SOHONOS capsules are available in 5 different strengths:
1 mg
1.5 mg
2.5 mg
5 mg
10 mg
SOHONOS capsules are available in 5 different strengths:
1 mg
1.5 mg
2.5 mg
5 mg
10 mg
SOHONOS is a capsule taken once a day by mouth
The recommended dosing for SOHONOS includes a chronic daily dose and modified dosing specific to flare-ups.
- Avoid consuming foods or drinks that have grapefruit in them while taking SOHONOS, as they may increase the medication levels in your blood
- This medicine is not recommended for girls under 8 years of age or boys under 10 years of age due to the risk of stopping normal bone growth
How is a SOHONOS dose determined?
SOHONOS dosing is different for every patient, and changes could be made by your doctor depending on your circumstances. Work with your doctor to set an appropriate dose and be sure to take SOHONOS daily.
- For females ≥8-13 and males ≥10-13 years old, dosing is weight-based. It is important that your doctor has an accurate weight and that they check your weight often as you grow
- Your daily dose will need to change during a flare-up. Contact your doctor if you have any symptoms of a flare-up or experience a flare-up triggering event (such as the flu or a fall)
Weight-adjusted dosing
RECOMMENDED SOHONOS WEIGHT-BASED DOSAGE FOR CHILDREN AGED 8 TO 13 YEARS FOR FEMALES AND 10 TO 13 YEARS FOR MALES*
| Weight |
|---|
| 10 kg to 19.9 kg (22 lbs to 43.9 lbs) |
| 20 kg to 39.9 kg (44 lbs to 87.9 lbs) |
| 40 kg to 59.9 kg (88 lbs to 132.1 lbs) |
| ≥ 60 kg (≥ 132.2 lbs) |
Once daily.
Side effects may require your doctor to reduce your daily or flare-up dose. If side effects continue, your doctor may consider reducing your dose further or stopping SOHONOS.
Your SOHONOS dose is increased during a flare-up
Flare-up treatment should begin at the onset of the first symptom of an FOP flare-up or substantial high-risk traumatic event likely to lead to a flare-up. Talk to your doctor if you think a flare-up is starting or if you experience an event likely to lead to a flare-up.*
- Your chronic dose should stop at the time of initiation of flare-up treatment; re-initiation of the chronic (daily) dosing should occur after completion of the flare-up treatment
- If flare-up symptoms do not resolve at the end of the 12-week period, the weeks 5 to 12 once-daily-dose modification may be extended in 4-week intervals until the flare-up symptoms resolve
- If you experience marked worsening of the original flare-up or another flare-up at a new location at any point during flare-up treatment, the 12-week treatment should be restarted
High-risk traumatic event such as surgery, intramuscular immunization, mandibular blocks for dental procedures, muscle fatigue, blunt muscle trauma from bumps, bruises, falls, or influenza-like viral illnesses. Symptoms of an FOP flare-up typically include, but are not limited to, localized pain, soft-tissue swelling/inflammation, redness, warmth, decreased joint range of motion, and stiffness.
Side effects may require your doctor to reduce your daily or flare-up dose
If side effects continue, your doctor may continue to lower your dose or discontinue SOHONOS
These tables are provided for educational purposes only. Always consult with your doctor before making any changes to your dose.
Important information about taking SOHONOS
If swallowing the capsule is challenging: For patients unable to swallow capsules, the capsules may be opened and the contents sprinkled onto a teaspoon of soft food and taken immediately. If not taken immediately, it can be taken after a maximum of 1 hour after the sprinkling provided it was maintained at room temperature and not exposed to direct sunlight.
If the dose has been missed by more than 6 hours: Skip the missed dose and continue with the next scheduled dose. Do not take two doses at the same time or in the same day.
If you take more than the prescribed dose: Call your doctor or poison control center right away.
If you are a female who can become pregnant: Your doctor will require a negative pregnancy test within one week prior to initiating and periodically during SOHONOS therapy. If you become pregnant or think you may be pregnant during treatment with SOHONOS, stop taking SOHONOS and call your doctor right away.
Always take SOHONOS exactly as your doctor prescribed for you. Contact your doctor if you are not sure about what dose to take.
For more information on how to take SOHONOS, please see the SOHONOS Medication Guide.
IMPORTANT SAFETY INFORMATION
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.
- Your healthcare provider will ask you to take a pregnancy test 1 week before starting treatment with SOHONOS, periodically during treatment, and 1 month after you stop treatment.
- You must use effective birth control (contraception) starting at least 1 month before starting treatment with SOHONOS, during treatment, and for 1 month after the last dose. Talk to your healthcare provider about birth control methods that may be right for you.
- If you become pregnant or think you may be pregnant during treatment with SOHONOS, stop taking SOHONOS and call your healthcare provider right away.
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:
- have bone loss (osteoporosis), weak bones or any other bone problems
- have or had mental health problems
- have or have had kidney problems
- have or have had liver problems
- are breastfeeding or plan to breastfeed. It is not known if SOHONOS passes into your breastmilk. Breastfeeding is not recommended during treatment with SOHONOS and for at least 1 month after the last dose of SOHONOS. Talk to your healthcare provider about the best way to feed your baby if you take SOHONOS.
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?
- Do not get pregnant while taking SOHONOS.
- Avoid excessive exposure to sunlight and ultraviolet lights (tanning machines). SOHONOS may make your skin more sensitive to the exposure and you may burn more easily. Apply sunscreen and wear protective clothing and sunglasses when in sunlight.
- Avoid driving at night until you know if SOHONOS has affected your vision. SOHONOS may decrease your ability to see in the dark.
- Do not donate blood while taking SOHONOS and for 1 week after stopping SOHONOS.
What are the possible side effects of SOHONOS?
SOHONOS can cause serious side effects, including:
- skin-related events such as dry skin, lip and eye, hair loss, itching, redness, rash, and skin peeling. You may be at increased risk of developing skin and soft tissue infections while taking SOHONOS. If you develop these symptoms, your healthcare provider may tell you to use moisturizer, sunscreen, or artificial tears.
- bone mineral density problems (bone thinning) which can increase the risk of fractures in adults and children. Your healthcare provider should check you for this during treatment with SOHONOS.
- new or worsening mental health problems that may include depression, anxiety, mood changes, and suicidal thoughts and behaviors. If you have a history of mental health problems, you may be at a higher risk of developing these side effects. Call your healthcare provider if you develop new or worsening mental health symptoms during treatment with SOHONOS. Your healthcare provider should monitor you for signs of depression and refer you for appropriate treatment, if necessary.
- vision problems (night blindness) which may cause difficulty seeing at night or in low lit areas. Your healthcare provider should send you to see an eye specialist if you experience vision problems.
The most common side effects of SOHONOS include:
| dry skin | rash | nausea |
| dry lips | skin peeling | muscle and joint pain |
| hair loss | drug eruption | dry eyes |
| itching | skin irritation | headache |
| redness | swelling and small cracks in corner of the mouth | fatigue |
| dry skin | swelling and small cracks in corner of the mouth |
| dry lips | nausea |
| hair loss | muscle and joint pain |
| itching | dry eyes |
| redness | headache |
| rash | fatigue |
| skin peeling | |
| drug eruption | |
| skin irritation |
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.