Abacavir

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 Screen for the HLA-B*5701 allele prior to initiating therapy with abacavir [see Boxed Warning, Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage for Adult Patients The recommended dosage of abacavir 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 The recommended dosage of abacavir oral solution in HIV-1-infected pediatric patients aged 3 months and older is 8 mg per kg orally twice daily or 16 mg per kg orally once daily (up to a maximum of 600 mg daily) in combination with other antiretroviral agents. Abacavir is also available as a 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. Dosing Recommendations for Abacavir Scored Tablets in Pediatric Patients Weight (Kg) Once-Daily Dosing Regimen a Twice-Daily Dosing Regimen AM Dose PM Dose Total Daily Dose 14 to <20 1 tablet (300 mg) ½ tablet (150 mg) ½ tablet (150 mg) 300 mg ≥20 to <25 1½ tablets (450 mg) ½ tablet (150 mg) 1 tablet (300 mg) 450 mg ≥25 2 tablets (600 mg) 1 tablet (300 mg) 1 tablet (300 mg) 600 mg a Data regarding the efficacy of once-daily dosing is limited to subjects who transitioned from twice-daily dosing to once-daily dosing after 36 weeks of treatment [see Clinical Studies ( 14.2) ]. 2.4 Recommended Dosage for Patients with Hepatic Impairment The recommended dose of abacavir 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 is contraindicated in these patients.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of abacavir have been established in pediatric patients aged 3 months and older.
• Use of abacavir is supported by pharmacokinetic trials and evidence from adequate and well-controlled trials of abacavir in
• adults and pediatric subjects [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.2 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )].

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 Hetero Labs Limited at 1-866-495-1995 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. Serious and Fatal Abacavir-Associated Hypersensitivity Reactions In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir [see Boxed Warning, Warnings and Precautions ( 5.1) ]. 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. Other signs and symptoms have included lethargy, headache, myalgia, edema, arthralgia, and paresthesia. Anaphylaxis, liver failure, renal failure, hypotension, adult respiratory distress syndrome, respiratory failure, myolysis, and death have occurred in association with these hypersensitivity reactions. Physical findings have included lymphadenopathy, mucous membrane lesions (conjunctivitis and mouth ulcerations), and maculopapular or urticarial rash (although some patients had other types of rashes and others did not have a rash). There were reports of erythema multiforme. Laboratory abnormalities included elevated liver chemistries, elevated creatine phosphokinase, elevated creatinine, and lymphopenia, and abnormal chest x-ray findings (predominantly infiltrates, which were localized). Additional Adverse Reactions with Use of Abacavir Therapy-Naive
• Adults:
• Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 2. Table 2. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Naive
• Adults (CNA30024a) through 48 Weeks of Treatment Adverse Reaction Abacavir plus Lamivudine plus Efavirenz (n = 324) Zidovudine plus Lamivudine plus Efavirenz (n = 325) Dreams/sleep disorders 10% 10% Drug hypersensitivity 9% <1%b Headaches/migraine 7% 11% Nausea 7% 11% Fatigue/malaise 7% 10% Diarrhea 7% 6% Rashes 6% 12% Abdominal pain/gastritis/gastrointestinal signs and symptoms 6% 8% Depressive disorders 6% 6% Dizziness 6% 6% Musculoskeletal pain 6% 5% Bronchitis 4% 5% Vomiting 2% 9% a This trial used double-blind ascertainment of suspected hypersensitivity reactions. During the blinded portion of the trial, suspected hypersensitivity to abacavir was reported by investigators in 9% of 324 subjects in the abacavir group and 3% of 325 subjects in the zidovudine group. b Ten (3%) cases of suspected drug hypersensitivity were reclassified as not being due to abacavir following unblinding. Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily compared with indinavir 800 mg 3 times daily, lamivudine 150 mg twice daily, and zidovudine 300 mg twice daily from CNA3005 are listed in Table 3. Table 3. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Naive
• Adults (CNA3005) through 48 Weeks of Treatment Adverse Reaction Abacavir plus Lamivudine/Zidovudine (n = 262) Indinavir plus Lamivudine/Zidovudine (n = 264) Nausea Headache Malaise and fatigue Nausea and vomiting Hypersensitivity reaction Diarrhea Fever and/or chills Depressive disorders Musculoskeletal pain Skin rashes Ear/nose/throat infections Viral respiratory infections Anxiety Renal signs/symptoms Pain (non-site-specific) 19% 13% 12% 10% 8% 7% 6% 6% 5% 5% 5% 5% 5%<1% <1% 17% 9% 12% 10% 2% 5% 3% 4% 7% 4% 4% 5% 3% 5% 5% Five subjects receiving abacavir in CNA3005 experienced worsening of pre-existing depression compared with none in the indinavir arm. The background rates of pre-existing depression were similar in the 2 treatment arms. Abacavir Once Daily versus Abacavir Twice Daily (CNA30021):
• Treatment-emergent clinical adverse reactions (rated by the investigator as at least moderate) with a greater than or equal to 5% frequency during therapy with abacavir 600 mg once daily or abacavir 300 mg twice daily, both in combination with lamivudine 300 mg once daily and efavirenz 600 mg once daily from CNA30021, were similar. For hypersensitivity reactions, subjects receiving abacavir once daily showed a rate of 9% in comparison with a rate of 7% for subjects receiving abacavir twice daily. However, subjects receiving abacavir 600 mg once daily experienced a significantly higher incidence of severe drug hypersensitivity reactions and severe diarrhea compared with subjects who received abacavir 300 mg twice daily. Five percent (5%) of subjects receiving abacavir 600 mg once daily had severe drug hypersensitivity reactions compared with 2% of subjects receiving abacavir 300 mg twice daily. Two percent (2%) of subjects receiving abacavir 600 mg once daily had severe diarrhea while none of the subjects receiving abacavir 300 mg twice daily had this event. Laboratory Abnormalities:
• Laboratory abnormalities (Grades 3 to 4) in therapy-naive
• adults during therapy with abacavir 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily compared with zidovudine 300 mg twice daily, lamivudine 150 mg twice daily, and efavirenz 600 mg daily from CNA30024 are listed in Table 4. Table 4. Laboratory Abnormalities (Grades 3 to 4) in Therapy-Naive
• Adults (CNA30024) through 48 Weeks of Treatment Grade 3/4 Laboratory Abnormalities Abacavir plus Lamivudine plus Efavirenz (n = 324) Zidovudine plus Lamivudine plus Efavirenz (n = 325) Elevated CPK (>4 X ULN) Elevated ALT (>5 X ULN) Elevated AST (>5 X ULN) Hypertriglyceridemia (>750 mg/dL) Hyperamylasemia (>2 X ULN) Neutropenia (ANC <750/mm 3 ) Anemia (Hgb ≤6.9 gm/dL) Thrombocytopenia (Platelets <50,000/mm 3 ) Leukopenia (WBC ≤1,500/mm 3 ) 8% 6% 6% 6% 4% 2% <1% 1% <1% 8% 6% 5% 5% 5% 4% 2% <1% 2% ULN = Upper limit of normal. n = Number of subjects assessed. Laboratory abnormalities in CNA3005 are listed in Table 5. Table 5. Treatment-Emergent Laboratory Abnormalities (Grades 3 to 4) in CNA3005 Grade 3/4 Laboratory Abnormalities Abacavir plus Lamivudine/Zidovudine (n = 262) Indinavir plus Lamivudine/Zidovudine (n = 264) Elevated CPK (>4 x ULN) ALT (>5.0 x ULN) Neutropenia (<750/mm 3 ) Hypertriglyceridemia (>750 mg/dL) Hyperamylasemia (>2.0 x ULN) Hyperglycemia (>13.9 mmol/L) Anemia (Hgb ≤6.9 g/dL) 18 (7%) 16 (6%) 13 (5%) 5 (2%) 5 (2%) 2 (<1%) 0 (0%) 18 (7%) 16 (6%) 13 (5%)3 (1%) 1 (<1%) 2 (<1%) 3 (1%) ULN = Upper limit of normal. n = Number of subjects assessed. The frequencies of treatment-emergent laboratory abnormalities were comparable between treatment groups in CNA30021. 6.2 Clinical Trials Experience in Pediatric Subjects Therapy-Experienced Pediatric Subjects (Twice-Daily Dosing) Treatment-emergent clinical adverse reactions (rated by the investigator as moderate or severe) with a greater than or equal to 5% frequency during therapy with abacavir 8 mg per kg twice daily, lamivudine 4 mg per kg twice daily, and zidovudine 180 mg per m 2 twice daily compared with lamivudine 4 mg per kg twice daily and zidovudine 180 mg per m 2 twice daily from CNA3006 are listed in Table 6. Table 6. Treatment-Emergent (All Causality) Adverse Reactions of at Least Moderate Intensity (Grades 2 to 4, Greater than or Equal to 5% Frequency) in Therapy-Experienced Pediatric Subjects (CNA3006) through 16 Weeks of Treatment Adverse Reaction Abacavir plus Lamivudine plus Zidovudine (n = 102) Lamivudine plus Zidovudine (n = 103) Fever and/or chills Nausea and vomiting Skin rashes Ear/nose/throat infections Pneumonia Headache 9% 9% 7% 5% 4% 1% 7% 2% 1% 1% 5% 5% Laboratory Abnormalities:
• In CNA3006, laboratory abnormalities (anemia, neutropenia, liver function test abnormalities, and CPK elevations) were observed with similar frequencies as in a trial of therapy-naive
• adults (CNA30024). Mild elevations of blood glucose were more frequent in pediatric subjects receiving abacavir (CNA3006) as compared with adult subjects (CNA30024). Other Adverse Events In addition to adverse reactions and laboratory abnormalities reported in Tables 2, 3, 4, 5, and 6, other adverse reactions observed in the expanded access program were pancreatitis and increased GGT. Pediatric Subjects Once-Daily versus Twice-Daily Dosing (COL105677):
• The safety of once-daily compared with twice-daily dosing of abacavir was assessed in the ARROW trial. Primary safety assessment in the ARROW trial was based on Grade 3 and Grade 4 adverse events. The frequency of Grade 3 and 4 adverse events was similar among subjects randomized to once-daily dosing compared with subjects randomized to twice-daily dosing. One event of Grade 4 hepatitis in the once-daily cohort was considered as uncertain causality by the investigator and all other Grade 3 or 4 adverse events were considered not related by the investigator. 6.3 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of abacavir. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposures. Body as a Whole Redistribution/accumulation of body fat. Cardiovascular Myocardial infarction. Hepatic Lactic acidosis and hepatic steatosis [see Warnings and Precautions ( 5.2 )]. Skin 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. Because of the overlap of clinical signs and symptoms between hypersensitivity to abacavir and SJS and TEN, and the possibility of multiple drug sensitivities in some patients, abacavir should be discontinued and not restarted in such cases. There have also been reports of erythema multiforme with abacavir use [see Adverse Reactions ( 6.1 )].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hypersensitivity Reactions 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 oral solution and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about abacavir. The complete text of the Medication Guide is reprinted at the end of this document.
• to carry the Warning Card with them.
• how to identify a hypersensitivity reaction [see Warnings and Precautions ( 5.1 ), Medication Guide].
• that if they develop symptoms consistent with a hypersensitivity reaction they should call their healthcare provider right away to determine if they should stop taking abacavir oral solution.
• that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir is not immediately discontinued.
• to not restart abacavir oral solution or any other abacavir-containing product following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death.
• that if they have a hypersensitivity reaction, they should dispose of any unused abacavir oral solution to
• avoid restarting abacavir.
• that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir oral solution is stopped right away.
• that if they have interrupted abacavir oral solution for reasons other than symptoms of hypersensitivity (for example, those who have an interruption in drug supply), a serious or fatal hypersensitivity reaction may occur with reintroduction of abacavir.
• to not restart abacavir oral solution or any other abacavir-containing product without medical consultation and only if medical care can be readily accessed by the patient or others. Lactic Acidosis/Hepatomegaly with Steatosis Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking abacavir oral solution if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions ( 5.2 )]. Immune Reconstitution Syndrome Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when abacavir oral solution is started [see Warnings and Precautions ( 5.3 )]. Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy [see Use in Specific Populations ( 8.1 )]. Lactation Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Specific Populations ( 8.2 )]. Missed Dose Instruct patients that if they miss a dose of abacavir oral solution, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [see Dosage and Administration ( 2 )]. Availability of Medication Guide Instruct patients to read the Medication Guide before starting abacavir oral solution and to re-read it each time the prescription is renewed. Instruct patients to inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens. All brands listed are trademarks of their respective owners and are not trademarks of the Hetero Labs Limited. Manufactured for:
• Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 by:
• HETERO TM Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India Revised:
• 10/2022 abacaviroscaberlogo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Abacavir Oral Solution, USP contains 20 mg per mL of abacavir as abacavir sulfate, USP. The solution is clear yellowish, strawberry-banana flavored liquid filled in 250 cc HDPE opaque bottles.
• Oral Solution: 20 mg per mL ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Abacavir oral solution USP is a clear yellowish, strawberry-banana flavored liquid filled in 250 cc HDPE opaque bottles.
• Each mL of the solution contains abacavir sulfate USP equivalent to 20 mg of abacavir.
• They are supplied in:
• Bottles of 240 mL with Induction Sealing FSE Wad (NDC 31722-562-24).
• This product does not require reconstitution.
• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• DO NOT FREEZE.
• May be refrigerated.

Quoted from the official label, section “How Supplied”.

What is in it

• Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1 S , 4 R )-4-[2-Amino-6-(cyclopropylamino)-9 H -purin-9-yl]- 2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with 1S , 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C 14 H 18 N 6 O)2
• H 2 SO 4 and a molecular weight of 670.74 daltons. It has the following structural formula:
• Abacavir sulfate, USP is a white to off-white powder. Soluble in water, slightly soluble in methanol. Abacavir oral solution, USP is for oral administration. Each milliliter (1 mL) of abacavir oral solution, USP contains abacavir sulfate USP equivalent to 20 mg of abacavir (i.e., 20 mg per mL) as active ingredient and the following inactive ingredients:
• anhydrous citric acid, methylparaben and propylparaben (added as preservatives), propylene glycol, saccharin sodium, sodium citrate (dihydrate), noncrystallizing sorbitol solution, strawberry and banana flavors and water. In vivo, abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir. abacavirosstructure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

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Same active substance

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