What are the precautions for Capivasertib?

Capivasertib, trade name Truqap, is a targeted drug for breast cancer, mainly used to treat patients with locally advanced or metastatic breast cancer (mBC). Although capositinib has shown good clinical efficacy, its use is also accompanied by some precautions and potential adverse reactions, which require the joint attention and management of doctors and patients.

First, hyperglycemia is an important precaution during the use of capositinib. In clinical studies, the median time to first onset of hyperglycemia in patients was 15 days, and some patients may develop severe hyperglycemia related to ketoacidosis. Therefore, a comprehensive glycemic assessment, including determination of fasting plasma glucose (FG) and glycated hemoglobin (HbA1c), must be performed before treatment and appropriately optimized during treatment. It is recommended to assess FG at least every two weeks during the first month of medication, and at least monthly from the second month on, and to monitor HbA1c every three months. For patients with a known history of diabetes or risk factors for hyperglycemia, such as obesity (body mass index ≥ 30), FG elevation exceeding 160 mg/dL, HbA1c close to the upper limit of normal, simultaneous use of systemic corticosteroids, or concurrent infections, the frequency of monitoring needs to be increased, and consultation with professional medical personnel may be considered to promptly adjust and improve the patient's glycemic control.

Secondly, diarrhea is also one of the common adverse reactions in capositinib treatment. Clinical studies have shown that the median time for patients to first experience diarrhea is 4 days, a condition that can lead to severe dehydration. It is extremely important to monitor patients' diarrhea symptoms and signs. Physicians should promptly assess the patient's degree of diarrhea and advise patients to increase fluid intake while taking caposetinib to prevent dehydration. In addition, when patients experience diarrhea symptoms, they should start antidiarrheal treatment as soon as possible to relieve symptoms.

Skin adverse reactions are also aspects that need to be paid attention to when using capositinib. These reactions may include erythema multiforme, palmar-plantar red blood cell paresthesia, and even drug reactions with eosinophilia and systemic symptoms (DRESS). In clinical studies, the median time for patients to experience skin adverse reactions is 13 days, so doctors need to regularly monitor patients' skin conditions. Once adverse skin reactions are detected, it is recommended to treat them with corticosteroids as soon as possible, and patients are encouraged to seek help from a dermatologist for effective management of skin reactions.

In addition, capositinib also has embryonic properties- Fetotoxicity. In animal studies, pregnant rats treated with capositinib experienced adverse developmental outcomes during organogenesis, including embryo-fetal death, and reduced fetal body weight at maternal exposures 0.7 times the human exposure. Therefore, while patients are taking capositinib, pregnant women and women of reproductive potential need to be informed about the potential risks of the drug and advised to use effective contraception during treatment and for at least one month after the last dose. At the same time, it is also recommended that male patients of reproductive potential take effective contraceptive measures during the use of capositinib and within four months after the last dose to reduce the potential impact on their partners.

Reference materials:https://www.drugs.com/mtm/capivasertib.html