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Nintedanib Dosage

Medically reviewed on August 9, 2017.

Applies to the following strengths: 100 mg; 150 mg

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

Use: For the treatment of idiopathic pulmonary fibrosis (IPF)

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.

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