FUTIBATINIB
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: HAFIZA AMNA QADEER, MD
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
FUTIBATINIB is a Kinase Inhibitor that is FDA approved for the treatment of of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.. Common adverse reactions include Nail Toxicity, stomatitis, dry skin, dry eye, alopecia, Musculoskeletal pain, arthralgia, Palmar-plantar eryhtrodysesthesia syndrome, Constipation, diarrhea, fatigue, abdominal pain, nausea, vomiting, decreased appetite, urinary tract infection and lab findings include increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding FUTIBATINIB FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FUTIBATINIB FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is limited information regarding FUTIBATINIB Contraindications in the drug label.
Warnings
There is limited information regarding FUTIBATINIB Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding FUTIBATINIB Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding FUTIBATINIB Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding FUTIBATINIB Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of FUTIBATINIB in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of FUTIBATINIB in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of FUTIBATINIB during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of FUTIBATINIB in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of FUTIBATINIB in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of FUTIBATINIB in geriatric settings.
Gender
There is no FDA guidance on the use of FUTIBATINIB with respect to specific gender populations.
Race
There is no FDA guidance on the use of FUTIBATINIB with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of FUTIBATINIB in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of FUTIBATINIB in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of FUTIBATINIB in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of FUTIBATINIB in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding FUTIBATINIB Administration in the drug label.
Monitoring
There is limited information regarding FUTIBATINIB Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of FUTIBATINIB and IV administrations.
Overdosage
There is limited information regarding FUTIBATINIB 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 FUTIBATINIB Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding FUTIBATINIB Mechanism of Action in the drug label.
Structure
There is limited information regarding FUTIBATINIB Structure in the drug label.
Pharmacodynamics
There is limited information regarding FUTIBATINIB Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding FUTIBATINIB Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding FUTIBATINIB Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding FUTIBATINIB Clinical Studies in the drug label.
How Supplied
There is limited information regarding FUTIBATINIB How Supplied in the drug label.
Storage
There is limited information regarding FUTIBATINIB 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 FUTIBATINIB Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-FUTIBATINIB interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding FUTIBATINIB Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding FUTIBATINIB 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.