CAMZYOS 2.5 mg Hard capsules

Зміст інструкції

1. CAMZYOS 2.5 mg hard capsules, 5 mg hard capsules, 10 mg hard capsules, 15 mg hard capsules
   1. What is CAMZYOS and what is it 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

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

mavacamten

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

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 Guide for the Patient. Read them carefully and follow the instructions provided.
• Always show the Patient Card to your doctor, pharmacist or nurse when you consult them or if you go 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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 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, meaning it modifies the action of the muscle protein myosin in the heart muscle cells.

What is CAMZYOS used for
CAMZYOS is used to treat adults with a form of heart disease called obstructive hypertrophic cardiomyopathy (HCM).

Information about obstructive hypertrophic cardiomyopathy
Hypertrophic cardiomyopathy (HCM) is a condition in which the walls of the left heart chamber
(ventricle) contract with greater force and become thicker than normal. When the walls thicken they can block (obstruct) the flow of blood out of the heart and can also
stiffen the heart. The obstruction makes it more difficult for blood to enter and leave the heart and to be
pumped to the rest of the body with each heartbeat: this condition is known as obstructive hypertrophic cardiomyopathy (HCM). The symptoms of HCM are: chest pain and shortness of breath (in
particular during exercise), fatigue, abnormal heart rhythms, dizziness, feeling faint, fainting (syncope) and swelling of ankles, feet, legs, abdomen and/or neck veins.

How CAMZYOS works
CAMZYOS works by reducing the excessive contraction of the heart and the obstruction of blood flow
to the body. As a result, it can improve symptoms and the ability to lead an active life.

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)
• you are pregnant or are a woman of childbearing potential who is not using effective contraception
• you are taking medicines that can increase the level of CAMZYOS in the blood, such as:
• oral medicines to treat fungal infections such as itraconazole, ketoconazole, posaconazole, voriconazole,
• certain medicines to treat bacterial infections such as the antibiotic clarithromycin,
• certain medicines to treat HIV infection such as cobicistat, ritonavir,
• certain medicines to treat cancer such as ceritinib, idelalisib, 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 how your heart is working (cardiac function) using an echocardiogram (an
ultrasound scan that produces images of the heart) before the first dose and periodically during
treatment with CAMZYOS. It is very important to keep these appointments where echocardiograms are
performed, because the doctor needs to check the effect of CAMZYOS on the heart. The
dose of treatment 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 perform a test to check how this medicine is broken down (metabolized)
in your body, as this information may be used to guide treatment with CAMZYOS (see section 3).

Tell your doctor or pharmacist immediately:

• if you experience any of these symptoms during treatment with CAMZYOS:
• new or worsening shortness of breath,
• chest pain,
• fatigue,
• palpitations (strong heartbeat that 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 is unable to pump with sufficient force and which can be life-threatening and cause heart failure
• if you developa serious infection or an irregular heartbeat (arrhythmia), as this may increase the risk of developing heart failure. Depending on how you feel, your doctor may need to perform further tests of your cardiac function, stop treatment or adjust the dose.

Women of childbearing potential
If used during pregnancy, CAMZYOS can cause harm to the unborn child. Before starting treatment
with CAMZYOS, your doctor will explain the risks to you and perform a pregnancy test to
exclude the possibility that you are pregnant. Your doctor will give you a card explaining
why you should not become pregnant during treatment with CAMZYOS and what you should do to
avoid becoming pregnant during treatment with CAMZYOS. 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, tell your doctor immediately. The
doctor will stop the 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) because the efficacy and
safety of CAMZYOS have not been studied in children and adolescents.

Other medicines and CAMZYOS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This precaution is necessary because some other medicines can
affect the action of CAMZYOS.
Some medicines can increase the amount of CAMZYOS in the body and make side effects, even serious ones, more
likely. Other medicines can reduce the amount of CAMZYOS in the body and may reduce its beneficial effects.
In particular, before taking CAMZYOS tell your doctor or pharmacist if you are taking, have
recently taken or have changed the dose of any of the following medicines:

• some medicines used to reduce the amount of acid produced by the stomach (cimetidine, omeprazole, esomeprazole, pantoprazole)
• antibiotics for bacterial infections (such as clarithromycin, erythromycin)
• medicines used to treat fungal infections (such as itraconazole, fluconazole, ketoconazole, posaconazole 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 some types of cancer)
• medicines for seizures 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 for preventing heart attacks and strokes)
• letermovir (a medicine for treating cytomegalovirus infections)
• noretindrone (a medicine for treating various menstrual problems)
• prednisone (a steroid).

If you are taking or have taken any of these medicines or have changed the dose, your doctor needs to
monitor you carefully, may need to adjust the dose of CAMZYOS or consider
alternative treatments.
If you are not sure whether 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 before starting to take a new medicine, ask your doctor or pharmacist.
Do not take any of the above medicines occasionally or from time to time (not
regularly), as this may change the amount of CAMZYOS in the body.

CAMZYOS with food and drink
You should be careful when drinking grapefruit juice during treatment with CAMZYOS, as
it may change the amount of CAMZYOS in the body.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor for advice before taking this medicine.
Pregnancy
Do not take CAMZYOS during pregnancy, for 6 months before becoming pregnant or if you are a
woman who could become pregnant and is not using effective contraception.
CAMZYOS can cause harm to the unborn child. If you are a woman who could become pregnant, your doctor
will inform you of the risk and check if you are pregnant before starting treatment and periodically
during treatment. Your doctor will give you a card explaining why you should not become
pregnant during treatment with CAMZYOS. If you become pregnant, suspect you are pregnant or are
planning a pregnancy while taking CAMZYOS, tell your doctor immediately.
Breastfeeding
It is not known whether CAMZYOS passes into breast milk. Do not breastfeed while
taking CAMZYOS.

Driving and using machines
Mavacamten may have a slight effect on the ability to drive and operate machines. If
you experience dizziness while taking this medicine, do not drive, ride a bicycle or use
tools or machines.

CAMZYOS contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, that is to say it is essentially ‘sodium-free’.

3. How to take CAMZYOS

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor.

How much medicine to take
The recommended starting dose is 2.5 mg or 5 mg by mouth once a day. Your doctor may
perform a test to check how this medicine is broken down (metabolized) in your
body. The result may guide treatment with CAMZYOS. If you have liver problems,
your doctor may prescribe a reduced starting dose.
During treatment with CAMZYOS, your doctor will monitor the function of your heart using
an echocardiogram and, based on the results, may modify (increase, decrease or temporarily interrupt
) the dose.
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 single maximum
dose is 15 mg once a day.
Always take CAMZYOS as prescribed by your doctor.
The first echocardiogram will be performed before starting treatment, then again at
follow-up visits at weeks 4, 8 and 12 to evaluate your response to CAMZYOS. Subsequently
routine echocardiograms will be performed every 3 months or 6 months. If at any time your
doctor changes the dose of CAMZYOS, an echocardiogram will be performed 4 weeks later to verify
that the dose you are taking offers a benefit.

How to take this medicine

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

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 a dose 3 to 5 times the recommended dose. If possible, bring the packaging 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 the forgotten capsule.

If you stop taking CAMZYOS
Do not stop treatment with CAMZYOS unless your doctor tells you to. If you wish to
stop treatment with CAMZYOS, inform your doctor for explanations on the best
way to do so.
If you have any doubts about 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 experience any of the following symptoms
during treatment with CAMZYOS:

• onset or worsening of shortness of breath, chest pain, fatigue, palpitations (strong heartbeat that may be fast or irregular) or swelling of the legs. These may 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 life-threatening (common side effect).

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

• dizziness
• difficulty in breathing

Common (may affect up to 1 in 10 people)

• fainting

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system indicated 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 which is stated on the blister and the packaging box after
EXP/Scad. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CAMZYOS contains

• The active ingredient is mavacamten. Each hard capsule contains 2.5 mg, 5 mg, 10 mg or 15 mg of mavacamten.
• The other ingredients are:
• capsule contents: hydrated colloidal silica, mannitol (E421), hypromellose (E464), sodium croscarmellose (E468, see section 2 “CAMZYOS contains sodium”), magnesium stearate
• capsule shell: CAMZYOS 2.5 mg hard capsulesgelatin, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172) CAMZYOS 5 mg hard capsulesgelatin, titanium dioxide (E171), yellow iron oxide (E172) CAMZYOS 10 mg hard capsulesgelatin, titanium dioxide (E171), red iron oxide (E172) CAMZYOS 15 mg hard capsulesgelatin, 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

• The hard capsules (capsules) of CAMZYOS 2.5 mg, with a length of approximately 18.0 mm, 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.
• The hard capsules (capsules) of CAMZYOS 5 mg, with a length of approximately 18.0 mm, 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.
• The hard capsules (capsules) of CAMZYOS 10 mg, with a length of approximately 18.0 mm, 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.
• The hard capsules (capsules) of CAMZYOS 15 mg, with a length of approximately 18.0 mm, 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 packaged in blisters with aluminum foil 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 on this medicinal product, contact the local representative of the marketing
authorisation holder:

Belgique/België/Belgien
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Lietuva
Swixx Biopharma UAB
Tel: + 370 52 369140
[email protected]

България
Swixx Biopharma EOOD
Тел.: + 359 2 4942 480
[email protected]

Luxembourg/Luxemburg
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Česká republika
Bristol-Myers Squibb spol. s r.o.
Tel: + 420 221 016 111
[email protected]

Magyarország
Bristol-Myers Squibb Kft.
Tel.: + 36 1 301 9797
[email protected]

Danmark
Bristol-Myers Squibb Denmark
Tlf: + 45 45 93 05 06
[email protected]

Malta
A.M. Mangion Ltd
Tel: + 356 23976333
[email protected]

Deutschland
Bristol-Myers Squibb GmbH & Co. KGaA
Tel: 0800 0752002 (+ 49 89 121 42 350)
[email protected]

Nederland
Bristol-Myers Squibb B.V.
Tel: + 31 (0)30 300 2222
[email protected]

Eesti
Swixx Biopharma OÜ
Tel: + 372 640 1030
[email protected]

Norge
Bristol-Myers Squibb Norway AS
Tlf: + 47 67 55 53 50
[email protected]

Ελλάδα
Bristol-Myers Squibb A.E.
Τηλ: + 30 210 6074300
[email protected]

Österreich
Bristol-Myers Squibb GesmbH
Tel: + 43 1 60 14 30
[email protected]

España
Bristol-Myers Squibb, S.A.
Tel: + 34 91 456 53 00
[email protected]

Polska
Bristol-Myers Squibb Polska Sp. z o.o.
Tel.: + 48 22 2606400
[email protected]

France
Bristol-Myers Squibb SAS
Tél: + 33 (0)1 58 83 84 96
[email protected]

Portugal
Bristol-Myers Squibb Farmacêutica Portuguesa,
S.A.
Tel: + 351 21 440 70 00
[email protected]

Hrvatska
Swixx Biopharma d.o.o.
Tel: + 385 1 2078 500
[email protected]

România
Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19
[email protected]

Ireland
Bristol-Myers Squibb Pharmaceuticals uc
Tel: 1 800 749 749 (+ 353 (0)1 483 3625)
[email protected]

Slovenija
Swixx Biopharma d.o.o.
Tel: + 386 1 2355 100
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000
[email protected]

Slovenská republika
Swixx Biopharma s.r.o.
Tel: + 421 2 20833 600
[email protected]

Italia
Bristol-Myers Squibb S.r.l.
Tel: + 39 06 50 39 61
[email protected]

Suomi/Finland
Oy Bristol-Myers Squibb (Finland) Ab
Puh/Tel: + 358 9 251 21 230
[email protected]

Κύπρος
Bristol-Myers Squibb A.E.
Τηλ: 800 92666 (+ 30 210 6074300)
[email protected]

Sverige
Bristol-Myers Squibb Aktiebolag
Tel: + 46 8 704 71 00
[email protected]

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

Altre fonti d’informazioni
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, https://www.ema.europa.eu .