4.5 mg, 9 mg, 13.5 mg tablets
pemigatinib
What Pemazyre is and what it is used for
Pemazyre contains the active substance pemigatinib, which belongs to a group of cancer medicines called tyrosine kinase inhibitors. It blocks the effect of protein in the cell called fibroblast growth factor receptor types 1, 2, and 3 (FGFR1, FGFR2, and FGFR3) which helps regulate cell growth. Cancer cells may have an abnormal form of this protein. By blocking FGFR, pemigatinib can prevent the growth of such cancer cells.
Pemazyre is used:
- to treat adults with bile duct cancer (also called cholangiocarcinoma) whose cancer cells have an abnormal form of FGFR2‑ protein, and
- when cancer has spread to other parts of the body or cannot be removed by surgery, and
- when treatment with other drugs no longer works.
What you need to know before you use 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 use St. John’s wort, a traditional herbal remedy for treating mild depression
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Pemazyre if you have:
- been told that you have an increase or decrease in a mineral in the blood called phosphorus
- vision or eye problems
- severely impaired liver function. Your treatment may need to be adjusted.
- severely impaired renal function. Your treatment may need to be adjusted.
- cancer cells that have spread to the brain or spinal cord.
Eye examinations are recommended:
- before starting treatment with Pemazyre
- every two months during the first six months of treatment
- every three months thereafter or immediately if any visual symptoms occur, including flashes of light, visual disturbances, or dark spots.
Tell your doctor immediately if you get any vision-related symptoms.
You should also use lubricating or moisturizing eye drops or gels to prevent or treat dry eyes.
Pemacic acid can harm a fetus. An effective contraceptive must be used during treatment and for at least one week after the last dose of Pemazyre infertile women and in men with female fertile partners.
Children and young people
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 your treatment needs to be changed:
- St. John’s wort: a traditional herbal remedy for treating mild depression. You must not take St. John’s wort during treatment with Pemazyre.
- drugs with names of active substances ending in ” azole “: they are used to reduce the release of gastric acid. Avoid using these medicines during treatment with Pemazyre.
- itraconazole: a medicine used to treat fungal infections
- rifampicin: a medicine for tuberculosis or some other infection
- carbamazepine , phenytoin , phenobarbital , primidone : antiepileptic drugs
- efavirenz: anti – HIV drug
- cyclophosphamide, ifosfamide : other anticancer medicines
- methadone: a drug for the treatment of severe pain or to manage addiction
- digoxin: a drug used to treat heart disease
- dabigatran: a medicine to prevent blood clots
- colchicine: a drug used to treat gout attacks.
Pemazyre with food and drink
Avoid eating grapefruit and drinking grapefruit juice while using 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 can harm the unborn baby and should not be used during pregnancy unless your doctor tells you otherwise. A pregnancy test should be performed before starting treatment. - Contraceptive advise for men and women
Women treated with Pemazyre should not become pregnant. Therefore, women who may become pregnant must use effective contraception during treatment and for at least one week after the last dose of Pemazyre. Talk to your doctor about the most suitable contraceptive for you.
Men should avoid getting a woman pregnant. They must use effective contraception during treatment and for at least one week after the last dose of Pemazyre. - Breast-feeding
Do not breastfeed during treatment with Pemazyre and for at least one week after the last dose.
Driving and using machines
Pemacic acid can cause side effects such as fatigue or visual disturbances. Do not drive or use machines if this happens.
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 your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is
1 tablet of Pemazyre 13.5 mg was taken once daily for 14 days, followed by 7 days without taking Pemazyre.
Treatment continues with the same 14-day pattern of Pemazyre once daily, followed by a 7-day treatment interruption. Do not take Pemazyre for the 7 days without treatment. Your doctor will adjust the dose one or discontinue treatment if necessary.
Use
Swallow the tablet whole with a glass of water at the same time each day. Pemazyre can be taken with or without food.
The tablets should not be crushed, chewed, divided, or dissolved.
Usage time
Take Pemazyre for as long as your doctor prescribes it.
If you take more Pemazyre than you should
Tell 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 a double dose of Pemazyre tablets to make up for a forgotten dose. Take the next dose of Pemazyre at the scheduled time.
If you stop taking Pemazyre
Do not stop taking Pemazyre without discussing it with your doctor, as this may reduce the success of your treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the serious side effects below. These side effects can occur with the following frequency:
Very common (may affect more than 1 in 10 people):
- low sodium levels in the blood; symptoms include decreased ability to think, headache, nausea, poor balance, confusion, seizures, coma
- blood tests show an increase in creatinine, which may indicate kidney problems; Elevated creatinine does not usually 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 in blood samples
- taste disorders
- dry eyes
- nausea
- inflammation of the oral mucosa
- diarrhea
- constipation
- dry mouth
- skin reactions with redness, swelling, and pain on palms and soles of the feet, so-called hand-foot syndrome
- nail toxicity, including nails coming off the nail bed, nail paint, nail bleeding, nails breaking, discoloration or structural changes in the nails, 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 photosensitive layer on the back of the eye)
- inflammation of the cornea (the transparent outer layer of the eye)
- impaired vision
- eyelash changes including abnormally long eyelashes, ingrown eyelashes
- abnormal hair growth
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 carton and blister and after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage conditions.
The medicine 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 to protect the environment.
Contents of the pack and other information
Content declaration
- 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), and magnesium stearate.
What the medicine looks like and the contents of the pack
Pemazyre 4.5 mg tablets are round, white to off-white, debossed with “I” on one side and “4.5” on the other.
Pemazyre 9 mg tablets are oval, white to off-white, debossed with “I” on one side and “9” on the other.
Pemazyre 13.5 mg tablets are round, white to off-white, debossed with “I” on one side and “13.5” on the other.
The tablets are supplied in blister cards containing 14 tablets. Carton containing 14 or 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Incyte Biosciences Distribution BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Manufacturer
Incyte Biosciences Distribution BV
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Tjoapack Netherlands BV
New Donk 9
4879 AC Etten ‑ Leur
Netherlands