Ziagen^® 20 mg/ml oral solution

Each ml of oral solution contains 20 mg of abacavir (as sulfate).

Excipients with known effect:

Sorbitol (E420) 340 mg/ml

Methyl parahydroxybenzoate (E218) 1.5 mg/ml

Propyl parahydroxybenzoate (E216) 0.18 mg/ml

For the full list of excipients see section 6.1.

Oral solution

The oral solution is clear to slightly opalescent yellowish, aqueous solution.

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and 5.1).

The demonstration of the benefit of Ziagen is mainly based on results of studies performed in treatment-naïve adult patients on combination therapy with a twice daily regimen (see section 5.1).

Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin(see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

Ziagen should be prescribed by physicians experienced in the management of HIV infection.

Ziagen can be taken with or without food.

Ziagen is also available as a tablet formulation.

Adults, adolescents and children (weighing at least 25 kg):

The recommended dose of Ziagen is 600 mg daily (30 ml). This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1).

Children (weighing less than 25 kg):

Children from one year of age: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml).

Children from three months to one year of age: The recommended dose is 8 mg/kg twice daily. If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see sections 5.1 and 5.2).

Children less than three months of age: the experience in children aged less than three months is limited (see section 5.2).

Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recomended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recomended once daily dose (as described above) approximately every 24 hours. When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.

Special populations

Renal impairment

No dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).

Hepatic impairment

Abacavir is primarily metabolised by the liver. No definitive dose recommendation can be made in patients with mild hepatic impairment (Child-Pugh score 5-6). In patients with moderate or severe hepatic impairment, no clinical data are available, therefore the use of abacavir is not recommended unless judged necessary. If abacavir is used in patients with mild hepatic impairment, then close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).

Elderly

No pharmacokinetic data are currently available in patients over 65 years of age.