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Pemigatinib Dosage

Medically reviewed by Drugs.com. Last updated on Aug 3, 2022.

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

Comments:

  • FGFR 2 fusion positivity status must be known prior to initiation of therapy.
  • Assessment for FGFR 2 fusion positivity in tumor specimen should be performed with an appropriate diagnostic test.
  • Treatment should be continued 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 as detected by an FDA-approved test

Renal Dose Adjustments

Mild or moderate renal dysfunction (CrCl greater than 30 to less than 90 mL/min: No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles

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 dysfunction (total bilirubin Greater than 1.5 to 3 × ULN with any AST): No adjustment recommended.
Severe hepatic dysfunction (total bilirubin greater than 3 x ULN with any AST): 9 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles

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: 4.5 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

Hemodialysis: No adjustment recommended.

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).

Monitoring:
  • Serum phosphate: Monitor weekly

Patient advice:
  • Females should be advised not to breastfeed during therapy and for 1 week after.
  • Advise females of reproductive potential to use effective contraception during therapy and for 1 week after.
  • Advise males with female partners of reproductive potential to use effective contraception during therapy and for 1 week.
  • Advise patients to avoid eating grapefruit or drinking grapefruit juice while taking this drug.
  • Advise patients to use ocular demulcents, in order to prevent or treat dry eye.
  • Advise patients that this drug may cause nail disorders.
  • Advise patients that this drug may cause ocular toxicities.
  • Advise patients to immediately report to the healthcare provider any symptoms of muscle cramps, numbness, or tingling around the mouth.

Further information

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