Description
Mavacamten is used to treat symptomatic obstructive hypertrophic cardiomyopathy (HCM). This medicine helps improve your symptoms and ability to be active.
This medicine is available only under a restricted distribution program called Camzyos™ REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of mavacamten in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mavacamten in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Apalutamide
- Asunaprevir
- Boceprevir
- Bosentan
- Cannabidiol
- Cannabis
- Carbamazepine
- Cenobamate
- Ceritinib
- Clarithromycin
- Cobicistat
- Dabrafenib
- Dicloxacillin
- Dipyrone
- Efavirenz
- Elagolix
- Enzalutamide
- Esomeprazole
- Etravirine
- Fedratinib
- Felbamate
- Fexinidazole
- Fluconazole
- Fluoxetine
- Fluvoxamine
- Fosphenytoin
- Idelalisib
- Indinavir
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lonafarnib
- Lopinavir
- Lorlatinib
- Lumacaftor
- Mifepristone
- Mitotane
- Moclobemide
- Modafinil
- Nafcillin
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amprenavir
- Aprepitant
- Armodafinil
- Asciminib
- Atazanavir
- Berotralstat
- Cimetidine
- Ciprofloxacin
- Clofazimine
- Clopidogrel
- Codeine
- Conivaptan
- Crizotinib
- Darunavir
- Desogestrel
- Dienogest
- Dihydrocodeine
- Diltiazem
- Disopyramide
- Dronedarone
- Drospirenone
- Duvelisib
- Enasidenib
- Erythromycin
- Eslicarbazepine Acetate
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Fosamprenavir
- Fosnetupitant
- Garlic
- Gestodene
- Givosiran
- Imatinib
- Isavuconazole
- Isoniazid
- Letermovir
- Levonorgestrel
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abemaciclib
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acalabrutinib
- Alfentanil
- Alfuzosin
- Alprazolam
- Amiodarone
- Amlodipine
- Apixaban
- Aripiprazole
- Artemether
- Astemizole
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Avatrombopag
- Axitinib
- Bedaquiline
- Belumosudil
- Benzhydrocodone
- Bictegravir
- Bosutinib
- Brexpiprazole
- Brigatinib
- Bromocriptine
- Budesonide
- Buprenorphine
- Buspirone
- Cabozantinib
- Capivasertib
- Capmatinib
- Cariprazine
- Carisoprodol
- Carvedilol
- Celecoxib
- Cilostazol
- Cinacalcet
- Cisapride
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Heart rhythm problems (eg, atrial fibrillation, tachyarrhythmia) or
- Infection, severe—Use with caution. May increase risk of heart failure.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
It is very important that you understand the requirements of the Ultomiris® REMS program, and become familiar with the Camzyos™ Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
You may take this medicine with or without food.
Swallow the capsule whole. Do not break, chew, or open it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For symptomatic obstructive hypertrophic cardiomyopathy (HCM):
- Adults—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For symptomatic obstructive hypertrophic cardiomyopathy (HCM):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
You should not use this medicine together with diltiazem (Cardizem®) with a beta blocker, disopyramide (Norpace®), ketoconazole (Nizoral®), ranolazine (Ranexa®), rifampin (Rifadin®), or verapamil (Isoptin®) with a beta blocker. Using these medicines together with mavacamten may increase the risk of heart rhythm problems and heart failure.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may increase your risk of heart failure. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Dizziness
- fainting
Incidence not known
- Chest pain or tightness
- decreased urine output
- dilated neck veins
- irregular breathing
- irregular heartbeat
- swelling of the face, fingers, feet, or lower legs
- trouble breathing
- unusual tiredness or weakness
- weight gain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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