Product image of Isturisa (Osilodrostat) supplied by GNH India

Isturisa

Active Ingredient:
Osilodrostat
Origin:
EU

Isturisa (Osilodrostat)

Osilodrostat, the active ingredient in Isturisa, is a steroidogenesis inhibitor presented as a tablet for oral use. It reduces cortisol synthesis and is indicated for the treatment of Cushing's disease and Cushing's syndrome in patients with endogenous hypercortisolism. The medication is approved for use within the European Union and is prescribed by endocrinologists experienced in managing adrenal disorders.

GNH India supplies Isturisa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. All batches are manufactured under GMP standards and undergo rigorous quality testing before distribution.

Manufacturer / TM Owner

Recordati Rare Diseases

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Indications & Clinical Uses

Isturisa (osilodrostat) is used to manage disorders of excess cortisol production.

  • Cushing's disease: lowers cortisol levels in patients with pituitary ACTH‑secreting tumors.
  • Cushing's syndrome: reduces cortisol in patients with ectopic ACTH production or adrenal causes.
  • Endogenous hypercortisolism: helps control cortisol excess regardless of source.

How It Works

  • Osilodrostat inhibits the adrenal enzyme 11β‑hydroxylase (CYP11B1), a key step in cortisol biosynthesis. By blocking this enzyme, the drug decreases the conversion of 11‑deoxycortisol to cortisol, leading to reduced circulating cortisol concentrations and mitigation of hypercortisolism associated with Cushing's disease and syndrome.

Side Effects

Common Side Effects

  • Nausea
  • Fatigue
  • Headache
  • Dizziness

Serious or Rare Side Effects

  • Adrenal crisis
  • Severe hypokalemia
  • Hepatic injury

Precautions & Warnings

Before initiating therapy, consider the following precautions:

  • Monitor cortisol levels: adjust dose based on biochemical response.
  • Assess for adrenal insufficiency: watch for signs of under‑replacement.
  • Check electrolyte balance: especially potassium and sodium.
  • Use caution in hepatic impairment: dose may need adjustment.
  • Avoid use in pregnancy: safety is unknown; only if benefit outweighs risk.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) may increase osilodrostat exposure.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce osilodrostat effectiveness.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin) can modestly raise drug levels.
  • CYP2C19 inhibitors (e.g., fluoxetine) may increase exposure.
  • QT‑prolonging agents (e.g., macrolide antibiotics) may heighten cardiac risk.

Frequently Asked Questions

Isturisa contains osilodrostat and is prescribed to lower cortisol production in patients with Cushing's disease or Cushing's syndrome. By reducing excess cortisol, it helps control the signs and symptoms associated with these endocrine disorders.

Osilodrostat blocks the adrenal enzyme 11β‑hydroxylase (CYP11B1), which is essential for the final step of cortisol synthesis. Inhibition of this enzyme decreases the conversion of precursors to cortisol, thereby lowering circulating cortisol levels.

The dose of Isturisa is individualized and set by the prescribing clinician based on the patient’s cortisol levels, clinical response, and tolerability. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety of osilodrostat in pregnancy and lactation has not been established. It should be avoided unless the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made by a qualified healthcare professional.

To order Isturisa, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Isturisa (osilodrostat) is a potent 11β‑hydroxylase inhibitor, offering rapid cortisol reduction. Compared with ketoconazole, which has broader enzyme inhibition, osilodrostat provides more specific targeting with a different side‑effect profile, while metyrapone acts earlier in the steroidogenesis pathway.

Isturisa tablets should be stored at temperatures below 25 °C in their original packaging, protected from moisture and direct sunlight. Keep the product out of reach of children and do not use after the expiry date printed on the label.

Isturisa is taken orally as a tablet, with or without food, according to the prescriber’s dosing schedule. Swallow the tablet whole with water; do not crush or chew unless specifically instructed by a healthcare professional.

The most serious risks include adrenal crisis due to over‑suppression of cortisol, severe hypokalemia, and potential liver injury. Patients should be monitored regularly for signs of these conditions and instructed to seek immediate medical attention if they occur.

Isturisa should not be used by individuals with known hypersensitivity to osilodrostat, severe hepatic impairment, or during pregnancy unless the benefit outweighs the risk. Patients with uncontrolled hypertension or significant electrolyte disturbances should be evaluated carefully before starting therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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