lamivudine (Rx)

Brand and Other Names:Epivir, Epivir HBV, more...3TC
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mg (Epivir HBV)
  • 150mg (Epivir)
  • 300mg (Epivir)

oral solution

  • 5mg/mL (Epivir HBV)
  • 10mg/mL (Epivir)

HIV Infection

Epivir: 300 mg PO qDay or 150 mg PO q12hr

Chronic Hepatitis B

Epivir HBV: 100 mg PO qDay

Renal Impairment

CrCl ≥ 50 mL/min: 150 mg PO q12hr or 300 mg PO qDay

CrCl 30-49 mL/min: 150 mg PO qDay

CrCl 15-29 mL/min: 150 mg first dose, then 100 mg qDay

CrCl 5-14 mL/min: 150 mg first dose, then 50 mg qDay

CrCl <5 mL/min: 50 mg first dose, then 25 mg qDay

See Also Combos

with zidovudine (Combivir)

with abacavir (Epzicom)

with abacavir/zidovudine

Dosing Considerations

Monitor amylase q4-8week

Dosage Forms & Strengths

tablet

  • 100mg (Epivir HBV)
  • 150mg (Epivir)
  • 300mg (Epivir)

oral solution

  • 5mg/mL (Epivir HBV)
  • 10mg/mL (Epivir)

HIV Infection

Indicated for treatment of HIV infection in combination with other antiretroviral agents

Epivir oral solution

  • Neonates (aged <4 weeks): 2 mg/kg PO q12hr (for prevention of transmission or treatment)
  • ≥1 month: 4 mg/kg PO q12hr  
  • ≥3 months: 5 mg/kg PO q12hr or 10 mg/kg PO qDay; not to exceed 300 mg/day
  • May switch to once daily dosing after age 3 yr in clinically stable patients with undetectable viral load and stable CD4 count (NIH HIV guidelines)
  • Also see Dosing Considerations

Epivir tablet

  • Weight-based dosing
    • 14 to <20 kg: 75 mg PO q12hr, OR 150 mg qDay
    • ≥20 to <25 kg: 75 mg AM and 150 mg PM PO, OR 220 mg qDay
    • ≥25 kg: 150 mg PO q12hr, OR 300 mg PO qDay
    • The NIH pediatric HIV treatment guideline (March, 2016) does not recommend initiating once-daily lamivudine liquid formulation for HIV-infected infants and young children

Chronic Hepatitis B

Use Epivir HBV

<2 years: Safety and efficacy not established

≥2 years: 3 mg/kg PO qDay; not to exceed 100 mg/day  

Dosing Considerations

Monitor amylase q4-8week

Lamiduvine 150-mg scored tablet is the preferred formulation for HIV-1 infected children and adolescents ≥14kg and whom a solid dosage form is appropriate

Tablet regimens are recommended when possible to avoid potential interactions with sorbitol

Consider more frequent monitoring of HIV-1 viral load when treating with lamiduvine (Epivir) oral solution; see also warnings and precautions section

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Interactions

Interaction Checker

and lamivudine

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      Serious - Use Alternative

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            Adverse Effects

            >10%

            Cough

            Diarrhea

            Fatigue & malaise

            Fever (peds)

            Headache

            Musculoskeletal pain

            Nausea

            Nervous system neuropathy

            Pancreatitis

            Peripheral neuropathy

            Nasal S/S

            Vomiting

            1-10%

            Abdominal cramps, abdominal pain

            Anorexia &/or decr appetite

            Arthralgia

            Chills

            Depression

            Dizziness

            Dyspepsia

            Insomnia

            Myalgia

            Rash

            Thrombocytopenia

            Creatine phosphokinase increased

            Frequency Not Defined

            Body fat redistribution

            Elevated amylase

            Neutropenia

            Hepatitis B exacerbation

            Postmarketing reports

            Immune reconstitution

            Blood and lymphatic system disorders

            Anemia (including pure red cell aplasia and severe anemias progressing on therapy), lymphadenopathy, splenomegaly, thrombocytopenia

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            Warnings

            Black Box Warnings

            Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination with other antiretrovirals; discontinue therapy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur

            Epivir-HBV is not FDA approved for treatment of HIV-1 infection; lamivudine dosage in EPIVIR-HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection and the safety and efficacy of this drug have not been established in patients co-infected with HBV and HIV; severe acute exacerbations of hepatitis B reported in patients who have discontinued anti-hepatitis B therapy (including HBV formulation); hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy; if appropriate, initiation of anti-hepatitis B therapy may be warranted

            Tablets and oral solution formulations used to treat HIV infection contain a higher dose of lamivudine than formulations indicated for chronic hepatitis B infection; HBV is not approved for treatment of HIV-1 infection because lamivudine dosage in HBV formulation is subtherapeutic and monotherapy is inappropriate for treatment of HIV-1 infection; patients with HIV should receive only formulation specific for HIV

            Contraindications

            Hypersensitivity

            Cautions

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogues, including lamivudine; a majority of these cases have been in women; female sex and obesity may be risk factors for development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analogues; suspend treatment in any patient who develops 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

            Exacerbation of hepatitis B in HBV/HIV coinfected patients may occur on discontinuation

            Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs

            Discontinue immediately if signs or symptoms of pancreatitis occur in patients with history of pancreatitis

            EPIVIR-HBV is not appropriate for patients co-infected with HBV and HIV-1; if patient with unrecognized or untreated HIV-1 infection is prescribed EPIVIR-HBV for treatment of HBV, rapid emergence of HIV-1 resistance is likely to result because of subtherapeutic dose and inappropriate use of monotherapy for HIV-1 treatment

            In order to reduce risk of resistance in patients receiving monotherapy, consider a switch to alternative regimen if serum HBV DNA remains detectable after 24 weeks of treatment; optimal therapy should be guided by resistance testing

            Patients with HIV-1 infection should receive only dosage forms of lamivudine appropriate for treatment of HIV-1

            Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens reported

            Concomitant administration of emtricitabine with lamivudine-containing products not recommended

            Hepatic decompensation (some fatal) reported in HIV-1/HCV co-infected patients receiving interferon and ribavirin-based regimens; monitor for treatment-associated toxicities; discontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both

            Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis; discontinue treatment as clinically appropriate

            Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution

            • Pediatric subjects who received lamivudine (Epivir) oral solution concomitantly with other antiretroviral oral solutions at any time in the ARROW trial had lower rates of virologic suppression, lower plasma lamivudine exposure, and developed viral resistance more frequently than those receiving lamivudine (Epivir) tablets; lamivudine (Epivir) scored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriate; consider more frequent monitoring of HIV-1 viral load when treating with lamivudine (EPIVIR) oral solution
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            Pregnancy & Lactation

            Pregnancy

            A pregnancy registry has been established to monitor maternal-fetal outcomes of women exposed to lamivudine: 1-800-258-4263

            Available data from the APR show no difference in the overall risk of birth defects for lamivudine or zidovudine compared with background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population; APR uses the MACDP as the U.S. reference population for birth defects in the general population; MACDP evaluates women and infants from a limited geographic area and does not include outcomes for births that occurred at less than 20 weeks gestation; rate of miscarriage is not reported in the APR

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed infants to avoid risking postnatal transmission of HIV-1 infection; lamivudine is 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 a 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.

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            Pharmacology

            Mechanism of Action

            Nucleoside Reverse Transcriptase Inhibitor (NRTI); following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog

            Useful in combination with ZDV

            ZDV-induced codon mutations result in viral sensitivity to drug

            Pharmacokinetics

            Absorption: Rapid

            Vd: 1.3 L/kg

            Protein Bound: <36%

            Metabolism: 5.6% to trans-sulfoxide metabolite

            Bioavailability: Absolute; Cp max decreased with food although AUC not significantly affected, 66% (children); 87% (adults)

            Half-life elimination: 2 hr (children); 5-7 hr (adults)

            Excretion: Primarily urine

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            Formulary

            FormularyPatient Discounts

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            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.
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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.