1. Name of the medicinal product
Fuzeon 90 mg/ml powder and solvent for solution for injection

2. Qualitative and quantitative composition
Each vial contains 108 mg enfuvirtide.

Each ml of reconstituted solution contains 90 mg enfuvirtide.

Excipient with known effect: sodium. Contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodium-free'.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Powder and solvent for solution for injection.

White to off-white lyophilised powder.

4. Clinical particulars
4.1 Therapeutic indications
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).

4.2 Posology and method of administration
Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.

Posology

Adults and adolescents ≥ 16 years: 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.

Elderly: There is no experience in patients > 65 years old.

Children ≥ 6 years and adolescents: The experience in children is limited (see section 5.2). In clinical trials the dosage regimen in Table 1 below was used:

Table 1: Paediatric Dosing

Weight (kg)
 Dose per bid injection

(mg/dose)
 Injection volume

(90 mg 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
 1.0 ml
 

Fuzeon is not recommended for use in children below age 6 due to insufficient data on safety and efficacy (see section 5.2).

Renal impairment: No dose adjustment is required for patients with renal impairment including those receiving dialysis (see sections 4.4 and 5.2).

Hepatic impairment: No data are available to establish a dose recommendation for patients with hepatic impairment (see sections 4.4 and 5.2).

Method of Administration

Fuzeon is only to be administered by subcutaneous injection. For instructions on reconstitution before administration, see section 6.6.

4.3 Contraindications
Hypersensitivity to the active su