Active Ingredient: Abacavir
Abacavir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children.
The demonstration of the benefit of abacavir is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy.
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. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 300 milligrams abacavir, 2 times daily.
Regimen B: Oral, 600 milligrams abacavir, once daily.
The recommended dose of abacavir is 600 mg daily. This may be administered as either 300 mg twice daily or 600 mg once daily.
Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose 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.
It can be taken with or without food.
For:
Regimen A: In case that patient weight is ≥ 25 kg, oral, 300 milligrams abacavir, 2 times daily.
Regimen B: In case that patient weight is ≥ 25 kg, oral, 600 milligrams abacavir, once daily.
Regimen C: In case that patient weight is ≥ 20 kg and patient weight is ≤ 25 kg, oral, 450 milligrams abacavir, once daily.
Regimen D: In case that patient weight is ≥ 20 kg and patient weight is ≤ 25 kg, oral, 450 milligrams abacavir, divided daily, 2 doses in total.
Regimen E: In case that patient weight is ≥ 14 kg and patient weight is ≤ 20 kg, oral, 150 milligrams abacavir, divided 2 times daily.
Regimen F: In case that patient weight is ≥ 14 kg and patient weight is ≤ 20 kg, oral, 300 milligrams abacavir, divided once daily.
The recommended dose of abacavir is 600 mg daily. This may be administered as either 300 mg twice daily or 600 mg once daily.
Children weighing ≥20 kg to <25 kg: The recommended dose is 450 mg daily. This may be administered as either one 150 mg taken in the morning and 300 mg taken in the evening, or 450 mg taken once daily.
Children weighing 14 to <20 kg: The recommended dose is 300 mg daily. This may be administered as either 150 mg twice daily or 300 mg once daily.
Children less than three months of age: The clinical experience in children aged less than three months is limited and are insufficient to propose specific dosage recommendations.
Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose 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.
It can be taken with or without food.
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