Abacavir (tablets)

Generic name: abacavir (as abacavir sulfate) · Brand names: Ziagen

Quick facts

Drug class
Label: a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor (Highlights, Indications and Usage)
Rx or otc
Rx
Forms and strengths
  • Tablets: 300 mg scored (label section 3). Oral solution exists as separate labels and is NOT covered here.
Generic available
Yes: abacavir tablets are marketed under ANDA-type generic labels by several labelers (DailyMed list API, fetched 2026-11-02). Marketing category of the chosen label not read.
Common use one line
Used with other antiretroviral medicines to treat HIV-1 infection (label section 1).

What it is used for

Abacavir tablets are used together with other HIV medicines to treat HIV-1 infection.
Section
1 INDICATIONS AND USAGE
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.

How it works

Abacavir is changed inside cells into an active form that blocks HIV-1 reverse transcriptase, an enzyme the virus needs to copy itself.
Section
12.1 and 12.4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Abacavir is an antiretroviral agent [see Microbiology (12.4)]. 12.4: Abacavir is a carbocyclic synthetic nucleoside analogue. Abacavir is converted by cellular enzymes to the active metabolite, carbovir triphosphate (CBV-TP), an analogue of deoxyguanosine-5′-triphosphate (dGTP). CBV-TP inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA.

Dosage: adults

Before starting, a test for the HLA-B*5701 allele is done. Adults take 600 mg daily, either 300 mg twice daily or 600 mg once daily, with other HIV medicines. It can be taken with or without food.
Section
2.1, 2.2, 12.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir tablets. 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. Abacavir tablets may be administered with or without food (12.3: Bioavailability of abacavir tablets was assessed in the fasting and fed states with no significant difference in systemic exposure (AUC∞); therefore, abacavir tablets may be administered with or without food.)

Dosage: children

Scored tablets are for children weighing 14 kg or more who can reliably swallow tablets; otherwise the oral solution is used. The label's Table 1 gives the tablet count by weight (for example 300 mg total daily for 14 to <20 kg and 600 mg for 25 kg or more). The daily dose should not exceed 600 mg.
Section
2.3; Highlights
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
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. Table 1 (Once-Daily Dosing Regimen; Twice-Daily AM dose / PM dose; Total Daily Dose): 14 to <20 kg: 1 tablet (300 mg); ½ tablet (150 mg) / ½ tablet (150 mg); 300 mg. >20 to <25 kg: 1½ tablets (450 mg); ½ tablet (150 mg) / 1 tablet (300 mg); 450 mg. ≥25 kg: 2 tablets (600 mg); 1 tablet (300 mg) / 1 tablet (300 mg); 600 mg. Highlights: 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.

Dosage adjustments

Drug interaction caps
A small number of people on methadone may need a higher methadone dose, and the riociguat dose may need to be lowered.
Section
7.1, 7.2
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
7.1: ...an increased methadone dose may be required in a small number of patients. 7.2: The riociguat dose may need to be reduced.
Kidney
No kidney dose is given; abacavir has not been studied in kidney impairment, and the kidneys are a minor route of removal.
Section
12.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
12.3 Patients with Renal Impairment: The pharmacokinetic properties of abacavir have not been determined in patients with impaired renal function. Renal excretion of unchanged abacavir is a minor route of elimination in humans.
Liver
Mild liver impairment: 200 mg twice daily using the oral solution. Moderate to severe liver impairment: do not use the tablets.
Section
2.4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
The recommended dose of abacavir tablets in patients with mild hepatic impairment (Child-Pugh Class A) is 200 mg twice daily. To enable dose reduction, abacavir oral solution (10 mL twice daily) should be used for the treatment of these patients. The safety, efficacy, and pharmacokinetic properties of abacavir have not been established in patients with moderate to severe hepatic impairment; therefore, abacavir tablets are contraindicated in these patients.
Elderly
Not enough people aged 65 and over were studied; caution is advised because older people more often have reduced liver, kidney or heart function.
Section
8.5
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Clinical trials of abacavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, caution should be exercised in the administration of abacavir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Missed dose

Confidence
low
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec

Overdose

There is no specific treatment for overdose; the person is monitored and given supportive care. Call poison control at 1-800-222-1222.
Section
10 OVERDOSAGE
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
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.

Storage

Store at 20° to 25°C (68° to 77°F).
Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. (Aurobindo labeler-specific: bottles of 60, NDC 65862-073-60.)

Boxed warning

Abacavir can cause serious, sometimes fatal, allergic-type reactions that involve several organs. People with the HLA-B*5701 gene have higher risk, so a test is done before starting. Do not use it if you had this reaction before or are HLA-B*5701-positive. Stop right away if a reaction is suspected, and never restart abacavir or any abacavir-containing product after one, because worse symptoms, including death, can occur within hours.
Section
Boxed Warning (WARNING: HYPERSENSITIVITY REACTIONS)
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with 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 [see Warnings and Precautions (5.1)]. Abacavir is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients [see Contraindications (4), Warnings and Precautions (5.1)]. All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir or reinitiation of therapy with abacavir, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible [see Contraindications (4), Warnings and Precautions (5.1)]. Following a hypersensitivity reaction to abacavir, NEVER restart abacavir or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity [see Warnings and Precautions (5.1)].

Contraindications

Do not use if you carry the HLA-B*5701 allele.
Section
4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
who have the HLA-B*5701 allele.
Do not use if you ever had a hypersensitivity reaction to abacavir.
Section
4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
with prior hypersensitivity reaction to abacavir.
Do not use with moderate or severe liver impairment.
Section
4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
with moderate or severe hepatic impairment.

Warnings and precautions

Serious reactions usually appear within the first 6 weeks (median 9 days) but can occur any time. About 8% of 2,670 patients had hypersensitivity when not screened, versus 1% when HLA-B*5701 carriers were excluded. Never restart after a reaction.
Heading
5.1 Hypersensitivity Reactions
Section
5.1
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
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. 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. NEVER restart abacavir or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status. A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill.
Lactic acid build-up and an enlarged fatty liver, including fatal cases, have been reported with this drug class, mostly in women. Female sex and obesity may be risk factors. Abacavir should be suspended if signs appear.
Heading
5.2 Lactic Acidosis and Severe Hepatomegaly with Steatosis
Section
5.2
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including abacavir. A majority of these cases have been in women. Female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues. Treatment with abacavir should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations.
As the immune system recovers on HIV treatment, it can react to hidden infections, and autoimmune conditions can appear, sometimes many months later.
Heading
5.3 Immune Reconstitution Syndrome
Section
5.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including abacavir. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.
Some observational studies link abacavir to heart attack, but clinical trials did not, so the evidence is inconclusive. Prescribers consider heart disease risk and try to reduce risk factors such as high blood pressure, high cholesterol, diabetes and smoking.
Heading
5.4 Myocardial Infarction
Section
5.4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Several prospective, observational, epidemiological studies have reported an association with the use of abacavir and the risk of myocardial infarction (MI). Meta-analyses of randomized, controlled, clinical trials have observed no excess risk of MI in abacavir-treated subjects as compared with control subjects. To date, there is no established biological mechanism to explain a potential increase in risk. In totality, the available data from the observational studies and from controlled clinical trials show inconsistency; therefore, evidence for a causal relationship between abacavir treatment and the risk of MI is inconclusive. As a precaution, the underlying risk of coronary heart disease should be considered when prescribing antiretroviral therapies, including abacavir, and action taken to minimize all modifiable risk factors (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking).

Pregnancy and breastfeeding

In people, registry data show no difference in birth defect risk compared with the 2.7% background rate. In rats at 35 times the human exposure, birth defects were seen; none were seen in rabbits at about 9 times. Abacavir is in breast milk, and mothers are told not to breastfeed while taking it, mainly to avoid passing HIV.
Section
8.1, 8.2
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
8.1: 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. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. In animal reproduction studies, oral administration of abacavir to pregnant rats during organogenesis resulted in fetal malformations and other embryonic and fetal toxicities at exposures 35 times the human exposure (AUC) at the recommended clinical daily dose. However, no adverse developmental effects were observed following oral administration of abacavir to pregnant rabbits during organogenesis, at exposures approximately 9 times the human exposure (AUC) at the recommended clinical dose. 8.2: The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Abacavir is present in human milk. ...instruct mothers not to breastfeed if they are receiving abacavir.

Side effects

Common
In adult trials the most common reactions (10% or more, at least moderate) were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. In children (5% or more) they were fever and/or chills, nausea and vomiting, skin rashes, and ear/nose/throat infections.
Section
Highlights 6; 6.1; 6.2
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Threshold
adult >=10%; pediatric >=5%
Source text (exact source wording)
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. (Highlights, 6.1) Pediatric: 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. (Highlights, 6.2)
Less common
The label's trial tables list reactions with their percentages for each study (see source text). Percentages differ between studies because they used different combinations of other HIV medicines.
Section
6.1 Tables 2, 3; 6.2 Table 6
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Table 2 (CNA30024, abacavir plus lamivudine plus efavirenz, n = 324, at least moderate, >=5%): Dreams/sleep disorders 10%; Drug hypersensitivity 9%; Headaches/migraine 7%; Nausea 7%; Fatigue/malaise 7%; Diarrhea 7%; Rashes 6%; Abdominal pain/gastritis/gastrointestinal signs and symptoms 6%; Depressive disorders 6%; Dizziness 6%; Musculoskeletal pain 6%; Bronchitis 4%; Vomiting 2%. Table 3 (CNA3005, abacavir plus lamivudine/zidovudine, n = 262): Nausea 19%; Headache 13%; Malaise and fatigue 12%; Nausea and vomiting 10%; Hypersensitivity reaction 8%; Diarrhea 7%; Fever and/or chills 6%; Depressive disorders 6%; Musculoskeletal pain 5%; Skin rashes 5%; Ear/nose/throat infections 5%; Viral respiratory infections 5%; Anxiety 5%. Table 6 (pediatric CNA3006, n = 102): Fever and/or chills 9%; Nausea and vomiting 9%; Skin rashes 7%; Ear/nose/throat infections 5%; Pneumonia 4%; Headache 1%.
Serious
Label
A hypersensitivity reaction shows up as 2 or more of: fever, rash, stomach symptoms, feeling very tired or achy, or breathing symptoms. Other serious reactions listed are lactic acidosis, enlarged fatty liver, immune reconstitution syndrome, heart attack, body fat changes, and suspected Stevens-Johnson syndrome and toxic epidermal necrolysis.
Section
5.1-5.4; 6.1; 6.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
high
Source text (exact source wording)
Serious and sometimes fatal hypersensitivity reactions (boxed warning, 5.1); lactic acidosis and severe hepatomegaly with steatosis (5.2); immune reconstitution syndrome (5.3); myocardial infarction (5.4). 6.1: These reactions have been characterized by 2 or more of the following signs or symptoms: (1) fever; (2) rash; (3) gastrointestinal symptoms (including nausea, vomiting, diarrhea, or abdominal pain); (4) constitutional symptoms (including generalized malaise, fatigue, or achiness); (5) respiratory symptoms (including dyspnea, cough, or pharyngitis). Almost all abacavir hypersensitivity reactions include fever and/or rash as part of the syndrome. 6.3 Postmarketing: Redistribution/accumulation of body fat. Myocardial infarction. Lactic acidosis and hepatic steatosis. Suspected Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving abacavir primarily in combination with medications known to be associated with SJS and TEN, respectively. ...abacavir should be discontinued and not restarted in such cases. There have also been reports of erythema multiforme with abacavir use.
Led to discontinuation
In one adult trial, 14% on abacavir regimen and 16% on the comparison regimen stopped because of side effects.
Section
14.1 Table 7
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
medium
Source text (exact source wording)
Table 7 (CNA30024): Discontinued due to adverse reactions: abacavir plus lamivudine plus efavirenz 14%; zidovudine plus lamivudine plus efavirenz 16%.

Interactions

Drugs
Abacavir can increase how fast the body clears methadone; most people need no change but a few may need more methadone.
Name
Methadone
Section
7.1
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Source text (exact source wording)
In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg of abacavir twice daily (twice the currently recommended dose), oral methadone clearance increased [see Clinical Pharmacology (12.3)]. This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.
Riociguat levels can go up, so its dose may need to be reduced.
Name
Riociguat
Section
7.2
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Source text (exact source wording)
Coadministration with fixed-dose abacavir/dolutegravir/lamivudine resulted in increased riociguat exposure, which may increase the risk of riociguat adverse reactions [see Clinical Pharmacology (12.3)]. The riociguat dose may need to be reduced. See full prescribing information for ADEMPAS (riociguat).
Food and alcohol
Alcohol slows removal of abacavir (41% higher exposure in a study of men). The label says it has not been studied in females.
Name
Ethanol (alcohol)
Section
12.3 Drug Interaction Studies
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Source text (exact source wording)
Ethanol decreases the elimination of abacavir causing an increase in overall exposure. ... Coadministration of ethanol and abacavir resulted in a 41% increase in abacavir AUC∞ and a 26% increase in abacavir t1/2. Abacavir had no effect on the pharmacokinetic properties of ethanol, so no clinically significant interaction is expected in men. This interaction has not been studied in females.
Can be taken with or without food.
Name
Food
Section
12.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Source text (exact source wording)
Bioavailability of abacavir tablets was assessed in the fasting and fed states with no significant difference in systemic exposure (AUC∞); therefore, abacavir tablets may be administered with or without food.
Other
No clinically relevant changes when used with lamivudine or zidovudine.
Name
Other HIV medicines (lamivudine, zidovudine)
Section
12.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Source text (exact source wording)
Analysis showed no clinically relevant changes in the pharmacokinetics of abacavir with the addition of lamivudine or zidovudine or the combination of lamivudine and zidovudine. Lamivudine exposure (AUC decreased 15%) and zidovudine exposure (AUC increased 10%) did not show clinically relevant changes with concurrent abacavir.
Liverpool hiv checker
not checked: Chrome access to hiv-druginteractions.org was not attempted in this run. Interactions above are from the label only; the label lists only methadone and riociguat in section 7.

Patient tips

Label section 17
Read the Medication Guide and carry the Warning Card that summarize signs of the hypersensitivity reaction.
Section
17
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Confidence
medium
Source text (exact source wording)
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients: that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of abacavir...

Alternatives

Class source
Label Highlights: a nucleoside analogue HIV-1 reverse transcriptase inhibitor. openFDA EPC not checked.
Note
Abacavir combination products exist (abacavir/lamivudine, abacavir/dolutegravir/lamivudine, abacavir/lamivudine/zidovudine). They are NOT covered by this record.

Frequently asked questions

Question
What is abacavir used for?
Answer
It is used with other antiretroviral medicines to treat HIV-1 infection.
Source section
1
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
Why is a gene test needed first?
Answer
People who carry the HLA-B*5701 allele are at higher risk of a serious hypersensitivity reaction, so patients are screened before starting. Abacavir must not be used in HLA-B*5701-positive patients.
Source section
Boxed Warning; 2.1; 4
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
What should I do if I think I am having a reaction?
Answer
The label says to discontinue abacavir immediately if a hypersensitivity reaction is suspected, and never to restart abacavir or any abacavir-containing product afterward.
Source section
Boxed Warning; 5.1
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
Can I take it with food?
Answer
Yes. Abacavir tablets may be taken with or without food.
Source section
12.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
What are the most common side effects?
Answer
In adult trials (10% or more, at least moderate): nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders.
Source section
6.1
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
Can I breastfeed while taking it?
Answer
The label instructs mothers not to breastfeed while receiving abacavir, because of potential HIV transmission, viral resistance, and possible reactions in the infant.
Source section
8.2
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
Does alcohol affect abacavir?
Answer
Alcohol increased abacavir exposure by 41% in a study of men. It has not been studied in females.
Source section
12.3
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec
Question
What if I take too much?
Answer
There is no specific treatment for overdose; the person is monitored and given supportive care. Call poison control at 1-800-222-1222.
Source section
10
Source
DailyMed printer-friendly label, Aurobindo Pharma Limited abacavir tablets, set ID 5409c8ed-17c3-454f-bb88-d597ba8f84ec

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug