What to expect when starting ISTURISA

Model shown is not an actual patient.

ISTURISA CAN HELP YOU REACH AND MAINTAIN NORMAL CORTISOL LEVELS1

The primary treatment goal for patients with Cushing’s disease is to bring your body’s cortisol levels back to normal2,3

ISTURISA reduces the amount of cortisol made in your adrenal glands. With ISTURISA, less cortisol is made, so less cortisol is released into your bloodstream.1

DOSING THAT CAN BE INDIVIDUALIZED TO FIT YOUR UNIQUE NEEDS

ISTURISA is an oral tablet you take twice a day, with or without food1

There are three different tablet strengths of ISTURISA, and you may take a combination of different tablets based on how you respond to ISTURISA. This allows your doctor to determine the precise dose that works best for you.

Once you start treatment, your dosage may be adjusted up or down depending on your cortisol levels and how you respond to ISTURISA1

Talk to your doctor about how you’re feeling, your symptoms, and your treatment goals so he or she can help find the amount of ISTURISA that’s right for you.1

  • This process is referred to as titration
  • Your doctor will help determine the dose that works best for you
  • If you miss a dose of ISTURISA, take the next dose at your regularly scheduled time
  • Do not change your dose or stop taking ISTURISA unless your doctor tells you to do so

If you experience side effects, please contact your doctor right away.

The best way to know if ISTURISA is working for you is to track your progress.

  • Use a treatment journal to keep track of any symptoms
  • Share how you’re feeling and any changes in your activity level since starting ISTURISA
  • Your healthcare team will use this information to help optimize your treatment plan
A treatment journal is the best way to track your progress on ISTURISA.

After starting ISTURISA, my doctor and I worked together to find the dose that was right for me.

Model shown is not an actual patient.

The most common side effects experienced by patients in the clinical study of ISTURISA included1:

  • Very low cortisol levels (hypocortisolism)
  • Tiredness (fatigue)
  • Nausea
  • Headache
  • Swelling of the legs, ankles, or other signs of fluid retention (edema)

There are other serious side effects that can occur with ISTURISA. For more information, ask your healthcare provider.

As your cortisol levels decline, you might have symptoms of cortisol withdrawal. These include flu-like feelings, such as1:

  • Nausea
  • Vomiting
  • Tiredness (fatigue)
  • Low blood pressure
  • Stomach (abdominal) pain
  • Loss of appetite
  • Dizziness

If you experience more than one of the symptoms above, tell your doctor right away. They may indicate very low cortisol levels (hypocortisolism).1

Your doctor can modify your dose of ISTURISA based on your individual response. If you experience side effects, your doctor can adjust your dose.1

You should take ISTURISA exactly as your doctor recommends. And, if you begin to experience any side effects, be sure to talk to your doctor right away.1

A FULLY-DEDICATED TEAM TO SUPPORT YOU DURING YOUR TREATMENT

Once you're prescribed ISTURISA you are automatically enrolled in the Recordati Access, Resource, and Engagement (R.A.R.E.) program

R.A.R.E. is a patient support program designed to make it easier for you to access and stay on your treatment. Our knowledgeable and reliable professionals have been fully trained about ISTURISA and are dedicated to supporting your treatment goals.

With R.A.R.E. you’ll have access to:

  • Coverage support from an Insurance Specialist
  • A dedicated Nurse Ambassador
  • 24/7 Pharmacist support
  • Savings and financial assistance.*

R.A.R.E. can also help commercially-insured patients get their medication for no more than $20 per month.*

*Restrictions, limitations, and/or eligibility requirements apply.

ISTURISA® (osilodrostat) Important Safety Information

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.

ISTURISA® (osilodrostat) Important Safety Information

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.

Please see the accompanying Full Prescribing Information, including the Medication Guide, for ISTURISA and talk with your healthcare provider.

References: 1. ISTURISA® (osilodrostat) [full prescribing information]. Lebanon, NJ: Recordati; March 2020. 2. Pivonello R, De Martino MC, De Leo M, Simeoli C, Colao A. Cushing’s disease: the burden of illness. Endocrine. 2017;56(1):10-18. 3. Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831.