FULVESTRANT injection

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

FULVESTRANT (UNII: 22X328QOC4) (FULVESTRANT - UNII:22X328QOC4)

Boleh didapati daripada:

BluePoint Laboratories

Laluan pentadbiran:

INTRAMUSCULAR

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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. Fulvestrant injection is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema, ha

Ringkasan produk:

Fulvestrant injection is supplied as two 5 mL clear glass (Type 1) barrels, each containing 250 mg/5 mL of Fulvestrant solution for intramuscular injection and fitted with a tamper evident closure. Fulvestrant Injection is a clear, colorless to yellow, viscous solution. 5 mL single-dose pre-filled syringe: NDC 68001-522-86 Two pre-filled syringes each containing 250 mg/5 mL of Fulvestrant solution for intramuscular injection and two safety needles (SafetyGlide™) are packaged per carton with NDC 68001-522-85 The single-dose prefilled syringes are presented in a tray with polypropylene plunger rod and safety needles (SafetyGlide™) for connection to the barrel. Discard each syringe after use. If a patient dose requires only one syringe, unused syringe should be stored as directed below. Storage: REFRIGERATE, 2°C TO 8°C (36°F TO 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE .

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

FULVESTRANT- FULVESTRANT INJECTION
BLUEPOINT LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FULVESTRANT INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
FULVESTRANT INJECTION.
FULVESTRANT INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Fulvestrant injection is an estrogen receptor antagonist 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. (1)
HR-positive advanced breast cancer in postmenopausal women with
disease progression following
endocrine therapy. (1)
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. (1)
HR-positive, HER2-negative advanced or metastatic breast cancer in
combination with palbociclib or
abemaciclib in women with disease progression after endocrine therapy.
(1)
DOSAGE AND ADMINISTRATION
Fulvestrant injection 500 mg should 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. ( 2.1, 14)
A dose of 250 mg is recommended in patients with moderate hepatic
impairment to be administered
intramuscularly into the buttock (gluteal area) slowly (1 - 2 minutes)
as one 5 mL injection on Days 1,
15, 29, and once monthly thereafter. ( 2.2, 5.2, 8.6)
DOSAGE FORMS AND STRENGTHS
Fulvestrant injection, an injection for intramuscular administration,
is supplied as 250 mg/5 mL fulvestrant.
(3)
CONTRAINDICATIONS
Hypersensitivity. (4)
WARNINGS AND PRECAUTIONS
Risk of Bleeding: Use with caution in patients with bleeding
diatheses, thrombocytopenia, or
anticoagulant use. (5.1)
Increased Exposure in Patients with Hepatic Imp