INDICATIONS AND USAGE（适应症）

Monotherapy

Fulvestrant Injection is indicated for the treatment of:

Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or

HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.

Combination Therapy

Fulvestrant Injection is indicated for the treatment of:

HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy.

HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.

DOSAGE（服用剂量）

Monotherapy

The recommended dose of Fulvestrant Injection is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter.

Combination Therapy

When Fulvestrant Injection is used in combination with palbociclib, abemaciclib, or ribociclib, the recommended dose of Fulvestrant Injection is 500 mg to be administered intramuscularly into the buttocks (gluteal area) slowly (1 - 2 minutes per injection) as two 5 mL injections, one in each buttock, on Days 1, 15, 29, and once monthly thereafter.

When Fulvestrant Injection is used in combination with palbociclib, the recommended dose of palbociclib is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food. Refer to the Full Prescribing Information for palbociclib.

When Fulvestrant Injection is used in combination with abemaciclib, the recommended dose of abemaciclib is 150 mg orally, twice daily. Abemaciclib may be taken with or without food. Refer to the Full Prescribing Information for abemaciclib.

When Fulvestrant Injection is used in combination with ribociclib, the recommended dose of ribociclib is 600 mg taken orally, once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days. Ribociclib can be taken with or without food. Refer to the Full Prescribing Information for ribociclib.

Pre/perimenopausal women treated with the combination of Fulvestrant Injection plus palbociclib, abemaciclib, or ribociclib, should be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards.

ADVERSE REACTIONS（不良反应）

Risk of Bleeding

Increased Exposure in Patients with Hepatic Impairment

Injection Site Reaction

Embryo-Fetal Toxicity

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/fabe9bd8-ac23-4df1-a89a-223d5cd38914/spl-doc?hl=Fulvestrant

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