MYLERAN- busulfan tablet, film coated

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

BUSULFAN (UNII: G1LN9045DK) (BUSULFAN - UNII:G1LN9045DK)

Disponible desde:

Woodward Pharma Services LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

MYLERAN (busulfan) is indicated for the palliative treatment of chronic myelogenous (myeloid, myelocytic, granulocytic) leukemia. MYLERAN is contraindicated in patients in whom a definitive diagnosis of chronic myelogenous leukemia has not been firmly established. MYLERAN is contraindicated in patients who have previously suffered a hypersensitivity reaction to busulfan or any other component of the preparation.

Resumen del producto:

MYLERAN is supplied as white, film-coated, round, biconvex tablets containing 2 mg busulfan in amber glass bottles with child-resistant closures. One side is imprinted with "GX EF3" and the other side is imprinted with an "M.” Bottle of 25 (NDC 69784-620-25). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).

Estado de Autorización:

New Drug Application

Ficha técnica

MYLERAN- BUSULFAN TABLET, FILM COATED
WOODWARD PHARMA SERVICES LLC
----------
MYLERAN
(BUSULFAN) TABLETS
WARNING
_MYLERAN is a potent drug. It should not be used unless a diagnosis of
chronic_
_myelogenous leukemia has been adequately established and the
responsible_
_physician is knowledgeable in assessing response to chemotherapy._
_MYLERAN can induce severe bone marrow hypoplasia. Reduce or
discontinue the_
_dosage immediately at the first sign of any unusual depression of
bone marrow_
_function as reflected by an abnormal decrease in any of the formed
elements of the_
_blood. A bone marrow examination should be performed if the bone
marrow status_
_is uncertain._
_SEE WARNINGS FOR INFORMATION REGARDING BUSULFAN-INDUCED_
_LEUKEMOGENESIS IN HUMANS._
DESCRIPTION
MYLERAN (busulfan) is a bifunctional alkylating agent. Busulfan is
known chemically as
1,4-butanediol dimethanesulfonate and has the following structural
formula:
CH SO O(CH ) OSO CH
Busulfan is _not _a structural analog of the nitrogen mustards.
MYLERAN is available in
tablet form for oral administration. Each film-coated tablet contains
2 mg busulfan and
the inactive ingredients hypromellose, lactose (anhydrous), magnesium
stearate,
pregelatinized starch, triacetin, and titanium dioxide.
The activity of busulfan in chronic myelogenous leukemia was first
reported by D.A.G.
Galton in 1953.
CLINICAL PHARMACOLOGY
Busulfan is a small, highly lipophilic molecule that easily crosses
the blood brain barrier.
Following absorption, 32% and 47% of busulfan are bound to plasma
proteins and red
®
3
2
2 4
2
3
blood cells, respectively.
Busulfan absorption from the gastrointestinal tract is essentially
complete. This has been
demonstrated in radioactive studies after both intravenous and oral
administration of
S-busulfan,
C-busulfan, and
H-busulfan. Following intravenous administration of a
single therapeutic dose of
S-busulfan, there was rapid disappearance of radioactivity
from the blood and 90% to 95% of the
S-label disappeared within 3 to 5 minutes after
injecti