Initial US Approval:
2024
Key Clinical Studies:
INAVO120 (NCT04191499)
Drug Class/Description:
Kinase inhibitor
Indications and Usage:
ITOVEBI is a kinase inhibitor indicated in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
Dosage Administration:
- Select patients for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer with ITOVEBI based on the presence of one or more PIK3CA mutations in plasma specimen.
- Recommended dosage: 9 mg orally once daily with or without food.
- See Full Prescribing Information for dosage modifications of ITOVEBI due to adverse reactions.
- Reduce the starting dose in patients with moderate renal impairment.
Dosage Forms and Strengths:
Tablets: 3 mg and 9 mg
Contraindications:
None.
Warnings and Precautions:
Hyperglycemia: ITOVEBI can cause hyperglycemia. Initiate or optimize anti-hyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue ITOVEBI if severe hyperglycemia occurs.
Stomatitis: ITOVEBI can cause severe stomatitis. Consider treating with a corticosteroid-containing mouthwash if stomatitis occurs. Monitor patients for signs and symptoms of stomatitis. Withhold, reduce dose, or permanently discontinue ITOVEBI based on severity.
Diarrhea: ITOVEBI can cause diarrhea, which may be severe, and result in dehydration and acute kidney injury. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider if severe diarrhea occurs. Interrupt, reduce dose, or discontinue ITOVEBI if severe diarrhea occurs.
Embryo-Fetal Toxicity: ITOVEBI can cause fetal harm. Advise patients of potential risk to a fetus and to use effective non-hormonal contraception.
Refer to the Full Prescribing Information of palbociclib and fulvestrant for pregnancy and contraception information.
Adverse Reactions:
The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased ALT, nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted from:
https://www.gene.com/download/pdf/itovebi_prescribing.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
