Osilodrostat oral tablets

What is this medication?

OSILODROSTAT (oh SIL oh DROE stat) is used to treat Cushing's disease. It is used when surgery is not an option or has not worked well enough.

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

COMMON BRAND NAME(S): Isturisa

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

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

• acne
• heart disease
• high blood pressure
• history of irregular heartbeat
• liver disease
• low levels of magnesium or potassium in the blood
• an unusual or allergic reaction to osilodrostat, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician about the use of this medicine in children. Special care may be needed.

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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dofetilide
• dronedarone
• pimozide
• thioridazine

This medicine may also interact with the following medications:

• carbamazepine
• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• clarithromycin
• other medicines that prolong the QT interval (an abnormal heart rhythm)
• phenobarbital
• rifampin
• theophylline
• tizanidine

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?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. You may need blood work done while you are taking this medicine.

Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• acne in women
• excessive hair growth on the face or body
• loss of appetite
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast, irregular heartbeat; palpitations; feeling faint or lightheaded; falls; breathing problems
• signs and symptoms of low potassium like muscle cramps; muscle pain; chest pain; dizziness; feeling faint or lightheaded, falls; palpitations; breathing problems; or fast, irregular heartbeat
• swelling of the ankles, feet, hands
• unusually weak or tired
• vomiting

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• headache
• nausea
• tiredness

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.

Store this medicine at room temperature between 15 to 30 degrees C (59 to 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date on the label.

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.