BEYONTTRA – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine BEYONTTRA, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet ca refully 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 thi s leaflet. See section 4.
ℹ️ 1. What BEYONTTRA is and what it is used for
BEYONTTRA contains the active substance acoramidis (as hydrochloride ).
It is used to treat adults with cardiomyopathy (a disease that affects the heart muscle) resulting from transthyretin amyloidosis (ATTR-CM).
In people with transthyretin amyloidosis, a protein called transthyretin (TTR) does not work properly , causing it to break up and form fibrous clusters called amyloids . When amyloids form in the heart, the heart muscle stiffens, and the heart can no longer work normally. BEYONTTRA stabilises TTR, which can prevent it from breaking up and forming amyloid s. This helps people whose heart has been affected by transthyretin amyloidosis cardiomyopathy .
⚠️ 2. What you need to know before you take BEYONTTRA
Do not take BEYONTTRA
If you are allergic to acoramidis or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking BEYONTTRA , especially if you have liver or severe kidney problems.
When starting your treatment you may experience changes in your kidney function blood tests , but these changes should not be harmful to your kidneys .
Children and adolescents
BEYONTTRA is not used in children and adolescents . Its use has not been studied in this population .
Other medicines and BEYONTTRA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
BEYONTTRA may change your thyroid blood tests, b ut these changes should not be harmful to your thyroid function.
Pregnancy, breast -feeding and fertility If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as it is not known if BEYONTTRA may harm the unborn baby .
It is not known whether this medicine passes into breast milk. If you are breast -feeding or plan to breast feed, ask your doctor or pharmacist for advice before taking this medicine. There are no data on the use of BEYONTTRA in pregnant women.
Driving and using machines
BEYONTTRA has no or negligible influence on your ability to drive and use machine s.
Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium – free’.
💊 3. How to take BEYONTTRA
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 is two film-coated tablets (712 mg) taken by mouth twice a day . The total daily dose is 1 424 mg acoramidis .
BEYONTTRA tablets should be swallowed whole. You can take them with water, with or without food.
If you take more BEYONTTRA than you should
Do not take more tablets than your doctor t old you to take. Contact your doctor i f think you have taken too much of t his medicine.
If you forget to take BEYONTTRA
If you forgot to take your tablets, take them at the next usual time. Do not take a double dose to make up for a forgotten dose.
24 If you stop taking BEYONTTRA Do not stop taking BEYONTTRA without first speaking to your doctor. Your disease may progress if you stop taking BEYONTTRA .
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.
The possible side effects are:
Very common (may affect more than 1 in 10 people)
- diarrhoea
- painful inflammation in the joints (gout)
Reporting of side effects
If you get any side ef fects, 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 BEYONTTRA
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 after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 BEYONTTRA contains
- The active substance is acoramidis (as hydroch loride). Each tablet contains acoramidis hydrochloride equivalent to 356 mg acoramidis.
- The other ingredients are: microcrystalline cellulose (E 460), croscarmellose sodium (E 468), colloidal hydrated silica (E 551), magnesium stearate (E 470b), macrogol poly(vinyl alcohol) grafted copolymer (E 1209), talc (E 553b), titanium di oxide (E 171), glyceryl monocaprylocaprate Type I (E 471), poly(vinyl alcohol) (E 1203), iron oxide black (E 172), propylene glycol (E 1520), hypromellose 2910 (E 464).
See section 2 for information regarding sodium .
What BEYONTTRA looks like and contents of the pack
BEYONTTRA 356 mg film-coated tablets (tablets) are white, oval film -coated tablets approximately 15 mm × 7.5 mm with the BridgeBio company logo followed by “ACOR” in black ink printed on one side.
BEYONTTRA is available in dual -cavity blisters of PVC/PCTFE with aluminium foil lidding in a pack containing 120 tablets.
Marketing Authorisation Holder Manufact urer Bayer AG Rottendorf Pharma GmbH 51368 Leverkusen Ostenfelder Strasse 51-61 Germany Ennigerloh, 59320 Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Bayer SA -NV Tél/Tel: +32 -(0)2-535 63 11 Lietuva UAB Bayer Tel. +37 05 23 36 868 България Байер България ЕООД Tел.: +359 (0)2 4247280 Luxembourg/Luxemburg Bayer SA -NV Tél/Tel: +32 -(0)2-535 63 11 Česká republika Bayer s.r.o.
Tel: +420 266 101 111 Magyarország Bayer-Hungária Kft.
Tel.: +36 1 487 4100 Danmark Bayer A/S Tlf.: +45 45 23 50 00 Malta Alfred Gera and Sons Ltd.
Tel: +35 621 44 62 05 Deutschland Bayer Vital GmbH Tel: +49 (0)214 -30 513 48 Nederland Bayer B.V.
Tel: +31-23 – 799 1000 Eesti Bayer OÜ Tel: +372 655 8565 Norge Bayer AS Tlf: +47 23 13 05 00 Ελλάδα Bayer Ελλάς ΑΒΕΕ Τηλ: +30-210-61 87 500 Österreich Bayer Austria Ges.m.b.H.
Tel: +43-(0)1-711 46-0 España Bayer Hispania S.L.
Tel: +34-93-495 65 00 Polska Bayer Sp. z o.o.
Tel: +48 22 572 35 00 France Bayer HealthCare Tél (N° vert): +33 -(0)800 87 54 54 Portugal Bayer Portugal, Lda.
Tel: +351 21 416 42 00 26 Hrvatska Bayer d.o.o.
Tel: +385 -(0)1-6599 900 România SC Bayer SRL Tel: +40 21 529 59 00 Ireland Bayer Limited Tel: +353 1 216 3300 Slovenija Bayer d. o. o.
Tel: +386 (0)1 58 14 400 Ísland Icepharma hf.
Sími: +354 540 8000 Slovenská republika Bayer spol. s r.o.
Tel. +421 2 59 21 31 11 Italia Bayer S.p.A.
Tel: +39 02 397 8 1 Suomi/Finland Bayer Oy Puh/Tel: +358 – 20 785 21 Κύπρος NOVAGEM Limited Tηλ: +357 22 48 38 58 Sverige Bayer AB Tel: +46 (0) 8 580 223 00 Latvija SIA Bayer Tel: +371 67 84 55 63
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu
📄 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 BEYONTTRA (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1906).
⚠️ 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.