FASLODEX- fulvestrant injection

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

AstraZeneca Pharmaceuticals LP

INN (Միջազգային անվանումը):

FULVESTRANT

Կազմը:

FULVESTRANT 50 mg in 1 mL

Կառավարման երթուղին:

INTRAMUSCULAR

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Monotherapy FASLODEX is indicated for the treatment of: Combination Therapy FASLODEX is indicated for the treatment of: FASLODEX is contraindicated in patients with a known hypersensitivity to the drug or to any of its components. Hypersensitivity reactions, including urticaria and angioedema, have been reported in association with FASLODEX [see Adverse Reactions (6.2)]. Risk Summary Based on findings from animal studies and its mechanism of action, FASLODEX can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of fulvestrant to pregnant rats and rabbits during organogenesis caused embryo-fetal toxicity, including skeletal malformations and fetal loss, at daily doses that were 6% and 30% of the maximum recommended human dose based on mg/m2 , respectively [see Data] . Advise pregnant women of the potential risk to a fetus. The estimated backg

Ապրանքի ամփոփագիր:

FASLODEX is supplied as two 5 mL clear neutral glass (Type 1) barrels, each containing 250 mg/5 mL of FASLODEX solution for intramuscular injection and fitted with a tamper evident closure. NDC 0310–0720–10 The single-dose prefilled syringes are presented in a tray with polystyrene 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°-8°C (36°-46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE .

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

FASLODEX- FULVESTRANT INJECTION
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FASLODEX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FASLODEX.
FASLODEX (FULVESTRANT) INJECTION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
FASLODEX is an estrogen receptor antagonist indicated for the
treatment of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
FASLODEX, an injection for intramuscular administration, is supplied
as 250 mg/5 mL fulvestrant. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
®
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)
FASLODEX 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)
Hypersensitivity. (4)
Risk of Blee