Pemazyre

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pemigatinib

Available from:

Incyte Biosciences Distribution B.V.

ATC code:

L01EN02

INN (International Name):

pemigatinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Cholangiocarcinoma

Therapeutic indications:

Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Product summary:

Revision: 6

Authorization status:

Authorised

Authorization date:

2021-03-26

Patient Information leaflet

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEMAZYRE 4.5 MG TABLETS
PEMAZYRE 9 MG TABLETS
PEMAZYRE 13.5 MG TABLETS
pemigatinib
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pemazyre is and what it is used for
2.
What you need to know before you take Pemazyre
3.
How to take Pemazyre
4.
Possible side effects
5.
How to store Pemazyre
6.
Contents of the pack and other information
1.
WHAT PEMAZYRE IS AND WHAT IT IS USED FOR
Pemazyre contains the active substance pemigatinib, which belongs to a
group of cancer medicines
called tyrosine kinase inhibitors. It blocks the action of proteins in
the cell called fibroblast growth
factor receptor types 1, 2 and 3 (FGFR1, FGFR2, and FGFR3) that help
regulate cell growth. Cancer
cells may have an abnormal form of this protein. By blocking FGFR,
pemigatinib can prevent the
growth of such cancer cells.
Pemazyre is used:
•
to treat adults with bile duct cancer (also known as
cholangiocarcinoma) whose cancer cells
have an abnormal form of the FGFR2 protein, and
•
when the cancer has spread to other parts of the body or cannot be
removed by surgery, and
•
when treatment with other medicines is no longer working.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEMAZYRE
_ _
DO NOT TAKE PEMAZYRE IF YOU ARE
•

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Pemazyre 4.5 mg tablets
Pemazyre 9 mg tablets
Pemazyre 13.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pemazyre 4.5 mg tablets
Each tablet contains 4.5 mg of pemigatinib.
Pemazyre 9 mg tablets
Each tablet contains 9 mg of pemigatinib.
Pemazyre 13.5 mg tablets
Each tablet contains 13.5 mg of pemigatinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pemazyre 4.5 mg tablets
Round (5.8 mm), white to off-white tablet debossed on one side with
"I" and "4.5" on the reverse.
Pemazyre 9 mg tablets
Oval (10 × 5 mm), white to off-white tablet debossed on one side with
"I" and "9" on the reverse.
Pemazyre 13.5 mg tablets
Round (8.5 mm), white to off-white tablet debossed on one side with
"I" and "13.5" on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pemazyre monotherapy is indicated for the treatment of adults with
locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2)
fusion or rearrangement that
have progressed after at least one prior line of systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
diagnosis and treatment of patients with
biliary tract cancer.
FGFR 2 fusion positivity status must be known prior to initiation of
Pemazyre therapy. Assessment for
FGFR 2 fusion positivity in tumor specimen should be performed with an
appropriate diagnostic test.
3
Posology
The recommended dose is 13.5 mg pemigatinib taken once daily for 14
days followed by 7 days off
therapy.
If a dose of pemigatinib is missed by 4 or more hours or vomiting
occurs after taking a dose, an
additional dose should not be administered and dos