ITOVEBI Tablet Ref.[112407] Active ingredients: Inavolisib

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

ITOVEBI contains inavolisib, a kinase inhibitor. The chemical name of inavolisib is (2S)2[[2-[(4S)4(difluoromethyl)-2-oxo-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide. Inavolisib is a white to off-white, greyish pink, greyish orange, or greyish yellow powder or powder with lumps. Inavolisib demonstrates pH-dependent aqueous solubility; the greatest solubility is at low pH, and solubility decreases with increasing pH. The molecular formula for inavolisib is C18H19F2N5O4 and the molecular weight is 407.37 g/mol. The chemical structure of inavolisib is shown below:

ITOVEBI film-coated tablets are supplied for oral administration with two strengths that contain 3 mg and 9 mg of inavolisib. The tablets also contain lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film-coating contains the following inactive ingredients: polyvinyl alcohol (partially hydrolyzed), titanium dioxide, macrogol/polyethylene glycol, talc, iron oxide red, and iron oxide yellow (in the 9 mg tablet only).

Dosage Forms and Strengths

Tablets:

  • 3 mg: red and round convex-shaped with an “INA 3” debossing on one side.
  • 9 mg: pink and oval-shaped with an “INA 9” debossing on one side.
How Supplied

ITOVEBI is supplied in the following strengths and package configurations:

Package Configuration Tablet Strength NDC Tablet Description
Bottle of 30 tablets 3 mg 50242-084-01Red and round convex-shaped
with an “INA 3” debossing on
one side
Bottle of 30 tablets 9 mg 50242-079-01 Pink and oval-shaped with an
“INA 9” debossing on one side

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [see USP Controlled Room Temperature].

Distributed by: Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990

Drugs

Drug Countries
ITOVEBI United States

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