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 available in a single-dose lyophilized powder for injection containing 108 mg enfuvirtide per vial.
FUZEON is administered subcutaneously into the upper arm, anterior thigh or abdomen after reconstituting the lyophilized powder containing 108 mg enfuvirtide with 1 mL of Sterile Water for Injection [see Dosage and Administration (2.5)]. Patients should contact their healthcare provider for any questions regarding the administration of FUZEON by calling the toll-free number 1-877-4-FUZEON (1-877-438-9366) or visiting the FUZEON website, www.FUZEON.com.
The recommended dosage of FUZEON in pediatric patients weighing at least 11 kg is 2 mg per kg twice daily up to a maximum dose of 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen [see Dosage and Administration (2.5 and 2.6) and Use in Specific Populations (8.4)]. Table 1 contains dosing recommendations for FUZEON based on body weight. Weight should be monitored periodically and the FUZEON dose adjusted accordingly.
|Weight||Recommended Daily Dosage (mg)||Injection Volume(mL)|
|11.0 to 15.5||27 mg twice daily||0.3 mL twice daily|
|15.6 to 20.0||36 mg twice daily||0.4 mL twice daily|
|20.1 to 24.5||45 mg twice daily||0.5 mL twice daily|
|24.6 to 29.0||54 mg twice daily||0.6 mL twice daily|
|29.1 to 33.5||63 mg twice daily||0.7 mL twice daily|
|33.6 to 38.0||72 mg twice daily||0.8 mL twice daily|
|38.1 to 42.5||81 mg twice daily||0.9 mL twice daily|
|≥42.6||90 mg twice daily||1.0 mL twice daily|
FUZEON for injection can be administered by patients after training by medical professional using aseptic technique. Refer patients to FUZEON Injection Instructions for step by step instructions during self-administration.
A vial is suitable for single-dose only; unused portions must be discarded.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Patients should return product to pharmacy if there is evidence of particulate matter after mixing FUZEON with sterile water as described below.
- Remove the flip-off cap from the single-dose Sterile Water for Injection vile and from the FUZEON vial.
- Wipe each vial with a new sterile alcohol swab and let the tops air-dry.
- Using the 3 mL (large) syringe with the plunger pulled back to the 1 mL mark, slowly inject the air into the sterile water vial.
- Insert sterile syringe needle into the vial through the center of the stopper.
- Turn the vial upside down and draw 1 mL of the sterile water into the syringe then remove the needle and syringe from the vial.
- Insert the syringe with sterile water into the FUZEON vial at an angle.
- Inject the sterile water slowly, so that it drips down the side of the vial into the FUZEON powder.
- Never shake the vial but gently tap the FUZEON vial with fingertip for 10 seconds to start dissolving the powder.
- Then gently roll the FUZEON vial between hands to reduce the mixing time, making sure no FUZEON is stuck to the vial wall.
- Once the powder starts to dissolve, just set it aside and it will completely dissolve; it could take up to 45 minutes for the powder to completely dissolve and become a solution.
- When completely mixed, the FUZEON solution should be clear, colorless and without bubbles or particulate matter. If the FUZEON is foamy or jelled, allow more time for it to dissolve.
FUZEON contains no preservatives. Once reconstituted, FUZEON should be injected immediately or kept refrigerated in the original vial until use. Reconstituted FUZEON must be used within 24 hours. Refrigerated reconstituted solution should be brought to room temperature before injection and the vial should be inspected visually again to ensure that the contents are fully dissolved in solution and that the solution is clear, colorless, and without bubbles or particulate matter.
The subsequent dose of FUZEON can be reconstituted in advance but must be stored in the refrigerator in the original vial and used within 24 hours.
Each injection should be given at a site different from the preceding injection site, and only where there is no current injection site reaction from an earlier dose.
Do not inject FUZEON:
- Near anatomical areas where large nerves course close to the skin, such as near the elbow, knee, groin or the inferior or medial section of the buttocks.
- Directly over or near skin abnormalities such as moles, scar tissue, bruises, surgical scars, tattoos or burn sites.
- Directly over a blood vessel.
- Near the naval.
- Clean the injection site with a new sterile alcohol pad.
- Clean the FUZEON vial top again, using a new sterile alcohol pad.
- Using the 1 mL (small) syringe with plunger pulled back to 1 mL, insert the syringe with needle into the vial FUZEON solution.
- Before turning the vial upside down, slowly inject the air into the FUZEON.
- Gently turn the vial upside down and slowly pull the plunger to get 1 mL of FUZEON solution and remove the needle and syringe from the vial.
- Pinch and hold a fold of skin around the injection site and pierce the skin. The needle should be inserted most of the way in. Slowly push the plunger all the way to inject FUZEON.
- Remove the needle from the injection site.
- Instruct patients how to safely discard the syringe and needle.
- Cover the injection site with a small bandage if needed.
Lyophilized powder for injection: 108 mg enfuvirtide per single-dose vial
FUZEON is contraindicated in patients with known hypersensitivity to FUZEON or any of its components [see Warnings and Precautions (5.4)].
The majority of subjects (98%) receiving FUZEON in randomized, controlled, open-label, multicenter clinical trials had at least one local injection site reaction; ISRs occurred throughout treatment with FUZEON. Manifestations may include pain and discomfort, induration, erythema, nodules and cysts, pruritus, and ecchymosis [see Adverse Reactions (6)]. Reactions are often present at more than one injection site. Patients must be familiar with the FUZEON Injection Instructions in order to know how to inject FUZEON appropriately and how to monitor carefully for signs or symptoms of cellulitis or local infection.
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