Dosing & Uses
Dosage Forms & Strengths
abacavir/lamivudine
tablet
- 600mg/300mg
HIV Infection
Indicated to treat HIV infection in combination with other antiretroviral drugs
1 tablet (600 mg abacavir/300 mg lamivudine) PO qDay
Dosage Modifications
Renal impairment
- CrCl ≥50 mL/min: No dosage adjustment required
CrCl 30-49 mL/min
Monitor for hematologic toxicities; if new or worsening neutropenia or anemia develops, dose adjustment of lamivudine, per lamivudine prescribing information, recommended; if lamivudine dose adjustment indicated, the drug combination should be discontinued and individual components used to construct the treatment regimen
-
CrCl <30 mL/min
- Not recommended; fixed-dose tablet and cannot be dose adjusted
- Consider using lamivudine oral solution or tablets plus abacavir oral solution
Hepatic impairment
- Moderate or severe (Child-Pugh Class B or C): Contraindicated
-
Mild (Child-Pugh Class A)
- Not recommended; fixed-dose tablet and cannot be dose adjusted
- Consider using lamivudine oral solution or tablets plus abacavir oral solution
Dosage Forms & Strengths
abacavir/lamivudine
tablet
- 600mg/300mg
HIV Infection
Indicated to treat HIV infection in combination with other antiretroviral drugs
<25 kg: Safety and efficacy not established
≥25 kg: 1 tablet (600 mg abacavir/300 mg lamivudine) PO qDay
Assess child's ability to swallow the tablet whole
Dosage Modifications
Renal impairment
- CrCl ≥30 mL/min: No dosage adjustment required
CrCl 30-49 mL/min
Monitor for hematologic toxicities; if new or worsening neutropenia or anemia develops, dose adjustment of lamivudine, per lamivudine prescribing information, recommended; if lamivudine dose adjustment indicated, the drug combination should be discontinued and individual components used to construct the treatment regimen
-
CrCl <30 mL/min
- Not recommended; fixed-dose tablet and cannot be dose adjusted
- Consider using lamivudine oral solution or tablets plus abacavir oral solution
Hepatic impairment
- Moderate or severe (Child-Pugh Class B or C): Contraindicated
-
Mild (Child-Pugh Class A)
- Not recommended; fixed-dose tablet and cannot be dose adjusted
- Consider using lamivudine oral solution or tablets plus abacavir oral solution
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
abacavir, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.
Serious - Use Alternative (6)
- betibeglogene autotemcel
abacavir, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.
- cabotegravir
abacavir, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
- elivaldogene autotemcel
elivaldogene autotemcel, abacavir. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- ganciclovir
ganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.
- ribavirin
ribavirin increases toxicity of abacavir by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of lactic acidosis and hepatic decompensation.
- valganciclovir
valganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.
Monitor Closely (21)
- atazanavir
atazanavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- cabozantinib
abacavir will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity
- didanosine
abacavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- efavirenz
abacavir and efavirenz both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- emtricitabine
abacavir and emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- enfuvirtide
abacavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- fosamprenavir
fosamprenavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- indinavir
indinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- lamivudine
abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- methadone
abacavir will decrease the level or effect of methadone by unknown mechanism. Use Caution/Monitor. Monitor for opioid withdrawal symptoms.
- nelfinavir
nelfinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nevirapine
abacavir and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- orlistat
orlistat will decrease the level or effect of abacavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.
- riociguat
abacavir will increase the level or effect of riociguat by unknown mechanism. Modify Therapy/Monitor Closely. Riociguat dose reduction may be necessary
- ritonavir
ritonavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- saquinavir
saquinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- stavudine
abacavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tenofovir DF
abacavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tipranavir
tipranavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tipranavir decreases levels of abacavir by unspecified interaction mechanism. Use Caution/Monitor. - ublituximab
ublituximab decreases effects of abacavir by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely.
- zidovudine
abacavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (1)
- ethanol
ethanol increases levels of abacavir by decreasing metabolism. Minor/Significance Unknown. Interaction usually not clinically significant.
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
Patients with creatinine clearance between 30-49 mL/min receiving drug combination may experience a 1.6-3.3-fold higher lamivudine exposure (AUC) than patients with a creatinine clearance ≥50 mL/min; monitor for hematologic toxicities
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
Patients with hepatitis B virus co-infection
-
Posttreatment exacerbation of hepatitis
- Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine; patients should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment
-
Emergence of lamivudine resistant HBV
- Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in subjects dually infected with HIV-1 and HBV; emergence of hepatitis B virus variants associated with resistance to lamivudine has been reported in HIV-1-infected subjects who have received lamivudine-containing antiretroviral regimens in presence of concurrent infection with hepatitis B virus
Due to the potential for severe, serious, and possibly fatal hypersensitivity reactions with abacavir:
- All patients should be screened for the HLA-B*5701 allele prior to initiating or reinitiating therapy, unless patients have a previously documented HLA-B*5701 allele assessment
- Therapy is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients
- Before starting therapy, review medical history for prior exposure to any abacavir containing product; never restart treatment or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status
- To reduce risk of a life-threatening hypersensitivity reaction, regardless of HLA-B*5701 status, discontinue therapy immediately if a hypersensitivity reaction is suspected, even when other diagnoses are possible (eg, acute onset respiratory diseases such as pneumonia, bronchitis, pharyngitis, or influenza; gastroenteritis; or reactions to other medications)
- If a hypersensitivity reaction cannot be ruled out, do not restart treatment or any other abacavir-containing products because more severe symptoms, which may include life-threatening hypotension and death, can occur within hours
- If a hypersensitivity reaction is ruled out, patients may restart therapy; rarely, patients who have stopped abacavir for reasons other than symptoms of hypersensitivity have also experienced life-threatening reactions within hours of reinitiating abacavir therapy; therefore, reintroduction to drug combination or any other abacavir-containing product is recommended only if medical care can be readily accessed
- A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill
Pregnancy & Lactation
Pregnancy
If pregnant woman exposed to abacavir, report to the Antiretroviral Pregnancy Registry 1-800-258-4263
Abacavir
- Based on prospective reports to APR of exposures to abacavir during pregnancy resulting in live births (including over 1,300 exposed in the first trimester and over 1,300 exposed in the second/third trimester), there was no difference between overall risk of birth defects for abacavir compared with the background birth defect rate of 2.7% in the U.S. reference population of the MACDP
- The prevalence of defects in live births was 3.2% (95% CI: 2.3% to 4.3%) following first-trimester exposure to abacavir-containing regimens and 2.9% (95% CI: 2.1% to 4.0%) following second/third trimester exposure to abacavir-containing regimens
Lamivudine
- Based on prospective reports to APR of exposures to lamivudine during pregnancy resulting in live births (including over 5,300 exposed in first trimester and over 7,400 exposed in second/third trimester), there was no difference between overall risk of birth defects for lamivudine compared with background birth defect rate of 2.7% in U.S. reference population of MACDP
- The prevalence of birth defects in live births was 3.1% (95% CI: 2.7% to 3.6%) following first-trimester exposure to lamivudine-containing regimens and 2.9% (95% CI: 2.5%, 3.3%) following second/third-trimester exposure to lamivudine- containing regimens
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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Formulary
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