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 a tablet for oral use. It treats Cushing's disease by reducing cortisol production in patients with pituitary‑dependent hypercortisolism.

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

  • Osilodrostat is used to manage disorders of cortisol excess, particularly Cushing's disease.
  • Cushing's disease (pituitary‑dependent): lowers cortisol levels and improves clinical signs.
  • Adrenal Cushing's syndrome: suppresses excess cortisol synthesis from the adrenal gland.
  • Ectopic ACTH‑producing tumors: reduces cortisol production when the source is non‑pituitary.

How It Works

  • Osilodrostat inhibits the enzyme 11β‑hydroxylase (CYP11B1), a key step in the final conversion of 11‑deoxycortisol to cortisol within the adrenal cortex. By blocking this enzymatic pathway, the drug decreases endogenous cortisol synthesis, thereby mitigating the hypercortisolism characteristic of Cushing's disease.

Side Effects

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Fatigue: reduced energy levels, especially during dose titration.
  • Headache: transient cranial discomfort.
  • Decreased appetite: reduced food intake leading to mild weight loss.
  • Dizziness: sensation of light‑headedness, often positional.
  • Hypertension: modest increase in blood pressure.

Serious or Rare Side Effects

  • Adrenal insufficiency: signs of cortisol deficiency requiring medical attention.
  • Hypokalemia: low potassium levels that may cause muscle weakness.
  • QT interval prolongation: potential cardiac rhythm disturbance.
  • Severe hypertension: marked elevation in blood pressure needing urgent care.

Precautions & Warnings

  • Osilodrostat requires careful monitoring to ensure safe and effective use.
  • Monitor cortisol levels: adjust dose based on biochemical response.
  • Assess blood pressure: watch for hypertension or hypotension.
  • Evaluate electrolytes: check potassium and sodium regularly.
  • Review hepatic function: liver enzymes should be measured periodically.
  • Avoid abrupt discontinuation: taper under medical supervision to prevent adrenal crisis.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Osilodrostat may interact with other medicines that affect steroid metabolism or cardiovascular function.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): may reduce osilodrostat exposure.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole): may increase drug levels and toxicity.

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: blood pressure may fall further; dose adjustment may be needed.
  • Diuretics that cause potassium loss: risk of hypokalemia may increase.
  • Oral contraceptives: cortisol reduction could affect hormonal balance; monitor efficacy.

Frequently Asked Questions

Isturisa contains osilodrostat and is prescribed to treat Cushing's disease, a condition characterized by excess cortisol production. By lowering cortisol levels, it helps improve symptoms such as weight gain, hypertension, and glucose intolerance associated with the disease.

Osilodrostat blocks the enzyme 11β‑hydroxylase (CYP11B1) in the adrenal cortex, which is essential for the final step of cortisol synthesis. Inhibiting this enzyme reduces the amount of cortisol produced, thereby addressing the hormonal imbalance in Cushing's disease.

The dosage of Isturisa is individualized. A qualified prescriber determines the starting dose and any subsequent adjustments based on the patient’s cortisol levels, clinical response, and tolerance. Patients should follow the prescribing clinician’s instructions exactly.

Safety data for osilodrostat in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To request 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 necessary import documentation.

Isturisa (osilodrostat) is a 11β‑hydroxylase inhibitor, whereas other agents such as ketoconazole or metyrapone inhibit different steps of steroidogenesis. Osilodrostat offers a targeted mechanism with once‑daily oral dosing, but the choice of therapy depends on efficacy, safety profile, drug interactions, and individual patient factors.

Isturisa tablets should be stored at ambient temperature, below 25 °C, in the original blister pack. Protect them from moisture, heat, and direct sunlight to maintain potency throughout the shelf life.

Isturisa is taken orally, usually once daily with or without food, as directed by the prescribing clinician. The tablet should be swallowed whole with water and not chewed or crushed unless specifically instructed.

The most serious risks include adrenal insufficiency, severe hypertension, hypokalemia, and QT‑interval prolongation, all of which may require immediate medical attention. Regular monitoring of cortisol, electrolytes, blood pressure, and cardiac rhythm helps mitigate these risks.

Isturisa is contraindicated in patients with known hypersensitivity to osilodrostat or any tablet excipients, and in those with uncontrolled severe hypertension or significant cardiac arrhythmias. Caution is also advised for patients with pre‑existing adrenal insufficiency or electrolyte disturbances.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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