Vibegron

DRUG INFORMATION

  ADULT
    - The recommended dose is one 75 mg tablet orally once daily.
      Source: US FDA label for vibegron (GEMTESA), section 'dosage and administration',
      retrieved 2026-08-29
    - ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of GEMTESA is one 75 mg
      tablet orally, once daily with or without food.
      Source: US FDA label for vibegron (GEMTESA), section 'dosage and administration',
      retrieved 2026-08-29
    - The recommended dose is one 75 mg tablet orally once daily. ( 2.1 ) Swallow tablet
      whole with water. ( 2.1 ) Tablet may be crushed and mixed with applesauce. ( 2.1 )
      2.1 Recommended Dosage The recommended dosage of GEMTESA is one 75 mg tablet
      orally, once daily with or without food. Swallow GEMTESA tablets whole with a
      glass of water.
      Source: US FDA label for vibegron (GEMTESA), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of GEMTESA in pediatric patients have not been
      established.
      Source: US FDA label for vibegron (GEMTESA), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - No overall differences in safety of GEMTESA have been observed between patients 65
      years of age and older and younger adult patients. 8.6 Renal Impairment No dosage
      adjustment for GEMTESA is recommended for patients with mild, moderate, or severe
      renal impairment (eGFR 15 to <90 mL/min/1.73 m 2 ).
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29
    - GEMTESA has not been studied in patients with eGFR <15 mL/min/1.73 m 2 (with or
      without hemodialysis) and is not recommended in these patients [see Clinical
      Pharmacology ( 12.3 )] . 8.7 Hepatic Impairment No dosage adjustment for GEMTESA
      is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A
      and B).
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 8.6 ) Severe Hepatic Impairment : Not recommended.
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29
    - GEMTESA has not been studied in patients with eGFR <15 mL/min/1.73 m 2 (with or
      without hemodialysis) and is not recommended in these patients [see Clinical
      Pharmacology ( 12.3 )] . 8.7 Hepatic Impairment No dosage adjustment for GEMTESA
      is recommended for patients with mild to moderate hepatic impairment (Child-Pugh A
      and B).
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29
    - GEMTESA has not been studied in patients with severe hepatic impairment (Child-
      Pugh C) and is not recommended in this patient population [see Clinical
      Pharmacology ( 12.3 )] .
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary There are no available data on GEMTESA use in pregnant women to
      evaluate for a drug-associated risk of major birth defects, miscarriage, or
      adverse maternal or fetal outcomes.
      Source: US FDA label for vibegron (GEMTESA), section 'pregnancy', retrieved
      2026-08-29
    - In animal studies, no effects on embryo-fetal development were observed following
      administration of vibegron during the period of organogenesis at exposures
      approximately 275-fold and 285-fold greater than clinical exposure at the
      recommended daily dose of GEMTESA, in rats and rabbits, respectively.
      Source: US FDA label for vibegron (GEMTESA), section 'pregnancy', retrieved
      2026-08-29
    - Delayed fetal skeletal ossification was observed in rabbits at approximately
      898-fold clinical exposure, in the presence of maternal toxicity.
      Source: US FDA label for vibegron (GEMTESA), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In rats treated with vibegron during pregnancy and lactation, no effects on
      offspring were observed at 89-fold clinical exposure.
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29
    - In a pre- and post-natal developmental toxicity study, pregnant or lactating rats
      were treated with daily oral doses of 0, 30, 100, or 500 mg/kg/day vibegron from
      day 6 of gestation through day 20 of lactation.
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29
    - Maternal toxicity was observed during lactation (decreased body weight gain) at
      doses ≥100 mg/kg/day and during gestation (decreased body weight gain and food
      consumption) at 500 mg/kg/day.
      Source: US FDA label for vibegron (GEMTESA), section 'use in specific
      populations', retrieved 2026-08-29