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

1. What is BEYONTTRA and what is it used for
2. What you need to know before you take BEYONTTRA
3. How to take BEYONTTRA
4. Possible side effects
5. Storage of BEYONTTRA
6. 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.

You can request more information about this medicine from the local representative of the marketing authorisation holder:

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.