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Select patients for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer with Capivasertib, based on the presence of one or more of the following genetic alterations in tumor tissue: PIK3CA/AKT1/PTEN.
Evaluate fasting blood glucose (FG) and hemoglobin A1C (HbA1C) prior to starting Capivasertib and at regular intervals during treatment.
The recommended dosage of Capivasertib, in combination with fulvestrant, is 400 mg orally twice daily (approximately 12 hours apart) with or without food, for 4 days followed by 3 days off. Continue Capivasertib until disease progression or unacceptable toxicity.
Capivasertib dosing schedule for each week is provided in Table 1.
Swallow Capivasertib tablets whole. Do not chew, crush, or split tablets prior to swallowing. Do not take tablets that are broken, cracked, or otherwise not intact.
If a patient misses a dose within 4 hours of the scheduled time, instruct the patient to take the missed dose.
If a patient misses a dose more than 4 hours of the scheduled time, instruct the patient to skip the dose and take the next dose at its usual scheduled time.
If a patient vomits a dose, instruct the patient not to take an additional dose and take the next dose at its usual scheduled time.
Refer to the fulvestrant Full Prescribing Information for recommended fulvestrant dosing information.
For premenopausal and perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards.
For men, consider administering a LHRH agonist according to current clinical practice standards.
The recommended dose reductions for adverse reactions are listed in Table 2. Permanently discontinue Capivasertib if unable to tolerate the second dose reduction.
The recommended dosage modifications for adverse reactions are provided in Table 3.
Avoid concomitant use with strong CYP3A inhibitors. If concomitant use with a strong CYP3A inhibitor cannot be avoided, reduce the dosage of Capivasertib to 320 mg orally twice daily for 4 days followed by 3 days off.
When concomitantly used with a moderate CYP3A inhibitor, reduce the dosage of Capivasertib to 320 mg orally twice daily for 4 days followed by 3 days off.
After discontinuation of a strong or moderate CYP3A inhibitor, resume the Capivasertib dosage (after 3 to 5 half-lives of the inhibitor) that was taken prior to initiating the strong or moderate CYP3A inhibitor.
from FDA，2024.09
