BEYONTTRA 356 mg FILM-COATED TABLETS
Ask a doctor about a prescription for BEYONTTRA 356 mg FILM-COATED TABLETS
How to use BEYONTTRA 356 mg FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the Patient
BEYONTTRA 356 mg film-coated tablets
acoramidis
This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of this leaflet includes information on how to report side effects.
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.
Contents of the pack
- What is BEYONTTRA and what is it used for
- What you need to know before you take BEYONTTRA
- How to take BEYONTTRA
- Possible side effects
- Storage of BEYONTTRA
- Contents of the pack and other information
1. What is BEYONTTRA and what is it used for
BEYONTTRA contains the active substance acoramidis (as hydrochloride).
It is used to treat adults who have a cardiomyopathy (a disease that affects the heart muscle) caused by transthyretin amyloidosis (ATTR-CM).
In people with transthyretin amyloidosis, a protein called transthyretin (TTR) does not work properly, causing it to break down and form a buildup of fibers called amyloids. When amyloids build up in the heart, the heart muscle becomes stiff and the heart stops working properly. BEYONTTRA stabilizes TTR, which can prevent it from breaking down and forming amyloids. This helps people whose hearts have been affected by transthyretin amyloid 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
Tell your doctor, pharmacist, or nurse before starting BEYONTTRA, especially if you have liver or severe kidney problems.
When starting treatment, you may experience changes in blood tests for kidney function, although these changes should not negatively affect 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 affect thyroid blood tests, although these changes should not negatively affect your thyroid function.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as it is not known whether BEYONTTRA can harm the fetus.
It is not known whether this medicine passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using 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 machines.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".
3. How to take BEYONTTRA
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is two film-coated tablets (712 mg) taken orally twice a day. The total daily dose is 1,424 mg of acoramidis.
The tablets should be swallowed whole. They can be taken with water and with or without food.
If you take more BEYONTTRA than you should
Do not take more tablets than your doctor has told you. Contact your doctor if you think you have taken more tablets than you should.
If you forget to take BEYONTTRA
If you forget to take the tablets, take them at the next scheduled time. Do not take a double dose to make up for forgotten doses.
If you stop taking BEYONTTRA
Do not stop taking BEYONTTRA without consulting your doctor first. If you stop taking BEYONTTRA, your disease may progress.
If you have any other questions about 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.
Possible side effects are:
Very common (may affect more than 1 in 10 people)
- Diarrhea
- Painful inflammation of the joints (gout)
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 is the last day of the month shown.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
What BEYONTTRA contains
- The active substance is acoramidis (as hydrochloride). Each tablet contains hydrochloride equivalent to 356 mg of acoramidis.
- The other ingredients are: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), colloidal hydrated silica (E 551), magnesium stearate (E 470b), macrogol/polyvinyl alcohol grafted copolymer (E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylocaprate type I (E 471), polyvinyl alcohol (E 1203), black iron oxide (E 172), propylene glycol (E 1520), hypromellose 2910 (E 464).
- See section 2 for information on sodium.
Appearance and packaging
BEYONTTRA 356 mg film-coated tablets are oval, white tablets, approximately 15 mm x 7.5 mm, with the company logo BridgeBio followed by "ACOR" printed in black ink on one side.
BEYONTTRA is available in double-cavity PVC/PCTFE blisters sealed with an aluminum foil in a pack containing 120 tablets.
Marketing authorisation holder | Manufacturer |
Bayer AG 51368 Leverkusen Germany | Rottendorf Pharma GmbH Ostenfelder Strasse 51-61 Ennigerloh, 59320 Germany |
You can request more information about this medicine from 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 |
| Luxembourg/Luxemburg Bayer SA-NV Tél/Tel: +32-(0)2-535 63 11 |
Ceská 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 |
Ελλáδα Bayer Ελλáς 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 |
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 |
Κúπρος NOVAGEM Limited Τηλ: +357 22 48 38 58 | Sverige Bayer AB Tel: +46 (0) 8 580 223 00 |
Latvija SIA Bayer Tel: +371 67 84 55 63 |
Date of last revision of this leaflet:
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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