| Cushing Syndrome

Recorlev vs Isturisa

Side-by-side clinical, coverage, and cost comparison for cushing syndrome.
Deep comparison between: Recorlev vs Isturisa with Prescriber.AI
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Safety signalsIsturisa has a higher rate of injection site reactions vs Recorlev based on FDA-approved prescribing information
Coverage gaps3 major payers require step therapy for Isturisa but not Recorlev, including UnitedHealthcare
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Recorlev
Isturisa
At A Glance
Oral
Twice daily
Cortisol synthesis inhibitor
Oral
Twice daily
CYP11B1 inhibitor
Indications
  • Cushing Syndrome
  • Cushing Syndrome
Dosing
Cushing Syndrome Initiate at 150 mg orally twice daily; titrate by 150 mg daily no more frequently than every 2-3 weeks based on 24-hour urine free cortisol levels and tolerability; maximum 1200 mg per day (600 mg twice daily).
Cushing Syndrome Initiate at 2 mg orally twice daily with or without food; titrate by 1-2 mg twice daily no more frequently than every 2 weeks based on cortisol changes and tolerability; maximum 30 mg twice daily. Hepatic impairment: Child-Pugh B start at 1 mg twice daily; Child-Pugh C start at 1 mg once daily in the evening.
Contraindications
  • Cirrhosis, acute liver disease, poorly controlled chronic liver disease, baseline AST or ALT >3x ULN, recurrent symptomatic cholelithiasis, prior drug-induced liver injury due to ketoconazole or any azole antifungal requiring discontinuation, or extensive metastatic liver disease
  • Concomitant use of drugs that cause QT prolongation associated with ventricular arrhythmias, including torsades de pointes
  • QTcF interval >470 msec at baseline, or history of torsades de pointes, ventricular tachycardia, ventricular fibrillation, or long QT syndrome (including first-degree family history)
  • Known hypersensitivity to levoketoconazole, ketoconazole, or any excipient in RECORLEV
  • Concomitant use of certain sensitive substrates of CYP3A4 or CYP3A4 and P-gp
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Adverse Reactions
Most common (>=10%) Nausea/vomiting, hypokalemia, systemic hypertension, hemorrhage/contusion, headache, abnormal uterine bleeding, arrhythmia, fatigue, upper respiratory infection, abdominal pain/dyspepsia, dizziness, diarrhea, decreased appetite, dry mouth, dry skin, adrenal insufficiency
Serious Hepatotoxicity, QT prolongation, hypocortisolism, hypersensitivity reactions, decreased testosterone
Postmarketing Thrombocytopenia, adrenocortical insufficiency, serious hepatotoxicity (hepatitis cholestatic, hepatic necrosis, cirrhosis, hepatic failure), anaphylactic shock, anaphylactic reaction, angioneurotic edema, reversible intracranial pressure increased, erectile dysfunction, azoospermia, acute generalized exanthematous pustulosis, photosensitivity
Most common (>10%) Adrenal insufficiency, fatigue, nausea, headache, edema, nasopharyngitis, vomiting, arthralgia, back pain, rash, diarrhea, dizziness, abdominal pain, hypokalemia, myalgia, decreased appetite, hormone level abnormal, hypotension, urinary tract infection, blood testosterone increased, pyrexia, anemia, cough, hypertension, influenza
Serious Hypocortisolism, QT prolongation, adrenal hormone precursor accumulation and androgen excess, pituitary corticotroph tumor volume increase
Postmarketing Neutropenia associated with fever and infection
Pharmacology
Levoketoconazole is a cortisol synthesis inhibitor that blocks key steroidogenic enzymes (CYP11B1, CYP11A1, CYP17A1) involved in cortisol and testosterone biosynthesis; it is the 2S,4R-enantiomer of racemic ketoconazole and a strong CYP3A4 inhibitor and P-gp, OCT2, and MATE1 transporter inhibitor in vivo.
Osilodrostat is a cortisol synthesis inhibitor that inhibits 11beta-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland, leading to dose-dependent reductions in cortisol and increases in ACTH and cortisol precursors.
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Most Common Insurance
Anthem BCBS
Recorlev
  • Covered on 5 commercial plans
  • PA (10/12) · Step Therapy (10/12) · Qty limit (9/12)
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Isturisa
  • Covered on 5 commercial plans
  • PA (10/12) · Step Therapy (0/12) · Qty limit (0/12)
View full coverage details ›
UnitedHealthcare
Recorlev
  • Covered on 4 commercial plans
  • PA (1/8) · Step Therapy (0/8) · Qty limit (0/8)
View full coverage details ›
Isturisa
  • Covered on 4 commercial plans
  • PA (6/8) · Step Therapy (0/8) · Qty limit (0/8)
View full coverage details ›
Humana
Recorlev
  • Covered on 0 commercial plans
  • PA (3/3) · Step Therapy (2/3) · Qty limit (2/3)
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Isturisa
  • Covered on 0 commercial plans
  • PA (1/3) · Step Therapy (0/3) · Qty limit (0/3)
View full coverage details ›
Coverage data sourced from MMIT. Updated monthly.
Savings
Cost estimate not availableHealthWell: Cushing's Disease or Cushing's Syndrome
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
$20/momo
R.A.R.E. Patient Support Copay Program: Isturisa
Commercial or private insurance
Medicare, Medicaid, VA, TRICARE
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RecorlevView full Recorlev profile
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Clinical data sourced from FDA-approved labeling. Coverage data via MMIT. Updated monthly.