Futibatinib
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From MedlinePlus, U.S. National Library of Medicine
Kinase Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Hepatic Impairment There are limited data in patients treated with LYTGOBI with total bilirubin >1.5🞨 ULN, and patients with cholangiocarcinoma with total bilirubin >3🞨 ULN were excluded from enrollment in clinical trials. Patients with cirrhosis and total bilirubin >1.5🞨 ULN to 3🞨 ULN may have the potential for increased adverse reactions compared to patients with normal hepatic function due to higher unbound futibatinib exposure [see Clinical Pharmacology ] .
Drug interactions
Check futibatinib against a medication listLabel text (2 paragraphs)
Strong CYP3A inhibitors : Avoid concomitant use. ( 7.1 ) Strong CYP3A inducers : Avoid concomitant use. ( 7.1 )
7.1 Effect of Other Drugs on LYTGOBI Strong CYP3A Inhibitors Avoid concomitant use of strong CYP3A inhibitors with LYTGOBI. Futibatinib is a CYP3A substrate [see Clinical Pharmacology (12.3) ] . Concomitant use of a strong CYP3A inhibitor increases futibatinib exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions. Strong CYP3A Inducers Avoid concomitant use of strong CYP3A inducers with LYTGOBI. Futibatinib is a CYP3A substrate [see Clinical Pharmacology (12.3) ] . Concomitant use of a strong CYP3A inducer decreases futibatinib exposure [see Clinical Pharmacology (12.3) ] , which may reduce the effectiveness of LYTGOBI.
Contraindications
None. None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm or loss of pregnancy when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of LYTGOBI in pregnant women. Oral administration of futibatinib to pregnant rats during the period of organogenesis at maternal plasma exposures below the human exposure at the clinical dose of 20 mg resulted in fetal malformations, fetal growth retardation, and embryo-fetal death ( see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Once daily oral administration of futibatinib to pregnant rats during the period of organogenesis resulted in 100% embryofetal mortality due to post-implantation loss at doses ≥10 mg/kg (approximately 5 times the recommended clinical dose of 20 mg based on body surface area, BSA).
Fetal survival was unaffected at 0.5 mg/kg per day; however, once daily oral administration of futibatinib at the 0.5 mg/kg dose level (approximately 0.2 times the recommended clinical dose of 20 mg based on BSA) resulted in reduced mean fetal body weight and an increase in fetal skeletal and visceral malformations, major blood vessel variations, and reduced ossification.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.