abacavir
Ziagen · ATC code J05AF06
Also known as: Abakavir
- Key facts
- Active substance
- abacavir
- Drug class
- Direct acting antiviral
- ATC code
- J05AF06
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Ziagen 300 mg film-coated tablets · Ziagen 20 mg/ml oral solution
- Marketing authorisation holder
- ViiV Healthcare B.V.
- Information as of
- 2026-10-28
Key facts
Abacavir (Ziagen) is a nucleoside reverse transcriptase inhibitor used in antiretroviral combination therapy for HIV infection in adults, adolescents and children.
What it is used for
- Antiretroviral combination therapy for the treatment of HIV infection in adults, adolescents and children.
- Screening for the HLA-B*5701 allele should be performed before starting treatment; abacavir should not be used in patients known to carry this allele.
Dosing
- Adults, adolescents and children weighing at least 25 kg (tablets or oral solution): 600 mg daily, as 300 mg twice daily or 600 mg once daily (oral solution: 15 ml twice daily or 30 ml once daily).
- Ziagen 300 mg tablets, children weighing 20 to < 25 kg: 450 mg daily; children weighing 14 to < 20 kg: 300 mg daily, each given once daily or split across the day.
- Ziagen 20 mg/ml oral solution, children from one year of age: 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg; children from three months to one year: 8 mg/kg twice daily.
- Can be taken with or without food.
- Renal impairment: no dose adjustment, but not recommended in end-stage renal disease.
- Hepatic impairment: no definitive dose recommendation for mild impairment (close monitoring needed); not recommended in moderate or severe impairment unless judged necessary.
Contraindications
- Hypersensitivity to abacavir or to any of the excipients.
Important warnings
- Hypersensitivity reactions (fever and/or rash with multi-organ involvement) can be life-threatening and in rare cases fatal; the risk is high in HLA-B*5701 carriers.
- HLA-B*5701 status must be documented before starting; abacavir must be stopped without delay if a hypersensitivity reaction is suspected and must never be restarted afterwards.
- Several studies suggest an increased risk of cardiovascular events, notably myocardial infarction; modifiable risk factors should be minimised.
- Immune reactivation syndrome and autoimmune disorders may occur after starting combination antiretroviral therapy.
- Weight, blood lipids and glucose may increase during antiretroviral therapy; osteonecrosis has been reported.
Side effects
- Common: anorexia, headache, nausea, vomiting, diarrhoea, rash (without systemic symptoms), fever, lethargy, fatigue.
- Rare: pancreatitis.
- Very rare: lactic acidosis, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
- Many of these symptoms also occur in abacavir hypersensitivity, so such patients should be evaluated for hypersensitivity.
Interactions
- Low potential for P450-mediated interactions.
- Potent enzyme inducers such as rifampicin, phenobarbital and phenytoin may slightly decrease abacavir plasma concentrations.
- No clinically significant interactions between abacavir, zidovudine and lamivudine.
Pregnancy and breastfeeding
- Animal studies showed embryo-foetal toxicity in rats; placental transfer occurs in humans. Both animal data and clinical experience should be considered when using antiretrovirals in pregnancy.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ZiagenViiV Healthcare B.V. · EMEA/H/C/000252
Source: European Medicines Agency (EMA), product information
Turkey
- ZiagenGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 10 more European countries
- Finland
- Abacavir Accord
- France
- Abacavir Arrow, Abacavir Sandoz, Abacavir Viatris
- Iceland
- Ziagen
- Italy
- Abacavir Mylan
- Liechtenstein
- Ziagen
- Netherlands
- Abacavir Accord, Abacavir Sandoz
- Norway
- Ziagen
- Portugal
- Abacavir Farmoz, Abacavir Generis, Abacavir Mylan
- Romania
- Abacavir Aurobindo
- Spain
- Abacavir Tarbis
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Ziagen – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/ziagen-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC J05AF.
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.