Palovarotene is used to reduce the number of new heterotopic ossifications (bony formations in muscle and soft tissue) in adults and female children aged 8 years or older or male children aged 10 years or older with fibrodysplasia ossificans progressiva.

Palovarotene may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Use effective birth control.

Palovarotene can affect growth in children. Tell your doctor if your child is not growing at a normal rate while taking this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take palovarotene with food at the same time each day.

Doses are based on weight in children and teenagers at least 13 years old. Your child's dose may change if the child gains or loses weight.

If you cannot swallow a capsule whole, open it and mix the medicine onto a teaspoon (5 mL) of soft food such as low-fat yogurt, warm oatmeal, or applesauce. Swallow the mixture without chewing within 1 hour of opening the capsule.

You may be given other products to help with serious side effects or allergic reaction. Use these products exactly as directed on the label, or as prescribed by your doctor.

You may need frequent medical tests. You may also need frequent eye exams.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

You should not take palovarotene if you are allergic to palovarotene or similar retinoids medicines such as tretinoin, isotretinoin, or alitretinoin.

People with depression or mental illness may have thoughts about suicide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Tell your doctor if you have or have ever had:

• mental illness;

• any bone problem such as bone loss (osteoporosis), weak bones; or

• liver or kidney disease.

You will need to take a pregnancy test before, during, and after treatment with palovarotene.

May cause birth defects. Do not use if you are pregnant. You must use effective birth control while taking palovarotene and for at least one month after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while taking this medicine, and for at least one month after your last dose.

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms include severe headache, nausea or vomiting, drowsiness, irritability and itching.

Do not donate blood while taking palovarotene, and for at least one week after your last dose.

palovarotene may cause night blindness and make it difficult to see at night. Avoid driving or hazardous activity until you know how this medicine will affect you.

Palovarotene could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing, sunglasses, and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit may interact with palovarotene and cause side effects. Avoid consuming grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Palovarotene can affect growth in children. Tell your doctor if your child is not growing at a normal rate while taking palovarotene.

This medicine can cause serious side effects, including:

• low bone mineral density;

• new or worsening mental problems such as depression, anxiety, mood changes, or suicidal thoughts or actions;

• skin problems such as dry skin, lips and eyes, hair loss, itching, redness, rash, and skin peeling; or

• night blindness (difficulty seeing at night).

Your palovarotene treatments may be changed, delayed or permanently discontinued if you have certain side effects.

Common side effects of palovarotene may include:

• itching, redness, rash;

• skin problems (dryness, irritation, peeling, blistering);

• hair loss;

• dry lips, mouth sores;

• dry eyes;

• nausea;

• fatigue, muscle or joint pain; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.