Pemazyre

Patient Information Leaflet

Pemazyre 4.5 mg tablets, 9 mg tablets, 13.5 mg tablets

pemigatinib
This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Pemazyre is and what it is used for
2. What you need to know before taking 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 anticancer medicines called tyrosine kinase inhibitors. It blocks the action of proteins in the cell called fibroblast growth factor receptors types 1, 2 and 3 (FGFR1, FGFR2 and FGFR3), which help regulate cell growth. Cancer cells may have an abnormal form of this protein. By blocking FGFR, pemigatinib can prevent the growth of such tumour cells.
Pemazyre is used:

• for the treatment of adults with bile duct cancer (also known as cholangiocarcinoma) whose tumour cells have an abnormal form of the FGFR2 protein
• when the tumour has spread to other parts of the body or cannot be removed by surgery
• when treatment with other medicines is no longer effective.

2. What you should know before taking Pemazyre

Do not take Pemazyre

• if you are allergic to pemigatinib or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking St. John’s wort, a herbal remedy used to treat depression

Warnings and precautions
Talk to your doctor or pharmacist before taking Pemazyre if:

• you have been told that you have increased or decreased levels of a mineral in your blood called phosphate
• you have eye problems or vision disorders
• you have severely impaired liver function. Your treatment may require dose adjustment
• you have severely impaired kidney function. Your treatment may require dose adjustment
• there are tumour cells that have spread to the brain or spinal cord

Ophthalmological examinations are recommended:

• before starting treatment with Pemazyre
• every 2 months during the first 6 months of treatment
• thereafter every 3 months, or immediately if any visual symptoms occur, including flashes of light, blurred vision, or dark spots.

Inform your doctor immediately if you experience any visual symptoms.
You should also use lubricating or hydrating eye drops or gels to help prevent or treat dry eyes.
Pemazyre may harm an unborn baby. An effective method of contraception must be used during treatment and for at least 1 week after the last dose of Pemazyre in women of childbearing potential and in men with female partners of childbearing potential.

Children and adolescents
Pemazyre must not be given to children or adolescents under 18 years of age. Its efficacy and safety have not been established in this age group.

Other medicines and Pemazyre
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, if you are taking any of the following medicines, inform your doctor so that they can decide whether your treatment needs to be adjusted:

• St. John’s wort: a herbal remedy used to treat depression. You must not take St. John’s wort during treatment with Pemazyre
• medicines whose active ingredient has a name ending in “-prazole”: used to reduce gastric acid secretion. Avoid using these medicines during treatment with Pemazyre
• itraconazole: a medicine used to treat fungal infections
• rifampicin: a medicine used to treat tuberculosis or certain other infections
• carbamazepine, phenytoin, phenobarbital, primidone: medicines used to treat epilepsy
• efavirenz: a medicine used to treat HIV infection
• cyclophosphamide, ifosfamide: other anticancer medicines
• methadone: a medicine used to treat severe pain or for management of addiction
• digoxin: a medicine used to treat heart conditions
• dabigatran: a medicine used to prevent blood clots
• colchicine: a medicine used to treat gout attacks

Pemazyre with food and drink
Avoid consuming grapefruit or drinking grapefruit juice during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Pregnancy Pemazyre may harm an unborn baby and must not be used during pregnancy, unless otherwise directed by your doctor. A pregnancy test must be performed before starting treatment.
• Contraceptive advice for men and women Women undergoing treatment with Pemazyre must not become pregnant. Therefore, women of childbearing potential must use an effective method of contraception during treatment and for at least 1 week after the last dose of Pemazyre. Discuss with your doctor which contraceptive method is most suitable for you. Men must avoid fathering a child: they must use an effective method of contraception during treatment and for at least 1 week after the last dose of Pemazyre.
• Breastfeeding Do not breastfeed during treatment with Pemazyre and for at least 1 week after the last dose.

Driving and using machines
Pemazyre may cause side effects such as fatigue or visual disturbances. If this occurs, do not drive or operate machinery.

3. How to take Pemazyre

Treatment with Pemazyre should be initiated by a physician experienced in the diagnosis and treatment of bile duct cancer. Always take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
1 tablet of Pemazyre 13.5 mg taken once daily for 14 days, followed by 7 days without taking Pemazyre.
Treatment continues in the same cycle of 14 days of Pemazyre once daily, followed by 7 days of treatment interruption. Do not take Pemazyre during the 7-day treatment break. Your doctor will adjust the dose or interrupt treatment, if necessary.
Method of administration
Swallow the tablet whole with a glass of water, at the same time each day. Pemazyre may be taken with food or on an empty stomach.
Do not crush, chew, divide, or dissolve the tablets.
Duration of use
Take Pemazyre for as long as prescribed by your doctor.
If you take more Pemazyre than you should
Inform your doctor if you have taken more Pemazyre than you should.
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 an additional tablet to make up for the missed dose. Take the next dose of Pemazyre at the scheduled time.
If you stop taking Pemazyre
Do not stop taking Pemazyre without first discussing it with your doctor, as this may reduce the effectiveness of the treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the serious side effects listed below.
These side effects may occur with the following frequencies:
very common (may affect more than 1 in 10 people)

• low levels of sodium in the blood; symptoms include reduced ability to think, headache, nausea, poor balance, confusion, seizures, coma
• blood tests showing increased creatinine, which may suggest kidney problems; usually an increase in creatinine does not cause symptoms, but symptoms of kidney problems may include nausea and changes in urination

Other side effects may occur with the following frequencies:
very common (may affect more than 1 in 10 people)

• high or low phosphate levels detected in blood tests
• taste disturbance
• dry eye
• nausea
• inflammation of the mucous lining inside the mouth
• diarrhoea
• constipation
• dry mouth
• hand-foot syndrome, characterised by skin reactions with redness, swelling and pain on the palms of the hands and soles of the feet
• nail toxicity, including nails separating from the nail bed, nail pain, nail bleeding, nail breakage, changes in nail colour or structure, infection of the skin around the nails
• hair loss
• dry skin
• joint pain
• fatigue

common (may affect up to 1 in 10 people)

• fluid accumulation under the retina (the light-sensitive layer at the back of the eye)
• inflammation of the cornea (the transparent outer layer of the eye)
• reduced vision
• eyelash changes, including abnormal length and inward growth
• abnormal growth of hair or body hair

uncommon (may affect up to 1 in 100 people)

• formation of calcium salt deposits appearing as papules, nodules or plaque-like hard lumps within the skin or under the skin of any part of the body, which may cause pain and ulcers

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system detailed in Annex V. 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 stated on the carton and blister after
Exp/EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pemazyre contains

• The active substance is pemigatinib. Each 4.5 mg tablet contains 4.5 mg of pemigatinib. Each 9 mg tablet contains 9 mg of pemigatinib. Each 13.5 mg tablet contains 13.5 mg of pemigatinib.
• The other components are microcrystalline cellulose, sodium glycolate starch (type A), magnesium stearate.

Description of the appearance of Pemazyre and package contents
Pemazyre 4.5 mg tablets are round, white to off-white, with "I" imprinted on one side and "4.5" on the other side.
Pemazyre 9 mg tablets are oval, white to off-white, with "I" imprinted on one side and "9" on the other side.
Pemazyre 13.5 mg tablets are round, white to off-white, with "I" imprinted on one side and "13.5" on the other side.
The tablets are supplied in blisters containing 14 tablets. The pack contains 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Manufacturer
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Tjoapack Netherlands B.V.
Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

This medicinal product has been granted a marketing authorization under "conditional approval". This means that additional data on this medicinal product are required.
The European Medicines Agency will review new information on this medicinal product at least annually, and this package leaflet will be updated if necessary.

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.