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Pemazyre Dosage

Generic name: PEMIGATINIB 4.5mg
Dosage form: tablet

Medically reviewed by Drugs.com. Last updated on April 17, 2020.

Patient Selection

Select patients for the treatment of locally advanced or metastatic cholangiocarcinoma with PEMAZYRE based on the presence of an FGFR2 fusion or rearrangement as detected by an FDA-approved test [see Clinical Studies (14.1)].

Information on FDA-approved test(s) for the detection of an FGFR2 fusion or rearrangement in cholangiocarcinoma is available at http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage

The recommended dosage of PEMAZYRE is 13.5 mg orally once daily for 14 consecutive days followed by 7 days off therapy, in 21-day cycles. Continue treatment until disease progression or unacceptable toxicity occurs.

Take PEMAZYRE with or without food at approximately the same time every day [see Clinical Pharmacology (12.3)].

Swallow tablets whole. Do not crush, chew, split, or dissolve tablets.

If the patient misses a dose of PEMAZYRE by 4 or more hours or if vomiting occurs, resume dosing with the next scheduled dose.

Dosage Modification for Adverse Reactions

The recommended dose reductions for adverse reactions are provided in Table 1.

Table 1: Recommended Dose Reductions for PEMAZYRE for Adverse Reactions
*
Permanently discontinue PEMAZYRE if unable to tolerate 4.5 mg once daily.
Dose Reduction Recommended Dosage
First 9 mg once daily for first 14 days of each 21-day cycle
Second* 4.5 mg once daily for first 14 days of each 21-day cycle

The recommended dosage modifications for adverse reactions are provided in Table 2.

Table 2: Recommended Dosage Modifications for PEMAZYRE Adverse Reactions
*
Severity as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Adverse Reaction Severity* PEMAZYRE Dosage Modification
Retinal Pigment Epithelial Detachment (RPED) [see Warnings and Precautions (5.1)] RPED
  • If asymptomatic and stable on serial examination, continue PEMAZYRE.
  • If symptomatic or worsening on serial examination, withhold PEMAZYRE.
    • If asymptomatic and improved on subsequent examination, resume PEMAZYRE at a lower dose
    • If symptoms persist or examination does not improve, consider permanent discontinuation of PEMAZYRE, based on clinical status.
Hyperphosphatemia
[see Warnings and Precautions (5.2)]
Serum phosphate
> 7 mg/dL- ≤10 mg/dL
  • Initiate phosphate lowering therapy and monitor serum phosphate weekly.
  • Withhold PEMAZYRE if levels are not < 7 mg/dL within 2 weeks of starting phosphate lowering therapy.
  • Resume PEMAZYRE at the same dose when phosphate levels are < 7 mg/dL for first occurrence; resume at a lower dose level for subsequent recurrences.
Serum phosphate >10 mg/dL
  • Initiate phosphate lowering therapy and monitor serum phosphate weekly.
  • Withhold PEMAZYRE if levels are not ≤ 10 mg/dL within 1 week after starting phosphate lowering therapy.
  • Resume PEMAZYRE at the next lower dose level when phosphate levels are < 7 mg/dL.
  • Permanently discontinue PEMAZYRE for recurrence of serum phosphate > 10mg/dL following 2 dose reductions.
Other Adverse Reactions Grade 3
  • Withhold PEMAZYRE until resolves to Grade 1 or baseline.
  • Resume PEMAZYRE at next lower dose if resolves within 2 weeks.
  • Permanently discontinue PEMAZYRE if does not resolve within 2 weeks.
  • Permanently discontinue PEMAZYRE for recurrent Grade 3 after 2 dose reductions.
Grade 4
  • Permanently discontinue PEMAZYRE.

Dosage Modification for Concomitant Use with Strong or Moderate CYP3A Inhibitors

Avoid concomitant use of strong and moderate CYP3A inhibitors with PEMAZYRE. If concomitant use with a strong or moderate CYP3A inhibitor cannot be avoided:

  • Reduce PEMAZYRE dose from 13.5 mg to 9 mg.
  • Reduce PEMAZYRE dose from 9 mg to 4.5 mg.

If concomitant use of a strong or moderate CYP3A inhibitor is discontinued, increase the PEMAZYRE dose (after 3 plasma half-lives of the CYP3A inhibitor) to the dose that was used before starting the strong inhibitor [see Clinical Pharmacology (12.3)].

Further information

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