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 11β‑hydroxylase inhibitor presented as an oral formulation for systemic use. It is indicated for the treatment of Cushing's disease in adults, helping to reduce excess cortisol production. The drug works by targeting adrenal enzyme activity, offering a pharmacologic option when surgery is not feasible or as adjunct therapy.

GNH India supplies Isturisa as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Recordati Rare Diseases

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Indications & Clinical Uses

Isturisa (osilodrostat) is used to manage hypercortisolism associated with Cushing's disease and related conditions.

  • Cushing's disease: lowers cortisol in adults with pituitary‑derived excess cortisol.
  • Cushing's syndrome (non‑pituitary): may be employed to control cortisol when surgery is not possible.
  • Recurrent or persistent hypercortisolism: used when cortisol remains elevated after prior therapy.

How It Works

  • Osilodrostat inhibits the adrenal enzyme 11β‑hydroxylase (CYP11B1), which is essential for the final step of cortisol synthesis. By blocking this enzyme, the drug reduces the conversion of 11‑deoxycortisol to cortisol, thereby decreasing circulating cortisol levels and alleviating the clinical manifestations of Cushing's disease.

Side Effects

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Fatigue: feeling unusually tired or weak.
  • Headache: intermittent pressure or pain in the head.
  • Dizziness: light‑headed sensation, especially when standing.
  • Decreased appetite: reduced desire to eat.
  • Hypertension: elevated blood pressure readings.

Serious or Rare Side Effects

  • Adrenal insufficiency: signs of cortisol deficiency such as severe fatigue, hypotension, or hypoglycemia.
  • Hypokalemia: low potassium levels causing muscle weakness or arrhythmia.
  • QT interval prolongation: potential cardiac rhythm disturbances.
  • Severe hypertension: sudden, marked increase in blood pressure.
  • Hepatic injury: abnormal liver function tests or jaundice.
  • Allergic reactions: rash, itching, swelling, or difficulty breathing.

Precautions & Warnings

Before starting treatment, patients should be evaluated for baseline cortisol, electrolyte, and blood pressure status.

  • Monitor cortisol levels: adjust dose based on biochemical response.
  • Assess electrolytes: watch for potassium and sodium abnormalities.
  • Evaluate blood pressure: treat hypertension promptly.
  • Review concomitant CYP11B1‑affecting drugs: avoid interactions that may alter exposure.
  • Counsel on pregnancy: discuss potential risks with a healthcare professional.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Avoid Interactions

Osilodrostat may interact with several medication classes.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): can markedly increase osilodrostat exposure.
  • Potent CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce therapeutic effect.
  • Concurrent glucocorticoids: risk of additive cortisol suppression.

Moderate Interactions (Monitor Closely)

  • Antihypertensives: monitor blood pressure as cortisol reduction may alter response.
  • Anticoagulants (warfarin): observe INR values for potential changes.
  • Oral contraceptives: hormonal levels may be affected, requiring clinical review.

Frequently Asked Questions

Isturisa contains osilodrostat and is prescribed to lower excess cortisol in adults with Cushing's disease, a condition characterized by chronic overproduction of cortisol from the adrenal glands.

Osilodrostat blocks the enzyme 11β‑hydroxylase (CYP11B1) in the adrenal cortex, preventing the final step of cortisol synthesis and thereby decreasing the amount of cortisol released into the bloodstream.

The dose of Isturisa is individualized by the prescribing physician 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 data for osilodrostat in pregnancy and lactation are limited. Women who are pregnant, planning pregnancy, or breastfeeding should discuss potential risks and benefits with their healthcare provider before using Isturisa.

To order Isturisa, submit an enquiry on the product page at gnhindia.com, specifying 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 required import documentation.

Isturisa (osilodrostat) is a direct inhibitor of cortisol synthesis, whereas other agents such as ketoconazole or metyrapone act on different steps of steroidogenesis. Osilodrostat’s potency and oral dosing schedule may offer advantages in certain patients, but choice of therapy depends on individual clinical factors.

Isturisa should be stored at ambient temperature, below 25 °C, in its original container, protected from moisture and direct sunlight. Keep the product out of reach of children.

Isturisa is taken orally, usually with or without food, as directed by the prescribing clinician. The tablets are swallowed whole with a glass of water.

Serious risks include adrenal insufficiency, severe hypertension, hypokalemia, QT‑interval prolongation, and rare cases of liver injury. Patients should be monitored regularly for these adverse events, especially during dose adjustments.

Isturisa is contraindicated in patients with known hypersensitivity to osilodrostat or any excipients, and it should be used with caution in individuals with uncontrolled hypertension, significant electrolyte disturbances, or pre‑existing cardiac arrhythmias.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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