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Sonidegib Oral Capsule (SONIDEGIB - ORAL)

For treating cancer.

Brand Name(s): Odomzo

Generic Name: Sonidegib

Instructions

Take on empty stomach - 1 hour before or 2 hours after eating.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

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.

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

If you forget a dose, just wait. Use the next dose at the usual time. Do not use 2 doses at once.

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

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

Do not use the medication any more than instructed.

Do not breastfeed while on this medicine. You may safely start breastfeeding 20 months after stopping treatment.

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

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 20 months after stopping to prevent pregnancy.

Men with a partner who is of childbearing age or pregnant must prevent pregnancy, or harm to the partner and unborn child, by using a condom during sex and another reliable form of birth control while taking this medicine and for 8 months after.

Do not donate blood during treatment and for 20 months after the last dose of this medicine.

Do not donate sperm during treatment and for 8 months after the last dose.

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.

  • decreased appetite
  • diarrhea
  • lack of energy and tiredness
  • hair loss
  • headaches
  • itching
  • nausea and vomiting
  • stomach upset or abdominal pain
  • changes in taste or unpleasant taste

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

  • bleeding or bruising
  • chest pain
  • fever
  • hallucinations (unusual thoughts, seeing or hearing things that are not real)
  • fast or irregular heart beats
  • signs of kidney damage (such as change in urine color or bubbly urine)
  • menstruation changes (missed or fewer periods)
  • muscle aches, spasms or abnormal movements
  • muscle pain or weakness

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.