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What to expect when starting ISTURISA

Model shown is not an actual patient.

ISTURISA® (osilodrostat) MAY HELP YOU REACH AND MAINTAIN NORMAL CORTISOL LEVELSa

The primary treatment goal for patients with Cushing’s disease is to bring the body’s cortisol levels down to a normal range

ISTURISA blocks an enzyme that helps make cortisol, so your adrenal glands don't make as much. Because less cortisol is made, less cortisol is released into your bloodstream.

ISTURISA is the first FDA-approved medicine for Cushing's disease that works this way.

aThe safety and effectiveness of ISTURISA were studied in a 48-week clinical trial with 137 patients with Cushing's disease that involved a dose titration period, a maintenance dose period, a randomized withdrawal period, and an open-label period during which all patients received ISTURISA. Period 3 (weeks 26 to 34) was the 8-week randomized, double-blind, withdrawal period where patients were randomly assigned to receive ISTURISA or placebo. At the end of Period 3, 31 out of 36 patients who received ISTURISA maintained normal cortisol levels vs 10 out of 34 patients who received placebo. Individual results may vary.

SIDE EFFECTS OF ISTURISA

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.

ISTURISA may cause serious side effects, including:

  • 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
  • swelling of the legs, ankles or other signs of fluid retention (edema)

These are not all of the possible side effects of ISTURISA.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 2 different strengths: 1 mg and 5 mg. Your healthcare provider may recommend you take a combination of different tablets, and adjust based on how you respond. This allows your healthcare provider the flexibility to adjust your dose. The goal when treating Cushing’s disease is to normalize cortisol levels while trying to balance the risk of side effects.

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

2 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 the treatment journal to keep track of any symptoms
  • Share how you’re feeling since starting ISTURISA
  • Your healthcare team will use this information, along with the results of monitoring tests, to help optimize your treatment plan
A treatment journal is the best way to track your progress on ISTURISA.

My endocrinologist explained the benefits and risks of ISTURISA. We decided that it was a good match for me.

-Andrea, an ISTURISA Patient Ambassador who has been living with Cushing’s disease since 1996
Our knowledgeable professionals are dedicated to supporting your treatment goals Connect with the R.A.R.E.® Support Team Have questions about treatment with ISTURISA? Visit our FAQs for more information Hear from someone who is taking ISTURISA Learn more

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.

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 full Prescribing Information.