Precautions of Capivasertib

1 Hyperglycemia

If a patient experiences hyperglycemia after initiating treatment with Capivasertib, monitor FG as clinically  indicated, and at least twice weekly until FG decreases to normal levels. During treatment with antihyperglycemic medication, continue monitoring FG at least once a week for 8 weeks, followed by once  every 2 weeks and as clinically indicated. Consider consultation with a healthcare practitioner with  expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes.

2 Diarrhea

Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start  antidiarrheal treatment at the first sign of diarrhea while taking Capivasertib. Withhold, reduce dose, or  permanently discontinue Capivasertib based on severity.

3 Cutaneous Adverse Reactions

Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a  dermatologist is recommended. Withhold, reduce dose, or permanently discontinue Capivasertib based on severity.

4 Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Capivasertib and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use  effective contraception during treatment with Capivasertib and for 4 months after the last dose.

from FDA，2024.09