Palovarotene Oral Capsule (PALOVAROTENE - ORAL)

Palovarotene Oral Capsule (PALOVAROTENE - ORAL)

For bone disease.

Brand Name(s): Sohonos

Generic Name: Palovarotene

Instructions

Swallow the medicine without crushing or chewing it.

If medicine is mixed with food, use it within 60 minutes. Throw away any leftover food. Do not save for later use.

If unable to swallow the capsule, open the capsule and sprinkle onto 1 teaspoon of soft foods such as applesauce. Eat the mixture right away. Do not chew the mixture.

Keep the medicine in its original container.

Take the medicine with food.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Avoid grapefruit and grapefruit juice while on this medicine.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it if you remember within 6 hours of the scheduled dose. If you don’t remember until after more than 6 hours, skip the missed dose and return to your regular schedule with the next dose. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Wear disposable gloves when handling this medicine.

If powder spills from the capsules, wipe it up with a wet paper towel and throw it away immediately in a closed plastic bag. Avoid breathing in the powder.

Wash your hands before and after handling this medicine.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

This medicine may cause blurry vision or increased sensitivity to light. Avoid driving at night.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 month after stopping treatment.

Do not use this medicine if you are pregnant. If you become pregnant, contact your doctor immediately.

This medicine can cause birth defects. Speak with your doctor about birth control methods that should be used while on this medicine and for some time after stopping it.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 1 month after stopping to prevent pregnancy.

Female patients of childbearing age should have monthly pregnancy tests during treatment to make sure they are not pregnant.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not donate blood for at least 1 week after the last dose of this medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • bone pain
  • dry mouth
  • dry skin
  • dry eyes
  • hair loss
  • headaches
  • pain in the joints

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • depression or feeling sad
  • slow or reduced growth in children and teenager
  • mood changes
  • suicidal thoughts
  • blurring or changes of vision
  • vision problems - difficulty seeing at night

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.