Sohonos
Sohonos (palovarotene) is the first medication FDA-approved to treat a rare, genetic condition called fibrodysplasia ossificans progressiva (FOP). It's available as a capsule that's taken by mouth once daily with food. Because of the risk of serious birth defects, people who can get pregnant need to use birth control before, during, and after treatment. Common side effects include dry skin, itching, chapped lips, and joint pain.
What is Sohonos (palovarotene)?
What is Sohonos (palovarotene) used for?
- Treatment of fibrodysplasia ossificans progressiva (FOP) in:
- Females 8 years of age and older
- Males 10 years of age and older
How Sohonos (palovarotene) works
Sohonos (palovarotene) is a retinoid. It lowers the amount of new abnormal bone growth in people with fibrodysplasia ossificans progressiva (FOP) by blocking an important process involving bone morphogenetic proteins (BMPs).
People with FOP have mutated BMPs that cause bones to grow in areas that don't typically have bones, such as muscles, ligaments, and tendons. Sohonos (palovarotene) helps to lower the amount of abnormal bone growth, which then helps to improve movement and relieve symptoms of FOP.
Drug facts
Side effects of Sohonos (palovarotene)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Dry skin (57-61%)
- Itching (34-48%)
- Dry or chapped lips (38-47%)
- Joint pain (31-36%)
- Skin redness (19-32%)
- Rash (28-30%)
- Hair loss (24-30%)
- Pain in hands and feet (28-29%)
- Skin peeling (15-29%)
- Dry eye (10-22%)
Less Common Side Effects
- Nausea
- Back pain
- Headache
- Muscle pain
- Swelling in the arms and legs
- Feeling tired
Sohonos (palovarotene) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Suicidal thoughts and behavior
- Serious skin reaction: skin pain, rash, fever, blisters, peeling skin
The following Sohonos (palovarotene) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Dryness or irritation of the eyes, lips, mouth, or nose
- Hair loss
- Skin reactions on sun-exposed areas
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Pros and cons of Sohonos (palovarotene)
Pros
- The first and currently only treatment for FOP
- Can open capsule and mixed with yogurt, applesauce, or oatmeal for people with difficulty swallowing pills
- Shown to lower abnormal bone growth by more than 50% in people with FOP
Cons
- Can cause serious birth defects so it's not safe in pregnancy
- Not a good choice if you have a history of mental health problems including depression, hallucinations, or suicidal thoughts
- Interacts with many medications, such as vitamin A and tetracyclines
Pharmacist tips for Sohonos (palovarotene)
- Take Sohonos (palovarotene) by mouth with food at the same time each day can help your body absorb the medication better.
- If you have trouble swallowing, open the Sohonos (palovarotene) capsule and sprinkle the contents onto a teaspoon (5 mL) of soft food (e.g., applesauce, yogurt, oatmeal). Make sure to take the mixture within 1 hour.
- Don't eat or drink juices containing grapefruit or pomelo during treatment with Sohonos (palovarotene). Doing so can cause the body to absorb more of this medication, causing greater risk of side effects.
- If you miss a dose of Sohonos (palovarotene), take the dose as soon as you remember. If it's been more than 6 hours since you missed a dose, just skip it and take your next dose as scheduled. Don't take two doses at the same time to make up for missed doses.
- Sohonos (palovarotene) can cause you to sunburn more easily. To lower your risk, make sure to limit or avoid sun exposure during treatment with Sohonos (palovarotene). Wear protective clothing when outside, even on overcast days.
- Sohonos (palovarotene) can cause you to have trouble seeing at night. Don't drive at night until you know how this medication affects your vision.
- Avoid donating blood while taking Sohonos (palovarotene) and for a week after stopping the medication. This is to prevent pregnant people from accidentally receiving your blood donations since this medication is harmful to unborn babies.
- Let your provider know if you experience symptoms of depression or worsening mood while taking Sohonos (palovarotene). In cases of serious depression, your provider might ask you to stop taking this medication.
- Sohonos (palovarotene) can interact with some medications. Let your provider or pharmacist know what medications you're taking, including over-the-counter products and supplements, before you start Sohonos (palovarotene). Your provider might adjust your dose of Sohonos (palovarotene) to help you avoid side effects.
More tips for people who can get pregnant:
- Use an effective form of birth control while you're taking Sohonos (palovarotene) since it can cause serious birth defects. Talk to your healthcare provider about appropriate forms of birth control.
- You mustn't get pregnant a week before starting, during, and 1 month after treatment with Sohonos (palovarotene). Your provider will require you to get pregnancy tests done throughout your treatment.
Common questions about Sohonos (palovarotene)
Sohonos (palovarotene) is the first and currently only oral medication to reduce abnormal bone growth in people with FOP. In one study, Sohonos (palovarotene) lowered the amount of new bone growth by 54% in people with FOP. If you have any questions about the medication, follow up with your provider for more information.
It's not clear whether Sohonos (palovarotene) is safe to use while breastfeeding. Since there's a risk of serious side effects to babies, it's recommended that you don't give your baby breast milk during and for at least a month after treatment with Sohonos (palovarotene). If you're breastfeeding, please talk with your provider to see whether this medication is an option for you.
Some common side effects of Sohonos (palovarotene) include chapped lips, dry skin, and dry eyes. You can ease these side effects by regularly applying a skin moisturizer, lip balm, or lubricating eye drops. It also helps to stay hydrated by drinking water throughout the day. In addition, Sohonos (palovarotene) can cause you to sunburn more easily and severely. Make sure to use sunscreen and wear sunglasses when you go outside. Always let your provider know if you experience side effects from this medication.
Yes. Taking medications like ketoconazole and vitamin A can raise the amount of Sohonos (palovarotene) in your body. This should be avoided since it can cause a higher risk of side effects. Taking tetracycline antibiotics with Sohonos (palovarotene) might also raise the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Let your provider and pharmacist know all the medications and supplements you take before starting this medication.
People with FOP might have a flare-up where they experience sudden symptoms of swelling, pain, inflammation, reduced movement, and stiffness. When this happens, your provider might have you take a higher dose of Sohonos (palovarotene) for a few months to help relieve these symptoms. In addition, let your provider know if you have a planned procedure (e.g., surgery, dental appointment, immunization), recent trauma (e.g., falls, bruises), or have been sick recently (e.g., flu symptoms). These events can raise your risk of a FOP flare-up and your provider might have you take a higher dose of Sohonos (palovarotene) beforehand.
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Risks and warnings for Sohonos (palovarotene)
Sohonos (palovarotene) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Harm to unborn baby
Sohonos (palovarotene) can cause serious birth defects to unborn babies. If you can get pregnant, your provider will ask you to take a pregnancy test a week before starting Sohonos (palovarotene), periodically during treatment, and a month after stopping this medication. Make sure to use an effective contraception (e.g., condom, birth control pills) starting a month before your first dose and up to a month after your last dose. If you become pregnant or think you might be pregnant while taking Sohonos (palovarotene), stop treatment right away and speak to your provider.
Bone growth problems in children
- Risk factor: Young children
Sohonos (palovarotene) can cause the growth plate to close early in children with FOP. This can cause some children to stop growing during treatment. Before starting Sohonos (palovarotene), your child's provider will examine your child to make sure their growth is normal. They'll continue to monitor your child's growth and height every 6-12 months during treatment with this medication. If your child's growth seems to have slowed down during treatment with Sohonos (palovarotene), let your child's provider know. They might ask your child to stop the medication until they're finished growing.
Severe skin reactions
- Risk factors: History of skin problems | High dose of Sohonos (palovarotene) | Excessive exposure to sun or UV light
Sohonos (palovarotene) can sometimes cause chapped lips, itching, rash, hair loss, and dry eye. It can also cause severe skin reactions, such as dry skin and skin peeling. These reactions raise your risk of skin infections and skin ulcers. If you experience any skin or allergic reactions, let your provider know. Your provider might lower your dose to help relieve these symptoms. Consider using lotion, lip balm, or artificial tears to help prevent or lower the risk of these reactions.
In addition, Sohonos (palovarotene) can cause you to sunburn more easily and severely. To lower your risk, make sure to limit or avoid sun exposure during treatment with this medication. Wear protective clothing, sunglasses, or sunscreen when outside, even on overcast days.
Bone problems
- Risk factors: Weaker bones or bone-related conditions | Taking Sohonos (palovarotene) for a long time, especially at a high dose
Sohonos (palovarotene) can cause weakened bones, bone spurs (lumps that grow at the end of a bone), calcium buildups in your tendons or ligaments, and bone fractures. The risk is higher if you currently have bone problems or if you take Sohonos (palovarotene) for a long time, especially at a high dose. Your provider will monitor you for bone fractures regularly during treatment with this medication.
Depression and thoughts of self-harm
- Risk factors: History of depression or other mental health condition
Sohonos (palovarotene) can cause depression, anxiety, aggressive behavior, and suicidal thoughts or behavior. Talk to your provider as soon as possible if you or anyone around you notice any unusual changes in your mood or behavior, especially during the first few months of treatment or when the dose changes.
Vision problems
- Risk factors: Taking Sohonos (palovarotene) at a high dose
Sohonos (palovarotene) can worsen your vision at night. Be careful driving, especially at night, until you know how this medication affects you. If you notice changes in your vision, stop taking Sohonos (palovarotene) and talk to your provider right away.
Sohonos (palovarotene) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 14 capsules of 1mg | 1 carton | $4,930.10 | $4,930.10 |
| 14 capsules of 1.5mg | 1 carton | $7,391.53 | $7,391.53 |
| 14 capsules of 2.5mg | 1 carton | $12,315.39 | $12,315.39 |
| 14 capsules of 5mg | 1 carton | $24,625.42 | $24,625.42 |
| 14 capsules of 10mg | 1 carton | $49,243.69 | $49,243.69 |
Typical dosage for Sohonos (palovarotene)
Maintenance treatment
- Adults and children 14 years and older: The typical dose is 5 mg by mouth daily with food.
- Children ages 8 to 13 years old (females) or 10 to 13 years old (males): The dose will depend on your child’s weight. Dosage ranges from 2.5 mg to 5 mg daily.
- Children weighing 10 kg to 19.9 kg: The typical dose is 2.5 mg by mouth daily with food.
- Children weighing 20 kg to 39.9 kg: The typical dose is 3 mg by mouth daily with food.
- Children weighing 40 kg to 59.9 kg: The typical dose is 4 mg by mouth daily with food.
- Children weighing 60 kg and more: The typical dose is 5 mg by mouth daily with food.
Flare-up treatment
- If your symptoms get worse and you experience a flare-up, your provider will raise your dose for a few months and give you a new schedule for taking the medication.
Your dose might differ if you take other medications or if you experience side effects from this medication.
How much does Sohonos (palovarotene) cost?
$4,930.10
Sohonos (palovarotene) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Sohonos (palovarotene) will not be safe for you to take.
- Currently pregnancy
- History of allergies to retinoids, such as isotretinoin and tretinoin
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