developed by Alexion Pharmaceuticals, Inc. and Hoffmann-La Roche Inc.FUZEON is manufactured by Hoffmann-La Roche Inc.
  • Distributed by:n n A Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080
  • Arrayn- u00a9
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.Revised: 12/2019
  • Representative sample of labeling (see the section for complete listing):
  • NDC 0004-0381-40
  • Fuzeonn
  • 90 mg
  • For Subcutaneous use after reconstitution.Each vial contains 108 mg enfuvirtide to providedelivery of 90 mg.n n
  • GTIN 00300040381405
  • Rx only
  • Package Contains:
  • Genentech

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