Medically reviewed by Drugs.com. Last updated on Aug 13, 2020.
Applies to the following strengths: 4.5 mg; 9 mg; 13.5 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Cholangiocarcinoma of biliary tract
13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles until disease progression or unacceptable toxicity
Use: 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.
Renal Dose Adjustments
Mild or moderate renal impairment (CrCl greater than 30 to less than 90 mL/min: No adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min): Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended
Liver Dose Adjustments
Mild (total bilirubin greater than the upper limit of normal (ULN) to 1.5 x ULN or AST greater than ULN) or moderate hepatic impairment (total bilirubin
Greater than 1.5 to 3 × ULN with any AST): No adjustment recommended.
Severe hepatic impairment (total bilirubin greater than 3 x ULN with any AST): Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution recommended.
RECOMMENDED DOSE MODIFICATION SCHEDULE:
-First dose reduction: 9 mg once daily for first 14 days of each 21-day cycle
-Second dose reduction: 3.5 mg once daily for first 14 days of each 21-day cycle
-Permanently discontinue this drug if unable to tolerate 4.5 mg once daily.
DOSE MODIFICATION FOR ADVERSE REACTIONS:
RETINAL PIGMENT EPITHELIAL DETACHMENT (RPED): If asymptomatic and stable on serial examination, continue this drug; if symptomatic or worsening on serial examination, withhold this drug; if asymptomatic and improved on subsequent examination, resume this drug at a lower dose; if symptoms persist or examination does not improve, consider permanent discontinuation of therapy.
-Serum phosphate greater than 7 mg/dL to 10 mg/dL or less: Initiate phosphate lowering therapy and monitor serum phosphate weekly; withhold this drug if levels are not less than 7 mg/dL within 2 weeks of starting phosphate lowering therapy; resume this drug at the same dose when phosphate levels are less than 7 mg/dL for first occurrence; resume at a lower dose level for subsequent recurrences.
-Serum phosphate greater than 10 mg/dL: Initiate phosphate lowering therapy and monitor serum phosphate weekly; withhold therapy if levels are not 10 mg/dL or less within 1 week after starting phosphate lowering therapy; resume therapy at the next lower dose level when phosphate levels are less than 7 mg/dL.
OTHER ADVERSE REACTIONS:
-GRADE 3: Withhold therapy until resolves to Grade 1 or baseline; resume therapy at next lower dose if resolves within 2 weeks; permanently discontinue therapy if does not resolve within 2 weeks; permanently discontinue therapy for recurrent Grade 3 after 2 dose reductions.
-GRADE 4: Permanently discontinue therapy.
DOSE MODIFICATION FOR CONCOMITANT USE WITH STRONG OR MODERATE CYP450 3A INHIBITORS:
Avoid concomitant use of strong and moderate CYP450 3A inhibitors with this drug. If concomitant use with a strong or moderate CYP450 3A inhibitor cannot be avoided:
-Reduce the pemigatinib dose from 13.5 mg to 9 mg.
-Reduce pemigatinib dose from 9 mg to 4.5 mg.
-If concomitant use of a strong or moderate CYP450 3A inhibitor is discontinued, increase the pemigatinib dose (after 3 plasma half-lives of the CYP450 3A inhibitor) to the dose that was used before starting the strong inhibitor.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Take this drug with or without food at approximately the same time every day.
-Swallow tablets whole; do not crush, chew, split, or dissolve tablets.
-If the patient misses a dose by 4 or more hours or if vomiting occurs, resume dosing with the next scheduled dose.
-Store this drug at room temperature 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59°F to 86F).
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