Abacavir

Abacavir is an antiretroviral agent [see Microbiology (12.4) ].

• Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.ICD-10: B20

• Abacavir tablets are contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions (5.1) ]. with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1) ].contraindicated

Before initiating abacavir, screen for the HLA-B*5701 allele. (2.1) Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. (2.2) 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. (2.3) Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily. (2.4) 2.1 Screening for HLA-B*5701 Allele prior to Starting Abacavir Tablets Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir tablets [see Boxed Warning , Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage for Adult Patients The recommended dosage of abacavir tablets for adults is 600 mg daily, administered orally as either 300 mg twice daily or 600 mg once daily, in combination with other antiretroviral agents. 2.3 Recommended Dosage for Pediatric Patients Abacavir tablets are available as scored tablet for HIV-1-infected pediatric patients weighing greater than or equal to 14 kg for whom a solid dosage form is appropriate. Before prescribing abacavir tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow abacavir tablets, the oral solution formulation should be prescribed. The recommended oral dosage of abacavir tablets for HIV-1-infected pediatric patients is presented in Table 1. Table 1.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.2) Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. (5.3) 5.1 Hypersensitivity Reactions Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment [see Adverse Reactions (6.1) ]. Patients who carry the HLA-B*5701 allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the HLA-B*5701 allele have developed hypersensitivity reactions. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where HLA-B*5701 screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the HLA-B*5701 allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.

The following adverse reactions are discussed in other sections of the labeling: Serious and sometimes fatal hypersensitivity reactions [see Boxed Warning , Warnings and Precautions (5.1) ]. Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.2) ]. Immune reconstitution syndrome [see Warnings and Precautions (5.3) ]. Myocardial infarction [see Warnings and Precautions (5.4) ]. 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. (6.1) 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. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience in Adult Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Lactation: Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission. (8.2) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MACDP as the U.S. reference population for birth defects in the general population. The MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks’ gestation. The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown.

Metabolism

Pharmacokinetics in Adults The pharmacokinetic properties of abacavir were independent of dose over the range of 300 to 1,200 mg per day. Absorption: Following oral administration, abacavir is rapidly absorbed and extensively distributed.

There is no known specific treatment for overdose with abacavir. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

• Dec 17, 1998NDANDA020978Viiv Hlthcare
• Jun 18, 2012ANDAANDA091294Mylan Pharms Inc
• Dec 17, 2012ANDAANDA077844Aurobindo Pharma Ltd
• Sep 13, 2013ANDAANDA091560Hetero Labs Ltd Iii
• Dec 5, 2013ANDAANDA202912Lupin
• Aug 22, 2014NDANDA205551Viiv Hlthcare
• Sep 26, 2016ANDAANDA201107Hetero Labs Ltd Iii
• Mar 30, 2022NDANDA215413Viiv Hlthcare

1. 1Pain1,5059.5%
2. 2Anxiety1,1006.9%
3. 3Emotional Distress1,0246.5%
4. 4Pyrexia9676.1%
5. 5Nausea9456.0%
6. 6Anhedonia9225.8%
7. 7Product Dose Omission Issue8475.4%
8. 8Fatigue8145.1%
9. 9Headache7624.8%
10. 10Rash7594.8%
11. 11Chronic Kidney Disease7544.8%
12. 12Vomiting7134.5%
13. 13Exposure During Pregnancy6834.3%
14. 14Renal Failure6794.3%
15. 15Off Label Use6223.9%

The 10 most recently updated of 270 ClinicalTrials.gov registrations naming Abacavir as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
  Recruiting · Phase 4 · Interventional · 350 enrolled · Gilead Sciences
  NCT06337032updated 2026-06-10
• Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
  Active not recruiting · Phase 3 · Interventional · 600 enrolled · Gilead Sciences
  NCT06630299updated 2026-05-29
• Study of GS-3242 in Participants With HIV-1; Substudy-05
  Completed · Phase 1 · Interventional · 27 enrolled · Gilead Sciences
  NCT07001319updated 2026-05-11
• Preliminary Testing and Development of a Short Digital Intervention for Patients on Waiting Lists for Psychological Treatment
  Enrolling by invitation · Interventional · 80 enrolled · University of Oslo
  NCT07499219updated 2026-05-01
• A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection
  Active not recruiting · Phase 2 · Interventional · 83 enrolled · Gilead Sciences
  NCT05729568updated 2026-04-27
• Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 133 enrolled · Gilead Sciences
  NCT02016924updated 2026-04-21
• Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
  Completed · Phase 3 · Interventional · 640 enrolled · ANRS, Emerging Infectious Diseases
  NCT03256422updated 2026-04-13
• Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults
  Completed · Phase 2 · Interventional · 45 enrolled · ANRS, Emerging Infectious Diseases
  NCT00820118updated 2026-04-07
• Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
  Active not recruiting · Phase 3 · Interventional · 631 enrolled · ViiV Healthcare
  NCT02938520updated 2026-03-19
• Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan
  Recruiting · Interventional · 26,376 enrolled · Pakistan Institute of Living and Learning
  NCT07015944updated 2026-03-18

CPIC-curated drug–gene pairs for Abacavir. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• HLA-BCPIC AClinPGx 1AFDA label: Testing Required
  HLA-B and Abacavir

Frequently asked questions

How does Abacavir work?

Abacavir is an antiretroviral agent [see Microbiology (12.4) ].

What is Abacavir used for?

According to FDA labeling, Abacavir carries indications including: Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Abacavir?

Abacavir is classified as Nucleoside and nucleotide reverse transcriptase inhibitors, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Cytochrome P450 1A1 Inhibitors, Nucleoside Reverse Transcriptase Inhibitors, Decreased Reverse Transcription to DNA.

What are the brand names for Abacavir?

Abacavir is marketed under brand names including Epzicom, Triumeq, Trizivir, Ziagen.

What are the contraindications for Abacavir?

Abacavir labeling lists contraindications including: Abacavir tablets are contraindicated in patients: who have the HLA-B*5701 allele [see Warnings and Precautions (5.1) ]. with prior hypersensitivity reaction to abacavir [see Warnings and Precautions (5.1) ].. Always consult the full prescribing information and a clinician.