CANCIDAS POWDER FOR INJECTION 50 mgvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CASPOFUNGIN ACETATE EQV CASPOFUNGIN

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

J02AX04

Dosage:

50 mg

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

CASPOFUNGIN ACETATE EQV CASPOFUNGIN 50 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

FAREVA Mirabel (bulk production/primary & secondary packaging)

Authorization status:

ACTIVE

Authorization date:

2002-01-10

Patient Information leaflet

 
SG-MK0991-IV-082014  

PRODUCT CIRCULAR 

CANCIDAS
® 

(caspofungin acetate) FOR INJECTION 

I. THERAPEUTIC CLASS 

CANCIDAS* is a sterile, lyophilized product
for intravenous infusion that contains a semi-synthetic 
lipopeptide (echinocandin) compound
synthesized from a fermentation product of _Glarea lozoyensis. _
CANCIDAS is the first of a
new class of antifungal drugs (echinocandins) that inhibit the
synthesis of 
E(1,3)-
D-glucan, an integral component of the fungal cell wall. 

II. CLINICAL PHARMACOLOGY 

_IIA. MECHANISM OF ACTION _

Caspofungin acetate, the active ingredient of CANCIDAS,
inhibits the synthesis of 
E(1,3)-D-glucan, an 
essential
component of the cell wall of many filamentous fungi and yeast. 
E(1,3)-D-glucan is not present in 
mammalian cells. 

_IIB. PHARMACOKINETICS _

_IIB-1. ABSORPTION _

Absorption is not relevant since
caspofungin acetate is administered intravenously. 

_IIB-2. DISTRIBUTION _

Plasma concentrations of caspofungin decline in a
polyphasic manner following single 1-hour intravenous 
infusions. A short 
D-phase occurs immediately post-infusion,
followed by a E-phase with a half-life of 9 to 11 
hours that characterizes much of the profile
and exhibits clear log-linear behavior from 6 to 48 hours 
postdose, during which the plasma concentration
decreases by 10-fold. An additional 
J-phase also occurs 
with half-life 40-50 hours. Distribution, rather than excretion
or biotransformation, is the dominant mechanism 
influencing plasma clearance. Caspofungin is extensively bound
to albumin (approximately 97%), and 
distribution into red blood cells is minimal. Mass balance
results showed that approximately 92% of the 
administered
radioactivity was distributed to tissues by 36 to 48 hours after a single
70-mg dose of [
3
H] 
caspofungin acetate. There is�

Summary of Product characteristics

SG-MK0991-IV-072022
PRODUCT CIRCULAR
CANCIDAS®
(caspofungin acetate) Powder for injection
I. THERAPEUTIC CLASS
CANCIDAS is a sterile, lyophilized product for intravenous infusion
that contains a semi-synthetic lipopeptide
(echinocandin) compound synthesized from a fermentation product of
Glarea lozoyensis.
CANCIDAS is the
first of a new class of antifungal drugs (echinocandins) that inhibit
the synthesis of β (1,3)-D-glucan, an
integral component of the fungal cell wall.
II. CLINICAL PHARMACOLOGY
IIa. Mechanism of Action
Caspofungin acetate, the active ingredient of CANCIDAS, inhibits the
synthesis of β (1,3)-D-glucan, an
essential component of the cell wall of many filamentous fungi and
yeast. β (1,3)-D-glucan is not present in
mammalian cells.
IIb. Pharmacokinetics
IIb-1. Absorption
Absorption is not relevant since caspofungin acetate is administered
intravenously.
IIb-2. Distribution
Plasma concentrations of caspofungin decline in a polyphasic manner
following single 1-hour intravenous
infusions. A short α -phase occurs immediately post-infusion,
followed by a β -phase with a half-life of 9 to
11 hours that characterizes much of the profile and exhibits clear
log-linear behavior from 6 to 48 hours
postdose, during which the plasma concentration decreases by 10-fold.
An additional γ -phase also occurs
with half-life 40-50 hours. Distribution, rather than excretion or
biotransformation, is the dominant mechanism
influencing plasma clearance. Caspofungin is extensively bound to
albumin (approximately 97%), and
distribution into red blood cells is minimal. Mass balance results
showed that approximately 92% of the
administered radioactivity was distributed to tissues by 36 to 48
hours after a single 70-mg dose of [
3
H]
caspofungin acetate. There is little excretion or biotransformation of
caspofungin during the first 30 hours
after administration.
IIb-3. Metabolism
Caspofungin
is
slowly
metabolized
by
hydrolysis
and
N-acetylation.
Caspofungin
also
undergoes
spontaneous chemical degradation to an open-ring p