Erin, patient living with fibrodysplasia ossificans progressiva (FOP), and her mother, Lori, United States
If you are a patient interested in enrolling, click the button below and sign the Patient Authorization Form to begin the process.
This website is intended for U.S. residents only
This website is intended for U.S. residents only
Erin, patient living with fibrodysplasia ossificans progressiva (FOP), and her mother, Lori, United States
If you are a patient interested in enrolling, click the button below and sign the Patient Authorization Form to begin the process.
IMPORTANT SAFETY INFORMATION & INDICATION for SOHONOSTM (palovarotene) Capsules
What is the most important information I should know about SOHONOS?
SOHONOS can cause birth defects (deformed babies) if taken during pregnancy. Females who are pregnant or who plan to become pregnant must not take SOHONOS.
Because SOHONOS can cause birth defects, SOHONOS is only for people who can understand and agree to carry out all instructions for pregnancy prevention.
SOHONOS can cause bone growth changes. Children may stop growing while taking SOHONOS. Bone growth changes such as permanent early closure of the growth plate in growing children have happened with SOHONOS. Your healthcare provider will closely monitor your child’s bone growth and height during treatment with SOHONOS.
Who should not take SOHONOS?
Do not take SOHONOS if you are pregnant, or allergic to medicines known as retinoids or any of the ingredients in SOHONOS.
What should I tell my healthcare provider before taking SOHONOS?
Before taking SOHONOS, tell your healthcare provider about all your medical conditions, including:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOHONOS and certain other medicines can interact with each other, sometimes causing serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.
What should I avoid while taking SOHONOS?
What are the possible side effects of SOHONOS?
SOHONOS can cause serious side effects, including:
The most common side effects of SOHONOS include:
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These are not all the possible side effects of SOHONOS. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
WHAT IS SOHONOS?
SOHONOS is a prescription medicine used to reduce the amount of new heterotopic ossification in adults and children 8 years of age and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). SOHONOS is not recommended for females younger than 8 years of age or males younger than 10 years of age.
Please see full Prescribing Information, including Medication Guide with IMPORTANT WARNING.