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Pemigatinib Dosage

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 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.

Dose Adjustments

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.
HYPERPHOSPHATEMIA:
-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.

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-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.

Storage requirements:
-Store this drug at room temperature 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59°F to 86F).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.