Prospect: information for the patient

CAMZYOS 2.5mg hard capsules

CAMZYOS 5mg hard capsules

CAMZYOS 10mg hard capsules

CAMZYOS 15mg hard capsules

mavacamten

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• Your doctor will provide you with a patient information leaflet and a patient guide. Read the guide carefully and follow the instructions.
• Always show the patient information leaflet to your doctor, pharmacist, or nurse when you see them or visit the hospital.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section4.

What is CAMZYOS

CAMZYOS contains the active ingredient mavacamten. Mavacamten is a reversible inhibitor of cardiac myosin, meaning it changes the action of myosin, a muscle protein, in heart cells.

What is CAMZYOS used for

CAMZYOS is used to treat adults with a type of heart disease called obstructive hypertrophic cardiomyopathy (OHCM) that causes symptoms.

About obstructive hypertrophic cardiomyopathy

Obstructive hypertrophic cardiomyopathy (OHCM) is a disease in which the walls of the left heart chamber (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 stiff. This obstruction makes it harder for blood to enter and leave the heart and be pumped to the body with each heartbeat, a disease called obstructive hypertrophic cardiomyopathy (OHCM). Symptoms of OHCM include chest pain and difficulty breathing (especially with physical exercise); fatigue, abnormal heart rhythms, dizziness, feeling like you are about to 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 blood flow obstruction to the body. As a result, it may improve your symptoms and ability to stay active.

Do not take CAMZYOS

• If you are allergic to mavacamten or any of the other components of this medication (listed in section6).
• If you are pregnant or may become pregnant and are not using effective birth control methods.
• If you are taking medications that may increase the level of CAMZYOS in your blood, such as:

• Oral medications for treating infections like itraconazole, ketoconazole, posaconazole, or voriconazole;
• Certain medications for treating bacterial infections like antibiotics or clarithromycin;
• Certain medications for treating HIV like cobicistat or ritonavir;
• Certain medications for treating cancer like certinib, idelalisib, or tucatinib;

Ask your doctor if the medication you are taking prevents you from taking mavacamten. See section "Other medications and CAMZYOS".

Warnings and precautions

Routine tests

Your doctor will evaluate the functioning of your heart using an echocardiogram (a test that takes images of your heart) before your first dose and periodically during treatment with CAMZYOS. It is very important to attend these appointments for echocardiograms 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 may become pregnant, your doctor may perform a pregnancy test before starting treatment with CAMZYOS.

Your doctor may perform a test to know how this medication is degraded (metabolized) in your body, as this information can be used to guide your treatment with CAMZYOS (see section3).

Inform your doctor or pharmacist immediately

• If you have any of the following symptoms during your treatment with CAMZYOS:
• • Appearance or worsening of difficulty breathing,
  • Chest pain,
  • Fatigue,
  • Palpitations (strong, accelerated, or irregular heartbeats) or
  • Swelling of the legs.

These may be signs and symptoms of systolic dysfunction, a condition in which the heart is not pumping strongly enough, which can be potentially fatal and lead to heart failure.

• 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 cardiac function, interrupt treatment, or change the dose based on how you feel.

Women who may become pregnant

If used during pregnancy, CAMZYOS may harm the fetus. Before starting treatment with CAMZYOS, your doctor will inform you of the risk and ask you to perform a pregnancy test to ensure you are not pregnant. Your doctor will give you a card explaining why you should not become pregnant while taking CAMZYOS. You will also be told what to do to avoid becoming pregnant while taking CAMZYOS. You must use effective birth control methods during treatment and for 6months after stopping treatment (see section "Pregnancy and breastfeeding").

If you become pregnant while taking CAMZYOS, inform your doctor immediately. Your doctor will interrupt treatment (see "If you interrupt treatment with CAMZYOS" in section3).

Children and adolescents

Do not administer this medication to children (under 18years) because the efficacy and safety of CAMZYOS have not been studied in children or adolescents.

Other medications and CAMZYOS

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because other medications may affect the functioning of CAMZYOS.

Some medications may increase the amount of CAMZYOS in your body and, consequently, the likelihood of experiencing adverse effects that may be severe. Other medications may reduce the amount of CAMZYOS in your body and may reduce its beneficial effects.

Especially, before taking CAMZYOS, inform your doctor or pharmacist if you are taking or have taken recently any of the following medications, or if you have changed your dose:

• Some medications 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).
• Medications for treating fungal infections (such as itraconazole, fluconazole, ketoconazole, posaconazole, and voriconazole).
• Medications used to treat depression (such as fluoxetine, fluvoxamine, or citalopram).
• Medications 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 (medications used to treat different types of cancer).
• Medications for seizures or epilepsy (such as carbamazepine, phenytoin, phenobarbital, or primidone).
• St. John's Wort (a medication made from plants to treat depression).
• Medications that affect the heart (such as beta-blockers and calcium channel blockers, for example, verapamil and diltiazem).
• Medications that make the heart more resistant to abnormal activity (such as sodium channel blockers, for example, disopyramide).
• Ticlopidine (a medication that prevents heart attacks and strokes).
• Letermovir (a medication for treating cytomegalovirus infections).
• Noretindrone (medication for treating various menstrual problems).
• Prednisone (corticosteroid).

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

If you are unsure whether you are taking any of the medications mentioned above, ask your doctor or pharmacist before taking CAMZYOS. Before interrupting or changing the dose of a medication or starting a new one, inform your doctor or pharmacist.

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

Administration of CAMZYOS with food and beverages

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Do not take CAMZYOS during pregnancy or for 6months before becoming pregnant, or if you may become pregnant and are not using effective birth control methods. CAMZYOS may harm the fetus. If you are a woman who may become pregnant, your doctor will inform you of this 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, inform your doctor immediately.

Breastfeeding

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

Driving and operating machinery

Mavacamten has a small effect on your ability to drive and operate machinery. If you feel dizzy while taking this medication, do not drive, ride a bike, or use tools or machinery.

CAMZYOS contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

How much to take

The recommended initial dose is 2.5mg or 5mg orally once a day. Your doctor may perform a test to know how this medication degrades (metabolizes) in your body. 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 the functioning of your heart while taking CAMZYOS through echocardiograms and may modify your dose (increase, decrease, or temporarily suspend it) based on the results.

Your doctor will indicate the amount of CAMZYOS you should take.

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

Take CAMZYOS exactly as your doctor has prescribed.

The first echocardiogram will be performed before starting treatment, and then again during follow-up visits at weeks4, 8, and12 to evaluate your response to CAMZYOS. From then on, routine echocardiograms will be performed every 3 or 6months. If your doctor changes your CAMZYOS dose at any time, an echocardiogram will be performed 4weeks later to ensure you are receiving a beneficial dose.

How to take this medication

• Swallow the entire capsule with a glass of water approximately at the same time every day.
• You can take the medication 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 3to 5times the recommended dose. If possible, bring the medication packaging 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 compensate for the missed doses.

If you interrupt treatment with CAMZYOS

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

If you have any other doubts about the use of this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Severe Adverse Effects

Inform your doctor or pharmacist immediatelyif you experience any of the following symptoms during treatment with CAMZYOS:

• appearance or worsening of difficulty breathing, chest pain, fatigue, palpitations (strong and possibly 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 sufficient force), which can cause heart failure and be potentially fatal(Frequent Adverse Effect)

Very Frequent (may affect more than1 in 10people)

• dizziness
• difficulty breathing

Frequent (may affect up to1 in 10people)

• syncope (fainting)

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the blister pack and on the outer packaging after EXP/CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of CAMZYOS

• The active principle(s) is (are) mavacamten.Cada cápsula dura contiene 2,5mg, 5mg, 10mg o 15mg de mavacamten.
• The other components are:

• content of the capsule: colloidal silica, mannitol (E421), hypromellose (E464), croscarmellose sodium (E468, see section2 "CAMZYOS contains sodium"), magnesium stearate.
• capsule coating:

CAMZYOS 2,5mg hard capsules

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

CAMZYOS 5mg hard capsules

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

CAMZYOS 10mg hard capsules

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

CAMZYOS 15mg hard capsules

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

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

Appearance of the product and contents of the pack

• The hard capsules (capsules) of CAMZYOS 2,5mg, approximately 18.0mm in length, have an opaque light purple cap and an opaque white body, and are printed in black on the cap with "2.5mg " and "Mava" on the body.
• The hard capsules (capsules) of CAMZYOS 5mg, approximately 18.0mm in length, have an opaque yellow cap and an opaque white body, and are printed in black on the cap with "5mg" and "Mava" on the body.
• The hard capsules (capsules) of CAMZYOS 10mg, approximately 18.0mm in length, have an opaque pink cap and an opaque white body, and are printed in black on the cap with "10mg" and "Mava" on the body.
• The hard capsules (capsules) of CAMZYOS 15mg, approximately 18.0mm in length, have an opaque grey cap and an opaque white body, and are printed in black on the cap with "15mg" and "Mava" on the body.

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

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

Marketing Authorisation Holder

Bristol‑Myers Squibb Pharma EEIG

Plaza 254

Blanchardstown Corporate Park2

Dublin 15, D15 T867

Irlanda

Manufacturer

Swords Laboratories Unlimited Company T/A Bristol‑Myers Squibb Pharmaceutical Operations, External Manufacturing

Plaza 254

Blanchardstown Corporate Park2

Dublin 15, D15 T867

Irlanda

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

Last update of the summary of product characteristics:

Other sources of information

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