mavacamten
What is the most important information I should know about mavacamten?
Call your doctor at once if you have shortness of breath, chest pain, tiredness, swelling in your legs, rapid weight gain, or racing or pounding heartbeats.
What is mavacamten?
Mavacamten is used in adults to treat a heart problem called obstructive hypertrophic cardiomyopathy (HCM). This medicine may improve people's symptoms and their ability to be active.
Mavacamten is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.
Mavacamten may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking mavacamten?
Some drugs should not be used with mavacamten. Your treatment plan may change if you also use:
- nefazodone;
- St. John's wort;
- an antibiotic --clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;
- antifungal medicine --itraconazole, ketoconazole;
- antiviral medicine for HIV or hepatitis C --boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir saquinavir, telaprevir, tipranavir;
- cancer medicine --apalutamide, enzalutamide, mitotane;
- seizure medicine --carbamazepine, oxcarbazepine, phenytoin, primidone;
- steroid medicine --dexamethasone, prednisone;
Tell your doctor if you have ever had:
- an irregular heartbeat; or
- if you have an infection.
Mavacamten may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using mavacamten and for at least 4 months after your last dose. Tell your doctor if you become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Mavacamten can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.
How should I take mavacamten?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Talk to your doctor before changing your dose.
You should get an echocardiogram before and during treatment with mavacamten.
Take mavacamten once a day.
Swallow the capsule whole and do not crush, chew, break, or open it.
Your treatment may be delayed or permanently discontinued if you have certain side effects.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking mavacamten?
Grapefruit may interact with mavacamten and cause side effects. Avoid consuming grapefruit products.
What are the possible side effects of mavacamten?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- heart failure symptoms-- shortness of breath, chest pain, tiredness, swelling in your legs, rapid weight gain, or racing or pounding heartbeats.
Common side effects may include:
- dizziness; or
- fainting.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect mavacamten?
Tell your doctor about all your other medicines, especially:
- other medicines to treat obstructive hypertrophic cardiomyopathy; or
- omeprazole, esomeprazole, or cimetidine.
This list is not complete. Other drugs may affect mavacamten, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Where can I get more information?
Your doctor or pharmacist can provide more information about mavacamten.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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