Dosing & Uses
Dosage Forms & Strengths
lamivudine/abacavir
tablet
- 300mg/600mg
HIV Infection
Indicated to treat HIV infection in combination with other antiretroviral drugs
1 tablet (300 mg lamivudine / 600 mg abacavir/) PO qDay
Dosage Modifications
Fixed-dose combination product; do not prescribe for patients requiring dosage adjustment (eg, CrCl <50 mL/min, hepatic impairment)
Dosage Forms & Strengths
lamivudine/abacavir
tablet
- 300mg/600mg
HIV Infection
Indicated to treat HIV infection in combination with other antiretroviral drugs
<25 kg: Safety and efficacy not established
≥25 kg: 1 tablet (300 mg lamivudine / 600 mg abacavir/) PO qDay
Assess child's ability to swallow the tablet whole
Dosage Modifications
Fixed-dose combination product; do not prescribe for patients requiring dosage adjustment (eg, CrCl <50 mL/min, hepatic impairment)
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Warnings
Black Box Warnings
Hypersensitivity reactions
- Severe and sometimes fatal hypersensitivity reaction, with multiple organ involvement, have occurred
- Reintroduction of abacavir or any other abacavir-containing product, even in patients who have no identified history or unrecognized symptoms of hypersensitivity to abacavir therapy, can result (within hours) in serious or fatal hypersensitivity reactions
- 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
- Contraindicated with history of prior hypersensitivity reaction to abacavir and in patients who are HLA-B*5701-positive
- All patients should be screened for the HLA-B*5701 allele before initiating or reinitiating abacavir, unless patients have a previously documented HLA-B*5701 allele assessment
- If hypersensitivity is suspected, discontinue abacavir immediately, regardless of HLA-B*5701 status and even when other diagnoses are possible
Exacerbations of hepatitis B
- Severe acute exacerbations of hepatitis B reported in patients who are coinfected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine
- Monitor hepatic function closely in these patients and, if appropriate, initiate antihepatitis B treatment
Contraindications
Patients who have the HLA-B*5701 allele
Prior hypersensitivity to abacavir or lamivudine
Moderate or severe hepatic impairment
Cautions
Review medical history for hypersensitivity to abacavir before administration; discontinue at first signs of hypersensitivity
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues, including abacavir and lamivudine (components of the combination product); a majority of these cases have been in women; female gender and obesity may be risk factors; suspend dosing in those who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
Exacerbation of hepatitis B may occur on discontinuation
Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) have also been reported
Use has been associated with increased risk of myocardial infarction in observational studies, but not in a meta-analysis of 26 randomized trials; caution with risks for coronary heart disease and minimizing modifiable risk factors, including smoking, hypertension, and hyperlipidemia, prior to use
Concomitant administration of emtricitabine with lamivudine-containing products not recommended
Hepatic decompensation, some fatal, reported in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin; discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both
Pregnancy & Lactation
Pregnancy
If pregnant woman exposed to abacavir, report to the Antiretroviral Pregnancy Registry 1-800-258-4263
Available data from antiretroviral pregnancy registry show no difference in overall risk of birth defects for abacavir or lamivudine compared with background rate for birth defects of 2.7% in Metropolitan Atlanta Congenital Defects Program (MACDP) reference population
Lactation
Abacavir and lamivudine are present in human milk; there is no information on effects of abacavir and lamivudine on breastfed infant or effects of drug on milk production; because of potential for (1) HIV-1 transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive infants), and (3) serious adverse reactions in breastfed infant, instruct mothers not to breastfeed if they are receiving therapy
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Pharmacogenomics
Patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction
Prior to initiating therapy with abacavir, screening for the HLA-B*5701 allele is recommended
For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended
Genetic testing laboratories
- The following companies provide genetic testing for HLA variants
- Kashi Clinical Laboratories (www.kashilab.com)
- LabCorp (http://www.labcorp.com/)
- Specialty Laboratories (http://www.specialtylabs.com)
- Quest (http://www.questdialgnotics.com)
Mechanism of Action
Lamivudine: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog
Abacavir: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by inhibiting viral replication; guanosine analogue
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Patient Handout
Formulary
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