Epivir Hbv
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
EPIVIR-HBV is indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation [see Clinical Studies (14.1, 14.2)].
The following points should be considered when initiating therapy with EPIVIR-HBV:
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- Due to high rates of resistance development in treated patients, initiation of treatment with EPIVIR-HBV should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
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- EPIVIR-HBV has not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.
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- EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
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- EPIVIR-HBV has not been evaluated in pediatric patients younger than 2 years of age with chronic HBV infection.
History
There is currently no drug history available for this drug.
Other Information
EPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2′,3′-dideoxy, 3′-thiacytidine. It has a molecular formula of C8H11N3O3S and a molecular weight of 229.3. It has the following structural formula:
Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg per mL in water at 20°C.
EPIVIR-HBV tablets are for oral administration. Each tablet contains 100 mg of lamivudine and the inactive ingredients hypromellose, macrogol 400, magnesium stearate, microcrystalline cellulose, polysorbate 80, red iron oxide, sodium starch glycolate, titanium dioxide, and yellow iron oxide.
EPIVIR-HBV oral solution is for oral administration. One milliliter (1 mL) of EPIVIR-HBV oral solution contains 5 mg of lamivudine (5 mg per mL) in an aqueous solution and the inactive ingredients artificial strawberry and banana flavors, citric acid (anhydrous), methylparaben, propylene glycol, propylparaben, sodium citrate (dihydrate), and sucrose (200 mg).
Sources
Epivir Hbv Manufacturers
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Glaxosmithkline Llc
![Epivir Hbv (Lamivudine) Tablet, Film Coated Epivir Hbv (Lamivudine) Solution [Glaxosmithkline Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Epivir Hbv | Glaxosmithkline Llc
2.1 HIV Counseling and TestingHIV counseling and testing should be offered to all patients before beginning treatment with EPIVIR-HBV and periodically during treatment because of the risk of emergence of resistant-HIV-1 and limitation of treatment options if EPIVIR-HBV is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of EPIVIR‑HBV is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe recommended oral dosage of EPIVIR‑HBV for pediatric patients aged 2 to 17 years is 3 mg per kg once daily up to a maximum daily dosage of 100 mg. The oral solution formulation should be prescribed for patients requiring a dosage less than 100 mg or if unable to swallow tablets.
2.4 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Dosage of EPIVIR-HBV in Adult Patients With Renal ImpairmentCreatinine Clearance (mL/min)
Recommended Dosage of EPIVIR-HBV
≥50
100 mg once daily
30-49
100 mg first dose, then 50 mg once daily
15-29
100 mg first dose, then 25 mg once daily
5-14
35 mg first dose, then 15 mg once daily
<5
35 mg first dose, then 10 mg once daily
Following correction of the dosage for renal impairment, no additional dosage modification of EPIVIR-HBV is required after routine (4-hour) hemodialysis or peritoneal dialysis [see Clinical Pharmacology (12.3)].
There are insufficient data to recommend a specific dosage of EPIVIR-HBV in pediatric patients with renal impairment.
2.5 Important Administration Instructions • EPIVIR-HBV tablets and oral solution may be administered with or without food. • The tablets and oral solution may be used interchangeably [see Clinical Pharmacology (12.3)]. • The oral solution should be used for doses less than 100 mg. • EPIVIR-HBV should not be used with other medications that contain lamivudine or medications that contain emtricitabine [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic response. Such observations should be taken into consideration when determining the advisability of continuing therapy with EPIVIR-HBV.
The optimal duration of treatment, the durability of HBeAg seroconversions occurring during treatment, and the relationship between treatment response and long‑term outcomes such as hepatocellular carcinoma or decompensated cirrhosis are not known.
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State Of Florida Doh Central Pharmacy
Epivir Hbv | State Of Florida Doh Central Pharmacy
2.1 HIV Counseling and TestingHIV counseling and testing should be offered to all patients before beginning treatment with EPIVIR-HBV and periodically during treatment because of the risk of emergence of resistant-HIV-1 and limitation of treatment options if EPIVIR-HBV is prescribed to treat chronic hepatitis B infection in a patient who has unrecognized HIV-1 infection or acquires HIV-1 infection during treatment [see Warnings and Precautions (5.3)].
2.2 Dosage in Adult PatientsThe recommended oral dosage of EPIVIR‑HBV is 100 mg once daily.
2.3 Dosage in Pediatric PatientsThe recommended oral dosage of EPIVIR‑HBV for pediatric patients aged 2 to 17 years is 3 mg per kg once daily up to a maximum daily dosage of 100 mg. The oral solution formulation should be prescribed for patients requiring a dosage less than 100 mg or if unable to swallow tablets.
2.4 Dosage Adjustment in Adult Patients With Renal ImpairmentDosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Dosage of EPIVIR-HBV in Adult Patients With Renal ImpairmentCreatinine Clearance (mL/min)
Recommended Dosage of EPIVIR-HBV
≥50
100 mg once daily
30-49
100 mg first dose, then 50 mg once daily
15-29
100 mg first dose, then 25 mg once daily
5-14
35 mg first dose, then 15 mg once daily
<5
35 mg first dose, then 10 mg once daily
Following correction of the dosage for renal impairment, no additional dosage modification of EPIVIR-HBV is required after routine (4-hour) hemodialysis or peritoneal dialysis [see Clinical Pharmacology (12.3)].
There are insufficient data to recommend a specific dosage of EPIVIR-HBV in pediatric patients with renal impairment.
2.5 Important Administration Instructions • EPIVIR-HBV tablets and oral solution may be administered with or without food. • The tablets and oral solution may be used interchangeably [see Clinical Pharmacology (12.3)]. • The oral solution should be used for doses less than 100 mg. • EPIVIR-HBV should not be used with other medications that contain lamivudine or medications that contain emtricitabine [see Warnings and Precautions (5.4)]. 2.6 Assessing Patients During TreatmentPatients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis B. During treatment, combinations of such 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/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic response. Such observations should be taken into consideration when determining the advisability of continuing therapy with EPIVIR-HBV.
The optimal duration of treatment, the durability of HBeAg seroconversions occurring during treatment, and the relationship between treatment response and long‑term outcomes such as hepatocellular carcinoma or decompensated cirrhosis are not known.
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