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RESOURCES & SUPPORT
Valuable Resources to Support Patients
Dealing with a rare disease can be challenging for you and your patients
R.A.R.E.® and the Patient Liaison Program can help.
A collaboration of support and services
ISTURISA® (osilodrostat) is available exclusively through the R.A.R.E.® patient support program.
- Designed to ensure your patients taking ISTURISA receive dedicated, multipoint services and support every step of the way
ACCESS AND FINANCIAL ASSISTANCE
DISPENSING AND DELIVERY
EDUCATION AND ADHERENCE
TO GET YOUR PATIENT STARTED:
STEP 1:
FILL OUT A PATIENT PRESCRIPTION FORM
- Visit RareResources.com to download Patient Prescription Forms
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
RECORDATI RARE DISEASES OFFERS A $20 CO-PAY FOR ELIGIBLE PATIENTS WITH COMMERCIAL INSURANCE
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
- Contact the R.A.R.E. Resources Patient Support Program team, including a clinical pharmacist
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 programa services may include:
- Providing education and answering your patients’ questions about Cushing’s disease and ISTURISA
- Helping your patients access their ISTURISA medication
- Connecting your patients with other Cushing’s disease educational resources
To get started, your patients can complete the Program Enrollment Opt‑In Form
Complete Opt-In FormHCP Resources
Patient Prescription Form
Start your patients onISTURISA by completing this
Patient Prescription Form.
Quick Start Guide
Information to start a patienton ISTURISA, including dosing, titration,
patient support, and more.
R.A.R.E. Patient Support Program
Learn how we ensure yourpatients taking ISTURISA receive dedicated,
multipoint services and support.
Example Insurance Letters
Download editable“Letter of Medical Necessity”
and “Letter of Appeal” templates.
Disease Education
Download this guide to identifying,diagnosing, and treating CD.
Cushing’s Disease Diagnostic Tool
Educate yourself on diagnosing Cushing’s disease and the importance of early screening if CD is suspected.
Medical Information
Contact information for healthcare professionals with medical inquiries or to report adverse events.
Patient Resources
Cushing’s Disease Overview Brochure
A post-diagnosis information source tohelp patients understand their condition
and the effects of living with CD.
Isturisa Patient Brochure
Help educate your patient on what to expect with ISTURISA.
Symptom and Self-Monitoring Diary
A useful tracking tool to help patients recordtheir experience as they undergo treatment,
which they can then share with their doctor.
Cushing’s Conversations™
Connect your patients to others who havebeen prescribed ISTURISA so that they can talk
with someone who knows.
CushingsDisease.com
A patient-focused site that offerseducational and support resources
for coping with CD.
INDICATION(S) AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
ISTURISA® (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary 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 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, and edema.
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:
- CYP3A4 Inhibitor: Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor.
- CYP3A4 and CYP2B6 Inducers: An increase of ISTURISA dosage may be needed if ISTURISA is used concomitantly with strong CYP3A4 and CYP2B6 inducers. A reduction in ISTURISA dosage may be needed if strong CYP3A4 and CYP2B6 inducers are discontinued while using ISTURISA.
Use in Specific Populations:
- Lactation: Breastfeeding is not recommended during treatment with ISTURISA and for at least one week after treatment.
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 the full Prescribing Information.
INDICATION(S) AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
ISTURISA® (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease for whom pituitary 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 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, and edema.
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:
- CYP3A4 Inhibitor: Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor.
- CYP3A4 and CYP2B6 Inducers: An increase of ISTURISA dosage may be needed if ISTURISA is used concomitantly with strong CYP3A4 and CYP2B6 inducers. A reduction in ISTURISA dosage may be needed if strong CYP3A4 and CYP2B6 inducers are discontinued while using ISTURISA.
Use in Specific Populations:
- Lactation: Breastfeeding is not recommended during treatment with ISTURISA and for at least one week after treatment.
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 the full Prescribing Information.