What are the precautions for Itovebi (inavolisib)-u200c inalise

In the clinical study of Itovebi (inavolisib) in the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer, warnings and precautions such as hyperglycemia, stomatitis, diarrhea, and embryo-fetal toxicity appeared. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Hyperglycemia: Patients receiving treatment may develop severe hyperglycemia. The safety of Itovebi has not been studied in patients with type 1 or type 2 diabetes who require ongoing systemic therapy. Before starting itovirbi treatment, test fasting blood glucose levels (FPG or FBG), hemoglobin A1C (HbA1C) levels, and optimize fasting blood glucose.

In patients who develop hyperglycemia after initiating treatment with Itovebi, monitor or self-monitor fasting blood glucose levels every 3 days for the first week (days 1 to 7), then weekly for the next 3 weeks (days 8 to 28), then every 2 weeks for the next 8 weeks, and every 4 weeks thereafter, and as clinically indicated. Monitor HbA1C every 3 months as clinically indicated.

Use antihyperglycemic agents to control hyperglycemia as clinically indicated. Continue to monitor fasting blood glucose levels during antihyperglycemic therapy. Patients with a history of well-controlled type 2 diabetes may require intensive antihyperglycemic therapy and close monitoring of fasting glucose levels. Inform patients about the signs and symptoms of hyperglycemia and recommend lifestyle changes.

2. Stomatitis: Patients undergoing treatment may develop severe stomatitis. In patients receiving Itovebi in combination with palbociclib and fulvestrant, patients used corticosteroid-containing mouthwashes to control or prevent stomatitis. Monitor patients for signs and symptoms of stomatitis.

3. Diarrhea: Patients receiving treatment may experience severe diarrhea, including dehydration and acute kidney injury, and anti-diarrhoeal drugs are used to control symptoms. Monitor patients for signs and symptoms of diarrhea. While taking Itovebi, patients are advised to increase oral fluid intake and initiate anti-diarrhoeal treatment if symptoms of diarrhea occur.

4. Embryo-Fetal toxicity: According to the results of animal tests and its mechanism of action, Itovebi taken by pregnant women may cause harm to the fetus. In an animal reproduction study, oral administration of inavolisib to pregnant rats during the period of organogenesis resulted in adverse developmental outcomes, including embryo-fetal death, structural abnormalities, and growth changes at a maternal exposure dose that was approximately equal to the human exposure dose (9 mg/day) based on the area under the curve (AUC).

Inform pregnant women and women of reproductive potential of the potential risks to the fetus. Advise females of reproductive potential to use an effective non-hormonal method of contraception during treatment with Itovebi and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Itovebi and for 1 week after the last dose.