LB Abnoba

LBracan Injection

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LBracan Injection

LBracan Injection

Category

Prescription Drug

※ A prescription medicine that requires professional supervision regarding dosage and administration under a physician’ s prescription.

Classification Number

429[Other Antitumor Agents]

Composition and Content

Fulvestrant 50.0 mg per 1 ml

Product Details

Product Information

Selective Estrogen Receptor Degrader (SERD) for Breast Cancer Treatment

Composition and Content

Each 1 mL contains 50.0 mg fulvestrant

Indications

Monotherapy
Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women
Combination Therapy
In combination with palbociclib for HR-positive, HER2-negative advanced or metastatic breast cancer in women

whose disease has progressed following endocrine therapy

In combination with abemaciclib for HR-positive, HER2-negative advanced or metastatic breast cancer in women

whose disease has progressed following endocrine therapy

In combination with ribociclib as first-line endocrine therapy or for disease progression after endocrine therapy in postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer

Dosage and Administration

Monotherapy
Adult women (including elderly patients): The recommended dose is 500 mg administered on days 1, 15, and 29, and once monthly thereafter.
Administer as two slow intramuscular injections (1–2 minutes per injection), one in each buttock (5 mL each).
Combination Therapy
When combined with palbociclib, abemaciclib, or ribociclib, the recommended dose of this drug is 500 mg on days 1, 15, and 29, and then once monthly thereafter. Administer as two slow intramuscular injections (1–2 minutes per injection), one in each buttock (5 mL each).
For palbociclib combination: The recommended dose is 125 mg orally once daily for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle. Palbociclib should be taken with food (refer to palbociclib prescribing information).

For abemaciclib combination: The recommended dose of abemaciclib is 150 mg orally twice daily. Abemaciclib may be taken with or without food (refer to abemaciclib prescribing information).

For ribociclib combination: The recommended dose is 600 mg orally once daily (three 200 mg film-coated tablets) for 21 consecutive days followed by 7 days off treatment, in a 28-day cycle. Ribociclib may be taken with or without food (refer to ribociclib prescribing information).

Premenopausal and perimenopausal women receiving this drug in combination with palbociclib, abemaciclib, or ribociclib should also be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to local clinical practice.

Pediatric population: Safety and efficacy have not been established; this drug should not be used.

Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment (creatinine clearance ≥30 mL/min).
Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance<30 mL/min).

Hepatic impairment: Use with caution in patients with mild to moderate hepatic impairment.
Safety and efficacy have not been evaluated in patients with hepatic impairment.

For dose adjustments and other safety information regarding palbociclib, abemaciclib, or ribociclib, refer to the prescribing information of the respective drugs.

LB Abnoba

LB Abnoba

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LBracan Injection