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Molecule

Abacavir

Also known as abacavir sulfate
Available on requestCold chainHepatitis B and CHIV
Presentations
4
Brands
2
Manufacturers
1
Available from stock
0

Abacavir is a human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus (HIV-1) infection. It is available as tablets, oral solution and kits. MedsAcross supplies Abacavir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Analog, Nucleoside Reverse Transcriptase Inhibitors, Cytochrome P450 1A1 Inhibitors
ATC classification
J05AF06 Abacavir · Direct acting antiviral, subgroup J05AF
US FDA first approval
17 December 1998
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Oral solution, Kit
Identifiers
UNII WR2TIP26VSRxCUI 190521CAS 136470-78-5DrugBank DB01048Q304330

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ZIAGEN tablets and oral solution, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. ZIAGEN, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Source: US FDA prescribing information

Dosing overview

• Before initiating ZIAGEN, screen for the HLA-B*5701 allele. • Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. • Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily. • Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily.

Source: US FDA prescribing information

Contraindications

ZIAGEN is contraindicated in patients: • who have the HLA‑B*5701 allele. • with prior hypersensitivity reaction to abacavir. • with moderate or severe hepatic impairment. • Presence of HLA-B*5701 allele. • Prior hypersensitivity reaction to abacavir. • Moderate or severe hepatic impairment.

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (hypersensitivity reactions): Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with ZIAGEN (abacavir). Patients who carry the HLA ‑ B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir, although, hypersensitivity reactions have occurred in patients who do not carry the HLA ‑ B*5701 allele. • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in other sections of the labeling: • Serious and sometimes fatal hypersensitivity reactions. • Lactic acidosis and severe hepatomegaly with steatosis. • Immune reconstitution syndrome. • Myocardial infarction. • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 5%) in pediatric HIV-1 clinical trials were fever and/or chills, nausea and vomiting, skin rashes, and ear/nose/throat infections.

Source: US FDA prescribing information

Interactions

• Methadone: An increased methadone dose may be required in a small number of patients. • Riociguat: The riociguat dose may need to be reduced.

Source: US FDA prescribing information

Storage

Store at controlled room temperature of 20° to 25°C (68° to 77°F). DO NOT FREEZE. May be refrigerated.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Abacavir, sorted by availability.

MedicineManufacturerRegisterAvailability
Abacavir 300 mg tabletOralGeneric name—US FDAAvailable on request
Abacavir 20 mg/mL oral solutionOral Cold chainGeneric name—US FDAAvailable on request
Triumeq PD kitViiV HealthcareUS FDAAvailable on request
Ziagen 20 mg/mL oral solutionOral Cold chainViiV HealthcareUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 17 December 1998Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Abacavir in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Abacavir available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Abacavir and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Abacavir have?

The catalogue lists 2 brand names for Abacavir, including Triumeq PD, Ziagen.

Is Abacavir approved by the US FDA?

Yes. The US FDA first approved Abacavir on 17 December 1998, according to Drugs@FDA.

Is Abacavir authorised in the European Union?

Yes. Abacavir has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Abacavir need cold chain shipping?

At least one listed presentation of Abacavir must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Abacavir in?

Abacavir is classified under ATC code J05AF06 (Abacavir).

References

  1. ZIAGEN prescribing information (ViiV Healthcare). U.S. National Library of Medicine, DailyMed. Retrieved 29 September 2023
  2. Ziagen: European public assessment report (EPAR). European Medicines Agency. Retrieved 19 January 2026

Request Abacavir for export supply

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