PEMAZYRE 4.5 MG Tablets

Зміст інструкції

1. Pemazyre 4.5 mg tablets, 9 mg tablets, 13.5 mg tablets
   1. What is Pemazyre and what is it 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. Package Contents and Other Information

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

pemigatinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. You can contribute by reporting any adverse effects encountered during the use of this medicine. See the end of section 4 for information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 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 is Pemazyre and what is it used for

Pemazyre contains the active substance pemigatinib, which belongs to a group of anticancer drugs
called tyrosine kinase inhibitors. It blocks the action of proteins called fibroblast growth factor receptors types 1, 2 and 3 (FGFR1, FGFR2 and FGFR3) in the cell, which help to regulate
cell growth. Cancer cells may have an abnormal form of this protein.
By blocking FGFR, pemigatinib is able to prevent the growth of these tumor cells.
Pemazyre is used:

• for the treatment of adults with bile duct cancer (also known as cholangiocarcinoma) whose tumor cells have an abnormal form of the FGFR2 protein
• when the tumor 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 need to know before you take Pemazyre

Do not take Pemazyre

• if you are allergic to pemigatinib or any of the other ingredients of this medicine (listed in section 6)
• if you are taking St John's Wort, a medicine to treat depression

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

• you have been told that you have an increase or a decrease in a mineral in your blood called phosphorus
• you suffer from vision or eye problems
• you have severely reduced liver function. Treatment may require an adjustment
• you have severely reduced kidney function. Treatment may require an adjustment
• there are cancer cells that have spread to the brain or spinal cord

Eye examinations are recommended:

• before starting treatment with Pemazyre
• every 2 months for the first 6 months of treatment
• thereafter every 3 months or immediately if any visual symptom occurs, including flashes of light, visual disturbances or dark spots.

Tell your doctor immediately if you experience any visual symptoms.
You should also use lubricating or moisturizing eye drops or gels to help prevent or treat
dry eyes.
Pemazyre can cause harm to the unborn child. Effective contraceptive methods 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 should 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
Tell 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 you must tell your doctor
so that they can decide whether the treatment needs to be changed:

• St John's Wort: a medicine used to treat depression . You must nottake St John's Wort during treatment with Pemazyre
• medicines with an active ingredient whose name ends in “ -prazole”: these are used to reduce the release of stomach acid. Avoid using these medicines during treatment with Pemazyre
• itraconazole: a medicine for the treatment of fungal infections
• rifampicin: a medicine for the treatment of tuberculosis or some other infections
• carbamazepine, phenytoin, phenobarbital, primidone: medicines for the treatment of epilepsy
• efavirenz: medicine for the treatment of HIV infection
• cyclophosphamide, ifosfamide: other anticancer medicines
• methadone: a medicine for the treatment of severe pain or for the management of dependence
• digoxin: a medicine for the treatment of heart disease
• dabigatran: a medicine to prevent blood clots from forming
• colchicine: a medicine for the treatment of gout attacks

Pemazyre with food and drink
Avoid consuming grapefruit or drinking grapefruit juice while using this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

• PregnancyPemazyre can cause harm to the unborn child and should not be used during pregnancy unless specifically indicated by your doctor. A pregnancy test must be performed before starting treatment.
• Contraceptive advice for men and womenWomen treated with Pemazyre should not become pregnant. Therefore, women of childbearing potential must use effective contraception during treatment and for at least 1 week after the last dose of Pemazyre. Talk to your doctor about the most suitable method of contraception for you. Men must avoid fathering a child: they must use effective contraception during treatment and for at least 1 week after the last dose of Pemazyre.
• BreastfeedingDo not breastfeed during treatment with Pemazyre and for at least 1 week after the administration of the last dose.

Driving and using machines
Pemazyre can cause side effects such as fatigue or visual disturbances. If this happens, do not drive
vehicles or use machines.

3. How to take Pemazyre

Treatment with Pemazyre must be initiated by a doctor experienced in the diagnosis and treatment
of bile duct cancer. Take this medicine following the instructions of your doctor or pharmacist exactly.
If you have any doubts, ask your doctor or pharmacist.

The recommended dose is:
1 Pemazyre 13.5 mg tablet taken once daily for 14 days, followed by 7 days
without taking Pemazyre.
Treatment is continued following the same schedule of 14 days of Pemazyre once daily, followed by 7
days of therapy suspension. Do not take Pemazyre during the 7 days of therapy suspension. The doctor
will adjust the dose or discontinue treatment, if necessary.

Method of use
Swallow the tablet whole with a glass of water, at the same time each day. Pemazyre may
be taken with or without food.
Do not crush, chew, split 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 forget a dose of Pemazyre for 4 hours or more, or if you vomit after taking Pemazyre, do not
take an extra Pemazyre 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 Pemazyre without talking to your doctor, as this could reduce the success
of the 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.

Contact your doctor immediatelyif you experience any of the serious side effects reported
below. These side effects can occur with the following frequency:

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, convulsions, coma
• blood tests showing an increase in 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 effectsmay occur with the following frequencies:

very common(may affect more than 1 in 10 people)

• high or low levels of phosphate detected in blood tests
• taste disturbance
• dry eye
• nausea
• inflammation of the inner lining of 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, skin infection 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
• changes in eyelashes, including abnormal length and growth turned inwards
• abnormal hair or hair growth

uncommon(may affect up to 1 in 100 people)

• formation of calcium salt deposits that appear as papules, nodules or plaques of hard consistency within the skin or under the skin of any part of the body and may cause pain and ulcers

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 through the national reporting system listed 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 which is stated on the box and blister after
Expiry/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient 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 ingredients are microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate.

Description of the Appearance of Pemazyre and Package Contents
Pemazyre 4.5 mg tablets are round, off-white to white in color, with “I” imprinted on one side and “4.5” on the other side.
Pemazyre 9 mg tablets are oval, off-white to white in color, with “I” imprinted on one side and “9” on the other side.
Pemazyre 13.5 mg tablets are round, off-white to white in color, with “I” imprinted on one side and “13.5” on the other side.
The tablets are supplied in blisters containing 14 tablets. The carton contains 14 or 28 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Tjoapack Netherlands B.V.
Nieuwe Donk 9
4879 AC Etten-Leur
Netherlands
This medicinal product is subject to ‘conditional approval’. This means that further data on this medicinal product must be provided.
The European Medicines Agency will review at least annually new information on this

Other Sources of Information
Detailed information on this medicine is available on the European Medicines Agency website, https://www.ema.europa.eu.