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What to expect when starting ISTURISA

Model shown is not an actual patient.

ISTURISA MAY HELP YOU REACH AND MAINTAIN NORMAL CORTISOL LEVELS

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

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.

SIDE EFFECTS OF ISTURISA

Like all medicines, ISTURISA can cause side effects.

The most common side effects experienced by patients in the clinical studies of ISTURISA included

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

Your healthcare provider will work with you to help manage these by temporarily stopping treatment, adjusting your dose, or treating them with other medicines.

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

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 experience symptoms of hypocortisolism while taking ISTURISA, your healthcare provider may change your dose or ask you to stop taking it.

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

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

DOSING THAT CAN BE INDIVIDUALIZED TO FIT YOUR UNIQUE NEEDS

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

ISTURISA offers flexible dosing options and comes in 3 different strengths: 1 mg, 5 mg, and 10 mg. This allows your healthcare provider the flexibility to adjust the dose you need to normalize your cortisol levels while trying to balance the risk of side effects.

ISTURISA comes in 1, 5, and 10mg tablets to allow your doctor to find the precise dose that works best.

3 tablet options provide the flexibility for your healthcare provider to adjust your dose up or down

Once you start treatment, your dosage may be adjusted depending on your cortisol levels and how you respond to ISTURISA

Talk to your healthcare provider 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.

  • This process is referred to as titration
  • Your healthcare provider 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 healthcare provider tells you to do so

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

TRACK AND SHARE YOUR PROGRESS

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.

Our knowledgeable professionals are dedicated to supporting your treatment goals Connect with the R.A.R.E.SM Support Team Have questions about treatment with ISTURISA? Visit our FAQs for more information Hear from real patients who have experience with ISTURISA Meet our Patient Ambassadors

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