Nintedanib Dosage

Usual Adult Dose for Idiopathic Pulmonary Fibrosis

150 mg orally every 12 hours with food

Maximum dose: 300 mg/day

Comments:
-Swallow whole with liquid; do not chew or crush due to bitter taste.
-Advise patient to skip missed dose.

Use: Treatment of idiopathic pulmonary fibrosis.

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): Unknown

Liver Dose Adjustments

Mild Liver Dysfunction (Child-Pugh A): Unknown
Moderate to 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:
-100 mg twice a day or hold doses.
-After return to baseline resume at 100 mg twice a day; if tolerated may return to full dose.
-Discontinue treatment if 100 mg twice a day is not tolerated.

Dose Adjustments

To manage severe side effects:
-100 mg twice a day or hold doses.
-Once resolved resume at 100 mg or 150 mg twice a day; if tolerated may return to full dose.
-Discontinue treatment if 100 mg twice a day is not tolerated or side effect does not resolve.

Precautions

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

General:
-Increased risk of bleeding when used with anticoagulation therapy due to VEGFR inhibition.

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