Active ingredient
- pemigatinib
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 42338/0008.
Pemazyre 4.5 mg, 9mg and 13.5mg - tablets
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.
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:
2. What you need to know before you take Pemazyre
Do not take Pemazyre if you are
Warnings and precautions
Talk to your doctor or pharmacist before taking Pemazyre if you have:
Eye examinations are recommended:
Tell your doctor straight away if you get any symptoms with your vision.
You should also use lubricating or hydrating eye drops or gels to help prevent or treat dry eyes.
Pemazyre may harm the unborn baby. An effective contraception must be used during treatment and for at least 1 week after the last dose of Pemazyre in women of childbearing age and in men with women partners of childbearing age.
Children and adolescents
Pemazyre should not be given to children or adolescents under 18 years. It is not known whether it is safe and effective in this age group.
Other medicines and Pemazyre
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, you should tell your doctor if you are taking any of the following medicines so that the doctor can decide if your treatment needs to change:
Avoid eating grapefruit or drinking grapefruit juice while using this medication.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Pemazyre can cause side effects such as fatigue or visual disturbances. Do not drive or operate machinery if this happens.
3. How to take Pemazyre
Pemazyre treatment should be started by a doctor who is experienced in the diagnosis and treatment of bile duct cancer. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
1 tablet of Pemazyre 13.5 mg taken once daily for 14 days, followed by 7 days without taking Pemazyre.
Treatment is continued with the same pattern of 14 days of Pemazyre once daily, followed by 7 days off therapy. Do not take Pemazyre during the 7 days off therapy. Your doctor will adjust the dose or stop treatment if needed.
Method of use
Swallow the tablet whole with one glass of water at the same time every day. Pemazyre may be taken with food or between meals.
Do not crush, chew, split or dissolve the tablets.
Duration of use
Take Pemazyre for as long as it is prescribed by the doctor.
If you take more Pemazyre than you should
Tell your doctor if you have taken more Pemazyre than you should have.
If you forget to take Pemazyre
If you miss a dose of Pemazyre by 4 hours or more, or if you vomit after taking Pemazyre, do not take another Pemazyre tablet to make up for the missed dose. Take your next dose of Pemazyre at the scheduled time.
If you stop taking Pemazyre
Do not stop taking Pemazyre without discussing it with your doctor, as this could reduce the success of therapy.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you have any of the serious side effects below. These side effects may occur with the following frequency:
Very common (may affect more than 1 in 10 people):
Other side effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
United Kingdom (Great Britain)
or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Pemazyre
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Pemazyre contains
What Pemazyre looks like and contents of the pack
Pemazyre 4.5 mg tablets are round, white to off-white, debossed on one side with “I” and “4.5” on the reverse.
Pemazyre 9 mg tablets are oval, white to off-white, debossed on one side with “I” and “9” on the reverse.
Pemazyre 13.5 mg tablets are round, white to off-white, debossed on one side with “I” and “13.5” on the reverse.
The tablets are provided in blisters containing 14 tablets. The carton contains 14 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 04/2021.
This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.
The Medicines and Healthcare products Regulatory Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare products Regulatory Agency http://www.mhra.gov.uk
First Floor Q1, The Square, Randalls Way, Leatherhead, Surrey, KT22 7TW, UK
+44 800 7833711
00800 000 274 23