Palovarotene Capsules

What is this medication?

PALOVAROTENE (PA loe VAR oh teen) treats fibrodysplasia ossificans progressiva (FOP), a genetic condition that causes bone to form in muscle or other soft tissue. It works by reducing bone formation in the soft tissue. It belongs to a group of medications called retinoids.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SOHONOS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Kidney disease
• Liver disease
• Mental health conditions
• Osteoporosis, weak bones
• Still growing, have not reached your final adult height
• An unusual or allergic reaction to palovarotene, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with food. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the capsules whole. You may open the capsule and put the contents in 1 teaspoon of soft food (applesauce, yogurt, warm oatmeal). Swallow the medication and soft food within 1 hour of opening the capsule. Keep the mixture at room temperature and do not expose to direct sunlight during this time period. Keep taking this medication unless your care team tells you to stop.

Do not take this medication with grapefruit, pomelo, or juices containing these fruits.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 8 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

• Certain antibiotics, such as tetracycline, doxycycline, minocycline
• Grapefruit, pomelo, or juices containing these fruits
• Other retinoids, such as acitretin, bexarotene, isotretinoin, tretinoin
• Vitamin A

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. Call your care team right away if you experience these thoughts or worsening depression.

This medication may cause dry eyes. If you wear contact lenses, you may feel some discomfort. Lubricating eye drops may help. See your care team if the problem does not go away or is severe.

This medication may cause dry lips and skin. Moisturizers, such as skin lotion and lip balm may help. See your care team if the problem does not go away or is severe.

This medication may make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

Tell your care team right away if you have any change in your eyesight. This medication may make it difficult to see at night or in low lit areas. Avoid driving at night until you know how it has affected your vision.

Children may stop growing while taking this medication. Your care team will monitor your child's growth and height during treatment.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 1 month after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended 1 month before treatment, during treatment, and for 1 month after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for 1 month after the last dose.

Do not donate blood while you are taking this medication and for 1 week after the last dose. Donated blood may contain enough of this medication to cause birth defects if transfused to someone who is pregnant.

What side effects may I notice from receiving this medication?

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from light. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in the bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.