Nintedanib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Nintedanib is a is a kinase inhibitor that is FDA approved for the treatment of of idiopathic pulmonary fibrosis (IPF). Common adverse reactions include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased and hypertension.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- OFEV is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Dosage
Testing Prior to OFEV Administration
- Conduct liver function tests prior to initiating treatment with OFEV.
Recommended Dosage
- The recommended dosage of OFEV is 150 mg twice daily administered approximately 12 hours apart.
- OFEV capsules should be taken with food and swallowed whole with liquid. OFEV capsules should not be chewed or crushed because of a bitter taste. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known.
- If a dose of OFEV is missed, the next dose should be taken at the next scheduled time. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg.
Dosage Modification due to Adverse Reactions
- In addition to symptomatic treatment, if applicable, the management of adverse reactions of OFEV may require dose reduction or temporary interruption until the specific adverse reaction resolves to levels that allow continuation of therapy. OFEV treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage. If a patient does not tolerate 100 mg twice daily, discontinue treatment with OFEV.
- Dose modifications or interruptions may be necessary for liver enzyme elevations. For aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times to <5 times the upper limit of normal (ULN) without signs of severe liver damage, interrupt treatment or reduce OFEV to 100 mg twice daily. Once liver enzymes have returned to baseline values, treatment with OFEV may be reintroduced at a reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage (150 mg twice daily). Discontinue OFEV for AST or ALT elevations >5 times ULN or >3 times ULN with signs or symptoms of severe liver damage.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nintedanib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nintedanib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nintedanib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Nintedanib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Nintedanib in pediatric patients.
Contraindications
There is limited information regarding Nintedanib Contraindications in the drug label.
Warnings
There is limited information regarding Nintedanib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Nintedanib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Nintedanib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Nintedanib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Nintedanib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nintedanib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nintedanib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nintedanib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Nintedanib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Nintedanib in geriatric settings.
Gender
There is no FDA guidance on the use of Nintedanib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nintedanib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nintedanib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nintedanib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nintedanib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nintedanib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Nintedanib Administration in the drug label.
Monitoring
There is limited information regarding Nintedanib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Nintedanib and IV administrations.
Overdosage
There is limited information regarding Nintedanib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Nintedanib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Nintedanib Mechanism of Action in the drug label.
Structure
There is limited information regarding Nintedanib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Nintedanib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Nintedanib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Nintedanib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nintedanib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Nintedanib How Supplied in the drug label.
Storage
There is limited information regarding Nintedanib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Nintedanib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Nintedanib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Nintedanib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Nintedanib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.