It is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children weighing at least 25 kg.
Qualitative and quantitative composition
Each film-coated tablet contains abacavir hydrochloride equivalent to 600 mg of abacavir and 300 mg of lamivudine.
Pharmaceutical form
Orange, capsule-shaped, biconvex, film-coated tablets, size 20.6 mm x 9.1 mm, debossed with “300” on one side and “600” on the other side.
Therapeutic indications
Abacavir / Lamivudine is indicated in combination antiretroviral therapy for the treatment of human immunodeficiency virus (HIV) infected adults, adolescents and children weighing at least 25 kg .
Before initiating treatment with abacavir , testing for the HLA-B * 5701 allele should be performed in HIV-infected patients, regardless of racial origin (see section 4.4). Abacavir should not be used in patients carrying the HLA-B * 5701 allele.
Dosage and administration
Treatment should be prescribed by a doctor with experience in treating HIV infection.
Posology
Adults, adolescents and children weighing at least 25 kg: The recommended dose of abacavir / lamivudine is one tablet once a day. Children below 25 kg: Abacavir / Lamivudine should not be administered to children weighing less than 25 kg, as the tablet has a fixed dose that cannot be reduced. Abacavir / Lamivudine is a fixed dose tablet and should not be prescribed to patients requiring dose adjustments. In cases where a treatment interruption or dose adjustment of one of the active substances is necessary, separate preparations of abacavir or lamivudine are available . In these cases the doctor should consult the individual information of these medications.
- Elderly patients:
Currently there are no pharmacokinetic data in patients over 65 years of age. Special care is recommended in this age group due to changes associated with age, such as a decrease in renal function and alterations in hematological parameters.
- Renal insufficiency
The use of abacavir / lamivudine is not recommended in patients with a creatinine clearance of 50 ml / min as the necessary dose adjustment cannot be made (see section 5.2).
- Liver failure
No data are available in patients with moderate hepatic impairment, therefore the use of abacavir / lamivudine is not recommended unless considered necessary. Close monitoring is required in patients with mild to moderate hepatic impairment and monitoring of plasma abacavir levels is recommended if possible (see sections 4.4 and 5.2). Abacavir / Lamivudine is contraindicated in patients with severe hepatic impairment (see section 4.3).
- Pediatric population
The safety and efficacy of abacavir / lamivudine in children weighing less than 25 kg has not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. See sections 4.4 and 4.8. Patients with severe liver failure.
Warnings and cautions
Special warnings and precautions for abacavir and lamivudine are included in this section. There are no additional warnings and precautions for abacavir / lamivudine.
Although effective antiretroviral therapy viral suppression has been shown to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded. Precautions should be taken, according to national guidelines, to prevent transmission.