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PATIENT PROFILES
Different Treatment Plans for Different Patients
Since you may see patients at different stages of diagnosis and treatment, there are questions to consider when developing a treatment plan and considering ISTURISA as an appropriate option.
Select a name to review different patient profiles:
Swipe to review different patient profiles:
Josie S.
Patient with Cushing’s Disease
Age: 36
Race: Caucasian
Cushing’s disease: Mild, recurrent
Time since diagnosis: 3 years
Surgery: Yes
Performed within 1 month of diagnosis
Status: In remission until 1 month ago
Beginning to develop symptoms of recurrence
Symptoms
- Sleep disturbances
- Fatigue
- Anxiety
- Menstrual irregularities
- Acne
Cortisol
-
UFC: 60 μg/24 hours (165.6 nmol/24 hours)
- UFC fold upper limit of normal:
1.2 x ULN mUFC
- UFC fold upper limit of normal:
Comorbidities
-
Gastroesophageal reflux disease (GERD)
- Current treatment: esomeprazole
Questions to consider when developing a treatment plan
What do you consider to be the appropriate next therapy option for this patient?
How would this patient’s use of a proton pump inhibitor affect your selection of next therapy?
What key concerns do you have that may affect your selection of an appropriate medical therapy for this patient?
Would you consider ISTURISA an appropriate option for this patient? Why or why not?
David A.
Patient with Cushing’s Disease
Age: 32
Race: Caucasian
Cushing’s disease: Recurrent,
on ketoconazole
Time since diagnosis: 2 years
Surgery: Yes
Performed within 1 month of diagnosis
Status: Dose of ketoconazole
increased to 900 mg/24 hrs
Despite dose adjustment, cortisol levels increasing; patient reports some symptoms of Cushing’s disease returning
Symptoms
- Low libido
- Difficulty losing weight
Cortisol
-
UFC: 90 μg/24 hours (248.4 nmol/24 hours)
- UFC fold upper limit of normal:
1.8 x ULN mUFC
- UFC fold upper limit of normal:
Comorbidities
-
Hypertension
- Current treatment: lisinopril 20 mg
Questions to consider when developing a treatment plan
What might be your next selection for your patient’s medical therapy?
Would you consider ISTURISA an appropriate option for this patient? Why or why not?
Do you have any concerns about this patient being prescribed other medications, now or in the future, for comorbid conditions?
Jenna M.
Patient with Cushing’s Disease
Age: 40
Race: African American
Cushing’s disease: Naïve
Time since diagnosis: 1 month
Surgery: None
Tumor not visible, but IPSS shows
Cushing’s disease; patient does not want
surgery due to risks
Status: N/A
Symptoms
- Weight gain
- Uncontrolled diabetes
- Fatigue
- Muscle weakness
- Mild depression
Cortisol
-
UFC: 135 μg/24 hours (372.6 nmol/24 hours)
- UFC fold upper limit of normal:
2.7 x ULN mUFC
- UFC fold upper limit of normal:
Comorbidities
-
Hypertension
- Current treatment: calcium channel blocker
-
Diabetes (HbA1c = 8.8)
- Current treatment: multiple medications, including insulin
Questions to consider when developing a treatment plan
What are your key considerations about potential drug-drug interactions when planning the treatment regimen for your medically naïve patient?
Is your primary goal to normalize cortisol or resolve signs and symptoms of Cushing’s disease, or do you value them equally?
For a patient with diabetes, would you prefer to block cortisol synthesis at the source or block the cortisol receptor?
Would you consider ISTURISA an appropriate option for this patient? Why or why not?
Tara H.
Patient with Cushing’s Disease
Age: 51
Race: Hispanic
Cushing’s disease: Persistent
Time since diagnosis: 9 months
Surgery: Yes
7 months ago; surgery was not successful
Status: Discontinued ketoconazole
3 months ago due to intolerance
Symptoms
- Anxiety
- Weight gain
- Depression
- Easy bruising
Cortisol
-
UFC: 265 μg/24 hours (731.4 nmol/24 hours)
- UFC fold upper limit of normal:
5.3 x ULN mUFC
- UFC fold upper limit of normal:
Comorbidities
-
Uncontrolled diabetes
- Current treatments: metformin, canagliflozin, and insulin
- Resistant hypertension
-
Child-Pugh A (mild hepatic abnormality)
- Total bilirubin: 2.1 mg/dL
- ALT: 1.5 x ULN; AST: 2 x ULN
-
Hirsutism
- Managed with: spironolactone
Questions to consider when developing a treatment plan
What is your first step for managing this patient’s high cortisol level?
For this patient, would you prefer to block cortisol synthesis at the source or block the cortisol receptor?
Do you have any potential concerns with this patient’s current liver panel, and how might that influence your treatment decision?
Would you consider ISTURISA an appropriate option for this patient? Why or why not?
How would this patient’s likely immunocompromised state influence your treatment selection?
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
Warnings and Precautions
-
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. Please see section 5.1 of full Prescribing Information.
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. Please see section 5.2 of full Prescribing Information.
- 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. Please see section 5.3 of full Prescribing Information.
Adverse Reactions
- 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.
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
Warnings and Precautions
-
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. Please see section 5.1 of full Prescribing Information.
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. Please see section 5.2 of full Prescribing Information.
- 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. Please see section 5.3 of full Prescribing Information.
Adverse Reactions
- 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.
References: 1. Geer EB, Shafiq I, Gordon MB, et al. Biochemical control during long-term follow-up of 230 adult patients with Cushing disease: a multicenter retrospective study. Endocr Pract. 2017;23(8):962-970. 2. Dekkers OM, Horváth-Puhó E, Jørgensen JOL, et al. Multisystem morbidity and mortality in Cushing’s syndrome: a cohort study. J Clin Endocrinol Metab. 2013;98(6):2277-2284. 3. Geer EB, Ayala A, Bonert V, et al. Follow-up intervals in patients with Cushing’s disease: recommendations from a panel of experienced pituitary clinicians. Pituitary. 2017;20(4):422-429. 4. Fleseriu M, Auchus R, Bancos I, et al. Consensus on diagnosis and management of Cushing’s disease: a guideline update. Lancet. 2021; https://doi.org/10.1016/S2213-8587(21)00235-7. 5. ISTURISA® (osilodrostat) [prescribing information]. Lebanon, NJ: Recordati Rare Diseases Inc.; 2020. 6. Bertagna X, Pivonello R, Fleseriu M, et al. LCI699, a potent 11β-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing’s disease: results from a multicenter, proof-of-concept study. The Journal of Clinical Endocrinology & Metabolism. 2014;99(4):1375-1383.