| Dose | Size & Price | Qty |
|---|
| Fact Table | |
|---|---|
| Formula | C18H19F2N5O4 |
| License | FDA approved (October?2024) |
| Bioavailability | ~76% (oral) |
| Legal status | Prescription only (Rx) |
| Chemical Name | (2S)-2-[[2-[(4S)-4-(difluoromethyl)-2-oxo-1,3-oxazolidin-3-yl]-5,6-dihydroimidazo[1,2-d][1,4]benzoxazepin-9-yl]amino]propanamide |
| Elimination half-life | ~15?hours |
| Dosage (Strength) | 9?mg oral tablet once daily |
| Pregnancy | Use only if clearly needed; expected to cause fetal harm |
| Brands | Itovebi (Roche/Genentech) |
| Protein binding | ~37% |
| PubChem CID | 124173720 |
| MedlinePlus | a624068 |
| ChEBI | – |
| ATC code | None assigned yet |
| DrugBank | DB15275 |
| KEGG | D11942 |
| Routes of administration | By mouth (oral tablet) |
Itovebi (Inavolisib) is an orally administered, investigational small molecule inhibitor targeting the phosphatidylinositol-3-kinase alpha (PI3Ka) pathway. It is designed for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated advanced or metastatic breast cancer. By selectively inhibiting the PI3Ka isoform, Itovebi helps reduce aberrant cell signaling involved in tumor growth and survival. This agent is typically used in combination with endocrine therapy in patients who have progressed on or after prior treatment.
Itovebi is administered orally once daily, with or without food. The specific dosage and treatment duration are determined by the prescribing physician, based on the patient’s clinical condition and treatment history. Regular monitoring of blood glucose, liver enzymes, and other laboratory parameters is recommended during therapy. It is essential to adhere strictly to the prescribed regimen and consult the healthcare provider before making any changes.
Each Itovebi tablet contains the active ingredient Inavolisib. Inactive components may include microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and film-coating agents. Exact excipient composition should be verified through the manufacturer’s official documentation or product insert.
Caution is advised when prescribing Itovebi to patients with a history of hyperglycemia, hepatic impairment, or severe gastrointestinal conditions. Baseline and periodic monitoring of fasting glucose and liver function tests are essential. Due to the risk of pneumonitis, any new or worsening respiratory symptoms should prompt immediate evaluation. Concomitant use with strong CYP3A inhibitors or inducers may affect drug exposure and should be managed accordingly. Effective contraception is required for patients of reproductive potential during treatment and for a defined period following the last dose.
Itovebi is contraindicated in patients with known hypersensitivity to Inavolisib or any of the tablet's excipients. It should not be used in individuals with uncontrolled diabetes mellitus or those with a history of severe hypersensitivity reactions to other PI3K inhibitors. The use of Itovebi during pregnancy or breastfeeding is not recommended due to potential risks to the fetus or infant.
Common and clinically significant side effects associated with Itovebi may include:
Patients should report any persistent or severe adverse effects to their healthcare provider promptly.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.