lamivudine/zidovudine (Rx)

Brand and Other Names:Combivir, 3tc/zdv
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lamivudine/zidovudine

tablet

  • 150mg/300mg

HIV Infection

150 mg/300 mg (1 tablet) PO q12hr

Monitor amylase q4-8wk

Because of fixed dose, avoid administering to patients < 30 kg, patients with CrCl < 50 mL/min, or in hepatic impairment

Dosage Forms & Strengths

lamivudine/zidovudine

tablet

  • 150mg/300mg

HIV Infection

<12 years: Not recommended; fixed-dose combination cannot be adjusted for children

> 12 years and < 30 kg: Not recommended

>12 years and >30 kg: As adults; 150 mg/300 mg (1 tablet) PO q12hr

Monitor amylase q4-8wk

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Interactions

Interaction Checker

and lamivudine/zidovudine

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            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.

            • 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 (12)

            • cabotegravir

              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. .

            • 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 increases toxicity of zidovudine by pharmacodynamic synergism. Contraindicated.

            Monitor Closely (61)

            • 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

              atazanavir and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • 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.

            • 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.

              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.

            • enfuvirtide

              enfuvirtide and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • enfuvirtide

              enfuvirtide and zidovudine 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.

            • 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.

            • 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.

            • nelfinavir

              nelfinavir and lamivudine 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.

            • 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.

            • oxaliplatin

              oxaliplatin, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

            • 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 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 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.

              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.

              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 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. .

            Minor (17)

            • 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.

            • fluconazole

              fluconazole increases levels of zidovudine by decreasing metabolism. Minor/Significance Unknown.

            • flucytosine

              zidovudine increases toxicity of flucytosine by pharmacodynamic synergism. Minor/Significance Unknown.

            • food

              food decreases levels of zidovudine by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • isavuconazonium sulfate

              isavuconazonium sulfate will increase the level or effect of lamivudine by Other (see comment). Minor/Significance Unknown. Isavuconazonium sulfate, an OCT2 inhibitor, may increase the effects or levels of OCT2 substrates.

            • kava

              kava increases toxicity of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.

            • lamivudine

              lamivudine increases effects of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Beneficial synergism.

            • methadone

              methadone increases levels of zidovudine by decreasing renal clearance. Minor/Significance Unknown.

            • pentamidine

              zidovudine increases toxicity of pentamidine by pharmacodynamic synergism. Minor/Significance Unknown.

            • pyrimethamine

              zidovudine, pyrimethamine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Increased bone marrow toxicity.

            • sulfamethoxazole

              sulfamethoxazole increases levels of zidovudine by decreasing renal clearance. Minor/Significance Unknown.

              zidovudine increases toxicity of sulfamethoxazole by pharmacodynamic synergism. Minor/Significance Unknown.

              sulfamethoxazole increases levels of lamivudine by decreasing renal clearance. Minor/Significance Unknown.

            • valacyclovir

              valacyclovir increases effects of zidovudine by unknown mechanism. Minor/Significance Unknown. Monitor for lethargy and fatigue.

            • zidovudine

              lamivudine increases effects of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Beneficial synergism.

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            Adverse Effects

            >10%

            Headache (35%)

            Nausea (33%)

            Malaise & fatigue (27%)

            Cough (18%)

            Diarrhea (18%)

            Vomiting (13%)

            Musculoskeletal pain (12%)

            Neuropathy (12%)

            Insomnia & other sleep disorders (11%)

            1-10%

            Anorexia &/or decreased appetite (10%)

            Dizziness (10%)

            Fever or chills (10%)

            Abdominal pain (9%)

            Depressive disorders (9%)

            Skin rashes (9%)

            Myalgia (8%)

            Neutropenia (7.2% )

            Abdominal cramps (6%)

            Arthralgia (5%)

            Dyspepsia (5%)

            Anemia (2.9% )

            Frequency Not Defined (serious)

            Erythema multiforme

            Stevens-Johnson syndrome

            Lactic acidosis

            Pancreatitis

            Hepatomegaly (Severe)

            Steatosis of liver (Severe)

            Anaphylaxis

            Immune hypersensitivity reaction

            Rhabdomyolysis

            Postmarketing reports

            Immune reconstitution syndrome and fat redistribution

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            Warnings

            Black Box Warnings

            lamivudine

            • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues, including lamivudine and zidovudine (components of the combination product) alone or in combination with other antiretrovirals; discontinue therapy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur alone or in combination with other antiretrovirals
            • Not FDA approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of this drug have not been established in patients coinfected with HBV and HIV
            • Tablets and oral solution formulations used to treat HIV infection contain a higher dose of lamivudine than formulations indicated for chronic hepatitis B infection; HIV patients should receive only formulation specific for HIV
            • Exacerbations of hepatitis reported after discontinuation of lamivudine; monitor patients closely with both clinical and laboratory follow-up for at least several months after stopping treatment; if appropriate, initiate anti-hepatitis B therapy

            zidovudine

            • Neutropenia and severe anemia reported, particularly in patients with advanced HIV disease
            • Myopathy associated with prolonged use
            • Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with nucleoside analogues alone or in combination

            Contraindications

            Hypersensitivity

            Patients requiring separate lamivudine or zidovudine dose reduction

            Cautions

            Risk of immune reconstitution syndrome

            Zidovudine use has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease; use with caution in patients who have bone marrow compromise evidenced by granulocyte count < 1,000 cells per mm³ or hemoglobin < 9.5 g/dL; frequent blood counts strongly recommended in patients with advanced HIV-1 disease; periodic blood counts recommended for other HIV-1-infected patients; if anemia or neutropenia develops, dosage interruption may be needed

            Myopathy and myositis, with pathological changes similar to that produced by HIV-1 disease associated with prolonged use of zidovudine

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including lamivudine and zidovudine (components of the combination product) and other antiretrovirals reported; a majority of these cases have been in women; female sex and obesity may be risk factors for the development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues; suspend treatment in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations)

            Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine; monitor patients closely with both clinical and laboratory follow-up for at least several months after stopping treatment

            Emergence of hepatitis B virus variants associated with resistance to lamivudine reported in HIV-1-infected subjects who received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus

            Concomitant administration with other products containing lamivudine or zidovudine not recommended

            Closely monitor patients receiving interferon alfa with or without ribavirin for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia; consider discontinuation of therapy as medically appropriate; dose reduction or discontinuation of interferon alfa, ribavirin, or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh greater than 6)

            Use with caution in patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis; treatment should be stopped immediately if clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis occur Immune reconstitution syndrome reported

            During initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment

            Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have been reported to occur in setting of immune reconstitution; however, time to onset is more variable, and can occur many months after initiation of treatment

            Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy; mechanism and long-term consequences of these events are currently unknown; causal relationship not established

            Treatment with zidovudine, a component of the combination product, 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 recommended for use in patients with hepatic or renal (CrCl< 50 mL/min) impairment

            See also individual monographs

            • lamivudine
            • zidovudine
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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to therapy during pregnancy; healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263

            Available data from APR show no difference in overall risk of birth defects for lamivudine or zidovudine compared with background rate for birth defects of 2.7% in Metropolitan Atlanta Congenital Defects Program (MACDP) reference population

            Hyperlactatemia, which may be due to mitochondrial dysfunction, reported in infants with in utero exposure to zidovudine-containing products; causal relationship between these events and exposure to zidovudine-containing products in utero or peri-partum not established

            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; lamivudine and zidovudine are present in human milk; there is no information on effects of lamivudine or zidovudine on breastfed infant or effects of drugs 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 breast infant similar to those seen in adults, 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.

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            Pharmacology

            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

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.