Label: ENTECAVIR tablet, film coated

  • NDC Code(s): 69097-425-02, 69097-426-02, 69097-426-05
  • Packager: Cipla USA Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 23, 2022

If you are a consumer or patient please visit this version.

  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS. ENTECAVIR tablets, for oral use ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY - Severe acute exacerbations of hepatitis B have been ...

    WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED 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 at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [seeWarnings 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 entecavir tablet is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with entecavir tablet is 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)].

    Close
  • 1 INDICATIONS AND USAGE
    Entecavir tablet is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and ...
  • 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Entecavir 0.5 mg film-coated tablets, USP are White to off-white, triangular shaped biconvex, film coated tablet debossed with 'CL' on one side and '426' on the other ...
  • 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 anti-hepatitis B therapy, including entecavir ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in other sections of the labeling: Exacerbations of hepatitis after discontinuation of treatment [seeBoxed Warning , Warnings and ...
  • 7 DRUG INTERACTIONS
    Since entecavir is primarily eliminated by the kidneys [see Clinical Pharmacology (12.3)], coadministration of entecavir with drugs that reduce renal function or compete for active tubular ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir tablets during pregnancy. Healthcare providers ...
  • 10 OVERDOSAGE
    There is limited experience of entecavir overdosage reported in patients. Healthy subjects who received single entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had ...
  • 11 DESCRIPTION
    Entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1, 9-dihydro-9-[(1S, 3R ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Entecavir is an antiviral drug against hepatitis B virus [see Microbiology (12.4)]. 12.3 Pharmacokinetics - The single- and multiple-dose pharmacokinetics of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Long-term oral carcinogenicity studies of entecavir in mice and rats were carried out at exposures up to approximately ...
  • 14 CLINICAL STUDIES
    14.1 Outcomes in Adults - At 48 Weeks - The safety and efficacy of entecavir in adults were evaluated in three Phase 3 active-controlled trials. These studies included 1633 subjects 16 years of ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Entecavir tablets, USP are available in the following strengths and configurations of plastic bottles with child-resistant closures for 30s and 90s pack: Product Strength and - Dosage ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment - Inform patients that discontinuation of anti-hepatitis B ...
  • PATIENT PACKAGE INSERT
    Patient Information - Entecavir (en-TEK-a-vir) Tablets, USP - Read this Patient Information before you start taking entecavir tablets and each time you get a refill. There may be new information ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    NDC 69097-426-02       RX ONLY - Entecavir - Tablets, USP -  0.5 mg - 30 Tablets - Cipla - NDC 69097-426-05       RX ONLY - Entecavir - Tablets, USP -  0.5 mg - 90 Tablets - Cipla - NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information