Orserdu(elacestrant,艾拉司群)

[Orserdu indications]

Orserdu is suitable for treating postmenopausal women or adult men with advanced or metastatic breast cancer with estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative and ESR1 mutation, which has progressed after at least one endocrine therapy.

[Orserdu recommended dosage and administration method]

First, patient selection

According to the existence of ESR1 mutation in plasma samples, patients with ER-positive and HER2-negative advanced or metastatic breast cancer were selected by using FDA-approved tests.

Second, the recommended dose

1) The recommended dose of Orserdu is 345mg, once a day, taken orally with food until the disease worsens or unacceptable toxicity appears.

2) Take Orserdu at about the same time every day. Taking it with food can reduce nausea and vomiting.

3) Swallow Orserdu tablets as a whole, and do not chew, crush or separate the tablets before swallowing. Do not take any Orserdu tablets that are broken, cracked or look broken.

4) If a dose of medicine is missed for more than 6 hours or vomiting occurs, skip the dose and take the next dose of medicine at the normal time the next day.

[Orserdu Warnings and Precautions]

First, dyslipidemia

The incidence of hypercholesterolemia and hypertriglyceridemia in patients taking Orserdu was 30% and 27%, respectively. The incidence of grade 3 and 4 hypercholesterolemia and hypertriglyceridemia was 0.9% and 2.2% respectively. Monitor blood lipids regularly before starting and during taking Orserdu.

II. Embryo-fetal toxicity

1) According to the research results of animals and its mechanism of action, when Orserdu is given to pregnant women, it will cause harm to the fetus. When the maternal exposure is lower than the recommended dose based on the area under the curve (AUC), pregnant rats taking elacestrant will lead to adverse developmental outcomes, including embryo-fetal death and structural abnormalities.

2) Inform pregnant women and women with reproductive potential of the potential risks of drugs to the fetus. It is recommended that women with reproductive ability use effective contraceptive measures during the treatment of Orserdu and within one week after the last administration. It is recommended that male patients with reproductive female partners use effective contraceptive methods during Orserdu treatment and within one week after the last administration.

[Orserdu is used in special people]

1. Pregnancy

According to the findings in animals and its mechanism of action, when Orserdu is given to pregnant women, it can cause fetal damage. There are no available human data on the use of Orserdu by pregnant women to illustrate the drug-related risks. In an animal reproduction study, according to AUC, oral administration of elacestrant to pregnant rats during organogenesis resulted in embryo-fetal death and structural abnormality when the maternal exposure was lower than the recommended dose. Inform pregnant women and women with reproductive potential of the potential risks of drugs to the fetus.

2, lactation

Data on whether breast milk contains elacestrant, its effect on milk production or breast-feeding children. Because breast-fed children may have serious adverse reactions, it is suggested that breast-feeding women should not breast-feed during the treatment of Orserdu and within one week after the last administration.

3. Women and men with reproductive potential

Pregnant women taking Orserdu will do harm to the fetus. Before starting Orserdu treatment, the pregnancy status of women with reproductive potential was verified by pregnancy test. It is recommended that women with reproductive ability use effective contraceptive measures during the treatment of Orserdu and within one week after the last administration. It is recommended that male patients with reproductive female partners use effective contraceptive measures during Orserdu treatment and within one week after the last administration. According to the results of animal research, Orserdu may damage the fertility of female and male animals with reproductive potential.

4. Pediatric medication

The safety and efficacy of Orserdu in pediatric patients have not been determined.

5. Medication for the elderly

Of the 237 patients treated with Orserdu in the EMERALD trial, 43% were 65 years old or older, and 17% were 75 years old or older. Compared with young patients, there was no overall difference in the safety or efficacy of Orserdu among patients aged 65 or above. The number of patients aged 75 or above is insufficient to assess whether there are differences in their safety or effectiveness.

6. Liver injury

Patients with severe liver function impairment (Child-Pugh C) should avoid using Orserdu. To reduce the dose of Orserdu in patients with moderate liver damage (Child-Pugh B). Dose adjustment is not recommended for patients with mild liver damage (Child-Pugh A grade).

[Orserdu Adverse Reaction]

1. Orserdu may cause serious side effects, including increased blood fat (lipid) levels (hypercholesterolemia and hypertriglyceridemia). Your doctor will take blood tests before and during Orserdu treatment to check your blood lipid level.

2. The most common side effects of Orserdu include: muscle and joint (musculoskeletal) pain; Abnormal renal function; Nausea; Loss of appetite; Cholesterol and triglyceride levels increased; Diarrhea; Headache; Abnormal liver function; Constipation; Fatigue; Stomach (abdomen) pain; Decreased red blood cell count; Hot flashes; Vomiting; Indigestion or heartburn; The level of salt (sodium) in the blood is decreased.

3. Orserdu may affect the fertility of men and women who can get pregnant.

Note: If there is any new packaging for drugs, the new packaging shall prevail. The above information comes from the Internet or translated by student volunteers in medical colleges and universities (if there are any mistakes or omissions, please help me to correct them). It is for internal discussion of medical staff only, without any basis for medication. Please consult the attending physician for specific medication guidelines.