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)
The recommended dosage of futibatinib is 20 mg (five 4 mg tablets) taken orally once daily until disease progression or unacceptable toxicity occurs. If the patient misses a dose of futibatinib for more than 12 hours or if vomiting occurs, resume dosing with the next scheduled dose.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
The safety and effectiveness of futibatinib have not been established in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Contraindications
There is no specific contraindication related to futibatinib.
Warnings
OCULAR TOXICITY
RETINAL PIGMENT EPITHELIAL DETACHMENT(RPED)
Futibatinib can cause RPED, which may cause symptoms such as blurred vision. Perform a comprehensive ophthalmological examination, including optical coherence tomography(OCT) of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of futibatinib.
DRY EYES/CORNEAL KERATITIS
Treat patients of dry eyes/keratitis with ocular demulcents as needed.
HYPERPHOSPHATEMIA AND SOFT TISSUE MINERALIZATION
Futibatinib can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Monitor for hyperphosphatemia throughout treatment. Initiate a low phosphate diet and phosphate lowering therapy when serum phosphate level is ≥5.5 mg/dl. For serum phosphate levels >7 mg/dl, initiate or intensify phosphate lowering therapy and dose reduce, withhold, or permanently discontinue futibatinib based on duration and severity of hyperphosphatemia.
EMBRYO-FETAL TOXICITY
Advise pregnant women of the potential risk to the fetus including fetal malformations, fetal growth retardation, and embryo-fetal death . Advise female patients of reproductive potential to use effective contraception during treatment with futibatinib and for 1 week after the last dose of futibatinib. Advise males with female partners of reproductive potential to use effective contraception during treatment with futibatinib and for 1 week after the last dose.
Adverse Reactions
Clinical Trials Experience
- GASTROINTESTINAL:
constipation, diarrhea, dry mouth, stomatitis, abdominal pain, nausea and vomiting.
- SKIN AND SUBCUTANEOUS TISSUE DISORDERS:
nail toxicity, alopecia, dry skin, palmar-plantar erythrodysesthesia syndrome.
- METABOLISM AND NUTRITION DISORDERS:
Decreased appetite.
- MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS:
Musculoskeletal pain and arthralgia
- EYE DISORDERS:
Dry eyes and retinal pigment epithelial detachment.
- NERVOUS SYSTEM DISORDER:
Dysgeusia
- INFECTION:
Urinary tract infection.
- GENERAL DISORDERS:
fatigue, decreased weight.
- HEMATOLOGY:
decreased hemoglobin, decreased lymphocytes, decreased platelets, decreased leukocytes and decreased neutrophils.
- CHEMISTRY:
Increased phosphate, increased creatinine, increased calcium, increased glucose, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphate, increased aspartate aminotransferase, decreased albumin, increased creatine kinase, increased bilirubin, decreased glucose, decreased potassium and increased potassium.
Postmarketing Experience
There is limited information regarding FUTIBATINIB Postmarketing Experience in the drug label.
Drug Interactions
- Futibatinib is a substrate of CYP3A and P-gp.
- Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors with futiatinib. Concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors with futibatinib may increase futibatinib exposure.
- Avoid concomitant use of dual P-gp and strong CYP3A inducers with futibatinib.
Concomitant use of drugs that are dual P-gp and strong CYP3A inducers may decrease futibatinib exposure
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.