Camzyos 15 mg hard capsules

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

CAMZYOS 2.5 mg hard capsules
CAMZYOS 5 mg hard capsules
CAMZYOS 10 mg hard capsules
CAMZYOS 15 mg hard capsules

mavacamten

This medicine is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any side effects you may experience. Section 4 includes information on how to report side effects.

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• Your doctor will provide you with a patient information card and a patient guide. Read the guide carefully and follow the instructions.
• Always show your patient information card to your doctor, pharmacist, nurse, or hospital staff when you visit them.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed solely for you. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet

1. What CAMZYOS is and what it is used for
2. What you need to know before taking CAMZYOS
3. How to take CAMZYOS
4. Possible side effects
5. How to store CAMZYOS
6. Contents of the pack and other information

1. What CAMZYOS is and what it is used for

What CAMZYOS is

CAMZYOS contains the active substance mavacamten. Mavacamten is a reversible cardiac myosin inhibitor, which means that it modifies the action of myosin, a muscle protein, in heart cells.

What CAMZYOS is used for

CAMZYOS is used to treat adults with a type of heart disease called symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

About obstructive hypertrophic cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the walls of the left chamber of the heart (ventricle) contract more strongly and become thicker than normal. This thickening of the walls may block (obstruct) blood flow out of the heart and may also make the heart stiff. This obstruction makes it harder for blood to enter and leave the heart and to be pumped to the body with each heartbeat, a condition known as obstructive hypertrophic cardiomyopathy (oHCM). Symptoms of oHCM include chest pain and shortness of breath (especially during physical exertion); fatigue, abnormal heart rhythms, dizziness, feeling faint, fainting (syncope), and swelling of the ankles, feet, legs, abdomen, and/or neck veins.

How CAMZYOS works

CAMZYOS works by reducing excessive heart contraction and obstruction of blood flow to the body. As a result, it may improve your symptoms and your ability to stay physically active.

2. What you need to know before taking CAMZYOS

Do not take CAMZYOS

• if you are allergic to mavacamten or any of the other ingredients of this medicine (listed in section 6).

• if you are pregnant or could become pregnant and are not using effective contraception.

• if you are taking medicines that may increase the level of CAMZYOS in your blood, such as:

• oral medicines used to treat infections like itraconazole, ketoconazole, posaconazole, or voriconazole;

• certain antibiotics used to treat bacterial infections such as clarithromycin;

• certain medicines used to treat HIV infection such as cobicistat or ritonavir;

• certain medicines used to treat cancer such as ceritinib, idelalisib, or tucatinib.

Ask your doctor whether the medicine you are taking prevents you from taking mavacamten. See section "Other medicines and CAMZYOS".

Warnings and precautions

Routine tests

Your doctor will assess your heart function using echocardiography (an ultrasound scan that takes images of the heart) before your first dose and periodically during treatment with CAMZYOS. It is very important to attend these echocardiography appointments so your doctor can monitor the effect of CAMZYOS on your heart. Your treatment dose may need to be adjusted to improve response or reduce side effects.

If you are a woman who could become pregnant, your doctor may perform a pregnancy test before starting treatment with CAMZYOS.

Your doctor may perform a test to determine how this medicine is broken down (metabolized) in your body, as this information may help guide your treatment with CAMZYOS (see section 3).

Tell your doctor or pharmacist immediately

• if you experience any of the following symptoms during treatment with CAMZYOS:
  • new or worsening shortness of breath,
  • chest pain,
  • fatigue,
  • palpitations (strong heartbeats, which may be fast or irregular), or
  • swelling of the legs.

These could be signs and symptoms of systolic dysfunction, a condition in which the heart cannot pump strongly enough, which may be potentially life-threatening and lead to heart failure.

• if you develop a serious infection or irregular heartbeats (arrhythmia), as this could increase the risk of developing heart failure.

Your doctor may need to perform additional tests of your heart function, interrupt treatment, or adjust your dose depending on how you feel.

Women of childbearing potential

If used during pregnancy, CAMZYOS may harm the unborn baby. Before starting treatment with CAMZYOS, your doctor will inform you of the risk and request a pregnancy test to confirm you are not pregnant. Your doctor will give you a card explaining why you must not become pregnant while taking CAMZYOS and what you should do to avoid pregnancy during treatment. You must use effective contraception during treatment and for 6 months after stopping treatment (see section "Pregnancy and breastfeeding").

If you become pregnant while taking CAMZYOS, inform your doctor immediately. Your doctor will stop treatment (see "If you stop taking CAMZYOS" in section 3).

Children and adolescents

Do not give this medicine to children (under 18 years of age) as the efficacy and safety of CAMZYOS have not been studied in children or adolescents.

Other medicines and CAMZYOS

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because other medicines may affect how CAMZYOS works.

Some medicines may increase the amount of CAMZYOS in your body and consequently increase the risk of serious side effects. Other medicines may reduce the amount of CAMZYOS in your body and may reduce its beneficial effects.

In particular, before taking CAMZYOS, tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines, or if you have changed your dose:

• certain medicines used to reduce stomach acid (such as cimetidine, omeprazole, esomeprazole, or pantoprazol).
• antibiotics for bacterial infections (such as clarithromycin, erythromycin).
• medicines for fungal infections (such as itraconazole, fluconazole, ketoconazole, posaconazole, and voriconazole).
• medicines used to treat depression (such as fluoxetine, fluvoxamine, or citalopram).
• medicines for HIV infection (such as ritonavir, cobicistat, or efavirenz).
• rifampicin (an antibiotic for bacterial infections such as tuberculosis).
• apalutamide, enzalutamide, mitotane, ceritinib, idelalisib, ribociclib, tucatinib (medicines used to treat various types of cancer).
• medicines for seizures or epilepsy (such as carbamazepine, phenytoin, phenobarbital, or primidone).
• St. John’s wort (a herbal medicine used to treat depression).
• medicines that affect the heart (such as beta-blockers and calcium channel blockers, e.g., verapamil and diltiazem).
• medicines that make the heart more resistant to abnormal activity (such as sodium channel blockers, e.g., disopyramide).
• ticlopidine (a medicine used to prevent heart attacks and strokes).
• letermovir (a medicine used to treat cytomegalovirus infection).
• norethisterone (a medicine used to treat various menstrual problems).
• prednisone (a corticosteroid).

If you are taking or have taken any of these medicines, or have changed your dose, your doctor should closely monitor you, as your dose of CAMZYOS may need to be changed or alternative treatments considered.

If you are unsure whether you are taking any of the medicines listed above, ask your doctor or pharmacist before taking CAMZYOS. Before stopping or changing the dose of a medicine or starting a new one, inform your doctor or pharmacist.

Do not take any of the above medicines occasionally or intermittently (instead of on a regular schedule), as this could alter the amount of CAMZYOS in your body.

Taking CAMZYOS with food and drink

Exercise caution when consuming grapefruit juice during treatment with CAMZYOS, as it may alter the amount of CAMZYOS in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Do not take CAMZYOS during pregnancy or during the 6 months before becoming pregnant, or if you could become pregnant and are not using effective contraception. CAMZYOS may harm the unborn baby. If you are a woman of childbearing potential, your doctor will inform you of this risk and check whether you are pregnant before starting treatment and regularly during treatment. Your doctor will give you a card explaining why you must not become pregnant while taking CAMZYOS. If you become pregnant, think you may be pregnant, or plan to become pregnant while taking CAMZYOS, inform your doctor immediately.

Breastfeeding

It is unknown whether CAMZYOS passes into breast milk. You must not breastfeed while taking CAMZYOS.

Driving and using machines

Mavacamten has a minor effect on the ability to drive and use machines. If you feel dizzy while taking this medicine, do not drive or ride a bicycle, or use tools or machinery.

CAMZYOS contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; essentially "sodium-free".

3. How to take CAMZYOS

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor again.

How much to take

The recommended starting dose is 2.5 mg or 5 mg taken orally once daily. Your doctor may perform a test to determine how this medicine is broken down (metabolized) in your body. The result may guide your treatment with CAMZYOS. If you have liver problems, your doctor may also prescribe you a reduced starting dose.

Your doctor will monitor your heart function while you are taking CAMZYOS by means of echocardiograms and may adjust your dose (increase, decrease, or temporarily suspend) based on the results.

Your doctor will tell you how much CAMZYOS you should take.

Your doctor will prescribe you a once-daily single dose of 2.5 mg, 5 mg, 10 mg, or 15 mg. The maximum single dose is 15 mg once daily.

Always take CAMZYOS exactly as prescribed by your doctor.

The first echocardiogram will be performed before starting treatment, and then again during follow-up visits at weeks 4, 8, and 12 to assess your response to CAMZYOS. After that, routine echocardiograms will be performed every 3 or 6 months. If your doctor changes your CAMZYOS dose at any time, an echocardiogram will be performed 4 weeks after the change to ensure you are receiving a beneficial dose.

How to take this medicine

• Swallow the capsule whole with a glass of water approximately at the same time each day.
• You may take the medicine with food or between meals.

If you take more CAMZYOS than you should

If you take more capsules than you should, contact your doctor or go immediately to a hospital if you have taken 3 to 5 times the recommended dose. If possible, bring the medicine package and this leaflet with you.

If you forget to take CAMZYOS

If you forget to take CAMZYOS at your usual time, take the dose as soon as you remember on the same day, and take your next dose at the usual time the following day. Do not take a double dose to make up for forgotten doses.

If you stop taking CAMZYOS

Do not stop taking CAMZYOS unless your doctor tells you to. If you wish to stop taking CAMZYOS, inform your doctor to discuss the best way to do so.

If you have any further questions about using this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

Tell your doctor or pharmacist immediately if you experience any of the following symptoms during treatment with CAMZYOS:

• onset or worsening of shortness of breath, chest pain, fatigue, palpitations (strong heartbeats that may be rapid or irregular), or swelling of the legs. These could be signs and symptoms of systolic dysfunction (a condition in which the heart cannot pump strongly enough), which may lead to heart failure and can be potentially fatal (Frequent adverse effect)

Very common (may affect more than 1 in 10 people)

• dizziness
• difficulty breathing

Common (may affect up to 1 in 10 people)

• fainting

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CAMZYOS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging following EXP/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CAMZYOS

• The active substance(s) is (are) mavacamten. Each hard capsule contains 2.5 mg, 5 mg, 10 mg, or 15 mg of mavacamten.

• The other components are:

• capsule contents: colloidal hydrated silica, mannitol (E421), hypromellose (E464), sodium croscarmellose (E468, see section 2 "CAMZYOS contains sodium"), magnesium stearate.

• capsule shell:

CAMZYOS 2.5mg hard capsules

gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172)

CAMZYOS 5mg hard capsules

gelatin, titanium dioxide (E171), yellow iron oxide (E172)

CAMZYOS 10mg hard capsules

gelatin, titanium dioxide (E171), red iron oxide (E172)

CAMZYOS 15mg hard capsules

gelatin, titanium dioxide (E171), black iron oxide (E172)

• printing ink: black iron oxide (E172), shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), and potassium hydroxide (E525).

Nature of the product and pack contents

• CAMZYOS 2.5 mg hard capsules, approximately 18.0 mm in length, have an opaque light purple cap and an opaque white body, with "2.5 mg" printed in black on the cap and "Mava" on the body.
• CAMZYOS 5 mg hard capsules, approximately 18.0 mm in length, have an opaque yellow cap and an opaque white body, with "5 mg" printed in black on the cap and "Mava" on the body.
• CAMZYOS 10 mg hard capsules, approximately 18.0 mm in length, have an opaque pink cap and an opaque white body, with "10 mg" printed in black on the cap and "Mava" on the body.
• CAMZYOS 15 mg hard capsules, approximately 18.0 mm in length, have an opaque grey cap and an opaque white body, with "15 mg" printed in black on the cap and "Mava" on the body.

The hard capsules are supplied in aluminum blisters containing 14 hard capsules.

Each pack contains 14, 28, or 98 hard capsules. Only certain pack sizes may be marketed.

Marketing Authorization Holder

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Manufacturer

Swords Laboratories Unlimited Company T/A Bristol-Myers Squibb Pharmaceutical Operations, External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.