Entecavir

DRUG INFORMATION

  ADULT
    - Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than
      or equal to 16 years old): 0.5 mg once daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - (2.2) Lamivudine-refractory or known lamivudine or telbivudine resistance
      substitutions (greater than or equal to 16 years old): 1 mg once daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - (2.2) Decompensated liver disease (adults): 1 mg once daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The efficacy and safety of entecavir have not been established in patients less
      than 2 years of age. Use of entecavir in this age group has not been evaluated
      because treatment of HBV in this age group is rarely required. 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.
      Source: US FDA label for entecavir (Entecavir), section 'pediatric use', retrieved
      2026-08-29
    - Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than
      or equal to 16 years old): 0.5 mg once daily. (2.2) Lamivudine-refractory or known
      lamivudine or telbivudine resistance substitutions (greater than or equal to 16
      years old): 1 mg once daily. (2.2) Decompensated liver disease (adults): 1 mg once
      daily. (2.2) Renal impairment: Dosage adjustment is recommended if creatinine
      clearance is less than 50 mL/min.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - (2.1) 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 nucleoside-inhibitor-
      treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once
      daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - (2.2) Renal impairment: Dosage adjustment is recommended if creatinine clearance
      is less than 50 mL/min.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - 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) ] .
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - 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.
      Source: This line points to a numbered table that this card does not show - read
      that table in the label before you dose. US FDA label for entecavir (Entecavir),
      section 'dosage and administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than
      or equal to 16 years old): 0.5 mg once daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - (2.2) Decompensated liver disease (adults): 1 mg once daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29
    - (2.1) 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 nucleoside-inhibitor-
      treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once
      daily.
      Source: US FDA label for entecavir (Entecavir), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Pregnancy Category C There are no adequate and well-controlled studies of
      entecavir in pregnant women.
      Source: US FDA label for entecavir (Entecavir), section 'pregnancy', retrieved
      2026-08-29
    - Because animal reproduction studies are not always predictive of human response,
      entecavir should be used during pregnancy only if the potential benefit justifies
      the potential risk to the fetus.
      Source: US FDA label for entecavir (Entecavir), section 'pregnancy', retrieved
      2026-08-29
    - Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women
      exposed to entecavir, an Antiretroviral Pregnancy Registry has been established.
      Source: US FDA label for entecavir (Entecavir), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - It is not known whether entecavir is excreted into human milk; however, entecavir
      is excreted into the milk of rats.
      Source: US FDA label for entecavir (Entecavir), section 'nursing mothers',
      retrieved 2026-08-29
    - Because many drugs are excreted into human milk and because of the potential for
      serious adverse reactions in nursing infants from entecavir, a decision should be
      made to discontinue nursing or to discontinue entecavir taking into consideration
      the importance of continued hepatitis B therapy to the mother and the known
      benefits of breastfeeding.
      Source: US FDA label for entecavir (Entecavir), section 'nursing mothers',
      retrieved 2026-08-29
    - Nursing mothers: Discontinue nursing or entecavir taking into consideration the
      importance of entecavir to the mother.
      Source: US FDA label for entecavir (Entecavir), section 'use in specific
      populations', retrieved 2026-08-29