Pemigatinib
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From MedlinePlus, U.S. National Library of Medicine
Kinase Inhibitor
Dosing in kidney impairment
Recommended Dosage for Severe Renal Impairment The recommended dosage of PEMAZYRE for patients with severe renal impairment (eGFR estimated by Modification of Diet in Renal Disease [MDRD] 15 mL/min/1.73 m 2 to 29 mL/min/1.73 m 2 ) is 9 mg with the schedule (intermittent or continuous) designated for the indication [see Dosage and Administration, Use in Specific Populations and Clinical Pharmacology] .
Dosing in liver impairment
Recommended Dosage for Severe Hepatic Impairment The recommended dosage of PEMAZYRE for patients with severe hepatic impairment (total bilirubin > 3 × ULN with any AST) is 9 mg with the schedule (intermittent or continuous) designated for the indication [see Dosage and Administration, Use in Specific Populations and Clinical Pharmacology] .
Drug interactions
Check pemigatinib against a medication listLabel text (3 paragraphs)
Strong and Moderate CYP3A Inducers: Avoid concomitant use of PEMAZYRE. ( 7.1 ) Strong and Moderate CYP3A Inhibitors: Avoid concomitant use. If concomitant use cannot be avoided, reduce PEMAZYRE dosage. ( 2.4 , 7.1 )
7.1 Effect of Other Drugs on PEMAZYRE Strong and Moderate CYP3A Inducers Concomitant use of PEMAZYRE with a strong or moderate CYP3A inducer decreases pemigatinib plasma concentrations [ see Clinical Pharmacology ( 12.3 )], which may reduce the efficacy of PEMAZYRE. Avoid concomitant use of strong and moderate CYP3A inducers with PEMAZYRE. Strong and Moderate CYP3A Inhibitors Concomitant use of a strong or moderate CYP3A inhibitor with PEMAZYRE increases pemigatinib plasma concentrations [see Clinical Pharmacology ( 12.3 )], which may increase the incidence and severity of adverse reactions. Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE.
Reduce PEMAZYRE dosage if concomitant use of strong and moderate CYP3A inhibitors cannot be avoided [see Dosage and Administration ( 2.4 )] .
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unproven but possible rare cause of clinically apparent liver injury.
Pemigatinib is a fibroblast growth factor (FGF) receptor kinase inhibitor that is used to treat unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma, as well as myeloid or lymphoid neoplasms with FGFR rearrangements. Pemigatinib is associated with transient and usually mild-to-moderate elevations in serum aminotransferase levels during therapy, but has not been convincingly linked to cases of clinically apparent liver injury with jaundice.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings in an animal study and its mechanism of action, PEMAZYRE 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 PEMAZYRE in pregnant women. Oral administration of pemigatinib to pregnant rats during the period of organogenesis at maternal plasma exposures below the human exposure at the clinical dose of 13.5 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 pemigatinib to pregnant rats during the period of organogenesis resulted in 100% embryofetal mortality due to post-implantation loss at doses ≥ 0.3 mg/kg (approximately 0.6 times the human exposure based on AUC at the clinical dose of 13.5 mg).
Fetal survival was unaffected at 0.1 mg/kg per day; however, once daily oral administration of pemigatinib at the 0.1 mg/kg dose level (approximately 0.2 times the human exposure based on AUC at the clinical dose of 13.5 mg) resulted in reduced mean fetal body weight and an increase in fetal skeletal and visceral malformations, major blood vessel variations, and reduced ossification.
Breastfeeding (LactMed)
No information is available on the clinical use of pemigatinib during breastfeeding. The manufacturer recommends that breastfeeding be discontinued during pemigatinib therapy and for 1 week after the last dose.
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.