FULVESTRANT injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Mylan Institutional LLC

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Monotherapy:  Fulvestrant injection is indicated for the treatment of: Combination Therapy: Fulvestrant injection is indicated for the treatment of: 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, have been reported in association with fulvestrant injection [see Adverse Reactions (6.2)]. Based on findings from animal studies and its mechanism of action, fulvestrant injection 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 wome

Resumen del producto:

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 and fitted with a tamper evident closure. NDC 67457-311-05 carton containing 2 x 5 mL single-dose prefilled syringes with 21 gauge x 1 ½ inch needles 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FULVESTRANT- FULVESTRANT INJECTION
MYLAN INSTITUTIONAL LLC
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Fulvestrant injection, 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 MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) 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)
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
the