Osilodrostat (oh-sil-oh-DROE-stat)

Treats Cushing disease.

Brand Name(s):

Isturisa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, skip the missed dose then go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how osilodrostat works. Tell your doctor if you are using carbamazepine, clarithromycin, itraconazole, phenobarbital, rifampin, S-mephenytoin, theophylline, or tizanidine.

Warnings While Using This Medicine:

• Do not breastfeed during treatment with this medicine and for 1 week after the last dose.
• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, heart rhythm problems, heart failure, high blood pressure, electrolyte imbalance, any type of infection, or stress.
• This medicine may cause the following problems:
  • Low cortisol levels, which could lead to adrenal insufficiency, low blood pressure, electrolyte imbalance, or low blood sugar levels
  • Heart rhythm problems (including QT prolongation)
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, dizziness, headache, pounding in the ears
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Fast, slow, pounding, or uneven heartbeat
• Swelling of the arms or legs

If you notice these less serious side effects, talk with your doctor:

• Acne and increased hair growth on the face, back, arms, and legs in females
• Back, stomach, joint, or muscle pain
• Decreased appetite
• Diarrhea

If you notice other side effects that you think are caused by this medicine, tell your doctor

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