Camzyos

Generic Name: mavacamten
Dosage Form: capsules

Medically reviewed by A Ras. MD Last updated on May 1, 2022.

What is Camzyos?

Camzyos is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Camzyos may improve your symptoms and your ability to be active.

Description

Camzyos capsules for oral use contain mavacamten, a cardiac myosin inhibitor.
The chemical name of mavacamten is 3-(1-methylethyl)-6-[[(1S)-1-phenylethyl]amino]-
2,4(1H,3H)-pyrimidinedione. The molecular formula is C15H19N3O2, and the molecular weight is
273.33 g/mol.
The structural formula of mavacamten is:

Mavacamten is a white to off-white powder that is practically insoluble in water and aqueous
buffers at pH 2-10, sparingly soluble in methanol and ethanol, and freely soluble in DMSO and
NMP.
This is supplied as immediate release Size 2 hard gelatin capsules, containing 2.5, 5, 10,
or 15 mg of mavacamten per capsule as active ingredient and the following inactive ingredients:
croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon
dioxide. The capsule shell contains black edible ink, black iron oxide, gelatin, red iron oxide,
titanium dioxide, and yellow iron oxide.

Important information to know

Camzyos may cause serious side effects, including:

Heart failure, a condition where the heart cannot pump with enough force. Heart failure 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. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment.
Tell your healthcare provider or get medical help right away if you develop new or worsening:
- shortness of breath
- chest pain
- fatigue
- swelling in your legs
- a racing sensation in your heart (palpitations)
- rapid weight gain
The risk of heart failure is also increased when Camzyos is taken with certain other medicines. Tell your healthcare provider about the medicines you take, both prescribed and obtained over-the-counter, before and during treatment.
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.
- Your healthcare provider must be enrolled in the Camzyos REMS Program in order for you to be prescribed this medication.
- Before you start treatment, you must enroll in the Camzyos REMS Program. Talk to your healthcare provider about how to enroll in the Camzyos REMS Program. You will be given information about the program when you enroll.
- Before you start treatment, your healthcare provider and pharmacist will make sure you understand how to take Camzyos safely, which will include returning for echocardiograms when advised by your healthcare provider.
  Camzyos can only be dispensed by a certified pharmacy that participates in the Camzyos REMS Program.
  Your healthcare provider can give you information on how to find a certified pharmacy. You will not be able to get Camzyos at a local pharmacy.
- If you have questions about the Camzyos REMS Program, ask your healthcare provider, go to www.CamzyosREMS.com, or call 1-833-628-7367.

See Camzyos side effects for information about side effects.

Before you take Camzyos

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. This medication may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment. You may also report your pregnancy by calling Bristol-Myers Squibb at 1-800-721-5072 or www.bms.com.
If you are a female and able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment.
- You should use effective birth control (contraception) during treatment, and for 4 months after your last dose.
- 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.
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.

What ar the other drugs that will affect Camzyos?

Before and during treatment, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Camzyos with certain medicines or grapefruit juice may cause heart failure. Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider.

Especially tell your healthcare provider if you:

Take over-the-counter medicines such as omeprazole (Prilosec), esomeprazole (Nexium), or cimetidine (for Tagamet).
Take other medicines to treat your obstructive HCM disease.
Develop an infection

How should I take Camzyos?

Take Camzyos capsules exactly as your healthcare provider tells you to take it.
Do not change your dose without talking to your healthcare provider first.
Take Camzyos once a day.
Swallow the capsule whole. Do not break, open, or chew the capsule.
If you 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 if you have certain side effects.
If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

Dosing information

Usual Adult Dosage for Hypertrophic Cardiomyopathy

– recommended starting dose is 5 mg once daily without regard to food; allowable subsequent doses with titration are 2.5, 5, 10, or 15 mg once daily. Patient’s clinical status and LVEF should be assessed prior to and regularly during treatment and the dose adjusted accordingly.

– Use: treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Camzyos side effects

This medication may cause serious side effects, including:

Heart failure. See Important information.

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

These are not all of the possible side effects. Call your doctor for medical advice 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 store Camzyos?

Store it at room temperature between 68°F to 77°F (20°C to 25°C).

Keep medicines out of the reach of children and pets.

General information about the safe and effective use of Camzyos.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Camzyos?

Active ingredient: mavacamten
Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate (non-bovine), mannitol, and silicon dioxide. The capsule contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

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