GLIADEL

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CARMUSTINE

MAH:

MEGAPHARM LTD

ATC_code:

L01AD01

pharmaceutical_form:

WAFER

composition:

CARMUSTINE 7.7 MG

administration_route:

IMPLANT

prescription_type:

Required

manufactured_by:

EISAI INC, USA

therapeutic_group:

CARMUSTINE

therapeutic_area:

CARMUSTINE

therapeutic_indication:

For use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated. Gliadel implant is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. Gliadel implant is indicated for use as an adjunct to surgery in patients with Recurrent histogically proved glioblastoma multiforme for whom surgical resection is indicated.

authorization_date:

2023-05-31

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS_ _
GLIADEL
 WAFER
℞ ONLY
(polifeprosan 20 with carmustine implant)
DESCRIPTION
GLIADEL

Wafer (polifeprosan 20 with carmustine implant) is a sterile,
off-white to
pale yellow wafer approximately 1.45 cm in diameter and 1 mm thick.
Each wafer
contains 192.3 mg of polideprosan (a biodegradable polyanhydride
copolymer and 7.7 mg
of carmustine [1,3-bis (2-chloroethyl)-1-nitrosourea, or BCNU]).
Carmustine is a
nitrosourea oncolytic agent. The copolymer, polifeprosan 20, consists
of poly[bis(p-
carboxyphenoxy) propane: sebacic acid] in a 20:80 molar ratio and is
used to control the
local delivery of carmustine. Carmustine is homogeneously distributed
in the copolymer
matrix.
The structural formula for polifeprosan 20 is:
The structural formula for carmustine is:
CLINICAL PHARMACOLOGY
GLIADEL

Wafer is designed to deliver carmustine directly into the surgical
cavity
created when a brain tumor is resected. On exposure to the aqueous
environment of the
resection cavity, the anhydride bonds in the copolymer are hydrolyzed,
releasing
carmustine, carboxyphenoxypropane, and sebacic acid. The carmustine
released from
GLIADEL

Wafer diffuses into the surrounding brain tissue and produces an
antineoplastic effect by alkylating DNA and RNA.
CH
2
CH
2
NCNHCH
2
CH
2
Cl
Cl
NO
O
2
Carmustine has been shown to degrade both spontaneously and
metabolically. The
production of an alkylating moiety, hypothesized to be chloroethyl
carbonium ion, leads
to the formation of DNA cross-links.
The tumoricidal activity of GLIADEL

Wafer is dependent on release of carmustine to
the tumor cavity in concentrations sufficient for effective
cytotoxicity.
More than 70% of the copolymer degrades by three weeks. The metabolic
disposition
and excretion of the monomers differ. Carboxyphenoxypropane is
eliminated by the
kidney and sebacic acid, an endogenous fatty acid, is metabolized by
the liver and expired
as CO
2
in animals.
The absorption, distribution, metabolism, and excretion of the
copolymer in h