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)
Dosing Considerations
Because it is a fixed-dose tablet and cannot be dose adjusted, this formulation is not recommended for:
- Patients with creatinine clearance <50 mL/min
- Patients with mild hepatic impairment; drug is contraindicated in patients with moderate or severe hepatic impairment
- Instead, use of lamivudine oral solution or tablets and abacavir oral solution may be considered
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)
Dosing Considerations
Because it is a fixed-dose tablet and cannot be dose adjusted, this formulation is not recommended for:
- Patients with creatinine clearance <50 mL/min
- Patients with mild hepatic impairment; drug is contraindicated in patients with moderate or severe hepatic impairment
- Instead, use of lamivudine oral solution or tablets and abacavir oral solution may be considered
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
lamivudine, 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.
- emtricitabine
emtricitabine and lamivudine both increase risk of immune reconstitution syndrome. Contraindicated. Coadministration of emtricitabine containing products and lamivudine containing products should be avoided. Combination will result in therapeutic duplication.
emtricitabine, lamivudine. Other (see comment). Contraindicated. Comment: Coadministration of emtricitabine containing products and lamivudine containing products should be avoided. Combination will result in therapeutic duplication.
Serious - Use Alternative (4)
- cabotegravir
lamivudine, 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.
- sorbitol
sorbitol will decrease the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Sorbitol-containing solution decreased systemic exposure of lamivudine oral solution in a pediatric study (ARROW trial). Results showed lower rates of virologic suppression, lower plasma lamivudine exposure, and development of viral resistance more frequently than children receiving lamivudine tablets.
- tafenoquine
tafenoquine will increase the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Tafenoquine inhibits organic cation transporter-2 (OCT2) and multidrug and toxin extrusion (MATE) transporters in vitro. Avoid coadministration with OCT2 or MATE substrates. If coadministration cannot be avoided, monitor for substrate-related toxicities and consider dosage reduction if needed based on product labeling of the coadministered drug.
- trilaciclib
trilaciclib will decrease the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.
Monitor Closely (24)
- abacavir
abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- atazanavir
atazanavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- cabozantinib
lamivudine will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity
- efavirenz
efavirenz and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- enfuvirtide
enfuvirtide and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- erdafitinib
lamivudine increases levels of erdafitinib by decreasing renal clearance. Modify Therapy/Monitor Closely. Consider alternatives that are not OCT2 substrates or consider reducing the dose of OCT2 substrates based on tolerability.
- fosamprenavir
fosamprenavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- ganciclovir
ganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Increased risk of hematologic toxicity.
- indinavir
indinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- interferon alfa 2b
interferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- nelfinavir
nelfinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nevirapine
lamivudine and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- orlistat
orlistat will decrease the level or effect of lamivudine 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.
- peginterferon alfa 2a
peginterferon alfa 2a, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- peginterferon alfa 2b
peginterferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- ribavirin
ribavirin increases toxicity of lamivudine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.
- ritonavir
ritonavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- saquinavir
saquinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- stavudine
lamivudine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tenofovir DF
lamivudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tipranavir
tipranavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- trimethoprim
trimethoprim increases effects of lamivudine by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor. Potential for increased toxicity.
- valganciclovir
valganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.
- zidovudine
lamivudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (2)
- sulfamethoxazole
sulfamethoxazole increases levels of lamivudine by decreasing renal clearance. Minor/Significance Unknown.
- zidovudine
lamivudine increases effects of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Beneficial synergism.
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
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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