Elacestrant

Elacestrant is developed by Stemline Therapeutics, a subsidiary of Menarini Group, and the product specifications produced by Lucius are 86mg * 32pills.

The types of breast cancer treated with drugs account for a certain proportion of breast cancer patients, and the drug resistance to traditional endocrine therapy is high. The research and development of new therapeutic drugs is particularly important.

Elacestrant, as a SERD, can selectively degrade estrogen receptor and block the promotion of estrogen on breast cancer cells.

1.Main components

Elacestrant

2.Adapt to the population

Elacestrant is indicated for the treatment of postmenopausal women or adult men with estrogen receptor  (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or  metastatic breast cancer with disease progression following at least one line of endocrine therapy.

3.Medication for special populations

3.1Pregnancy

There are no available human  data on Elacestrant use in pregnant women to inform the drug-associated risk. 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 elacestrant in human milk, its effects on milk production, or the  breastfed child. Because of the potential for serious adverse reactions in the breastfed child, advise  lactating women to not breastfeed during treatment with Elacestrant and for 1 week after the last dose.

3.3Females and Males of Reproductive Potential

Elacestrant can cause fetal harm when administered to a pregnant woman.

Females

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

Males

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Elacestrant and for 1 week after the last dose.

3.4Pediatric Use

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

3.5Geriatric Use

No overall differences in safety or effectiveness of Elacestrant were  observed between patients 65 years or older of age compared to younger patients. There are an  insufficient number of patients 75 years of age or older to assess whether there are differences in safety or effectiveness.

3.6Hepatic Impairment

Avoid use of Elacestrant in patients with severe hepatic impairment (Child-Pugh C). Reduce the dose of  Elacestrant in patients with moderate hepatic impairment (Child-Pugh B). No dosage adjustment is  recommended for patients with mild hepatic impairment (Child-Pugh A).

4.Drug overdose

Drug overdose is not yet clear.

5.Drug storage

Store at 20°C to 25°C (68°F to 77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F).

6.Pharmacokinetics

The time to achieve peak plasma concentration (tmax) ranges from 1 to 4 hours. The elacestrant oral  bioavailability is approximately 10%.

from FDA，2023.05