Nintedanib Dosage

Medically reviewed by Drugs.com. Last updated on June 18, 2020.

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Usual Adult Dose for Idiopathic Pulmonary Fibrosis

150 mg orally every 12 hours
Maximum dose: 300 mg/day

Comments:
-Conduct liver function tests prior to initiating therapy.
-Conduct a pregnancy test in females of reproductive potential prior to initiating therapy.

Uses:
-For the treatment of idiopathic pulmonary fibrosis (IPF)
-To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Usual Adult Dose for Chronic Lung Disease

150 mg orally every 12 hours
Maximum dose: 300 mg/day

Comments:
-Conduct liver function tests prior to initiating therapy.
-Conduct a pregnancy test in females of reproductive potential prior to initiating therapy.

Uses:
-For the treatment of idiopathic pulmonary fibrosis (IPF)
-To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Renal Dose Adjustments

Mild to Moderate Renal Dysfunction (CrCl 30 to 90 mL/min): No adjustment recommended.
Severe Renal Dysfunction (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

Mild Liver Dysfunction (Child-Pugh A): 100 mg orally 2 times a day; consider interruption or discontinuation of therapy for management of adverse reactions
Moderate or Severe Liver Dysfunction (Child-Pugh B or C): Not recommended.

AST or ALT elevation between 3 to 5 times the upper limit of normal (ULN) without signs of liver damage:
-Interrupt therapy or reduce the dose to 100 mg orally 2 times a day
-After return to baseline resume at 100 mg orally 2 times a day; if tolerated may return to full dose.
-Discontinue therapy if 100 mg orally 2 times a day is not tolerated.

Dose Adjustments

To manage severe side effects:
-Interrupt therapy or reduce the dose to 100 mg orally 2 times a day
-After resolution, resume at 100 mg orally 2 times a day; if tolerated may return to full dose.
-Discontinue therapy if 100 mg orally 2 times a day is not tolerated.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Take this drug with food.
-Swallow whole with liquid; do not chew or crush due to bitter taste.
-Advise patient to skip missed dose.

Storage requirements:
-Store at 25C (77F).
-Protect from exposure to high humidity and avoid excessive heat.

General:
-Increased risk of bleeding when used with anticoagulation therapy due to VEGFR inhibition.
-Conduct liver function tests prior to initiating therapy.
-Conduct a pregnancy test in females of reproductive potential prior to initiating therapy.

Monitoring:
-Hepatic: Liver function tests prior to treatment, monthly during first 3 months, and then every 3 months as clinically indicated.

Patient advice:
-Advise the patient to read the approved patient labeling.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer