Itovebi (Inavolisib)

Prescription Required
Brand
Dose Size & Price Qty
3mg
9mg
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Fact Table

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.

Directions

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.

Ingredients

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.

Cautions

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.

Contraindications

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.

Side Effects

Common and clinically significant side effects associated with Itovebi may include:

  • Hyperglycemia
  • Diarrhea
  • Nausea
  • Fatigue
  • Rash
  • Stomatitis
  • Decreased appetite
  • Pneumonitis
  • Elevated liver enzymes
  • Weight loss

Patients should report any persistent or severe adverse effects to their healthcare provider promptly.

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