Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Itovebi 3 mg film-coated tablets.
Itovebi 9 mg film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablet (tablet). Itovebi 3 mg film-coated tablets: Red, round convex-shaped film-coated tablet with an "INA 3" debossing on one side. Approximate diameter: 6 mm. Itovebi 9 mg film-coated tablets: Pink, oval film-coated tablet with an "INA 9" debossing on one side. Approximate size: 13 mm (length), 6 mm (width). |
Each film-coated tablet contains 3 mg of inavolisib.
Excipient(s) with known effect: Each film-coated tablet contains 22 mg of lactose.
Each film-coated tablet contains 9 mg of inavolisib.
Excipient(s) with known effect: Each film-coated tablet contains 66 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Inavolisib is an inhibitor of the phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) catalytic subunit alpha isoform protein (p110α; encoded by the PIK3CA gene). In addition, inavolisib promotes the degradation of mutated p110α (mutant degrader). The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations. With its dual mechanism of action, inavolisib inhibits the activity of downstream PI3K pathway targets, including AKT, resulting in reduced cellular proliferation and induction of apoptosis in PIK3CA-mutated breast cancer cell lines. |
| List of Excipients |
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Itovebi 3 mg and 9 mg tablet core: Lactose monohydrate Itovebi 3 mg film-coating: Polyvinyl alcohol, partially hydrolysed Itovebi 9 mg film-coating: Polyvinyl alcohol, partially hydrolysed |
Alu/Alu (aluminium/aluminium) perforated unit-dose blisters in cartons of 28 × 1 film-coated tablets.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/25/1942/001
EU/1/25/1942/002
| Drug | Countries | |
|---|---|---|
| ITOVEBI | Austria, Estonia, France, Italy, Lithuania, Romania, United States |
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