Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens (see section 5.1).
In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate (see sections 4.4 and 5.1).
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.
Posology
The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen.
In case a Fuzeon dose is missed, patients should be instructed to administer the dose as soon as possible. However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped.
There is no experience in patients >65 years old.
The experience in children is limited (see section 5.2). In clinical trials the dosage regimen in Table 1 below was used:
| Weight (kg) | Dose per bid injection (mg/δόση) | Injection volume (90mg enfuvirtide per ml) |
|---|---|---|
| 11,0 to 15,5 | 27 | 0,3 ml |
| 15,6 to 20,0 | 36 | 0,4 ml |
| 20,1 to 24,5 | 45 | 0,5 ml |
| 24,6 to 29,0 | 54 | 0,6 ml |
| 29,1 to 33,5 | 63 | 0,7 ml |
| 33,6 to 38,0 | 72 | 0,8 ml |
| 38,1 to 42,5 | 81 | 0,9 ml |
| ≥42,6 | 90 | 1,0ml |
Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).
No dose adjustment is required for patients with renal impairment including those receiving dialysis (see sections 4.4 and 5.2).
No data are available to establish a dose recommendation for patients with hepatic impairment (see sections 4.4 and 5.2).
Fuzeon is only to be administered by subcutaneous injection. For instructions on reconstitution before administration, see section 6.6.
No case of overdose has been reported. The highest dose administered to 12 patients in a clinical trial was 180 mg as a single dose subcutaneously. These patients did not experience any adverse reactions that were not seen with the recommended dose. In an Early Access Program study, one patient was administered 180 mg of Fuzeon as a single dose on one occasion. He did not experience an adverse reaction as a result.
There is no specific antidote for overdose with enfuvirtide. Treatment of overdose should consist of general supportive measures.
Powder: 4 years.
Solvent: 4 years.
After reconstitution: Store in a refrigerator (2°C–8°C). Chemical and physical in-use stability has been demonstrated for 48 hours at 5°C when protected from light.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Powder: Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Solvent: This medicinal product does not require any special storage conditions.
Powder:
Vial: 3 ml vial, colourless glass type 1
Closure: lyophilisate stopper, rubber (latex free)
Seal: aluminium seal with flip-off cap
Powder:
Vial: 2 ml vial, colourless glass type 1
Closure: rubber stopper (latex free)
Seal: aluminium seal with flip-off cap
Pack sizes:
60 vials powder for solution for injection
60 vials solvent
60 3 ml syringes
60 1 ml syringes
180 alcohol swabs
Any unused medicinal product should be disposed of in accordance with local requirements.
Patients should be instructed on the use and administration of Fuzeon by a healthcare professional before using for the first time.
Fuzeon must only be reconstituted with 1.1 ml of Water for Injections. Patients must be instructed to add the water for injections and then gently tap the vial with their fingertip until the powder begins to dissolve. They must never shake the vial or turn it upside down to mix—this will cause excessive foaming. After the powder begins to dissolve they can set the vial aside to allow it to completely dissolve. The powder may take up to 45 minutes to dissolve into solution. The patient can gently roll the vial between their hands after adding the water for injections until it is fully dissolved and this may reduce the time it takes for the powder to dissolve. Before the solution is withdrawn for administration, the patient should inspect the vial visually to ensure that the contents are fully in solution, and that the solution is clear and without bubbles or particulate matter. If there is evidence of particulate matter, the vial must not be used and should be discarded or returned to the pharmacy.
The solvent vials contain 2 ml Water for Injections, of which 1.1 ml must be withdrawn for the reconstitution of the powder. Patients should be instructed to discard the remaining volume in the solvent vials.
Fuzeon contains no preservative. Once reconstituted, the solution should be injected immediately. If the reconstituted solution cannot be injected immediately, it must be kept refrigerated until use and used within 24 hours. Refrigerated reconstituted solution should be brought to room temperature before injection.
1 ml of the reconstituted solution should be injected subcutaneously in to the upper arm, abdomen or anterior thigh. The injection should be given at a site different from the preceding injection site and where there is no current injection site reaction. A vial is suitable for single use only; unused portions must be discarded.
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