Pemazyre 4.5 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Pemazyre 4.5 mg tablets
Pemazyre 9 mg tablets
Pemazyre 13.5 mg tablets
pemigatinib
This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Pemazyre is and what it is used for
- What you need to know before taking Pemazyre
- How to take Pemazyre
- Possible side effects
- How to store Pemazyre
- 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 certain cell proteins called fibroblast growth factor receptors 1, 2, and 3 (FGFR1, FGFR2, and FGFR3), which help regulate cell growth. Cancer cells may have an abnormal form of these proteins. 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 effective.
2. What you need to 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).
- you are taking St. John’s wort, a herbal remedy used to treat depression.
Warnings and precautions
Talk to your doctor or pharmacist before starting Pemazyre if:
- you have been told you have high or low levels of a mineral in your blood called phosphate.
- you have vision or eye problems.
- you have severely impaired liver function. Your treatment may need to be adjusted.
- you have severely impaired kidney function. Your treatment may need to be adjusted.
- cancer cells have spread to your brain or spinal cord.
Regular eye examinations are recommended:
- before starting treatment with Pemazyre.
- every 2 months during the first 6 months of treatment.
- every 3 months thereafter, or immediately if you develop any visual symptoms, such as flashes of light, blurred vision, or dark spots.
Contact your doctor immediately if you experience any changes in your vision.
You should also use lubricating or hydrating eye drops or gels to help prevent or treat dry eye.
Pemazyre can 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. 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 need to take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines, so that your doctor can decide whether your treatment needs to be changed:
- St. John’s wort: a herbal remedy used to treat depression. You must not take St. John’s wort during treatment with Pemazyre.
- Medicines with active substance names ending in “prazole”: used to reduce stomach 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 and other infections.
- carbamazepine, phenytoin, phenobarbital, primidone: medicines used to treat epilepsy.
- efavirenz: a medicine used to treat HIV infection.
- cyclophosphamide, ifosfamide: other medicines used to treat cancer.
- methadone: a medicine used to treat severe pain or to manage 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.
Taking Pemazyre with food and drink
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 become pregnant, consult your doctor or pharmacist before using this medicine.
- Pregnancy
Pemazyre can harm an unborn baby and must not be used during pregnancy unless specifically instructed by your doctor. A pregnancy test should be performed before starting treatment.
- Contraception advice for men and women
Women receiving 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. Talk to your doctor about the most suitable contraceptive method for you.
Men must avoid fathering a child. Men 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. Do not drive or operate machinery if this occurs.
3. How to take Pemazyre
Treatment with Pemazyre should be initiated by a physician experienced in the diagnosis and treatment of biliary tract cancer. Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is
1 Pemazyre 13.5 mg tablet once daily for 14 days, followed by 7 days without taking Pemazyre.
Treatment continues with the same 14-day on, 7-day off cycle: 14 days of once-daily Pemazyre followed by 7 days without treatment. Do not take Pemazyre during the 7-day treatment-free period. 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 between meals.
Do not crush, chew, split, or dissolve the tablets.
Duration of treatment
Take Pemazyre for the duration specified by your doctor.
If you take more Pemazyre than you should
Inform your doctor if you have taken more Pemazyre than prescribed.
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 dose. Take the next dose of Pemazyre at the scheduled time.
If you stop taking Pemazyre
Do not stop taking Pemazyre without consulting your doctor, as this could reduce the effectiveness of treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Tell your doctor immediately if you experience any of the following serious adverse effects. Adverse 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 impaired thinking ability, 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 adverse effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 people)
- high or low phosphate levels observed in blood tests
- taste disturbances
- dry eye
- nausea
- inflammation of the inner 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, known as hand-foot syndrome
- nail toxicity, including nail separation from the nail bed, nail pain, bleeding under the nails, nail breakage, 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 transparent outer 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)
- deposition of calcium salts in the form of plaques, nodules, or hard papules appearing on the skin or under the skin in any part of the body, which may cause pain and ulcers
Reporting of adverse effects
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Pemazyre Storage
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 “CAD” or “EXP”. The expiry date refers to the last day of the month indicated.
This medicine requires no special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.
6. Contents of the pack and other information
Composition of Pemazyre
- 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 starch glycolate (type A), magnesium stearate.
Appearance of Pemazyre and contents of the pack
Pemazyre 4.5 mg tablets are round, white to off-white, engraved with "I" on one side and "4.5" on the other side.
Pemazyre 9 mg tablets are oval, white to off-white, engraved with "I" on one side and "9" on the other side.
Pemazyre 13.5 mg tablets 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 pack contains 14 or 28 tablets.
Only certain 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
Date of the most recent revision of this summary: {MM/YYYY}
This medicinal product has been authorised under a "conditional approval". This means that more information on this medicinal product is expected to become available.
The European Medicines Agency will review new information on this medicinal product at least once a year and this summary will be updated as necessary.
Other sources of information
Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.