ISTURISA Film-coated tablet Ref.[50897] Active ingredients: Osilodrostat

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France

Product name and form

Isturisa 1 mg film-coated tablets.

Isturisa 5 mg film-coated tablets.

Isturisa 10 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Isturisa 1 mg film-coated tablets: Pale yellow, round, biconvex bevelled-edge tablets, marked “Y1” on one side and “NVR” on the other side. Approximate diameter 6.1 mm.

Isturisa 5 mg film-coated tablets: Yellow, round, biconvex bevelled-edge tablets, marked “Y2” on one side and “NVR” on the other side. Approximate diameter 7.1 mm.

Isturisa 10 mg film-coated tablets: Pale orange brown, round, biconvex bevelled-edge tablets, marked “Y3” on one side and “NVR” on the other side. Approximate diameter 9.1 mm.

Qualitative and quantitative composition

Isturisa 1 mg film-coated tablets: Each film-coated tablet contains osilodrostat phosphate corresponding to 1 mg osilodrostat.

Isturisa 5 mg film-coated tablets: Each film-coated tablet contains osilodrostat phosphate corresponding to 5 mg osilodrostat.

Isturisa 10 mg film-coated tablets: Each film-coated tablet contains osilodrostat phosphate corresponding to 10 mg osilodrostat.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Osilodrostat

Osilodrostat is a cortisol synthesis inhibitor. It potently inhibits 11β-hydroxylase (CYP11B1), the enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland. In Cushing’s disease, the fall in plasma cortisol concentration also stimulates ACTH secretion, via the feedback mechanism which accelerates steroid biosynthesis.

List of Excipients

Tablet core:

Cellulose, microcrystalline
Mannitol
Croscarmellose sodium
Magnesium stearate
Silica, colloidal anhydrous

Film coat:

Hypromellose
Titanium dioxide (E171)
Macrogol
Talc

1 mg tablet:

Iron oxide yellow (E172)
Iron oxide red (E172)

5 mg tablet:

Iron oxide yellow (E172)

10 mg tablet:

Iron oxide yellow (E172)
Iron oxide red (E172)
Iron oxide black (E172)

Pack sizes and marketing

Alu/Alu blister of 10 tablets.

Packs containing 60 tablets (6 blisters of 10 tablets).

Marketing authorization holder

Recordati Rare Diseases, Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France

Marketing authorization dates and numbers

Isturisa 1 mg film-coated tablets: EU/1/19/1407/001
Isturisa 5 mg film-coated tablets: EU/1/19/1407/002
Isturisa 10 mg film-coated tablets: EU/1/19/1407/003

09 January 2020

Drugs

Drug Countries
ISTURISA Austria, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Poland, Romania, United Kingdom, United States

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