ONCOLOGY
DEFASTERA®
Solution for intramuscular injection
Pharmacotherapy group:
Antitumor hormone preparations and hormone antagonists; hormone antagonists and related compounds; anti-estrogens
INN:
Fulvestrant
Dosage:
250 mg / 5 ml
Available on a doctor's
prescription
What is the drug DEFASTERA®:
DEFASTERA®
contains the active substance fulvestrant. Fulvestrant
is an estrogen blocker. Estrogens are female sex hormones that in some cases
are involved in the growth of breast cancer.
Dosage form and packaging
DEFASTERA® is a solution for intramuscular administration. Transparent,
colorless to yellow, viscous liquid.
5 ml
of the drug in a pre-filled syringe made of transparent glass type I, with or
without a finger rest, equipped with a bromobutyl piston stroke limiter made of
polypropylene, a Luer nozzle made of polycarbonate, closed with a screw-on lid.
2 syringes each complete with 2 injection needles (21G, 40 mm) in a contour
cell package. Contour cell packaging is covered with a non-woven material made
of synthetic fibers or aluminum foil.
Indications for use
DEFASTERA® is used for the treatment of locally advanced or
metastatic breast cancer with positive estrogen receptors in postmenopausal
adult women:
-
previously not receiving endocrine therapy;
-
in case of relapse during or after adjuvant endocrine therapy, or in case of
progression during endocrine therapy.
Efficacy and safety studies
In accordance with
current legislation, the drug has proven its effectiveness, safety and quality
during state registration. For registration purposes, a bioequivalence study
was conducted with the original (reference) medicinal product.