INCYTE

PrPEMAZYRE® has been issued conditional marketing authorization pending the results of studies to verify its clinical benefit. Patients should be advised of this conditional marketing authorization.

The latest PEMAZYRE® tools all in one place

PEMAZYRE® (pemigatinib) is indicated 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.1

The resources below are designed to help you and your patients by providing key information about PEMAZYRE®.
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For Your Patients

PEMAZYRE® Patient Brochure

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PEMAZYRE® Patient Treatment Guide

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Safety information1

Clinical use:

Clinical effectiveness of PEMAZYRE® is based on overall response rate (ORR) and duration of response (DoR) from a single-arm Phase 2 trial in patients with specific FGFR2 rearrangements.

Treatment with PEMAZYRE® should be initiated following confirmation of a FGFR2 fusion or rearrangement using a validated test.

Pediatrics (18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

Contraindications:

  • PEMAZYRE® is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Relevant warnings and precautions:

  • If patients experience symptoms affecting their vision, it is recommended that they do not drive or use machines until the effect subsides.
  • Soft tissue mineralization, including cutaneous calcification, calcinosis, and non-uremic calciphylaxis may be associated with hyperphosphatemia and has been observed with PEMAZYRE® treatment.
  • Hypophosphatemia has been observed with PEMAZYRE®.
  • Phosphate concentrations should be assessed 14 days after initiating PEMAZYRE® treatment and then monitored every 6 weeks thereafter.
  • Opthalmological exams including the visual acuity test, slit-lamp exam, fundoscopy, and optical coherence tomograph should be performed prior to initating treatment with PEMAZYRE® and throughout treatment.
  • Pemigatinib may increase serum creatinine due to a blockade of tubular secretion via renal transporters OCT2 and MATE1.
  • PEMAZYRE® can cause serous retinal detachment events, which may present with symptoms such as blurred vision, visual floaters, or photopsia.
  • PEMAZYRE® may cause fetal harm and potential loss of pregnancy. Advise females of reproductive potential to use effective contraception during treatment with PEMAZYRE® and for 1 month after the last dose.
  • Advise male patients with female partners of the reproductive potential to use effective contraception during treatment with PEMAZYRE® and for 1 month after the last dose.
  • Advise women not to breastfeed during treatment with PEMAZYRE® and for 1 month after the final dose.

For more information:

Please consult the Product Monograph here for important information relating to monitoring and laboratory tests, adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-833-309-2759 or contacting medinfocanada@incyte.com.

Reference: 1. PEMAZYRE® Product Monograph. Incyte Corporation. September 8, 2021.