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 an oral tablet for oral use. It treats Cushing's disease in patients with endogenous 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

Isturisa (osilodrostat) is used to manage disorders of cortisol excess, specifically Cushing's disease.

  • Cushing's disease: reduces cortisol production and helps control hypercortisolism.

How It Works

  • Osilodrostat inhibits the enzymes 11β‑hydroxylase (CYP11B1) and aldosterone synthase (CYP11B2), which are essential steps in the biosynthesis of cortisol and aldosterone. By blocking these enzymes, the drug lowers the synthesis of cortisol, thereby mitigating the effects of excess glucocorticoid production in conditions such as Cushing's disease.

Side Effects

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Fatigue: feeling unusually tired.
  • Headache: intermittent mild pain.
  • Decreased appetite: reduced desire to eat.
  • Dizziness: light‑headed sensations.
  • Hypertension: elevated blood pressure readings.

Serious or Rare Side Effects

  • Adrenal insufficiency: signs of cortisol deficiency such as severe fatigue and hypotension.
  • Hypokalemia: low potassium levels causing muscle weakness.
  • QT interval prolongation: potential cardiac rhythm disturbances.
  • Severe hypertension: markedly high blood pressure requiring urgent care.
  • Hepatic injury: abnormal liver function tests.
  • Allergic reactions: rash, swelling, or breathing difficulty.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline cortisol, electrolyte, and blood pressure status.

  • Monitor cortisol: regularly check serum cortisol to avoid over‑suppression.
  • Check electrolytes: watch potassium and sodium levels.
  • Observe blood pressure: adjust antihypertensive therapy as needed.
  • Pregnancy safety: use only if potential benefit justifies risk, as data are limited.
  • Drug interactions: review concomitant medications for CYP3A4 modulators.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture.

Avoid Interactions

Osilodrostat may interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): may reduce osilodrostat exposure.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase drug levels and toxicity.
  • Concomitant glucocorticoids: can mask adrenal insufficiency.

Moderate Interactions (Monitor Closely)

  • Antihypertensives: blood pressure may change, requiring dose adjustment.
  • Potassium‑sparing diuretics: risk of hyperkalemia.
  • Oral contraceptives: hormonal levels may be altered.
  • CYP3A4 substrate drugs (e.g., statins): monitor for increased concentrations.
  • Antifungal azoles (non‑potent): may modestly raise osilodrostat levels.

Frequently Asked Questions

Isturisa contains osilodrostat, a steroidogenesis inhibitor prescribed to treat Cushing's disease, a condition characterized by excessive cortisol production. By lowering cortisol levels, the medication helps control the signs and symptoms associated with this endocrine disorder.

Osilodrostat blocks the enzymes 11β‑hydroxylase (CYP11B1) and aldosterone synthase (CYP11B2). These enzymes are required for the final steps of cortisol and aldosterone synthesis. Inhibition reduces cortisol output, addressing the hormonal imbalance in Cushing's disease.

The dosage of Isturisa is individualized. A qualified prescriber determines the starting dose and any adjustments based on the patient’s cortisol levels, clinical response, and tolerability. Patients should follow the prescribing information provided by their healthcare professional.

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

To place an order, 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) directly inhibits cortisol synthesis, whereas other options such as ketoconazole or metyrapone also target steroidogenesis but differ in enzyme selectivity and side‑effect profiles. Pituitary surgery remains first‑line, and medical therapy is added when surgery is not feasible or fails.

Isturisa tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect them from moisture and light. Keep the container tightly closed and out of reach of children.

Isturisa is taken orally as a tablet. The exact timing and whether it is taken with food depend on the prescriber’s instructions. Patients should swallow the tablet whole with water and not split or crush it unless directed.

Serious risks include adrenal insufficiency, severe hypertension, hypokalemia, QT interval prolongation, and potential liver injury. Patients should be monitored regularly for these events, and any signs such as extreme fatigue, dizziness, or abnormal heart rhythm should prompt immediate medical evaluation.

Isturisa is contraindicated in patients with known hypersensitivity to osilodrostat or any tablet excipients. It should be used with caution in individuals with uncontrolled hypertension, significant electrolyte disturbances, or severe liver disease, and it is not recommended for pregnant women unless absolutely necessary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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