CAMZYOS

Generic Name/API: mavacamten

Manufacturer: Bristol-Myers Squibb Company

Dosage Forms & Strength & Pack Size:
Capsules: 2.5 mg, 5 mg, 10 mg, and 15 mg

Storage:
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C
(between 59°F and 86°F).

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
What is CAMZYOS?
CAMZYOS is a prescription medicine used to treat:
adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). CAMZYOS may improve your symptoms and your ability to be active.
It is not known if CAMZYOS is safe and effective in children.

IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEART FAILURE

CAMZYOS may cause serious side effects, including heart failure.
Heart failure, a condition where the heart cannot pump with enough force, is a serious condition that can lead to death.
You must have echocardiograms before you take your first dose and during your treatment with CAMZYOS to help your healthcare provider understand how your heart is responding to CAMZYOS. Echocardiograms (echos) are imaging tests, a type of ultrasound study, which take pictures of your heart and show how well your heart is working.

People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS.

Get medical help right away if you experience new or worsening symptoms, including:
shortness of breath
chest pain
fatigue
racing heart (palpitations)
leg swelling
rapid weight gain
The risk of heart failure is also increased when CAMZYOS is taken with certain other medications. Tell your healthcare provider about the medicines you take, both prescribed and obtained over-the-counter, before and during treatment with CAMZYOS.

Because of the serious risk of heart failure, CAMZYOS is only available through a restricted program called the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program. This means:

You and your healthcare provider must both be enrolled in the CAMZYOS REMS program in order to have it prescribed. Talk to your healthcare provider about how to enroll and for more information about the program.
Your healthcare provider and pharmacist will make sure you understand how to take CAMZYOS safely, which includes returning for echos when advised by your healthcare provider.
You can get CAMZYOS only from a certified pharmacy that is part of the CAMZYOS REMS program. Talk to your healthcare provider about finding a certified pharmacy. You will not be able to get CAMZYOS from a local pharmacy.
If you have questions about the CAMZYOS REMS program, ask your healthcare provider, visit www.CAMZYOSREMS.com or call 1-833-628-7367.
What should I discuss with my healthcare provider before starting CAMZYOS?

Talk to your healthcare provider about all of your medical conditions, including if:
You are pregnant or plan to become pregnant – CAMZYOS may harm your unborn baby
Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with CAMZYOS. You may also report your pregnancy by calling Bristol Myers Squibb at
1-800-721-5072 or by visiting www.bms.com.

If you are a female and able to become pregnant, your healthcare provider will do a pregnancy test before you start taking CAMZYOS. You should use an effective method of birth control (contraception) during treatment and for at least 4 months after your last dose of CAMZYOS.

CAMZYOS may reduce how well hormonal birth control works. Talk to your healthcare provider about the use of effective forms of birth control during treatment with CAMZYOS.
You are breastfeeding or plan to breastfeed
It is not known if CAMZYOS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with CAMZYOS.

What medicines should I discuss with my healthcare provider?

Tell your healthcare provider about all of the medicines you take before and during treatment with CAMZYOS, including:
prescription medicines
over-the-counter medicines
vitamins
herbal supplements
Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure.

Especially tell your healthcare provider if you:
take over-the-counter medicines, including medications like omeprazole (for example, Prilosec®), esomeprazole (for example, Nexium®), or cimetidine (for example, Tagamet®)
take other medicines to treat your obstructive
HCM disease
develop an infection
Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider.
What are the serious side effects of CAMZYOS?

A serious side effect is a side effect that can sometimes become life-threatening and can lead to death.

CAMZYOS may cause serious side effects, including heart failure (a condition where the heart cannot pump with enough force).
Get medical help right away if you experience new or worsening symptoms, including:
shortness of breath
chest pain
fatigue
racing heart (palpitations)
leg swelling
rapid weight gain
What are the most common side effects?

The most common side effects of CAMZYOS include dizziness and fainting (syncope).

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of CAMZYOS.

Talk to your healthcare provider for more information about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072.
How should I take CAMZYOS?

Before starting treatment with CAMZYOS, your healthcare provider will do an echocardiogram (echo) to assess your obstructive HCM. Your heart must be regularly monitored with echos while on treatment to help your healthcare provider understand how your heart is responding to CAMZYOS.
Talk to your healthcare provider for more information about echos and your echo schedule.

CAMZYOS comes in immediate release capsules, containing 2.5, 5, 10, or 15 mg of mavacamten. Each capsule is marked with the word MAVA and the number of milligrams (mg) it contains.
Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide.

Capsule: contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

Take CAMZYOS exactly as your healthcare provider tells you.

1 time a day, by mouth
Swallow the capsule whole
Do not break, open, bite, or chew the capsule
Do not change your dose of CAMZYOS without talking to your healthcare provider first
Talk to your healthcare provider about the right dose for you.
What if I miss a dose?

Take it as soon as possible and take your next dose at your regularly scheduled time the next day.
Do not take 2 doses on the same day to make up for a missed dose.
Your healthcare provider may change your dose, temporarily stop, or permanently stop your treatment with CAMZYOS if you have certain side effects.

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