CAMZYOS 15 mg HARD CAPSULES

Introduction

Patient Information Leaflet

CAMZYOS 2.5mg hard capsules

CAMZYOS 5mg hard capsules

CAMZYOS 10mg hard capsules

CAMZYOS 15mg hard capsules

mavacamten

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. See the end of section 4 for 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.
• Your doctor will give you a patient information card and a patient guide. Read the guide carefully and follow the instructions.
• Always show the patient information card to your doctor, pharmacist or nurse when you see them or go to hospital.
• If you have any further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is CAMZYOS and what is it used for

What is CAMZYOS

CAMZYOS contains the active substance mavacamten. Mavacamten is a reversible inhibitor of cardiac myosin, which means it changes 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 (HOCM).

About obstructive hypertrophic cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the walls of the left chamber of the heart (ventricle) contract more forcefully and become thicker than normal. The thickening of the walls can block (obstruct) blood flow out of the heart and also make the heart become stiff. This obstruction makes it more difficult for blood to enter and leave the heart and be pumped to the body with each heartbeat, a disease called obstructive hypertrophic cardiomyopathy (HOCM). The symptoms of HOCM are: chest pain and shortness of breath (especially with physical exercise); fatigue, abnormal heart rhythms, dizziness, feeling like you are about to pass out, fainting (syncope) and swelling of the ankles, feet, legs, abdomen and/or neck veins.

How CAMZYOS works

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

2. What you need to know before you take 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 may 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 for treating infections such as itraconazole, ketoconazole, posaconazole or voriconazole;
• certain medicines for treating bacterial infections such as antibiotics or clarithromycin;
• certain medicines for treating HIV infection such as cobicistat or ritonavir;
• certain medicines for treating cancer such as ceritinib, idelalisib or tucatinib;

Ask your doctor if 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 with an echocardiogram (an ultrasound test that takes pictures of the heart) before your first dose and periodically during treatment with CAMZYOS. It is very important to attend these echocardiogram appointments so that your doctor can check the effect of CAMZYOS on your heart. You may need to adjust the dose of your treatment to improve the response or reduce side effects.

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

Your doctor may perform a test to find out how your body breaks down (metabolizes) this medicine, as this information can be used to guide your treatment with CAMZYOS (see section 3).

Tell your doctor or pharmacist immediately

• if you have any of these symptoms during treatment with CAMZYOS:
• • worsening or appearance of shortness of breath,
  • chest pain,
  • fatigue,
  • palpitations (strong, fast or irregular heartbeats) or
  • swelling of the legs.

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

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

Your doctor may need to perform more tests of your heart function, interrupt treatment or change the dose based on how you feel.

Women of childbearing potential

If CAMZYOS is used during pregnancy, it may harm the unborn baby. Before starting treatment with CAMZYOS, your doctor will inform you of the risk and ask you to have a pregnancy test to make sure you are not pregnant. Your doctor will give you a card explaining why you should not become pregnant while taking CAMZYOS. If you become pregnant, think you may be pregnant or plan to become pregnant while taking CAMZYOS, tell your doctor immediately.

Children and adolescents

Do not give this medicine to children (under 18 years) because 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 take any other medicines. This is because other medicines may affect the way CAMZYOS works.

Some medicines may increase the amount of CAMZYOS in your body and, as a result, the likelihood of you experiencing side effects that can be serious. 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 the dose:

• certain medicines used to reduce the amount of acid produced by the stomach (such as cimetidine, omeprazole, esomeprazole or pantoprazole).
• antibiotics for bacterial infections (such as clarithromycin, erythromycin).
• medicines for treating fungal infections (such as itraconazole, fluconazole, ketoconazole, posaconazole and voriconazole).
• medicines used to treat depression (such as fluoxetine, fluvoxamine or citalopram).
• medicines for HIV infections (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 different types of cancer).
• medicines for fits (seizures) or epilepsy (such as carbamazepine, phenytoin, phenobarbital or primidone).
• St. John's Wort (a herbal medicine for treating depression).
• medicines that affect the heart (such as beta-blockers and calcium channel blockers, for example, verapamil and diltiazem).
• medicines that make the heart more resistant to abnormal activity (such as sodium channel blockers, for example, disopyramide).
• ticlopidine (a medicine that prevents heart attacks and strokes).
• letermovir (a medicine for treating cytomegalovirus infections).
• norethindrone (a medicine for treating various menstrual problems).
• prednisone (a corticosteroid).

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

If you are not sure if you are taking any of the medicines mentioned above, ask your doctor or pharmacist before taking CAMZYOS. Before stopping or changing the dose of a medicine or starting to take a new one, tell your doctor or pharmacist.

Do not take any of the above medicines on an occasional or as-needed basis (instead of on a regular schedule), as this could change the amount of CAMZYOS in your body.

Taking CAMZYOS with food and drinks

You should be cautious when taking grapefruit juice while being treated with CAMZYOS, as it may change the amount of CAMZYOS in your body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known if CAMZYOS passes into breast milk. You should 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 cycle or use tools or machines.

CAMZYOS contains sodium

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

3. How to take CAMZYOS

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor.

How much to take

The recommended initial dose is 2.5 mg or 5 mg orally once daily. Your doctor may perform a test to find out how your body breaks down (metabolizes) this medicine. The result may guide your treatment with CAMZYOS. If you have liver problems, your doctor may also prescribe a reduced initial dose.

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

Your doctor will tell you how much CAMZYOS to take.

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

Always take CAMZYOS as your doctor has prescribed.

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 dose of CAMZYOS at any time, you will have an echocardiogram 4 weeks later to make sure you are receiving a beneficial dose.

How to take this medicine

• Swallow the capsule whole with a glass of water at about the same time each day.
• You can take the medicine with or without food.

If you take more CAMZYOS than you should

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

If you forget to take CAMZYOS

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

If you stop taking CAMZYOS

Do not stop taking CAMZYOS unless your doctor tells you to. If you want to stop taking CAMZYOS, talk to your doctor about the best way to do so.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor or pharmacist immediatelyif you have any of these symptoms during treatment with CAMZYOS:

• appearance or worsening of shortness of breath, chest pain, fatigue, palpitations (strong, fast or irregular heartbeats) or swelling of the legs. These could be signs and symptoms of systolic dysfunction (a condition in which the heart cannot pump with enough force), which can lead to heart failure and be potentially life-threatening (Common side effect)

Very common (may affect more than1 in 10people)

• dizziness
• shortness of breath

Common (may affect up to1 in 10people)

• fainting

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are 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. Storage of CAMZYOS

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 blister and on the carton after EXP/CAD. The expiry date refers to 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. Packaging Contents and Additional Information

CAMZYOS Composition

• The active ingredient(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 content: hydrated colloidal 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).

Product Appearance and Packaging Contents

• The hard capsules (capsules) of CAMZYOS 2.5 mg, approximately 18.0 mm in length, have a light purple opaque cap and a white opaque body, and are printed with "2.5 mg" in black on the cap and "Mava" on the body.
• The hard capsules (capsules) of CAMZYOS 5 mg, approximately 18.0 mm in length, have a yellow opaque cap and a white opaque body, and are printed with "5 mg" in black on the cap and "Mava" on the body.
• The hard capsules (capsules) of CAMZYOS 10 mg, approximately 18.0 mm in length, have a pink opaque cap and a white opaque body, and are printed with "10 mg" in black on the cap and "Mava" on the body.
• The hard capsules (capsules) of CAMZYOS 15 mg, approximately 18.0 mm in length, have a gray opaque cap and a white opaque body, and are printed with "15 mg" in black on the cap and "Mava" on the body.

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

Each package contains 14, 28, or 98 hard capsules. Only certain package 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 Last Revision of this Leaflet:

Other Sources of Information

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