Entecavir

ENTECAVIR- entecavir tablet, film coated
Marlex Pharmaceuticals Inc

WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS COINFECTED

WITH HIV AND HBV, AND LACTIC ACIDOSIS AND HEPATOMEGALY

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for atleast several months in patients who dis continue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] .

Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if entecaviris used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with entecaviris not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions (5.2) ] .

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases , have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions (5.3) ] .

1 INDICATIONS AND USAGE

Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating therapy with Entecavir tablets:

  • In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease [see Clinical Studies (14.1)].

Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

2 DOSAGE AND ADMINISTRATION

2.1 Timing of Administration

Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

2.2 Recommended Dosage in Adults

Compensated Liver Disease

The recommended dose of Entecavir tablets for chronic hepatitis B virus infection in nucleosideinhibitor- treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.

The recommended dose of Entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.

Decompensated Liver Disease

The recommended dose of Entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.

2.3 Recommended Dos age in Pediatric Patients

Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

2.4 Renal Impairment

In adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2. The once-daily dosing regimens are preferred.

Table 2: Recommended Dos age of Entecavir Tablets in Adult Patients with Renal Impairment
Creatinine Clearance (mL/min) Usual Dose (0.5 mg) Lamivudine- Refractory or Decompensated Liver Disease (1 mg)
50 or greater 0.5 mg once daily 1 mg once daily
30 to less that 50 0.5 mg every 48 hours 0.5 mg once dailyOR1 mg every 48 hours
10 to less than 30 0.5 mg every 72 hours 1 mg every 72 hours
Less than 10Hempdialysis*ORCAPD 0.5 mg every 7 days 1 mg every 7 days

* If administered on a hemodialysis day, administer Entecavir tablets after the hemodialysis session.

Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

2.5 Hepatic Impairment

No dosage adjustment is necessary for patients with hepatic impairment.

2.6 Duration of Therapy

The optimal duration of treatment with Entecavir tablets for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

3 DOSAGE FORMS AND STRENGTHS

  • Entecavir tablets 0.5 mg are white to off-white, oval, film-coated, biconvex bevel edged, unscored tablets, debossed with “AN” on one side and “446” on the other side.
  • Entecavir tablets 1 mg are pink, oval, film-coated, biconvex bevel edged, unscored tablets, debossed with “AN” on one side and “449” on the other side.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Severe Acute Exacerbations of Hepatitis B

Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy, including Entecavir [see Adverse Reactions (6.1)]. 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.

5.2 Patients Co-infected with HIV and HBV

Entecavir has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if Entecavir is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated [see Microbiology (12.4)]. Therefore, therapy with Entecavir is not recommended for HIV/HBV co-infected patients who are not also receiving HAART. Before initiating Entecavir therapy, HIV antibody testing should be offered to all patients. Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.

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