Pyrukynd – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Pyrukynd, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Pyrukynd is and what it is used for
Pyrukynd contains the active substance mitapivat.
Pyrukynd is used to treat anaemia in adults with an inherited condition called thalassaemia, regardless of their genotype and transfusion needs. Patients with thalassaemia have red blood cells that break down too fast, a process known as haemolytic anaemia.
Pyrukynd helps an enzyme in red blood cells, called pyruvate kinase, work better to increase the energy in your red blood cells and stops them from being broken down too fast.
Talk to your doctor, pharmacist or nurse if you have any questions about how Pyrukynd works or why this medicine has been prescribed for you.
You must talk to a doctor if you do not feel better or if you feel worse.
⚠️ 2. What you need to know before you take Pyrukynd
Do not take Pyrukynd
- if you are allergic to mitapivat or any of the other ingredients of this medicine (listed in section 6).
89 Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Pyrukynd.
Liver i njury has happened during the first 6 months of treatment with Pyrukynd. Your healthcare provider will use blood tests to check your liver tests before you start taking Pyrukynd and monthly for the first 6 months of treatment with Pyrukynd. If increases in your liver tests are seen, your doctor may temporarily or permanently discontinue treatment with Pyrukynd. Tell your healthcare provider right away if you develop any signs or symptoms that may indicate liver problems including:
- yellowing of the skin or the whites of your eyes (jaundice)
- dark coloured urine
- pain in the upper right part of your belly
- nausea
- vomiting
- loss of appetite See section 4 below for more information about side effects.
Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age. This is because it is not known if mitapivat is safe and effective for them.
Other medicines and Pyrukynd
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular:
Tell your doctor or pharmacist if you take any of the following medicines because they may increase the risk of side effects of Pyrukynd (such as not sleeping) or they may stop Pyrukynd from working properly:
- certain medicines for fungal infections – such as itraconazole
- certain medicines for tuberculosis – such as rifampicin Tell your doctor or pharmacist if you take any of the following medicines because Pyrukynd may stop these medicines from working properly:
- certain sedatives – such as midazolam
- certain birth control (contraceptive) medicines containing hormones – such as ethinylestradiol
- certain chemotherapy medicines for cancer treatment – such as irinotecan, cyclophosphamide, paclitaxel
- certain medicines to help you stop smoking – such as bupropion
- certain medicines for type 2 diabetes – such as repaglinide
- certain blood thinners – such as warfarin, dabigatran etexilate
- certain medicines for heart problems – such as digoxin
- certain medicines to treat epilepsy – such as carbamazepine, phenytoin, valproic acid
- certain medicines used for strong pain relief – such as alfentanil
- certain medicines used to prevent organ rejection after an organ transplant – such as cyclosporine, sirolimus, tacrolimus
- certain medicines used to treat an abnormal heart rhythm – such as quinidine
- certain medicines used to treat migraines – such as ergotamine
- certain medicines used to treat chronic pain – such as fentanyl
- certain medicines used to control involuntary movements or sounds – such as pimozide
- certain medicines used to treat or prevent gout flares – such as colchicine 90 Pregnancy, breast -feeding and fertility
Pregnancy
If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should avoid becoming pregnant during treatment with Pyrukynd.
- This is because it may cause harm to your unborn baby.
- Talk to your doctor straight away if you become pregnant while taking this medicine.
Breast -feeding If you plan to breast feed, ask your doctor or pharmacist for advice before taking this medicine. This is because it is not known whether the medicine passes into human breast milk or what the effects might be on the baby.
Fertility
While taking Pyrukynd, there may be an impact on the ability of a woman and a man to conceive. Talk to your doctor or pharmacist for advice if you are planning to have a child.
Contraception for women If you could become pregnant, you must use reliable contraception while taking Pyrukynd. You must also do this for at least 1 month after taking your last dose.
While you are taking Pyrukynd, some birth control medicines containing hormones (such as pills) may not work as well as expected, meaning you might be at risk of becoming pregnant. Talk to your doctor, pharmacist or nurse about contraception methods that m ay be right for you while you are using this medicine.
Driving and using machines
You may experience difficulty sleeping (insomnia) during treatment with Pyrukynd. If this happens to you, be careful when driving or using machines.
Pyrukynd contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium – free’.
💊 3. How to take Pyrukynd
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Pyrukynd is one 100 mg tablet taken twice a day.
Pyrukynd is taken by mouth.
- Swallow the tablet whole.
- You can take it with or without food.
- Do not split, crush, chew or dissolve the tablets.
Elderly Pyrukynd has been used in a limited number of patients aged 65 years and older. There is no evidence to suggest that elderly patients need a different dose compared to younger adults.
Instructions for opening the blisters The following pictures show how to take the tablet out of the blister.
Find the correct blister pocket indicated by the day of the week and, if applicable, time of the day (morning or evening dose, as shown on the blister by sun and moon symbols). At the corresponding tab:
1. Use thumb to PUSH.
The image above shows the inside of the blister wallet.
2. Turn package over, PEEL the raised tab on the back.
The image above shows the back of the blister wallet.
3. Push tablet through the foil.
If you take more Pyrukynd than you should
If you have taken more Pyrukynd than you should, talk to a doctor straight away, or contact your nearest accident and emergency department. Take the medicine pack with you so that you can show the doctor what you have taken.
If you forget to take Pyrukynd
- If you miss a dose by 4 hours or less, take it as soon as possible.
- If you miss a dose by more than 4 hours, do not take a replacement dose. Take your next scheduled dose as you normally would.
Do not take a double dose to make up for a forgotten dose.
92 If you stop taking Pyrukynd If you want to stop taking Pyrukynd, talk to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people)
- Difficulty sleeping (insomnia)
- Headache
- Decreased levels of the hormones oestrone and oestradiol – seen in blood tests in men
- Increased levels of the hormone testosterone – seen in blood tests in men
Common (may affect up to 1 in 10 people)
- Dizziness
- Racing or pounding heartbeat (palpitations)
- Itchy skin (pruritus)
- Rash
- Joint pain
- Pain in the arms or legs
Uncommon (may affect up to 1 in 100 people )
- High liver enzymes
- Protein in the urine Other possible side effects Liver injury has happened in patients during the first 6 months of taking Pyrukynd. Tell your healthcare provider right away if you develop any signs or symptoms that may indicate liver problems including:
- yellowing of the skin or the whites of your eyes (jaundice)
- dark coloured urine
- pain in the upper right part of your belly
- nausea
- vomiting
- loss of appetite
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. How to store Pyrukynd
Keep this medicine out of the sight and reach of children.
93 Do not use this medicine after the expiry date which is stated on the carton, blister wallet and blister after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C) . If removed from refrigerator, store Pyrukynd at room temperature (below 25 °C), record the date it was removed from the refrigerator, and discard 3 months after the recorded date.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Pyrukynd contains
- The active substance is mitapivat. Each film -coated tablet contains 100 mg of mitapivat (as sulfate).
- The other ingredients are:
Tablet core : microcrystalline cellulose, croscarmellose sodium, mannitol (E421) and sodium stearyl fumarate.
Film -coating : hypromellose (E464), titanium dioxide (E171), lactose monohydrate, triacetin, indigo carmine aluminium lake (E132), and macrogol (polyethylene glycol) (E1521).
Printing ink : shellac (E904), FD&C Blue #1/Brilliant Blue FCF Aluminium Lake (E133), titanium dioxide (E171), and ammonium hydroxide (E527).
See section 2 “Pyrukynd contains lactose and sodium”.
What Pyrukynd looks like and contents of the pack
Pyrukynd 100 mg film- coated tablets are oblong shaped, blue, film -coated tablets of approximately 16 mm x 6.8 mm size with “M100” printed in blue ink on both sides.
Pyrukynd 100 mg film- coated tablets are available in 4 blister wallets, each containing 14 film -coated tablets. Each carton contains 56 film -coated tablets.
Marketing Authorisation Holder
Agios Netherlands B.V.
Zuidplein 36 Regus Amsterdam WTC 1077XV Amsterdam The Netherlands
Manufacturer
Almac Pharma Services Limited Seagoe Industrial Estate Portadown Craigavon, County Armagh BT63 5UA United Kingdom (Northern Ireland)
This leaflet was last revised in
94 Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Pyrukynd (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1662).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.