Pemazyre TM
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional. Always read the label. If symptoms persist see your healthcare professional.
Active ingredients: pemigatinib
Brand name
(ARTG)
: PEMAZYRE pemigatinib 4.5 mg tablet blister packDownload the Consumer Medicine Information Leaflet
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
What this medicine is used for
(ARTG)
Pemigatinib has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that has progressed after at least one prior line of systemic therapy. The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).
How to use this medicine
(ARTG)
This medicine contains one component only.
Component :
- Tablet
- Oral
- Round shaped (5.8 mm diameter) white to off-white tablet, debossed with I on one side and with 4.5 on the other side.
Storage conditions
(ARTG)
- Store below 25 degrees Celsius
- Shelf lifetime is 48 Months.
Do I need a prescription ?
(ARTG)
These medicine packs are available from a pharmacist and requires a prescription. It is
- 14 pack
- 28 pack
Pregnant or planning a pregnancy ?
(AHT)
For the active ingredient pemigatinib
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Reporting side effects
This medicine is under additional monitoring as it is new or being used in a different way. You can help identify new safety information by reporting any side effects you may get.
- You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
- For more information on the Black Triangle Scheme and how to report side effects, see www.tga.gov.au/black-triangle-scheme
