Generic Epivir

LAMIVUDINE (3ТС)
Tablets: 100 mg (Rx) Epivir-HBV (GlaxoSmithKline)
Tablets: 150 mg (Rx) Epivir (GlaxoSmithKline)
Oral solution: 5 mg/mL (Rx) Epivir-HBV (GlaxoSmithKline)
Oral solution: 10 mg/mL (Rx) Epivir (GlaxoSmithKline)

Warning:
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogs alone or in combination, including lamivudine and other antiretroviral agents.
Offer human immunodeficiency virus (HIV) counseling and testing to patients before beginning Epivir-HBV and periodically during treatment because Epivir-HBV tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as the Epivir tablets and oral solution used to treat HIV infection. If treatment with Epivir-HBV is prescribed for chronic hepatitis В for a patient with unrecognized or untreated HIV infection, rapid emergence of HIV resistance is likely because of sub-therapeutic dose and inappropriate monotherapy.
Epivir tablets and oral solution (used to treat HIV infection) contain a higher dose of the active ingredient (lamivudine) than Epivir-HBV tablets and oral solution (used to treat chronic hepatitis B). Patients with HIV infection should receive only dosing forms appropriate for the treatment of HIV.

Indications
HIV infection (Epivir): Lamivudine in combination with other antiretroviral agents is indicated for the treatment of HIV infection.
Chronic heparins В (Epivir-HBV): Treatment of chronic hepatitis В associated with evidence of hepatitis В viral replication and active liver inflammation.

Administration and Dosage
HIV infection:
Adults - 150 mg twice daily in combination with other antiretroviral agents. Lamivudine may be administered with or without food.
Children (3 months to Renal function impairment - Adjust lamivudine dose in accordance with renal function. Insufficient data are available to recommend a dosage of lamivudine in dialysis.
Chronic hepatitis B: 100 mg once daily in adults. Safety and efficacy of treatment > 1 year have not been established, and the optimum duration of treatment is not known.
Children (2 to 17 years of age) - 3 mg/kg once daily up to a maximum daily dose of 100 mg. Safety and effectiveness of treatment beyond 1 year have not been established, and the optimum duration of treatment is not known.
HIV co-infection - The formulation and dosage of lamivudine in Epivir-HBV are not appropriate for patients dually infected with HBV and HIV. If lamivudine is administered to such patients, use the higher dosage indicated for HIV therapy as part of an appropriate combination regimen.
Renal function impairment - Adjust the dose of lamivudine in accordance with renal function. No additional dosing of lamivudine is required after routine (4-hour) hemodialysis. Insufficient data are available to recommend a dosage of lamivudine in patients undergoing peritoneal dialysis.

Actions
Pharmacology: Lamivudine is a synthetic nucleoside analog with activity against HIV and hepatitis В virus (HBV). Lamivudine is phosphorylated intracellularly to lamivudine 5'-triphosphate (L-TP). Incorporation of the monophosphate form into viral DNA by HBV polymerase results in DNA chain termination. L-TP also inhibits the RNA- and DNA-dependent DNA polymerase activities of HIV-1 reverse transcriptase.
Pharmacokinetics:
Absorption/Distribution - Lamivudine is rapidly absorbed after oral administration in HIV- and HBV-infected patients and phosphorylated to its active form, L-TP. Absolute bioavailability as demonstrated in HIV-infected patients is 86% for the tablet and 87% for the oral solution. Although the solution demonstrates a slightly higher Cmax than the tablet, no significant difference exists in AUC; therefore, the solution and tablet may be used interchangeably.
The apparent volume of distribution (Vd) is 1.3 L/kg suggesting distribution into extravascular spaces. Cmax reported in HBV-infected patients was 0.5 to 2 hours. Binding of lamivudine to plasma proteins is Metabolism/Excretion - Metabolism is a minor route of elimination; the only known metabolite is the trans-sulfoxide metabolite. The mean elimination halt-life of lamivudine ranges from 5 to 7 hours. In HIV-infected patients, renal clearance is 280.4 mL/min, representing 71% of total clearance; total clearance is 398.5 mL/min. The majority of the dose is eliminated in the urine as unchanged drug, with about 5% excreted as the metabolite within 12 hours of dose administration.
Special populations:
Children - In HIV-infected pediatric patients about 4 months to 16 years of age and chronic hepatitis В pediatric patients 2 to 12 years of age, lamivudine was rapidly absorbed with a Tmax of 0.5 to 1 hour and an absolute bioavailability of 66%. After 8 mg/kg/day, Cmax was 1.1 mg/mL and half-life was 2 hours (vs 3.7 hours in adults). Weight-corrected oral clearances were higher, resulting in lower AUCs compared with adults. Total exposure to lamivudine, as reflected by mean AUC values, was comparable between pediatric patients receiving 8 mg/kg/day and adults receiving 4 mg/kg/day. Age-stratified oral clearance was highest at 2 years of age and declined from 2 to 12 years of age, where values were then similar to those seen in adults. In 8 patients, CSF lamivudine concentrations (0.04 to 0.3 mcg/mL) ranged from 5.6% to 30.9% of the concentration in a simultaneous serum sample.

Contraindications
Hypersensitivity to any of the components of the products.

Warnings
Lactic acidosis/severe hepatomegaly with steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have occurred with the use of antiretroviral nucleoside analogs alone or in combination, including lamivudine and other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Most of these reports have described patients receiving nucleoside analogs for treatment of HIV infection, but there have been reports of lactic acidosis in patients receiving lamivudine for hepatitis B. Exercise caution when administering lamivudine to any patient, particularly to those with known risk factors for liver disease. Suspend treatment with lamivudine 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).
HIV-HBV co-infection: Epivir-HBV tablets and oral solution contain a lower dose of the same active ingredient (lamivudine) as Epivir tablets and oral solution (and lamivudine/zidovudine tablets) used to treat HIV infection. The formulation and dosage of lamivudine in Epivir-HBV are not appropriate for patients infected with both HBV and HIV. If a decision is made to administer lamivudine to patients dually infected with HIV and HBV, Epivir tablets or oral solution or Combivir (lamivudine/ zidovudine) tablets should be used as a part of an appropriate combination regimen and prescribing information should be consulted. Combivir (a fixed-dose combination tablet of lamivudine and zidovudine) should not be administered concomitantly with Epivir, Epivir-HBV, or Retrovir (zidovudine).
Post-treatment exacerbations of hepatitis: Clinical and laboratory evidence of exacerbations of hepatitis have occurred after discontinuation of lamivudine (these have been primarily detected by serum ALT elevations in addition to the re-emergence of HBV DNA commonly observed after stopping treatment). Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from post-marketing experience after changes from 1am-ivudine-containing HIV treatment regimens to non-lamivudine-containing regimens in patients infected with both HIV and HBV. The causal relationship to discontinuation of lamivudine treatment is unknown. Closely monitor patients with clinical and laboratory follow-up for at least several months after stopping treatment. There is insufficient evidence to determine whether reinitiating of therapy alters the course of post-treatment exacerbations of hepatitis.
Elderly: Because elderly patients are more likely to have decreased renal function, take care in dose selection and monitor renal function.
Pregnancy: Category C.
Lamivudine has not affected the transmission of HBV from mother to infant; immunize infants appropriately to prevent neonatal acquisition of HBV.
Lactation: Instruct mothers to discontinue nursing if they are receiving lamivudine, which is consistent with the CDC recommendation that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV infection.
Children:
Heparins В - Safety and efficacy of lamivudine for treatment of chronic hepatitis В in children have been studied in pediatric patients from 2 to 17 years of age in a controlled clinical trial. Safety and efficacy in pediatric patients HIV infection - The safety and effectiveness of lamivudine in combination with other antiretroviral agents have been established in pediatric patients > 3 months of age.
Total exposure to lamivudine, as reflected by mean AUC values, was comparable between pediatric patients receiving an 8 mg/kg/day dose and adults receiving a 4 mg/kg/day dose.
Pancrearitis - Pancreatitis, which has been fatal in some cases, has been observed in antiretroviral nucleoside-experienced pediatric patients receiving lamivudine alone or in combination with other antiretroviral agents. Stop lamivudine treatment immediately it clinical signs, symptoms, or lab abnormalities suggestive of pancreatitis occur.

Precautions
Monitoring:
Epivir-HBV - Monitor patients regularly during treatment. The safety and efficacy of treatment with Epivir-HBV > 1 year have not been established. During treatment, combinations of events such as return of persistently elevated ALT, increasing levels of HBV DNA over time after an initial decline below assay limit, progression of clinical signs or symptoms of hepatic disease, and worsening of hepatic necro-inflammatory findings may be considered as potentially reflecting loss of therapeutic response. Consider such observations when determining the advisability of continuing therapy.
Emergence of resistance-associated HBV mutations: Progression of hepatitis B, including death, has been reported in some patients with YMDD-mutant HBV, including patients from the liver transplant setting and from other clinical trials. The long-term clinical significance of YMDD-mutant HBV is not known. Increased clinical and laboratory monitoring may aid in treatment decisions if emergence of viral mutants is suspected.
Special risk: Safety and efficacy of Epivir-HBV have not been established in patients with decompensated liver disease or organ transplants; pediatric patients

Drug Interactions
Drugs that may interact with lamivudine include zidovudine, zalcitabine, and triethoprim/sulfamethoxazole.

Adverse Reactions
HIV - Adverse reactions occurring in > 5% of patients include neuropathy, insomnia, dizziness, depression, nausea, diarrhea, vomiting, anorexia, abdominal pain/cramps, dyspepsia, myalgia, arthralgia, nasal symptoms, cough, headache, malaise, fatigue, fever, chills, and rash. Lab abnormalities may include neutropenia, thrombocytopenia, anemia, and elevations in amylase, AST, ALT, and bilirubin.
Chronic hepatitis В - Adverse reactions occurring in > 3% of patients include the following: Abdominal discomfort/pain; nausea/vomiting; diarrhea; myalgia; arthralgia; ear, nose, and throat infections; sore throat; malaise/fatigue; headache; fever or chills; rash. Lab abnormalities may include platelets and elevations in ALT, serum lipase, and CPK.
Children - Adverse reactions in children are similar to adults and include pancreatitis, hepatomegaly, splenomegaly, stomatitis, and ear pain/swelling.
Pancreatitis, which has been fatal in some cases, has been observed in antiretroviral nucleoside-experienced pediatric patients receiving lamivudine alone or in combination with other antiretroviral agents. In 1 study, 14% of patients developed pancreatitis while receiving monotherapy with lamivudine. Three of these Patients died of complications of pancreatitis. In a second study, 18% of patients developed pancreatitis.
Paresthesias and peripheral neuropathies were repotted in In a 1-month pharmacokinetic study in children (2 to 12 years of age) and adolescents (13 to 17 years of age) with chronic hepatitis В receiving Epivir-HBV, the most commonly observed adverse events were malaise, fatigue, cough, fever, diarrhea, headache, and viral respiratory tract infections.
HIV

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