IMPORTANT SAFETY INFORMATION
INDICATION(S) AND IMPORTANT SAFETY INFORMATION
WHAT is ISTURISA?
ISTURISA (osilodrostat) is a prescription medicine that is used to treat adults with Cushing’s disease:
- who cannot have pituitary surgery, or
- who have had pituitary surgery, but the surgery did not cure their Cushing’s disease
It is not known if ISTURISA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Before starting ISTURISA tell your healthcare provider about all your medical conditions, including if you:
- have or had heart problems, such as an irregular heartbeat, including a condition called prolonged QT syndrome (QT internal prolongation). Your healthcare provider will check the electrical signal of your heart (called an electrocardiogram) before you start taking ISTURISA, 1 week after starting ISTURISA, and as needed after that.
- have a history of low levels of potassium or magnesium in your blood.
- have liver problems.
- are breastfeeding or plan to breastfeed. It is not known if ISTURISA passes into your breast milk. You should not breastfeed if you take ISTURISA and for 1 week after stopping treatment.
Tell your healthcare provider about all the medicines you take, including any prescription and over-the-counter medicines, vitamins, or herbal supplements.
Especially tell your healthcare provider if you take medicines used to treat certain heart problems. Ask your healthcare provider if you are not sure whether your medicine is used to treat heart problems.
ISTURISA can cause serious side effects including:
- Low cortisol levels in your blood (hypocortisolism). Tell your healthcare provider right away if you experience more than one of the following symptoms, as these may be symptoms of very low cortisol level, known as adrenal insufficiency: nausea, vomiting, tiredness (fatigue), low blood pressure, stomach (abdominal) pain, loss of appetite, dizziness
If you get symptoms of hypocortisolism while taking ISTURISA, your healthcare provider may change your dose or ask you to stop taking it.
- Heart problem or a heart rhythm problem, such as an irregular heartbeat which could be a sign of a heart problem called QT prolongation. Call your healthcare provider right away if you have irregular heartbeats.
- Increase in other adrenal hormone levels. Your other adrenal hormones may increase when you take ISTURISA. Your healthcare provider may monitor you for the symptoms associated with these hormonal changes while you are taking ISTURISA:
- Low potassium (hypokalemia).
- High blood pressure (hypertension).
- Swelling (edema) in the legs, ankles or other signs of fluid retention.
- Excessive facial or body hair growth (hirsutism).
- Acne (in women).
Call your healthcare provider if you have any of these side effects.
The most common side effects of ISTURISA include very low cortisol levels (adrenal insufficiency), tiredness (fatigue), nausea, headache, and swelling of the legs, ankles or other signs of fluid retention (edema).
These are not all the possible side effects of ISTURISA. Call your healthcare provider for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch.
ISTURISA® (osilodrostat) tablets, for oral use, is available as 1 mg and 5 mg tablets.
Please see the accompanying full Prescribing Information.