Dosing & Uses
Dosage Forms & Strengths
lamivudine/zidovudine/abacavir
tablet
- 150mg/300mg/300mg
HIV Infection
Indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in patients who weigh at least 40 kg
1 tablet PO q12hr
<40 kg: Not recommended
Dosage modification
Renal impairment CrCl <50 mL/min: Fixed dose tablet cannot be dose adjusted
Hepatic impairment
- Mild: Fixed dose tablet cannot be dose adjusted
- Mild or moderate: Contraindicated
Dosage Forms & Strengths
lamivudine/zidovudine/abacavir
tablet
- 150mg/300mg/300mg
HIV Infection
Indicated in combination with other antiretrovirals or alone for the treatment of human immunodeficiency virus type 1 (HIV-1) infection who weigh at least 40 kg
<40 kg: Not recommended
≥40 kg: 1 tablet PO q12hr
Dosage Modifications
Renal impairment (CrCl <50 mL/min): Fixed dose tablet cannot be dose adjusted
Hepatic impairment
- Mild: Fixed dose tablet cannot be dose adjusted
- Mild or moderate: Contraindicated
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (2)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
zidovudine, 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.
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.
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. - 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 (14)
- 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.
zidovudine, 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.
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. - cidofovir
cidofovir, zidovudine. Either increases levels of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: When cidofovir is administered concurrently with probenecid, zidovudine clearance may be decreased. Reduce dose of zidovudine by 50% on days of cidofovir/probenecid administration. .
- 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.
- 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.
- clozapine
clozapine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of myelosuppression.
- deferiprone
deferiprone, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- ganciclovir
ganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.
- pretomanid
pretomanid will increase the level or effect of zidovudine by Other (see comment). Avoid or Use Alternate Drug. In vitro studies demonstrated that pretomanid significantly inhibits OAT3; monitor for increased adverse effects and consider dosage reduction for OAT3 substrates.
- ribavirin
ribavirin decreases effects of zidovudine by Other (see comment). Avoid or Use Alternate Drug. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.
- stavudine
zidovudine decreases effects of stavudine by Other (see comment). Contraindicated. Comment: Mechanism: Competition for thymidine kinase for conversion to active form.
- 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.
- valganciclovir
valganciclovir, abacavir. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Increased risk of hematologic toxicity.
valganciclovir increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.
Monitor Closely (70)
- abacavir
abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
abacavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - acalabrutinib
acalabrutinib, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- atazanavir
atazanavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
atazanavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - atazanavir
atazanavir and zidovudine 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
- azathioprine
azathioprine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- cabozantinib
lamivudine will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity
- carboplatin
carboplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- cidofovir
cidofovir, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- cisplatin
cisplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- clarithromycin
clarithromycin increases toxicity of zidovudine by unknown mechanism. Use Caution/Monitor. Increased risk of myelosuppression.
clarithromycin, zidovudine. Mechanism: unknown. Use Caution/Monitor. Clarithromycin may increase or decrease levels of zidovudine. Literature describes conflicting reports. Separate administration by minimum 2 to 4 hours. . - clofarabine
clofarabine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- conivaptan
conivaptan increases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- dasatinib
dasatinib, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- dexrazoxane
dexrazoxane, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- didanosine
abacavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- doxorubicin
zidovudine increases toxicity of doxorubicin by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.
doxorubicin decreases effects of zidovudine by Other (see comment). Use Caution/Monitor. - doxorubicin liposomal
zidovudine increases toxicity of doxorubicin liposomal by pharmacodynamic synergism. Use Caution/Monitor. Inreased risk of myelosuppression.
doxorubicin liposomal decreases effects of zidovudine by Other (see comment). Use Caution/Monitor. Comment: Concomitant administration of zidovudine and doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro. - efavirenz
efavirenz and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
abacavir and efavirenz both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
efavirenz and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - emtricitabine
emtricitabine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
abacavir and emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - enfuvirtide
enfuvirtide and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
abacavir and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - enfuvirtide
enfuvirtide and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- fosamprenavir
fosamprenavir and abacavir 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 zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
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.
- hydroxyurea
hydroxyurea, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
zidovudine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression. - ibritumomab tiuxetan
ibritumomab tiuxetan, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- ifosfamide
ifosfamide, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Ifosfamide may enhance the toxicities of myelosuppressive agents. Monitor for increased risk of myelosuppression.
- imatinib
imatinib, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- indinavir
indinavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
indinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
indinavir and abacavir 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.
interferon alfa 2b increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor. - lamivudine
abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- interferon alfa n3
interferon alfa n3 increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.
- methadone
abacavir will decrease the level or effect of methadone by unknown mechanism. Use Caution/Monitor. Monitor for opioid withdrawal symptoms.
- nelfinavir
nelfinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
nelfinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - interferon beta 1a
interferon beta 1a increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.
- nevirapine
abacavir and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- interferon beta 1b
interferon beta 1b increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Interferons may enhance potential for adverse effects. Patients should be monitored for signs and symptoms of increased myelosuppression and liver decompensation.
- ketoconazole
ketoconazole increases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- lamivudine
lamivudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- lenalidomide
lenalidomide, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- methotrexate
methotrexate, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- mitomycin
mitomycin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- nelfinavir
nelfinavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nevirapine
nevirapine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
lamivudine and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - orlistat
orlistat will decrease the level or effect of zidovudine 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.
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.
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. - oxaliplatin
oxaliplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- riociguat
abacavir will increase the level or effect of riociguat by unknown mechanism. Modify Therapy/Monitor Closely. Riociguat dose reduction may be necessary
- 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.
peginterferon alfa 2b will increase the level or effect of zidovudine by Other (see comment). Use Caution/Monitor. Interferons may enhance adverse effects of zidovudine including increased myelosuppression. - primaquine
primaquine, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- ribavirin
ribavirin increases toxicity of lamivudine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.
- probenecid
probenecid increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor.
- rifabutin
rifabutin will decrease the level or effect of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- rifampin
rifampin decreases levels of zidovudine by increasing metabolism. Use Caution/Monitor.
- ritonavir
ritonavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
ritonavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
ritonavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - saquinavir
saquinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
saquinavir and abacavir both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
saquinavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - stavudine
lamivudine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
abacavir and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
stavudine and zidovudine 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.
abacavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tenofovir DF and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - thiotepa
thiotepa, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
- 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. - tipranavir
tipranavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- tipranavir
tipranavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tipranavir decreases levels of zidovudine by unspecified interaction mechanism. Use Caution/Monitor. - tobramycin inhaled
tobramycin inhaled and zidovudine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- tocilizumab
tocilizumab decreases levels of zidovudine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Interaction applies to inflammatory conditions, such as rheumatoid arthritis, associated with increased levels of IL-6.
- trimethoprim
trimethoprim increases levels of zidovudine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
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.
- valproic acid
valproic acid increases levels of zidovudine by decreasing metabolism. Use Caution/Monitor. Potential for increased toxicity. .
- zidovudine
abacavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (7)
- amphotericin B deoxycholate
zidovudine increases toxicity of amphotericin B deoxycholate by pharmacodynamic synergism. Minor/Significance Unknown.
- black cohosh
black cohosh increases toxicity of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.
- cyanocobalamin
zidovudine decreases levels of cyanocobalamin by unspecified interaction mechanism. Minor/Significance Unknown.
- dapsone
zidovudine, dapsone. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased bone marrow toxicity.
- didanosine
zidovudine increases levels of didanosine by decreasing renal clearance. Minor/Significance Unknown.
- ethanol
ethanol increases levels of abacavir by decreasing metabolism. Minor/Significance Unknown. Interaction usually not clinically significant.
- fluconazole
fluconazole increases levels of zidovudine by decreasing metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Nausea
Headache
Fatigue
Malaise
Vomiting
1-10%
Rash
Fever/chills
Anxiety
Depression
Increased triglyceride levels
Diarrhea
Increased amylase
Neutropenia
Increased ALT
Increased CPK
Ear infection
Nose/throat infection
Viral infection
Frequency Not Defined
Immune reconstitution syndrome
GGT increased
Fat redistribution
Pancreatitis
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
Hematologic toxicity
- Hematologic toxicity, including neutropenia and anemia, has been associated with the use of zidovudine
Myopathy
- Symptomatic myopathy associated with prolonged use of zidovudine
Lactic acidosis and severe hepatomegaly with steatosis
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including abacavir, lamivudine, and zidovudine
- Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur
Contraindications
Hypersensitivity to any component
Moderate or severe hepatic impairment
Presence of HLA-B*5701 allele
Cautions
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
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including abacavir, lamivudine, and zidovudine (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 develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity
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
Use caution when treating in combination with interferon alfa with or without ribavirin in HIV/HBV; monitor for hepatic decompensation, neutropenia, or anemia and reduce interferon dose and or ribavirin or discontinue if toxicity occurs
Discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both in co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin
Exacerbation of anemia reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine; coadministration of ribavirin and zidovudine not advised
Treatment with zidovudine, a component of the combination formulation, has been associated with loss of subcutaneous fat; the incidence and severity of lipoatrophy are related to cumulative exposure; this fat loss, which is most evident in the face, limbs, and buttocks, may be only partially reversible and improvement may take months to years after switching to a non-zidovudine-containing regimen; patients should be regularly assessed for signs of lipoatrophy during therapy with zidovudine-containing products, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy
Not for administration with other products containing abacavir, lamivudine, or zidovudine; or emtricitabine-containing products
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the drug during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 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
Zidovudine
- Based on prospective reports to the APR of exposures during pregnancy resulting in live births (including over 4,200 exposed in the first trimester and over 9,700 exposed in the second/third trimester), there was no difference between the overall risk of birth defects for zidovudine compared with the background birth defect rate of 2.7% in a U.S. reference population of the MACDP
Lactation
The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection; abacavir, lamivudine and zidovudine are present in human milk; there is no information on effects of abacavir, lamivudine and zidovudine 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, similar to those seen in adults; instruct mothers not to breastfeed if they are being treated with the drug combination
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
Zidovudine: NRTI; interferes with HIV viral RNA-dependent DNA polymerase (inhibits viral replication); thymidine analog
Abacavir: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by inhibiting viral replication; guanosine analogue
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Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
