lamiVUDine
la-miv-yoo-deen
Trade Name(s): (Apo-LamiVUDine, 
Epivir, Epivir-HBV, Heptovir )
BLACK BOX ALERT Serious, sometimes fatal lactic acidosis, severe hepatomegaly with steatosis (fatty liver) have occurred. Severe acute exacerbation of hepatitis B virus (HBV) infection was reported in pts coinfected with HBV and HIV-1 after discontinuation. Monitor hepatic function for several mos after discontinuation. Do not use Epivir-HBV for treatment of HIV infection. Epivir contains a higher dose of active ingredient compared to Epivir-HBV. Pts with HIV-1 infection must receive dosage form that is appropriate for treatment.
Do not confuse Epivir with Combivir, or lamiVUDine with lamoTRIgine.
FIXED-COMBINATION(S)Cimduo: lamiVUDine/tenofovir (antiviral): 300 mg/300 mg. Combivir: lamiVUDine/zidovudine (an antiviral): 150 mg/300 mg. Delstrigo: lamiVUDine/doravirine/tenofovir (antivirals): 300 mg/100 mg/300 mg. Dovato: lamiVUDine/dolutegravir (antiviral): 300 mg/50 mg. Epzicom: lamiVUDine/abacavir (an antiviral): 300 mg/600 mg. Symfi: lamiVUDine/efavirenz/tenofovir: 300 mg/400 mg/300 mg. Triumeq: lamiVUDine/abacavir (antiretroviral)/dolutegravir (integrase inhibitor): 300 mg/600 mg/50 mg. Trizivir: lamiVUDine/zidovudine/abacavir (an antiviral): 150 mg/300 mg/300 mg.
Epivir: Treatment of HIV infection in combination with at least two other antiretroviral agents. Epivir-HBV: Treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active hepatic inflammation. OFF-LABEL: Prophylaxis in health care workers at risk of acquiring HIV after occupational exposure to virus. Use as part of multidrug regimen.
Contraindications: Hypersensitivity to lamiVUDine. Cautions: Hepatic impairment. Use in children with history of pancreatitis or risk factors for developing pancreatitis autoimmune disease, genetic mutations, pancreas divisum [congenital]). Use in combination with interferon alfa with or without ribavirin in pts coinfected with HIV/HBV.
Inhibits HIV reverse transcriptase by viral DNA chain termination. Inhibits RNA-, DNA-dependent DNA polymerase, an enzyme necessary for HIV, hepatitis B virus replication. Therapeutic Effect: Slows HIV replication; reduces progression of HIV infection, chronic hepatitis B virus infection.
Widely distributed. Protein binding: less than 36%. Primarily excreted unchanged in urine. Not removed by hemodialysis or peritoneal dialysis. Half-life: Children: 2 hrs. Adults: 5–7 hrs.
Pregnancy/Lactation: Drug crosses placenta. Unknown if distributed in breast milk. Breastfeeding not recommended due to risk of postnatal HIV transmission. Children: Safety and efficacy not established in pts younger than 3 mos. Elderly: Age-related renal impairment may require dosage adjustment.
DRUG: Interferon alfa, ribavirin may increase risk of hepatic decompensation. Zalcitabine may inhibit absorption;avoid concurrent administration. HERBAL: None significant. FOOD: None known. LAB VALUES: May increase serum amylase, ALT, AST, bilirubin. May decrease absolute neutrophil count, Hgb, platelets. May increase serum lipase in children.
Oral Solution: 5 mg/mL (Epivir-HBV), 10 mg/mL (Epivir). Tablets: 100 mg (EpivirHBV), 150 mg (Epivir), 300 mg (Epivir).
Note: Epivir tablets/oral solution contain a higher dose of lamivudine than Epivir-HBV tablets/oral solution.
HIV Infection (Epivir)PO: ADULTS, ELDERLY: 150 mg twice daily or 300 mg once daily. Children 3 yrs and older: 25 KG or more: 150 mg twice daily. 20–24 KG: 75 mg (1/2 tablet) in the morning and 150 mg in the evening. 14–19 KG: 75 mg (1/2 tablet) twice daily. INFANTS 3 MOS TO CHILDREN LESS THAN 3 YRS: (Oral solution): 5 mg/kg/dose twice daily. Maximum: 150 mg/dose. (Tablets): 25 KG OR MORE: 150 mg 2 times/day. 20–24 KG: 75 mg in AM and 150 mg in PM. 14–19 KG: 75 mg 2 times/day.
Chronic Hepatitis B (Epivir HBV)PO: ADULTS: 100 mg/day. CHILDREN 2–17 YRS: 3 mg/kg/day. Maximum: 100 mg/day.
Dosage in Renal ImpairmentDosage and frequency are modified based on creatinine clearance.
| Creatinine Clearance | Dosage HIV | Dosage Hepatitis B |
|---|
| 30–49 mL/min | 150 mg once/daily | 100 mg first dose, then 50 mg once/daily | | 15–29 mL/min | 150 mg first dose, then 100 mg once/daily | 100 mg first dose, then 25 mg once/daily | | 5–14 mL/min | 150 mg first dose, then 50 mg once/daily | 35 mg first dose, then 15 mg once/daily | | Less than 5 mL/min | 50 mg first dose, then 25 mg once/daily | 35 mg first dose, then 10 mg once/daily |
|
Hemodialysis: Dosing post-HD recommended.
Dosage in Hepatic ImpairmentNo dose adjustment.
Frequent (35%–10%): Headache, nausea, malaise, fatigue, nasal disturbances, diarrhea, cough, musculoskeletal pain, neuropathy, insomnia, anorexia, dizziness, fever, chills. Occasional (9%–5%): Depression, myalgia, abdominal cramps, dyspepsia, arthralgia.
Lactic acidosis, severe hepatomegaly with steatosis have occurred. If therapy is discontinued, pts coinfected with HBV have an increased risk for viral replication, worsening of hepatic function, and may experience hepatic decompensation and/or failure. Hepatitis B virus–resistant variants have occurred in pts coinfected with HIV-1/HBV. May increase risk of pancreatitis in children. May induce immune recovery syndrome (inflammatory response to dormant opportunistic infections such as Mycobacterium avium, cytomegalovirus, PCP, tuberculosis or acceleration of autoimmune disorders, including Graves' disease, polymyositis, Guillain-Barre). May cause redistribution/accumulation of body fat (lipodystrophy). Lymphadenopathy, splenomegaly reported in children. Paresthesia, peripheral neuropathy reported in 15% of pts.