Nintedanib Dosage

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Usual Adult Dose for Idiopathic Pulmonary Fibrosis

150 mg orally twice a day (every 12 hours)
Maximum daily dose: 300 mg

Comments:

• Conduct liver function tests prior to initiating therapy.
• Perform a pregnancy test in females of reproductive potential before starting treatment.

Uses:

• For the treatment of idiopathic pulmonary fibrosis (IPF)
• For the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
• To slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD)

Usual Adult Dose for Interstitial Lung Disease

150 mg orally twice a day (every 12 hours)
Maximum daily dose: 300 mg

Comments:

• Conduct liver function tests prior to initiating therapy.
• Perform a pregnancy test in females of reproductive potential before starting treatment.

Uses:

• For the treatment of idiopathic pulmonary fibrosis (IPF)
• For the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
• 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

LIVER DYSFUNCTION:
Mild Liver Dysfunction (Child-Pugh A): 100 mg orally twice a day (every 12 hours)
Moderate or Severe Liver Dysfunction (Child-Pugh B or C): Use is not recommended.

LIVER ENZYME ELEVATIONS:

• AST or ALT between 3 to 5 times the upper limit of normal (3 to 5 x ULN) without signs of liver damage: Interrupt therapy or reduce the dose to 100 mg orally twice a day (every 12 hours); once values return to baseline, resume at reduced dose and if tolerated, increase to full dose of 150 mg orally twice a day (every 12 hours).
• AST or ALT greater than 3 x ULN and WITH signs of liver damage: Discontinue therapy
• AST or ALT greater than 5 x ULN: Discontinue therapy

Dose Adjustments

Dose Adjustment for the Management of Adverse Reactions:

• Consider dose reduction or temporary treatment interruption until reaction has resolved to levels that allow therapy continuation.
• May resume therapy at full dosage of 150 mg orally twice a day (every 12 hours), or reduced dosage of 100 mg orally twice a day (every 12 hours); increase to full dose if tolerated.
• Discontinue therapy in patients who cannot tolerate 100 mg orally twice a day (every 12 hours).
• Patients with mild liver dysfunction (Child-Pugh A): Consider treatment interruption or discontinuation for the management of adverse reactions.

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:

• For oral use
• Administer this drug with food.
• Capsules should be swallowed whole with liquid; do not chew due to bitter taste.
• Do not open or crush capsules; wash hands immediately and thoroughly if contact with contents occurs.
• If a dose is missed, the next dose should be taken at the next scheduled time; patients should not make up for a missed dose.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Protect from exposure to high humidity and avoid excessive heat; if repackaged, use USP tight container.

General:

• It is recommended that patients stop smoking during treatment. Cigarette smoking was associated with decreased drug exposure.

Monitoring:

• Hematologic: For bleeding in patients on chronic, full dose anticoagulation (during treatment)
• Hepatic: Liver function tests, including AST/ALT and bilirubin (prior to treatment, monthly during first 3 months, and then every 3 months as clinically indicated; assess promptly in patients reporting signs of liver injury)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Take this medication with food and swallow capsules whole.
• Understand that monitoring of liver function tests is recommended prior to treatment and periodically; report any symptoms of a liver problem.
• Contact your health care provider at the first signs of diarrhea, nausea, and vomiting.
• Report any signs and symptoms of unusual bleeding, gastrointestinal perforation, or proteinuria.
• Seek immediate medical attention if signs/symptoms of acute myocardial ischemia occur.
• Stop smoking prior to and during treatment, if possible.
• Female patients of childbearing potential: Avoid becoming pregnant during treatment. Notify your health care provider of a known/suspected pregnancy. Breastfeeding is not recommended during therapy.

Frequently asked questions

• How effective is Ofev for pulmonary fibrosis?
• Can Ofev and Esbriet be given together?

Further information

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

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