芙仕得 Faslodex (Fulvestrant Injection)

[Function and Indications] Fulvestrant Injection This product can be used for postmenopausal (including natural menopause and artificial menopause) estrogen receptor-positive locally advanced or metastatic breast cancer that relapses after or during anti-estrogen adjuvant therapy, or progresses during anti-estrogen therapy.

[Model and Specification] 5ml: 0.25g

[Usage and Dosage] Adult women (including elderly women): The recommended dose is once a month, 250mg at a time. There is still a lack of safety and efficacy information for Chinese patients at higher doses. Children and adolescents: Because the safety and efficacy of this product in children and adolescents have not been determined, it is not recommended for use in this age group. Patients with renal impairment: For patients with mild to moderate renal impairment (creatinine clearance ≥ 30ml/min), no dose adjustment is required. The safety and efficacy of this product has not been evaluated in patients with severe renal impairment (creatinine clearance <30ml/min), so it is recommended that these patients use it with caution. Patients with hepatic impairment: No dose adjustment is required for patients with mild to moderate hepatic impairment. However, since the exposure of Fulvestrant may be increased in these patients, this product should be used with caution. There is no research data on this product for patients with severe liver damage. Usage: Slow intramuscular injection in the buttocks.

[Clinical Research] Fusode (Fulvestrant Injection) is a new type of estrogen receptor antagonist, which is used for postmenopausal women who have received anti-estrogen drugs (such as tamoxifen) but whose condition still worsens. Fusode (Fulvestrant Injection) targets the estrogen receptors of breast cancer cells and downregulates their effects. In 2007, Fusode (Fulvestrant) was launched in the United States and approved for the treatment of hormone receptor-positive metastatic breast cancer. In 2010, Fusode (Fulvestrant) passed clinical trials in my country and was officially launched in my country, and the trade name was named “Fusode”.

[Precautions] This product should be used with caution in patients with mild to moderate liver damage. This product should be used with caution in patients with severe renal impairment (creatinine clearance <30ml/min). Considering that the drug is administered intramuscularly, patients with bleeding diathesis or thrombocytopenia or who are receiving anticoagulant therapy should use this drug with caution. Thromboembolism is common in women with advanced breast cancer, which has also been observed in clinical studies. This should be taken into account when treating high-risk patients with this drug. There is no long-term data on the effects of fulvestrant on bones. Considering the mechanism of action of fulvestrant, there is a potential risk of osteoporosis. Athletes should use with caution. Effects on the ability to drive and operate machinery: This drug will not or rarely affect the patient’s ability to drive and operate machinery. However, weakness is often reported during treatment with this drug. Patients with these adverse reactions should be particularly cautious when driving and operating machinery.

[Contraindications] This drug is contraindicated in: 1. Patients with known allergies to the active ingredients or any excipients of this drug; 2. Pregnant and lactating women; 3. Patients with severe liver damage.

[Pregnant women use] This drug is contraindicated for pregnant women. After a single intramuscular injection of this drug in rats and rabbits, fulvestrant was observed to cross the placenta. Animal studies have shown that fulvestrant has reproductive toxicity, including increased fetal malformation and mortality. Women of childbearing age should be advised to use effective contraception during treatment. If the patient becomes pregnant while using this product, the potential harm to the fetus and the possibility of miscarriage should be informed. Fulvestrant can be secreted into breast milk in lactating rats. It is not clear whether fulvestrant is secreted into human breast milk. Considering the potential serious adverse reactions of fulvestrant to lactating infants, this product is contraindicated during breastfeeding.

[Pediatric Use] Because the safety and efficacy of this product in children and adolescents have not yet been determined, it is not recommended for use in this age group.

[Drug Interactions]

[Storage] Store at 2-8°C (in a refrigerator). To protect from light, the prefilled injection should be stored in the original packaging.

[Manufacturer] AstraZeneca Pharmaceuticals Ltd., UK