Now Approved
For the treatment of
FOP in people 12 years and older
ATEBRIOZ is indicated to reduce the volume of total new heterotopic ossification (HO) in adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP).
Starting ATEBRIOZ
Download the Patient Brochure to see what to expect when starting ATEBRIOZ.
Download Patient Brochure
How MAP can
assist you
Mirum Access Plus (MAP) is a support program with a dedicated team that helps patients, caregivers, and their health care providers access medication and connect with helpful resources.
Learn About MirumAccess Plus
IMPORTANT SAFETY INFORMATION
Who should not take ATEBRIOZ?
Do not take ATEBRIOZ if you are pregnant. ATEBRIOZ can harm your unborn baby, including birth defects.
What should I tell my health care provider before taking ATEBRIOZ?
Before taking ATEBRIOZ, tell your health care provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. ATEBRIOZ can harm your unborn baby, including birth defects.
- can become pregnant. Your health care provider should verify that you are not pregnant before you start ATEBRIOZ. Use effective birth control during treatment and for one week after your final dose. If you become pregnant while taking ATEBRIOZ, stop taking it immediately and contact your health care provider.
- are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with ATEBRIOZ and for at least one week after the final dose.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal products, and dietary supplements. Some medicines can affect ATEBRIOZ, and ATEBRIOZ can affect some other medicines.
- If you take a strong CYP3A4 inhibitor, your health care provider will reduce your ATEBRIOZ dose to 50 mg one time each day.
- Avoid taking ATEBRIOZ with strong or moderate CYP3A4 inducers.
- Avoid taking ATEBRIOZ with medicines that are MATE1 or MATE2-K substrates, such as metformin. If taking them together cannot be avoided, your health care provider may monitor you for side effects and may change the dose of the other medicine.
INDICATION
ATEBRIOZ is a prescription medicine used to reduce the volume of total new heterotopic ossification (HO) in adults and children 12 years of age and older with fibrodysplasia ossificans progressiva (FOP).
It is not known if ATEBRIOZ is safe and effective in children younger than 12 years of age.
What are the possible side effects of ATEBRIOZ?
The most common side effects of ATEBRIOZ include:
- headache
- joint pain
- common cold, sinus infections, or sore throat (upper respiratory tract infections)
- nosebleeds
- nausea
These are not all of the possible side effects of ATEBRIOZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Take ATEBRIOZ exactly as your health care provider tells you. ATEBRIOZ is taken by mouth one time each day with or without food. ATEBRIOZ tablets may be swallowed whole or crushed. If crushed, mix 4 tablets (100 mg total) with four tablespoons of water, orange juice, apple sauce, or plain yogurt and take immediately. Do not store the mixture for future use. Do not take ATEBRIOZ with grapefruit, pomelo, or juices containing these fruits.
Please see full Prescribing Information, including the Medication Guide, for ATEBRIOZ.
IMPORTANT SAFETY INFORMATION
Who should not take ATEBRIOZ?
Do not take ATEBRIOZ if you are pregnant. ATEBRIOZ can harm your unborn baby, including birth defects.
What should I tell my health care provider before taking ATEBRIOZ?
Before taking ATEBRIOZ, tell your health care provider about all of your medical conditions, including if you:
- are pregnant or plan to become pregnant. ATEBRIOZ can harm your unborn baby, including birth defects.
- can become pregnant. Your health care provider should verify that you are not pregnant before you start ATEBRIOZ. Use effective birth control during treatment and for one week after your final dose. If you become pregnant while taking ATEBRIOZ, stop taking it immediately and contact your health care provider.
- are breastfeeding or plan to breastfeed. Breastfeeding is not recommended during treatment with ATEBRIOZ and for at least one week after the final dose.
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal products, and dietary supplements. Some medicines can affect ATEBRIOZ, and ATEBRIOZ can affect some other medicines.
- If you take a strong CYP3A4 inhibitor, your health care provider will reduce your ATEBRIOZ dose to 50 mg one time each day.
- Avoid taking ATEBRIOZ with strong or moderate CYP3A4 inducers.
- Avoid taking ATEBRIOZ with medicines that are MATE1 or MATE2-K substrates, such as metformin. If taking them together cannot be avoided, your health care provider may monitor you for side effects and may change the dose of the other medicine.
INDICATION
ATEBRIOZ is a prescription medicine used to reduce the volume of total new heterotopic ossification (HO) in adults and children 12 years of age and older with fibrodysplasia ossificans progressiva (FOP).
It is not known if ATEBRIOZ is safe and effective in children younger than 12 years of age.
What are the possible side effects of ATEBRIOZ?
The most common side effects of ATEBRIOZ include:
- headache
- joint pain
- common cold, sinus infections, or sore throat (upper respiratory tract infections)
- nosebleeds
- nausea
These are not all of the possible side effects of ATEBRIOZ. For more information, ask your health care provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Take ATEBRIOZ exactly as your health care provider tells you. ATEBRIOZ is taken by mouth one time each day with or without food. ATEBRIOZ tablets may be swallowed whole or crushed. If crushed, mix 4 tablets (100 mg total) with four tablespoons of water, orange juice, apple sauce, or plain yogurt and take immediately. Do not store the mixture for future use. Do not take ATEBRIOZ with grapefruit, pomelo, or juices containing these fruits.
Please see full Prescribing Information, including the Medication Guide, for ATEBRIOZ.