Epivir-HBV

Indications
Dosage
How Supplied

INDICATIONS

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].

The following points should be considered when initiating therapy with EPIVIR-HBV:

  • 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.
  • EPIVIR-HBV has not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.
  • EPIVIR-HBV has not been evaluated in liver transplant recipients or in patients with chronic hepatitis B virus infection with decompensated liver disease.
  • EPIVIR-HBV has not been evaluated in pediatric patients younger than 2 years of age with chronic HBV infection.

DOSAGE AND ADMINISTRATION

HIV Counseling And Testing

HIV 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].

Dosage In Adult Patients

The recommended oral dosage of EPIVIR-HBV is 100 mg once daily.

Dosage In Pediatric Patients

The 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.

Dosage Adjustment In Adult Patients With Renal Impairment

Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see CLINICAL PHARMACOLOGY].

Table 1: Dosage of EPIVIR-HBV in Adult Patients With Renal Impairment

Creatinine 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].

There are insufficient data to recommend a specific dosage of EPIVIR-HBV in pediatric patients with renal impairment.

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].
  • 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].

Assessing Patients During Treatment

Patients 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.

HOW SUPPLIED

Dosage Forms And Strengths

  • EPIVIR-HBV tablets: 100 mg, butterscotch-colored, film-coated, biconvex, capsule-shaped tablets imprinted with “GX CG5” on one side.
  • EPIVIR-HBV oral solution: A clear, colorless to pale yellow, strawberry-banana-flavored liquid, containing 5 mg of lamivudine per 1 mL.

Storage And Handling

EPIVIR-HBV tablets, 100 mg, are butterscotch-colored, film-coated, biconvex, capsule-shaped tablets imprinted with “GX CG5” on one side.

Bottles of 60 tablets (NDC 0173-0662-00) with child-resistant closures.

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

EPIVIR-HBV oral solution, a clear, colorless to pale yellow, strawberry-banana-flavored liquid, contains 5 mg of lamivudine in each 1 mL in plastic bottles of 240 mL.

Bottles of 240 mL (NDC 0173-0663-00) with child-resistant closures. This product does not require reconstitution.

Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP) in tightly closed bottles.

GlaxoSmithKline, Research Triangle Park, NC 27709. Manufactured under agreement from Shire Pharmaceuticals Group plc, Basingstoke, UK. Revised: December 2013

Last reviewed on RxList: 1/6/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD