Resources & Support

Valuable Resources to Support Patients

Dealing with a rare disease can be challenging for you and your patients

R.A.R.E® - Recordati Access, Resources, and Engagement

A collaboration of support and services for you, your staff, and your patients

ISTURISA is available through the R.A.R.E. patient support program

Designed to ensure your patients receive dedicated, multi-point services and support every step of the way.

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Education and Adherence

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Access and Financial Assistance

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Dispensing and Delivery

All Prescriptions are Filled Through Our Specialty Pharmacy. To get a patient started, submit a Patient Prescription Form.

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STEP 1:

FILL OUT A PATIENT PRESCRIPTION FORM
  • Download the Patient Prescription Form
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STEP 2:

SUBMIT THE FORM

  • Fax the fully completed Patient Prescription Form to Anovo Specialty Rx at 1-855-813-2039

    - NCPDP #: 4445640

OR

  • Electronically submit the form in your EMR system

    - When ordering, choose Anovo#5

    - NCPDP #: 4445640

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RECORDATI RARE DISEASES OFFERS A $20 CO-PAY FOR ELIGIBLE PATIENTS WITH COMMERCIAL INSURANCE*

*Eligibility requirements, restrictions and limitations apply.

Patient Liaison services are provided to help support patients while on ISTURISA therapy. Information provided by the PL Program is for educational purposes only and is not intended to replace the advice of the health care provider.

Have you visited R.A.R.E. Resources?

RareResources.com is your one-stop source to starting a new patient, plus access to a full range of Recordati Rare Diseases tools and resources:

  • Get help to start a new patient
  • Access insurance letter templates
  • Connect with a Recordati Rare Diseases representative
Visit & bookmark
RareResources.com website displayed on a mobile phone

THE PATIENT LIAISON PROGRAM

Personalized, one-on-one support for your patients taking ISTURISA

The Patient Liaison (PL) is someone who helps your patients through their unique journey. This personalized support is provided at no additional cost to your patients by Recordati Rare Diseases.

PL program† services may include:

  • Providing education and answering your patients’ questions about Cushing’s and ISTURISA
  • Helping your patients access their ISTURISA medication
  • Connecting your patients with other Cushing’s educational resources

To get started, your patients can complete the Program Enrollment Opt‑In Form

Complete opt-in form

Patient Liaison services are provided to help support patients while on ISTURISA therapy. Information provided by the PL Program is for educational purposes only and is not intended to replace the advice of the health care provider.

HCP Resources

Patient Prescription Form Patient Prescription Form Start your patients on ISTURISA by completing this 
Patient Prescription Form. Quick Start Guide Quick Start Guide Information to start an ISTURISA 
patient, including dosing, titration, 
patient support and more. R.A.R.E. Patient Support Program R.A.R.E. Patient Support Program Learn how we ensure your ISTURISA patients receive dedicated, multi-point services and support. Medical Information Medical Information Contact information for healthcare professionals
with medical inquiries or to report adverse events. Example Insurance Letters Example Insurance Letters Download editable 
"Letter of Medical Necessity" 
and “Letter of Appeal" templates.

Patient Resources

ISTURISA Patient Brochure ISTURISA Patient Brochure An overview of how treatment with ISTURISA 
can help Cushing’s patients reach 
and maintain normal cortisol levels. Symptom and Self-Monitoring Diary Symptom and Self-Monitoring Diary A useful tracking tool to help patients record
 their experience as they undergo treatment 
which they can then share with their doctor. Cushing's Conversations<sup>®</sup> Cushing's Conversations® Connect your patients to others who have 
been prescribed ISTURISA so that they can talk 
to others in their shoes.

Helpful Link

The Pituitary Society The Pituitary Society Pituitary World News Pituitary World News Pituitary Network Association Pituitary Network Association National Institute of Diabetes 
and Digestive and Kidney Diseases National Institute of Diabetes 
and Digestive and Kidney Diseases
Who is ISTURISA right for?

INDICATIONS AND USAGE

ISTURISA® (osilodrostat) is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative.

IMPORTANT SAFETY INFORMATION

Hypocortisolism: ISTURISA lowers cortisol levels and can lead to hypocortisolism and sometimes life-threatening adrenal insufficiency. Lowering of cortisol can cause nausea, vomiting, fatigue, abdominal pain, loss of appetite, and dizziness. Significant lowering of serum cortisol may result in hypotension, abnormal electrolyte levels, and hypoglycemia.

Hypocortisolism can occur at any time during ISTURISA treatment. Evaluate patients for precipitating causes of hypocortisolism (infection, physical stress, etc.). Monitor 24-hr urine free cortisol, serum or plasma cortisol, and patient’s signs and symptoms periodically during ISTURISA treatment.

Decrease or temporarily discontinue ISTURISA if urine free cortisol levels fall below the target range, there is a rapid decrease in cortisol levels, and/or patients report symptoms of hypocortisolism. Stop ISTURISA and administer exogenous glucocorticoid replacement therapy if serum or plasma cortisol levels are below target range and patients have symptoms of adrenal insufficiency. After ISTURISA interruption or discontinuation, cortisol suppression may persist beyond the 4-hour half-life of ISTURISA.

Educate patients on the symptoms associated with hypocortisolism and advise them to contact a healthcare provider if they occur.

QTc Prolongation: ISTURISA is associated with a dose-dependent QT interval prolongation which may cause cardiac arrhythmias. Perform an ECG to obtain a baseline QTc interval measurement prior to initiating therapy with ISTURISA and monitor for an effect on the QTc interval thereafter.

Correct hypokalemia and/or hypomagnesemia prior to ISTURISA initiation and monitor periodically during treatment with ISTURISA. Use with caution in patients with risk factors for QT prolongation and consider more frequent ECG monitoring.

Elevations in Adrenal Hormone Precursors and Androgens: ISTURISA blocks cortisol synthesis and may increase circulating levels of cortisol and aldosterone precursors and androgens. This may activate mineralocorticoid receptors and cause hypokalemia, edema and hypertension. Hypokalemia should be corrected prior to initiating ISTURISA. Monitor patients treated with ISTURISA for hypokalemia, worsening of hypertension and edema. Inform patients of the symptoms associated with hyperandrogenism and advise them to contact a healthcare provider if they occur.

The most common adverse reactions (incidence >20%) are adrenal insufficiency, fatigue, nausea, headache, edema, decreased appetite, arthralgia, myalgia, and diarrhea.

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

Drug Interactions:

Use in Specific Populations:

Dosage Interruptions and Modifications: If treatment is interrupted, re-initiate ISTURISA at a lower dose when cortisol levels are within target ranges and patient symptoms have been resolved.

ISTURISA® (osilodrostat) tablets, for oral use, is available as 1 mg and 5 mg tablets.

Please see full Prescribing Information.

Patient portrayal.

Meghan, Actor Portrayal
BASELINE CHARACTERISTICS Age: 34 Race: White Height: 5'6" Weight: 80.1 kg (177 lb) BMI: 28.6 kg/m2
Diagnosis Cushing’s disease: recurrent
Time since diagnosis  6 years
Treatment
  • Transsphenoidal surgery was performed within 2 months of diagnosis 
  • Pituitary radiotherapy was performed 2 years ago
Status
  • In remission, but beginning to develop symptoms of recurrence
Symptoms
  • Weight gain in the abdomen
  • Fatigue and sleep disturbances
  • Anxiety and depression
  • Easy bruising
  • Increased thirst and urination
Comorbidities
  • Depression/anxiety
  • Hyperlipidemia
  • Prediabetes
Vital signs and labs Blood pressure: 124/86 mm Hg HR: 72 bpm Total cholesterol: 213 mg/dL (reference range: <200 mg/dL) LDL: 112 mg/dL (reference range: <100 mg/dL) HDL: 45 mg/dL (reference range: >60 mg/dL) Glucose: 123 mg/dL (reference range: <100 mg/dL) HbA1c: 6.2% (reference range: <5.7%) UFC: 217.5 nmol/24 h (78.8 μg/24 h) (reference range: <145 nmol/24 h [approximately 11-53 μg/24 h]) UFC fold ULN: 1.5 x ULN mUFC

Patient portrayal.

Questions to consider when developing a treatment plan

  1. What would be the consequences if this patient’s cortisol levels remain uncontrolled?
  2. How do you evaluate severity of disease in your patients?
  3. What are your treatment goals for this patient?
  4. What do you consider to be the appropriate next therapy option for this patient?
  5. Would you consider ISTURISA an appropriate option for this patient? Why or why not?

BMI, body mass index; bpm, beats per minute; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; HR, heart rate; LDL, low-density lipoprotein; mUFC, mean urinary free cortisol; UFC, urinary free cortisol; ULN, upper limit of normal.

Why ISTURISA May be Right for Your Patient

Patient portrayal.

Mike, Actor Portrayal
BASELINE CHARACTERISTICS Age: 34 Race: White Height: 5'10” Weight: 95.9 kg (211 lb) BMI: 30.3 kg/m2
Diagnosis Cushing’s syndrome: treatment naive
Time since diagnosis 7 months
Treatment
  • Exogenous sources of hypercortisolemia were ruled out
  • Standard imaging techniques were unsuccessful in locating the tumor
  • Inferior petrosal sinus sampling indicated an ectopic source
  • Patient is not a candidate for surgical intervention
Status
  • Further imaging investigation is required
  • Patient is experiencing symptoms of hypercortisolemia that may benefit from medication therapy
  • Cardiometabolic parameters are currently not controlled despite lifestyle changes and maximized treatment
Symptoms
  • Weight gain in the abdomen
  • Rounded face
  • Hypertension
  • Diabetes
  • Daytime fatigue and nighttime insomnia
  • Muscle weakness
Comorbidities
  • Hypertension
  • Diabetes
  • Hyperlipidemia
Vital signs and labs Blood pressure: 146/92 mm Hg HR: 68 bpm Total cholesterol: 238 mg/dL (reference range: <200 mg/dL) LDL: 121 mg/dL (reference range: <100 mg/dL) HDL: 42 mg/dL (reference range: >60 mg/dL) Glucose: 136 mg/dL (reference range: <100 mg/dL) HbA1c: 7.6% (reference range: <5.7%) UFC: 304.5 nmol/24 h (110.3 μg/24 h) (reference range: <145 nmol/24 h [approximately 11-53 μg/24 h]) UFC fold ULN: 2.1 x ULN mUFC

Patient portrayal.

Questions to consider when developing a treatment plan

  1. What would be the consequences if this patient’s cortisol levels remain uncontrolled?
  2. What are your treatment goals for this patient?
  3. What do you consider to be the appropriate next therapy option for this patient?
  4. Would you consider ISTURISA an appropriate option for this patient? Why or why not?

BMI, body mass index; bpm, beats per minute; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; HR, heart rate; LDL, low-density lipoprotein; mUFC, mean urinary free cortisol; UFC, urinary free cortisol; ULN, upper limit of normal.

Why ISTURISA May be Right for Your Patient

Patient portrayal.

Stephanie, Actor Portrayal
BASELINE CHARACTERISTICS Age: 31 Race: African American Height: 5'4” Weight: 75.0 kg (165 lb) BMI: 28.3 kg/m2
Diagnosis High clinical suspicion of hypercortisolemia in Cushing’s syndrome; further testing is required
Time since diagnosis Pending diagnosis
Notes
  • UFC labs were repeated twice over several weeks with consistent findings of elevated cortisol
  • Exogenous sources of hypercortisolemia were ruled out
  • Imaging investigation is required
Treatment
  • None
Status
  • Patient has seen an endocrinologist to discuss lack of symptom relief despite lifestyle modification and reported that symptoms are worsening
Symptoms
  • Weight gain in the abdomen
  • Weight gain in the face
  • Facial plethora
  • Muscle weakness
  • Menstrual irregularities
  • Fatigue and sleep disturbances
  • Anxiety and depression
Comorbidities
  • Diabetes
  • Polycystic ovarian syndrome
Vital signs and labs Blood pressure: 130/84 mm Hg HR: 86 bpm Total cholesterol: 208 mg/dL (reference range: <200 mg/dL) LDL: 106 mg/dL (reference range: <100 mg/dL) HDL: 58 mg/dL (reference range: >60 mg/dL) Glucose: 131 mg/dL (reference range: <100 mg/dL) HbA1c: 7.2% (reference range: <5.7%) UFC: 246.5 nmol/24 h (89.3μg/24 h) (reference range: <145 nmol/24 h [approximately 11-53 μg/24 h]) UFC fold ULN: 1.7 x ULN mUFC

Patient portrayal.

Questions to consider when developing a treatment plan

  1. What symptoms lead you to a high clinical suspicion of hypercortisolemia in Cushing’s syndrome?
  2. What would be the consequences if this patient’s cortisol levels remain uncontrolled?
  3. What are your treatment goals for this patient?

BMI, body mass index; bpm, beats per minute; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; HR, heart rate; LDL, low-density lipoprotein; mUFC, mean urinary free cortisol; UFC, urinary free cortisol; ULN, upper limit of normal.

Why ISTURISA May be Right for Your Patient