Pemazyre 13,5 mg comprimidos

Prospect: 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 expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

•Keep this prospect, as you may need to read it again.

•If you have any doubts, consult your doctor or pharmacist.

•This medicine has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

•If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Pemazyre and what it is used for

2.What you need to know before starting to take Pemazyre

3.How to take Pemazyre

4.Possible adverse effects

5.Storage of Pemazyre

6.Contents of the package and additional information

Pemazyre contains the active ingredient 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 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 may prevent the growth of 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;
• 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.

Do not take Pemazyre if:

•you are allergic to pemigatinib or any of the other components of this medication (listed in section 6).

•you are taking St. John's Wort, a medication for depression.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pemazyre if:

•you have been told that you have an increase or decrease in a mineral in the blood called phosphate.

•you have eye or vision problems.

•you have extremely reduced liver function. Your treatment may need to be adjusted.

•you have extremely reduced kidney function. Your treatment may need to be adjusted.

•the cancer cells have spread to the brain or spinal cord.

It is recommended to perform eye examinations:

•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 appear, such as flashes of light, visual disturbances, or dark spots.

Inform your doctor immediately if your vision presents any symptoms.

You should also use eye drops or ophthalmic gels to help prevent or treat dry eye.

Pemazyre may harm the fetus. You should use effective contraception during treatment and, at least, 1 week after the last dose of Pemazyre in fertile women and men with female partners in fertile age.

Children and adolescents

Pemazyre should not be administered to children or adolescents under 18 years of age. It is not known if it is safe and effective in this age group.

Other medications and Pemazyre

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, you should inform your doctor if you are taking any of the following medications so that your doctor can decide if your treatment needs to be changed:

•St. John's Wort: a medication for depression.Do nottake St. John's Wort during treatment with Pemazyre.

•medications with active ingredients that end with “prazol”: used to reduce the release of stomach acid. Avoid using these medications during treatment with Pemazyre.

•itraconazole: a medication for fungal infections.

•rifampicin: a medication for tuberculosis and other infections.

•carbamazepine, phenytoin, phenobarbital, primidone: medications for epilepsy.

•efavirenz: a medication for HIV infection.

•cyclophosphamide, ifosfamide: other medications for cancer.

•methadone: a medication for intense pain or to control addiction.

•digoxin: a medication for heart conditions.

•dabigatran: a medication to prevent blood clot formation.

•colchicine: a medication for gout attacks.

Taking Pemazyre with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

•Pregnancy

Pemazyre may harm the fetus and should not be used during pregnancy, unless your doctor tells you to. A pregnancy test should be performed before starting treatment.

•Contraception advice for men and women

Women treated with Pemazyre should not become pregnant. Therefore, women who may become pregnant should use effective contraception during treatment and, 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 children. They should use effective contraception during treatment and, at least, 1 week after the last dose of Pemazyre.

•Breastfeeding

Do not breastfeed during treatment with Pemazyre and, at least, 1 week after the last dose.

Driving and operating machines

Pemazyre may cause side effects such as fatigue or visual disturbances. Do not drive or operate machines if this happens.

Treatment with Pemazyre should be initiated by an experienced physician in the diagnosis and treatment of bile duct cancer. Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

1 Pemazyre 13.5 mg tablet 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 discontinue treatment as necessary.

Administration Form

Swallow the tablet whole with a glass of water at the same time each day. Pemazyre can be taken with food or between meals.

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

Treatment Duration

Take Pemazyre for the time indicated by your doctor.

If you take more Pemazyre than you should

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

If you forget to take Pemazyre

If you forget a dose of Pemazyre within 4 hours or more, or if you vomit after taking Pemazyre, do not take a double dose to compensate for the missed dose. Take the next dose of Pemazyre at the scheduled time.

If you interrupt treatment with Pemazyre

Do not stop taking Pemazyre without consulting your doctor, as this may reduce the effectiveness of treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediatelyif you experience any of the following severe side effects. Side effects can occur with the following frequencies:

Very frequent (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 an increase in creatinine, which may indicate kidney problems; in general, the 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 frequent(may affect more than 1 in 10 people)

•high or low phosphate levels observed in blood tests

•alteration of taste

•dry eye

•nausea

•inflammation of the mucous membrane inside 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 breakage, changes in nail color or texture, skin infection around the nail

•hair loss

•dry skin

•joint pain

•fatigue

Frequent(may affect up to 1 in 10 people)

•accumulation of fluid 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 abnormally long eyelashes, inflamed eyelashes

•abnormal hair growth

Rare(may affect up to1in100people)

•deposition of calcium salts 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 may cause pain and ulcers

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD” or “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Pemazyre

•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 components are microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.

Appearance of Pemazyre and content of the container

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

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

The 13.5 mg Pemazyre tablets are round, white to off-white, engraved with “I” on one side and with "13.5" on the other side.

The tablets are supplied in blisters containing 14 tablets. The box contains 14 or 28 tablets.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25

1105 BP Amsterdam

Netherlands

Responsible for manufacturing

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25

1105 BP Amsterdam

Netherlands

Tjoapack Netherlands B.V.

Nieuwe Donk 9

4879 AC Etten-Leur

Netherlands

Last review date of this leaflet: {MM/AAAA}.

This medicine has been authorized under a «conditional approval». This type of approval means that more information is expected to be obtained about this medicine.

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

Other sources of information

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