NRTI (Nucleoside Reverse Transcriptase Inhibitor)
Abacavir belongs to a class of drugs called the Nucleoside reverse transcriptase inhibitors (NRTI). Abacavir is a nucleoside analog which is incorporated in the viral DNA during replication and inhibits the process terminating viral replication.
Nucleoside is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
- A medication guide and warning card should be dispensed with each new prescription and refill.
- Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily.
- Pediatric Patients Aged 3 Months and Older: Dose should be calculated on body weight (kg) and should not exceed 300 mg twice daily
- Patients With Hepatic Impairment:
- Mild hepatic impairment – 200 mg twice daily
- moderate/severe hepatic impairment- contraindicated.
The most commonly reported adverse reactions were-
- dreams/sleep disorders
The most commonly reported adverse reactions of at least moderate intensity in pediatric HIV-1 clinical studies were-
- fever and/or chills
- nausea and vomiting
- skin rashes
- ear/nose/throat infections
- ZIAGEN has been linked to serious, and sometimes fatal, hypersensitivity reactions.
- Abacavir hypersensitivity is a multi-organ clinical syndrome.
Patients who have the HLA-B*5701 allele are more likely to have a hypersensitivity reaction to abacavir.
- If a hypersensitivity reaction is suspected, discontinue ZIAGEN immediately. If hypersensitivity cannot be ruled out, regardless of HLA-B*5701 status, discontinue ZIAGEN permanently, even if other diagnoses are possible.
- NEVER restart ZIAGEN or any other abacavir-containing product after a hypersensitivity reaction.
- The use of nucleoside analogues has been linked to lactic acidosis and severe hepatomegaly with steatosis, including fatal cases.
- In patients receiving combination antiretroviral therapy, immune reconstitution syndrome and redistribution/accumulation of body fat have been reported.