Infigratinib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Infigratinib is a kinase inhibitor that is FDA approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- Confirm t*Confirm the presence of an FGFR2 fusion or rearrangement prior to initiation of treatment with TRUSELTIQ.
- Recommended dosage: 125 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
- Take on an empty stomach at least 1 hour before or 2 hours after food, at approximately the same time each day.
- Swallow capsules whole with a glass of water. Do not crush, chew or dissolve.
- Mild and Moderate Renal Impairment: The recommended dosage is 100 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
- Mild Hepatic Impairment: The recommended dosage is 100 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
- Moderate Hepatic Impairment: The recommended dosage is 75 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles. he presence of an FGFR2 fusion or rearrangement prior to initiation of treatment with TRUSELTIQ.
- Recommended dosage: 125 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
- Take on an empty stomach at least 1 hour before or 2 hours after food, at approximately the same time each day.
- Swallow capsules whole with a glass of water. Do not crush, chew or dissolve.
- Mild and Moderate Renal Impairment: The recommended dosage is 100 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
- Mild Hepatic Impairment: The recommended dosage is 100 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
- Moderate Hepatic Impairment: The recommended dosage is 75 mg orally once daily for 21 consecutive days followed by 7 days off therapy, in 28-day cycles.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Infigratinib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Infigratinib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Infigratinib 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 Infigratinib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Infigratinib in pediatric patients.
Contraindications
There is limited information regarding Infigratinib Contraindications in the drug label.
Warnings
There is limited information regarding Infigratinib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Infigratinib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Infigratinib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Infigratinib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Infigratinib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Infigratinib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Infigratinib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Infigratinib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Infigratinib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Infigratinib in geriatric settings.
Gender
There is no FDA guidance on the use of Infigratinib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Infigratinib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Infigratinib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Infigratinib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Infigratinib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Infigratinib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Infigratinib Administration in the drug label.
Monitoring
There is limited information regarding Infigratinib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Infigratinib and IV administrations.
Overdosage
There is limited information regarding Infigratinib 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 Infigratinib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Infigratinib Mechanism of Action in the drug label.
Structure
There is limited information regarding Infigratinib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Infigratinib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Infigratinib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Infigratinib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Infigratinib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Infigratinib How Supplied in the drug label.
Storage
There is limited information regarding Infigratinib 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 Infigratinib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Infigratinib 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 Infigratinib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Infigratinib 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.