Pronunciation:

pa-loe-VAR-oh-teen

Brand Names:

• Sohonos

Dosage Forms:

• Capsule

Warnings:

Embryo-Fetal ToxicityPalovarotene is contraindicated in pregnancy. Palovarotene may cause fetal harm. Because of the risk of teratogenicity and to minimize fetal exposure, palovarotene is to be administered only if conditions for pregnancy prevention are met.Premature Epiphyseal ClosurePremature epiphyseal closure occurs in growing pediatric patients treated with Palovarotene, close monitoring is recommended

Classifications:

Therapeutic—

Musculoskeletal Agent

Chemical—

Retinoid

Uses of This Medicine:

Palovarotene is used to reduce the amount of new heterotopic ossification (bone forms in the soft tissues) in patients with fibrodysplasia ossificans progressiva (FOP).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of palovarotene in female children 8 years of age and older and in male children 10 years of age and older. Safety and efficacy have been established. However, this medicine is not recommended for use in female children younger than 8 years of age and in male children younger than 10 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of palovarotene in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acitretin
• Amprenavir
• Apalutamide
• Aprepitant
• Atazanavir
• Bexarotene
• Boceprevir
• Bosentan
• Carbamazepine
• Cenobamate
• Ceritinib
• Chlortetracycline
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Clofazimine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Darunavir
• Demeclocycline
• Diltiazem
• Dipyrone
• Doxycycline
• Dronedarone
• Duvelisib
• Efavirenz
• Elagolix
• Enzalutamide
• Eravacycline
• Erythromycin
• Etravirine
• Etretinate
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Isotretinoin
• Itraconazole
• Ivosidenib
• Josamycin
• Ketoconazole
• Lesinurad
• Letermovir
• Lonafarnib
• Lopinavir
• Lorlatinib
• Lumacaftor
• Lymecycline
• Meclocycline
• Methacycline
• Mibefradil
• Mifepristone
• Minocycline
• Mitotane
• Modafinil
• Nafcillin
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Omadacycline
• Oxytetracycline
• Phenobarbital
• Phenytoin
• Posaconazole
• Primidone
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rolitetracycline
• Saquinavir
• Sarecycline
• Schisandra sphenanthera
• St John's Wort
• Telaprevir
• Telithromycin
• Telotristat Ethyl
• Tetracycline
• Thioridazine
• Tigecycline
• Treosulfan
• Tretinoin
• Troleandomycin
• Tucatinib
• Verapamil
• Vitamin A
• Voriconazole
• Voxelotor

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems (eg, osteoporosis, weak bones) or
• Mental problems (eg, anxiety, depression, suicidal thoughts or behavior), history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease, moderate or severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food 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 (eg, apple sauce, low fat yogurt, or warm oatmeal) and take it within 1 hour of opening.

Do not eat grapefruit or pomelo, or drink grapefruit or pomelo juice while you are using this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For new heterotopic ossification (daily dose):
    • Adults and children 14 years of age and older—5 milligrams (mg) once a day. Stop daily dosing when flare-up dosing begins.
    • Female children 8 to 13 years of age and male children 10 to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 2.5 to 5 mg once a day. Stop daily dosing when flare-up dosing begins.
      • Weighing 60 kilograms (kg) or more—5 mg once a day.
      • Weighing 40 kg to 59.9 kg—4 mg once a day.
      • Weighing 20 kg to 39.9 kg—3 mg once a day.
      • Weighing 10 kg to 19.9 kg—2.5 mg once a day.
    • Female children younger than 8 years of age and male children younger than 10 years of age—Use is not recommended.
  • For new heterotopic ossification (flare-up dose):
    • Adults and children 14 years of age and older—20 milligrams (mg) once a day on Weeks 1 to 4, followed by 10 mg once a day on Weeks 5 to 12. Your doctor may adjust your dose as needed and tolerated.
    • Female children 8 to 13 years of age and male children 10 to 13 years of age—Dose is based on body weight and must be determined by your doctor. The dose is usually 5 to 20 mg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Weighing 60 kilograms (kg) or more—20 mg once a day on Weeks 1 to 4, followed by 10 mg once a day on Weeks 5 to 12.
      • Weighing 40 kg to 59.9 kg—15 mg once a day on Weeks 1 to 4, followed by 7.5 mg once a day on Weeks 5 to 12.
      • Weighing 20 kg to 39.9 kg—12.5 mg once a day on Weeks 1 to 4, followed by 6 mg once a day on Weeks 5 to 12.
      • Weighing 10 kg to 19.9 kg—10 mg on once a day Weeks 1 to 4, followed by 5 mg once a day on Weeks 5 to 12.
    • Female children younger than 8 years of age and male children younger than 10 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is more than 6 hours, skip the missed dose and go back to your regular schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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. Tell your doctor right away if you think you have become pregnant.

You or your child should not donate blood to a blood bank during treatment and for 1 week after the last dose. This is to prevent a pregnant patient from receiving blood that contains the medicine.

This medicine may cause bone growth changes. Talk to your doctor if your child has lack or slowing of normal growth in children.

This medicine may decrease bone mineral density (bone thinning), which may increase the risk of fractures. Check with your doctor right away if you have back pain, bone or joint pain, difficulty in moving or walking, muscle pan or stiffness, or pain or swelling in the arms or legs without any injury.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, check with you doctor right away.

Check with your doctor right away if you have dry eye, dry lips, dry skin, flushing, redness of the skin, itching skin, loss or thinning of the hair, peeling of the skin, or unusually warm skin. These maybe symptoms of serious skin reactions.

Avoid overexposing your skin to sunlight. Your skin will be more prone to sunburn, dryness, or irritation. Do not use a sunlamp or tanning beds. Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis. Also, wear protective clothing and hats.

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 take other medicines unless they have been discussed with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Back pain

bone pain

dark urine

difficulty in moving

difficulty in swallowing

dry lips or skin

fast heartbeat

flushing, redness of the skin

headache

itching of the skin

joint pain

lack or loss of strength

lack or slowing of normal growth in children

loss of appetite

loss or thinning of the hair

muscle aches, cramps, pain, or stiffness

nausea or vomiting

stomach pain, severe

swelling of the face, throat, or tongue

swelling of the hands, ankles, feet, or lower legs

swollen joints

trouble breathing

unusual tiredness or weakness

unusually warm skin

yellow eyes or skin

Incidence not known

Bloating

chills

constipation

discouragement

fear, nervousness

feeling sad or empty

fever

indigestion

irritability

lack of appetite

loss of bone mineral density

loss of interest or pleasure

pain or swelling in the arms or legs without any injury

pains in the stomach, side, or abdomen, possibly radiating to the back

thoughts or attempts at killing oneself

trouble concentrating

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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