Capivasertib

Capivasertib, developed by AstraZeneca, is a potent selective inhibitor targeting the AKT pathway.

The Capivasertib produced by Lucius has two specifications, 160mg and 200mg, for patients to choose from.

The mechanism of action of Capivasertib is to inhibit the activity of AKT, block this signaling pathway, ultimately suppress cancer cell proliferation, and even induce cancer cell death.

1.Main components

Capivasertib

2.Adapt to the population

Capivasertib is suitable for the treatment of adult patients with specific types of breast cancer.

3.Medication for special populations

3.1Pregnancy

There are no available data on the  use of Capivasertib in pregnant women. Advise pregnant women and females  of reproductive potential of the potential risk to a fetus.

3.2Lactation

There are no data on the presence of capivasertib or its metabolites in human milk or their effects on milk  production or the breastfed child. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed  during treatment with Capivasertib.

3.3 Females and Males of Reproductive Potential

Females

Advise females of reproductive potential to use effective contraception during treatment with Capivasertib  and for 1 month after the last dose.  

Males

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.

3.4Pediatric Use

The safety and effectiveness of Capivasertib have not been established in pediatric patients.

3.5Geriatric Use

No overall differences in the efficacy of Capivasertib were  observed between patients ≥ 65 years of age and younger patients.

3.6Renal Impairment

No dosage modification is recommended for patients with mild to moderate (creatinine clearance (CLcr)  30 to 89 mL/min) renal impairment. 

Capivasertib has not been studied in patients with severe (CLcr 15 to 29 mL/min) renal impairment.

3.7Hepatic Impairment

No dosage modification is recommended for patients with mild hepatic impairment (bilirubin ≤ upper  limit of normal (ULN) and AST > ULN or bilirubin > 1 to 1.5x ULN and any AST).  

Monitor patients with moderate (bilirubin > 1.5 to 3x ULN and any AST) hepatic impairment for adverse  reactions due to potential increased capivasertib exposure.  

Capivasertib has not been studied in patients with severe (bilirubin > 3x ULN and any AST) hepatic  impairment.

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store Capivasertib in original packaging to maintain stability at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F).

6.Pharmacokinetics

T_max is approximately 1-2 hours. The absolute bioavailability is 29%.  

from FDA，2024.09