CANCIDAS 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CASPOFUNGIN AS ACETATE

Available from:

MERCK SHARP & DOHME ISRAEL LTD

ATC code:

J02AX04

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

CASPOFUNGIN AS ACETATE 50 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATORIES MERCK, SHARP & DOHME - CHIBRET, FRANCE

Therapeutic group:

CASPOFUNGIN

Therapeutic area:

CASPOFUNGIN

Therapeutic indications:

Cancidas is indicated in adults and pediatric patients (3 months and older) for:- Empirical therapy for presumed fungal infections in febrile, neutropenic patients.- Treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. Cancidas has not been studied in endocarditis, ostemyelitis, and meningitis due to Candida.- Treatment of esophageal candidiasis.- Treatment of invasive aspergillosis in patients who are refractory to or intolerant to other therapies (i.e. amphotericin B, lipid formulations of amphotericin B, and/or itraconazole). Cancidas has not been studied as initial therapy for invasive aspergillosis.

Authorization date:

2011-11-30

Patient Information leaflet

ךיראת
:
4102
–
00
–
42
תילגנאב רישכת םש
:
CANCIDAS 50 MG, 70 MG
:םושיר רפסמ
23543144152.411
,
.21.30415.00
124
:םושירה לעב םש
LTD.
COMPANY
1996)
-
MERCK, SHARP & DOHME (ISRAEL
ןולעב םייונישה
בוהצ עקר לע םינמוסמ
םי/שקובמה םי/יונישה לע םיטרפ
ןולעב קרפ
יחכונ טסקט
שדח טסקט
ADVERSE
REACTIONS
6 ADVERSE REACTIONS
6.4 POSTMARKETING EXPERIENCE:
The following additional adverse reactions have been identified
during the post-approval use of CANCIDAS. Because these
reactions are reported voluntarily from a population of uncertain
size,
it
is
not
always
possible
to
reliably
estimate
their
frequency or establish a causal relationship to drug exposure. _ _

Laboratory abnormalities: gamma-glutamyltransferase
increased
CLINICAL
PHARMACOLOGY
12.4 MICROBIOLOGY
_Mechanism of Action _
Caspofungin, an echinocandin, inhibits the synthesis of
beta

(1,3)-D-glucan, an essential component of the cell wall of
susceptible _Aspergillus _species and _Candida _species.
Beta

(1,3)-D-glucan is not present in mammalian cells.
Caspofungin has shown activity against _Candida _species and
in regions of active cell growth of the hyphae of _Aspergillus _
_fumigatus_.
_Drug Resistance _
There have been reports of clinical failures in patients receiving
caspofungin therapy due to the development of drug
resistance. Some of these reports have identified specific
mutations in the Fks subunits of the glucan synthase enzyme.
These mutations are associated with higher MICs and
breakthrough infection. _Candida _species that exhibit reduced
susceptibility to caspofungin as a result of an increase in the
chitin content of the fungal cell wall have also been identified,
although the significance of this phenomenon _in vivo _is not well
known.

Summary of Product characteristics

CANCIDAS
® 50 MG
CANCIDAS
® 70 MG
CASPOFUNGIN (AS ACETATE)
Powder for concentrate for solution for infusion (IV)
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
CANCIDAS® is indicated in adults and pediatric patients (3 months and
older) for:
•
EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE,
NEUTROPENIC PATIENTS _[see _
_Clinical Studies (14.1, 14.5)]_.
•
TREATMENT
OF
CANDIDEMIA
AND
THE
FOLLOWING
CANDIDA
INFECTIONS:
intra-abdominal
abscesses, peritonitis and pleural space infections _[see Clinical
Studies (14.2, 14.5)]_.
_Limitations of Use:_ CANCIDAS has not been studied in endocarditis,
osteomyelitis, and
meningitis due to _Candida_.
•
TREATMENT OF ESOPHAGEAL CANDIDIASIS _[see Clinical Studies (14.3,
14.5)]. _
_Limitations of Use:_ CANCIDAS has not been approved for the treatment
of oropharyngeal
candidiasis (OPC). In the study that evaluated the efficacy of
caspofungin in the treatment of
esophageal candidiasis, patients with concomitant OPC had higher
relapse rate of the OPC
_[see Clinical Studies (14.3)]. _
•
TREATMENT OF INVASIVE ASPERGILLOSIS IN PATIENTS WHO ARE REFRACTORY TO
OR INTOLERANT OF
OTHER THERAPIES (e.g., amphotericin B, lipid formulations of
amphotericin B, itraconazole) _[see _
_Clinical Studies (14.4, 14.5)]._
_Limitations _
_of _
_Use:_
CANCIDAS
has
not
been
studied
as
initial
therapy
for
invasive
aspergillosis.
2 DOSAGE AND ADMINISTRATION
2.1 IMPORTANT ADMINISTRATION INSTRUCTIONS FOR USE IN ALL PATIENTS
Administer CANCIDAS by slow intravenous (IV) infusion over
approximately 1 hour. Do not
administer CANCIDAS by IV bolus administration.
2.2 RECOMMENDED DOSAGE IN ADULT PATIENTS [18 YEARS OF AGE AND OLDER]
The dosage and duration of CANCIDAS treatment for each indication are
as follows:
_Empirical Therapy_ _for Presumed Fungal Infections in Febrile
Neutropenic Patients _
Administer a single 70-mg loading dose on Day 1, followed by 50 mg
once daily thereafter.
Duration of treatment should be based on the patient’s clinical
response. Continue empirical
therapy unti