Multikinase inhibitors
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Pemazyre Dosage

Drug Detail:Pemazyre (Pemigatinib [ pem-i-ga-ti-nib ])

Generic Name: PEMIGATINIB 4.5mg

Dosage Form: tablet

Drug Class: Multikinase inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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.

Select patients for the treatment of relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement with PEMAZYRE based on the presence of an FGFR1 rearrangement [see Clinical Studies (14.2)]. An FDA-approved test for detection of FGFR1 rearrangement in patients with relapsed or refractory myeloid/lymphoid neoplasm for selecting patients for treatment with PEMAZYRE is not available.

Recommended Dosage

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.

Cholangiocarcinoma

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.

​Myeloid/Lymphoid Neoplasms with FGFR1 Rearrangement

The recommended dosage of PEMAZYRE is 13.5 mg orally once daily on a continuous basis. Continue treatment until disease progression or unacceptable toxicity occurs.

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 for 14 days of each 21-day cycle.
Dose Reduction Recommended Dosage
Cholangiocarcinoma with FGFR2 Fusion or Rearrangement
 MLNs with FGFR1 Rearrangement
First 9 mg once daily for first 14 days of each 21-day cycle 9 mg once daily
Second 4.5 mg once daily for first 14 days of each 21-day cycle 4.5 mg once daily
Third Discontinue 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 to ≤ 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 > 10 mg/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 dosage from 13.5 mg to 9 mg.
  • Reduce PEMAZYRE dosage from 9 mg to 4.5 mg.

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

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 m2 to 29 mL/min/1.73 m2) is 9 mg with the schedule (intermittent or continuous) designated for the indication [see Dosage and Administration (2.2), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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 (2.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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