Osilodrostat Tablets

What is this medication?

OSILODROSTAT (oh SIL oh DROE stat) treats Cushing syndrome, a condition that causes high levels of the hormone cortisol. Cortisol plays an important role in helping your body manage metabolism and respond to stress. Too much cortisol can cause weight gain, high blood pressure, diabetes, and bone loss. This medication works by decreasing levels of cortisol in the body.

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
• Irregular heartbeat or rhythm
• Liver disease
• Low levels of magnesium or potassium in the blood
• An unusual or allergic reaction to osilodrostat, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

Talk to your care team about the use of this medication 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 medication with any of the following:

• Dofetilide
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Carbamazepine
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as ketoconazole, itraconazole, or posaconazole
• Clarithromycin
• Other medications that cause heart rhythm changes
• 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?

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.

You may need blood work done while you are taking this medication.

Do not breast-feed while taking this medication and for 1 week after stopping therapy.

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
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood sugar (hypoglycemia)—tremors or shaking, anxiety, sweating, cold or clammy skin, confusion, dizziness, rapid heartbeat
• Low potassium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, constipation

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

• Acne
• Fatigue
• Headache
• Swelling of the ankles, hands, or feet
• Unexpected hair growth

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 between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Get rid of any unused medication after the expiration date on the label.

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 it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a 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.