FULVESTRANT injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

EBEWE Pharma Ges.m.b.H. Nfg.KG

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Monotherapy Fulvestrant injection is indicated for the treatment of: Fulvestrant injection is indicated for the treatment of: Fulvestrant 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 fulvestrant [seeAdverse Reactions (6.2) ]. Risk Summary Based on findings from animal studies and its mechanism of action, fulvestrant can cause fetal harm when administered to a pregnant woman [seeClinical 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 e

Product summary:

Fulvestrant injection is supplied as two 5 mL clear neutral glass (Type 1) barrels, each containing 250 mg/5 mL of fulvestrant solution for intramuscular injection. NDC 68842–301–12 Carton containing 2 single-dose pre-filled syringes 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° to 8°C (36° to 46°F). TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FULVESTRANT- FULVESTRANT INJECTION
EBEWE PHARMA GES.M.B.H. NFG.KG
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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
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Fulvestrant 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
Fulvestrant, 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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Indications and Usage (1) 3/2019
Dosage and Administration (2.1, 2.2) 3/2019
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)
Fulvestrant injection 500 mg should be administered intramuscularly
into the buttocks (gluteal area) slowly (1 to 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 to 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