PEMAZYRE 4.5 mg TABLETS

Introduction

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, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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.

Contents of the pack

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. Storage of 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 cancer medicines called tyrosine kinase inhibitors. It blocks the action of cell proteins called fibroblast growth factor receptors 1, 2 and 3 (FGFR1, FGFR2 and FGFR3), which help to control cell growth. Cancer cells may have an abnormal form of this protein. By blocking FGFR, pemigatinib can prevent the growth of cancer cells.

Pemazyre is used:

• to treat adults with cancer of the bile ducts (also known as cholangiocarcinoma), whose cancer cells have an abnormal form of the FGFR2 protein;
• 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 allergic to pemigatinib or any of the other ingredients of this medicine (listed in section 6).
• you are taking St. John's Wort, a medicine for depression.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pemazyre if:

• you have been told you have high or low levels of a mineral in the blood called phosphate.
• you have eye or vision problems.
• you have severely reduced liver function. Your treatment may need to be adjusted.
• you have severely reduced kidney function. Your treatment may need to be adjusted.
• the cancer has spread to the brain or spinal cord.

Eyel exams are recommended:

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

Tell your doctor right away if you have any symptoms with your vision.

You should also use lubricating or moisturizing eye drops or gels to help prevent or treat dry eyes.

Pemazyre may harm the fetus. Effective contraception should 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. It is not known if 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 your doctor can decide if it is necessary to change your treatment:

• St. John's Wort: a medicine for depression. Do not take St. John's Wort during treatment with Pemazyre.
• medicines with active substance names ending in "prazole": used to reduce stomach acid release. Avoid using these medicines during treatment with Pemazyre.
• itraconazole: a medicine for fungal infections.
• rifampicin: a medicine for tuberculosis and other infections.
• carbamazepine, phenytoin, phenobarbital, primidone: medicines for epilepsy.
• efavirenz: a medicine for HIV infection.
• cyclophosphamide, ifosfamide: other medicines for cancer.
• methadone: a medicine for severe pain or to control addiction.
• digoxin: a medicine for heart conditions.
• dabigatran: a medicine to prevent blood clots.
• colchicine: a medicine for gout attacks.

Taking Pemazyre with food and drinks

Avoid eating grapefruit or drinking grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Pregnancy

Pemazyre may harm the fetus and should not be used during pregnancy unless your doctor considers it necessary. A pregnancy test should be performed before starting treatment.

• Advice on contraception for men and women

Women treated with Pemazyre should not become pregnant. Therefore, women who can become pregnant should 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 contraceptive for you.

Men should avoid fathering a child. They should use effective 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 vision disturbances. Do not drive or use machines if this happens.

3. How to take Pemazyre

Treatment with Pemazyre should be started by a doctor who has experience in the diagnosis and treatment of bile duct cancer. Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is

1 tablet of Pemazyre 13.5 mg once a day for 14 days, followed by 7 days without taking Pemazyre.

Treatment continues with the same pattern of 14 days of Pemazyre once a day, followed by 7 days without treatment. Do not take Pemazyre during the 7 days without treatment. 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 can be taken with or without food.

Do not crush, chew, break, or dissolve the tablets.

Duration of treatment

Take Pemazyre for as long as your doctor tells you to.

If you take more Pemazyre than you should

Tell your doctor if you have taken more Pemazyre than you should have taken.

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 a double dose to make up for the missed doses. Take the next dose of Pemazyre at the scheduled time.

If you stop taking Pemazyre

Do not stop taking Pemazyre without talking to your doctor, as this could reduce the success of the treatment.

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 immediatelyif you have any of the following serious side effects. Side effects may occur with the following frequencies:

Very common (may affect more than 1 in 10 people):

• low sodium levels in the blood; symptoms include decreased ability to think, headache, nausea, balance problems, confusion, seizures, coma;
• blood tests showing increased creatinine, which may indicate kidney problems; usually, increased 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 phosphate levels seen in blood tests
• taste disturbances
• dry eyes
• nausea
• inflammation of the lining of the mouth
• diarrhea
• constipation
• dry mouth
• skin reactions with redness, swelling, and pain on the palms of the hands and soles of the feet, called hand-foot syndrome
• nail toxicity, including separation of the nail from the nail bed, nail pain, nail bleeding, nail breaking, changes in nail color or texture, infected skin around the nail
• 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 outer transparent layer of the eye)
• reduced vision
• changes in eyelashes, including abnormally long eyelashes, ingrown eyelashes
• abnormal hair growth

Uncommon(may affect up to 1 in 100 people)

• calcium salt deposits in the form of hard plates, nodules, or papules that appear on the skin or under the skin in any area of the body and can cause pain and ulcers

Reporting of side effects

If you experience 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 blister after "EXP". The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 ingredients are microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.

Appearance of Pemazyre and contents of the pack

The 4.5 mg tablets of Pemazyre are round, white to off-white, engraved with "I" on one side and "4.5" on the other side.

The 9 mg tablets of Pemazyre are oval, white to off-white, engraved with "I" on one side and "9" on the other side.

The 13.5 mg tablets of Pemazyre are round, white to off-white, engraved with "I" 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

Date of last revision of this leaflet: {MM/YYYY}.

This medicine has been authorised with a "conditional approval". This type of approval means that more information on this medicine is expected.

The European Medicines Agency will review any new information on this medicine at least once a year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.