Camzyos

Package leaflet: Information for the patient

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

mavacamten
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicinal product. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• Your doctor will provide you with a Patient Card and Patient Guide. Read them carefully and follow the instructions provided.
• Always show your Patient Card to your doctor, pharmacist or nurse when consulting them or if you are admitted to hospital.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 inhibitor of cardiac myosin, meaning it modifies the action of the muscle protein myosin in heart muscle cells.
What CAMZYOS is used for
CAMZYOS is used to treat adults with a form of heart disease called obstructive hypertrophic cardiomyopathy (oHCM).
Information on obstructive hypertrophic cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a condition in which the walls of the left heart chamber (ventricle) contract more forcefully and become thicker than normal. When the walls thicken, they can 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 exit the heart and to be pumped to the rest of the body with each heartbeat: this condition is known as obstructive hypertrophic cardiomyopathy (oHCM). Symptoms of oHCM include chest pain and shortness of breath (particularly during physical exercise), fatigue, abnormal heart rhythms, dizziness, lightheadedness, 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 can improve symptoms and the ability to carry out daily activities.

2. What you need to know before taking CAMZYOS

Do not take CAMZYOS if:

• you are allergic to mavacamten or to any of the other ingredients of this medicine (listed in section 6)
• you are pregnant or are a woman of childbearing potential who is not using an effective contraceptive method
• you are taking medicines that can increase the level of CAMZYOS in your blood, such as:
  • oral medicines for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole,
  • certain medicines for bacterial infections such as the antibiotic clarithromycin,
  • certain medicines for HIV infection such as cobicistat, ritonavir,
  • certain cancer treatments such as ceritinib, idelalisib, 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 examinations
Your doctor will assess how your heart is working (cardiac function) using an echocardiogram (an ultrasound test that produces images of the heart) before your first dose and periodically during treatment with CAMZYOS. It is very important to attend these scheduled echocardiogram appointments, as your doctor needs to monitor the effect of CAMZYOS on your heart. Your treatment dose may need to be adjusted to improve your response or to 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 carry out tests to monitor how this medicine is broken down (metabolized) in your body, as this information may help guide your treatment with CAMZYOS (see section 3).
Immediately inform your doctor or pharmacist:

• if you experience any of the following symptoms during treatment with CAMZYOS:
  • new or worsening shortness of breath,
  • chest pain,
  • fatigue,
  • palpitations (strong heartbeat 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 and which can be life-threatening and lead to heart failure.
• if you develop a serious infection or an irregular heartbeat (arrhythmia), as this may increase your risk of developing heart failure. Depending on how you feel, your doctor may need to perform additional tests of your cardiac function, suspend treatment, or adjust your dose.

Women of childbearing potential
If used during pregnancy, CAMZYOS may cause harm to the unborn child. Before starting treatment with CAMZYOS, your doctor will explain to you the risks involved and perform a pregnancy test to rule out pregnancy. Your doctor will provide you with a card explaining why you must not become pregnant during treatment with CAMZYOS and what you need to 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 discontinue 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 and adolescents.
Other medicines and CAMZYOS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This precaution is necessary because some other medicines may affect the action of CAMZYOS.
Some medicines may increase the amount of CAMZYOS in your body and make side effects, including serious ones, more likely. Other medicines may reduce the amount of CAMZYOS in your body and could reduce its beneficial effects.
In particular, before taking CAMZYOS, inform your doctor or pharmacist if you are taking, have recently taken, or have changed the dose of any of the following medicines:

• certain medicines used to reduce stomach acid production (cimetidine, omeprazole, esomeprazole, pantoprazole)
• antibiotics for bacterial infections (such as clarithromycin, erythromycin)
• medicines used to treat fungal infections (such as itraconazole, fluconazole, ketoconazole, posaconazolo, and voriconazole)
• medicines used to treat depression (such as fluoxetine, fluvoxamine, citalopram)
• medicines for HIV infection (such as ritonavir, cobicistat, efavirenz)
• rifampicin (an antibiotic for bacterial infections such as tuberculosis)
• apalutamide, enzalutamide, mitotane, ceritinib, idelalisib, ribociclib, tucatinib (medicines used to treat certain types of cancer)
• medicines for seizures (convulsions) or epilepsy (such as carbamazepine and phenytoin, phenobarbital, primidone)
• St. John’s wort (a herbal medicine for 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 to prevent heart attacks and strokes)
• letermovir (a medicine for the treatment of cytomegalovirus infections)
• norethindrone (a medicine for treating various menstrual disorders)
• prednisone (a steroid).

If you are taking or have taken any of these medicines or have changed their dose, your doctor must monitor you closely and may need to adjust your CAMZYOS dose or consider alternative treatments.
If you are unsure whether you are taking any of the medicines listed above, consult your doctor or pharmacist before taking CAMZYOS. Before stopping or changing the dose of any medicine or before starting a new medicine, consult your doctor or pharmacist.
Do not take any of the above medicines occasionally or intermittently (not regularly), as this could alter the amount of CAMZYOS in your body.
CAMZYOS with food and drinks
You should exercise caution when drinking grapefruit juice during treatment with CAMZYOS, as it may alter the amount of CAMZYOS in your body.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Do not take CAMZYOS during pregnancy, within 6 months before attempting pregnancy, or if you are a woman of childbearing potential who is not using an effective contraceptive method.
CAMZYOS may harm the unborn child. If you are a woman who could become pregnant, your doctor will inform you of the risks and will check whether you are pregnant before starting treatment and periodically during treatment. Your doctor will provide you with a card explaining why you must not become pregnant during treatment with CAMZYOS. If you become pregnant, suspect you are pregnant, or are planning a pregnancy while taking CAMZYOS, inform your doctor immediately.
Breastfeeding
It is not known whether CAMZYOS passes into breast milk. You must not breastfeed during treatment with CAMZYOS.
Driving and using machines
Mavacamten may have a slight effect on the ability to drive and use machines. If you feel dizzy while taking this medicine, do not drive, ride a bicycle, or use tools or machinery.
CAMZYOS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially ‘sodium-free’.

3. How to take CAMZYOS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor.

How much medicine to take

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

During treatment with CAMZYOS, your doctor will monitor your heart function using an echocardiogram and, based on the results, may adjust (increase, decrease, or temporarily interrupt) your dose.

Your doctor will determine the dose of CAMZYOS you should take.

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

Always take CAMZYOS exactly as prescribed by your doctor.

The first echocardiogram will be performed before starting treatment, followed by further echocardiograms at check-up visits at weeks 4, 8, and 12 to assess your response to CAMZYOS. Subsequently, routine echocardiograms will be performed every 3 or 6 months. If your doctor adjusts your CAMZYOS dose at any time, an echocardiogram will be performed 4 weeks after the dose change to confirm that the dose you are taking provides benefit.

How to take this medicine

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

If you take more CAMZYOS than you should

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

If you forget to take CAMZYOS

If you forget to take your usual dose of CAMZYOS, take it 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 a missed capsule.

If you stop taking CAMZYOS

Do not stop treatment with CAMZYOS unless your doctor tells you to. If you wish to discontinue treatment with CAMZYOS, inform your doctor to receive advice on the best way to do so.

If you have any questions about how to use this medicine, consult 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 immediately if you experience any of the following symptoms during treatment with CAMZYOS:

• new or worsening shortness of breath, chest pain, fatigue, palpitations (a strong heartbeat 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 is unable to pump with sufficient force), which may lead to heart failure and can be life-threatening (common side 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 side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton after
EXP/Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CAMZYOS contains

• The active substance is 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 2.5 mg hard capsules: gelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172)
    CAMZYOS 5 mg hard capsules: gelatin, titanium dioxide (E171), yellow iron oxide (E172)
    CAMZYOS 10 mg hard capsules: gelatin, titanium dioxide (E171), red iron oxide (E172)
    CAMZYOS 15 mg 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), potassium hydroxide (E525).

Description of the appearance of CAMZYOS and contents of the pack

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

The hard capsules are packed in aluminium foil blisters containing 14 hard capsules.
Each pack contains 14, 28, or 98 hard capsules. Not all pack sizes may be marketed.

Marketing Authorisation 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 Authorisation Holder in your country:

Belgique/België/Belgien Lietuva
N.V. Bristol-Myers Squibb Belgium S.A. Swixx Biopharma UAB
Tél/Tel: + 32 2 352 76 11 Tel: + 370 52 369140
[email protected] [email protected]

България Luxembourg/Luxemburg
Swixx Biopharma EOOD N.V. Bristol-Myers Squibb Belgium S.A.
Teл.: + 359 2 4942 480 Tél/Tel: + 32 2 352 76 11
[email protected] [email protected]

Česká republika Magyarország
Bristol-Myers Squibb spol. s r.o. Bristol-Myers Squibb Kft.
Tel: + 420 221 016 111 Tel.: + 36 1 301 9797
[email protected] [email protected]

Danmark Malta
Bristol-Myers Squibb Denmark A.M. Mangion Ltd
Tlf: + 45 45 93 05 06 Tel: + 356 23976333
[email protected] [email protected]

Deutschland Nederland
Bristol-Myers Squibb GmbH & Co. KGaA Bristol-Myers Squibb B.V.
Tel: 0800 0752002 (+ 49 89 121 42 350) Tel: + 31 (0)30 300 2222
[email protected] [email protected]

Eesti Norge
Swixx Biopharma OÜ Bristol-Myers Squibb Norway AS
Tel: + 372 640 1030 Tlf: + 47 67 55 53 50
[email protected] [email protected]

Ελλάδα Österreich
Bristol-Myers Squibb A.E. Bristol-Myers Squibb GesmbH
Τηλ: + 30 210 6074300 Tel: + 43 1 60 14 30
[email protected] [email protected]

España Polska
Bristol-Myers Squibb, S.A. Bristol-Myers Squibb Polska Sp. z o.o.
Tel: + 34 91 456 53 00 Tel.: + 48 22 2606400
[email protected] [email protected]

France Portugal
Bristol-Myers Squibb SAS Bristol-Myers Squibb Farmacêutica Portuguesa, S.A.
Tél: + 33 (0)1 58 83 84 96 Tel: + 351 21 440 70 00
[email protected] [email protected]

Hrvatska România
Swixx Biopharma d.o.o. Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 385 1 2078 500 Tel: + 40 (0)21 272 16 19
[email protected] [email protected]

Ireland Slovenija
Bristol-Myers Squibb Pharmaceuticals uc Swixx Biopharma d.o.o.
Tel: 1 800 749 749 (+ 353 (0)1 483 3625) Tel: + 386 1 2355 100
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: + 354 535 7000 Tel: + 421 2 20833 600
[email protected] [email protected]

Italia Suomi/Finland
Bristol-Myers Squibb S.r.l. Oy Bristol-Myers Squibb (Finland) Ab
Tel: + 39 06 50 39 61 Puh/Tel: + 358 9 251 21 230
[email protected] [email protected]

Κύπρος Sverige
Bristol-Myers Squibb A.E. Bristol-Myers Squibb Aktiebolag
Τηλ: 800 92666 (+ 30 210 6074300) Tel: + 46 8 704 71 00
[email protected] [email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

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