Nintedanib

DRUG INFORMATION

  ADULT
    - DOSAGE & ADMINISTRATION • Recommended dosage: 150 mg taken orally twice daily
      approximately 12 hours apart taken with food.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.3 , 8.6 ) • Consider temporary dose reduction to 100 mg, treatment
      interruption, or discontinuation for management of adverse reactions.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.1 , 5.2 , 5.4 ) 2.1 Testing Prior to Nintedanib capsules Administration
      Conduct liver function tests in all patients and a pregnancy test in females of
      reproductive potential prior to initiating treatment with nintedanib capsules [see
      Warnings and Precautions ( 5.2 , 5.4 )]. 2.2 Recommended Dosage The recommended
      dosage of nintedanib capsules is 150 mg taken orally twice daily administered
      approximately 12 hours apart.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of nintedanib capsules have not been established in
      pediatric patients for the treatment of fibrosing interstitial lung diseases.
      Effectiveness was not demonstrated in a randomized, double-blind, placebo-
      controlled study conducted in 26 nintedanib capsules-treated pediatric patients
      aged 6 to 17 years with fibrosing interstitial lung diseases, who were treated
      with nintedanib capsules based on weight.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'pediatric use',
      retrieved 2026-08-29
    - DOSAGE & ADMINISTRATION • Recommended dosage: 150 mg taken orally twice daily
      approximately 12 hours apart taken with food. ( 2.2 ) • Recommended dosage in
      patients with mild hepatic impairment (Child Pugh A): 100 mg taken orally twice
      daily approximately 12 hours apart taken with food. ( 2.3 , 8.6 ) • Consider
      temporary dose reduction to 100 mg, treatment interruption, or discontinuation for
      management of adverse reactions.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) • Recommended dosage in patients with mild hepatic impairment (Child Pugh
      A): 100 mg taken orally twice daily approximately 12 hours apart taken with food.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 8.2 ) • Renal impairment: The safety and efficacy of nintedanib capsules have
      not been studied in patients with severe renal impairment and end-stage renal
      disease.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'use in specific
      populations', retrieved 2026-08-29
    - Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C)
      hepatic impairment with nintedanib capsules is not recommended [see Warnings and
      Precautions ( 5.1 )]. 8.7 Renal Impairment Based on a single-dose study, less than
      1% of the total dose of nintedanib is excreted via the kidney [see Clinical
      Pharmacology ( 12.3 )].
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'use in specific
      populations', retrieved 2026-08-29
    - Adjustment of the starting dose in patients with mild to moderate renal impairment
      is not required.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - ( 2.2 ) • Recommended dosage in patients with mild hepatic impairment (Child Pugh
      A): 100 mg taken orally twice daily approximately 12 hours apart taken with food.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29
    - Do not exceed the recommended maximum daily dosage of 300 mg. 2.3 Recommended
      Dosage for Patients with Hepatic Impairment Mild Hepatic Impairment In patients
      with mild hepatic impairment (Child Pugh A), the recommended dosage of nintedanib
      capsules is 100 mg orally twice daily approximately 12 hours apart taken with food
      [see Use in Specific Populations ( 8.6 )].
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29
    - In patients with mild hepatic impairment (Child Pugh A), consider treatment
      interruption, or discontinuation for management of adverse reactions.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Based on findings from animal studies and its mechanism of action
      [see Clinical Pharmacology ( 12.1 )], nintedanib capsules can cause fetal harm
      when administered to a pregnant woman.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'pregnancy',
      retrieved 2026-08-29
    - There are no data on the use of nintedanib capsules during pregnancy.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'pregnancy',
      retrieved 2026-08-29
    - In animal studies of pregnant rats and rabbits treated during organogenesis,
      nintedanib caused embryo-fetal deaths and structural abnormalities at less than
      (rats) and approximately 5 times (rabbits) the maximum recommended human dose [see
      Data].
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Based on findings from animal studies and its mechanism of action, nintedanib
      capsules can cause fetal harm when administered to a pregnant woman and may reduce
      fertility in females of reproductive potential [see Use in Specific Populations (
      8.1 ), Clinical Pharmacology ( 12.1 , 12.3 ), and Nonclinical Toxicology ( 13.1
      )].
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'nursing
      mothers', retrieved 2026-08-29
    - Counsel patients on pregnancy prevention and planning.
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'nursing
      mothers', retrieved 2026-08-29
    - Pregnancy Testing Verify the pregnancy status of females of reproductive potential
      prior to treatment with nintedanib capsules and during treatment as appropriate
      [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.4 ), and Use
      in Specific Populations ( 8.1 )].
      Source: US FDA label for nintedanib (Nintedanib esylate), section 'nursing
      mothers', retrieved 2026-08-29