WHAT IS ISTURISA?
ISTURISA (osilodrostat) is a prescription medicine used to treat elevated levels of
cortisol in the blood
(endogenous hypercortisolemia) in adults with Cushing’s syndrome:
- who cannot have surgery, or
- who have had surgery which did not cure their Cushing’s syndrome
It is not known if ISTURISA is safe and effective in children.
ISTURISA is a prescription medicine used to treat elevated levels of cortisol in the blood
(known as
endogenous hypercortisolemia) in adults with Cushing’s syndrome. Appropriate patients either cannot have
surgery, or have had surgery which did not cure their Cushing’s syndrome. 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 interval 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 or plan to become pregnant. It is not known if ISTURISA will harm your unborn baby. There are risks
to the mother and unborn baby associated with active Cushing’s syndrome during pregnancy.
- 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 any 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, problems with body salt (electrolyte) levels in your blood, stomach (abdominal) pain, loss
of appetite, dizziness, low blood sugar.
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), decreased appetite, pain in your joints (arthralgia), muscle pain or soreness
(myalgia), weakness (asthenia), and diarrhea.
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 full Prescribing
Information.
