ISTURISA®

 

April 16, 2020

ISTURISA® (osilodrostat) Important Safety Information

(consumer version)


Indications and Usage


ISTURISA (osilodrostat) 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.


Important Safety Information:

  • Hypocortisolism: Treatment with ISTURISA may cause symptoms associated with low levels of cortisol 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 Heart Rhythm Problem: ISTURISA may cause 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 such as 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.
  •  Most common side effects include very low cortisol levels (adrenal insufficiency), tiredness (fatigue), nausea, headache, swelling of the legs, ankles or other signs of fluid retention (edema). These are not all of the possible side effects of ISTURISA.

To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.  Before taking ISTURISA, tell your doctor about all of 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 prescription medicines, over-the-counter medicines, vitamins, and 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.

 

 

PP-IST-US-0005

 

 

April 16, 2020

ISTURISA® (osilodrostat) Important Safety Information
(consumer version)

Indications and Usage

ISTURISA (osilodrostat) 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.

Important Safety Information:

  • Hypocortisolism: Treatment with ISTURISA may cause symptoms associated with low levels of cortisol 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 Heart Rhythm Problem: ISTURISA may cause 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 such as 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.
  • Most common side effects include very low cortisol levels (adrenal insufficiency), tiredness (fatigue), nausea, headache, swelling of the legs, ankles or other signs of fluid retention (edema).  These are not all of the possible side effects of ISTURISA.

To report SUSPECTED SIDE EFFECTS, contact Recordati Rare Diseases Inc. at 1-888-575-8344, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before taking ISTURISA, tell your doctor about all of 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.

Text Box: PP-IST-US-0005Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and 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.

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