Drug Detail:Nintedanib (Nintedanib)
Drug Class: Multikinase inhibitors
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.
Frequently asked questions
- Can Ofev and Esbriet be given together?
