Palovarotene (pa-loe-VAR-oh-teen)

Reduces the amount of new heterotopic ossification (bone forms in the soft tissues) in patients with fibrodysplasia ossificans progressiva (FOP).

Brand Name(s):

Sohonos

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk. Take this medicine at about the same time each day.
• Swallow the capsule whole. If you are not able to swallow the capsule whole, you may open it and mix it with 1 teaspoon (5 milliliters) of soft food (including apple sauce, low fat yogurt, or warm oatmeal) and take it within 1 hour of opening.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, take it as soon as possible, and then go back to your regular schedule. If you miss a dose and it is more than 6 hours, skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how palovarotene works. Tell your doctor if you are using any of the following:
  • Medicine to treat an infection (including doxycycline, erythromycin, ketoconazole, minocycline, rifampicin, tetracycline)
  • Vitamin A supplements
• Do not eat grapefruit or pomelo, or drink grapefruit or pomelo juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests 1 week before treatment, during treatment, and for 1 month after the last dose. Use an effective form of birth control 1 month before treatment, during treatment, and for 1 month after the last dose.
• Do not breastfeed during treatment and for 1 month after your last dose.
• Tell your doctor if you have kidney disease, liver disease, bone problems (including osteoporosis), or a history of mental problems (including anxiety, depression).
• This medicine may cause the following problems:
  • Bone growth changes
  • Serious skin reactions
  • Bone problems, including bone thinning and increased risk of fractures
  • Changes in mood or behavior
• This medicine may decrease your ability to see in the dark. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Do not donate blood during treatment and for 1 week after your last dose.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Arm, leg, or back pain, unusual tiredness or weakness
• Changes in vision
• Depression, unusual moods or behaviors, thought of hurting yourself or others
• Dry eyes, lips, or skin, hair loss or thinning, rash, redness, or peeling of the skin
• Headache, nausea
• Muscle, joint, or bone pain, fractures
• Rapid weight gain, swelling in your hands, ankles, or feet
• Slowed growth in children

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088