CASPOFUNGIN AN caspofungin (as acetate) 70 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

caspofungin acetate, Quantity: 77.7 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

caspofungin acetate

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol; sucrose; sodium hydroxide; hydrochloric acid

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CASPOFUNGIN AN is indicated for:,? Empirical therapy for presumed fungal infections in febrile, neutropenic patients whose fever has failed to respond to broad-spectrum antibiotics,? Treatment of:,-Invasive Candidiasis, including candidaemia,-Oesophageal Candidiasis,-Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies.

Product summary:

Visual Identification: Lyophilized white to off-white cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2016-12-22

Patient Information leaflet

CASPOFUNGIN AN v2.0
1
CASPOFUNGIN AN
_FOR INTRAVENOUS INFUSION_
_Caspofungin acetate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CASPOFUNGIN
AN. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using
CASPOFUNGIN AN against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT
CASPOFUNGIN AN
IS USED FOR
CASPOFUNGIN AN is used to
treat the following fungal
infections:
•
Invasive candidiasis, including
candidaemia
•
Oesophageal candidiasis
•
Invasive aspergillosis, when other
antifungal treatments have not
worked or when other antifungal
treatments have not been
tolerated.
Also, your doctor may suspect that
you have a fungal infection in the
following situation, and prescribe
CASPOFUNGIN AN to treat it.
•
Chemotherapy or other medical
treatments or conditions can
lower the body's resistance to
disease by lowering counts of
certain white blood cells. If you
have persistent fever following
chemotherapy or under other
conditions as noted above, and
your fever is not reduced by
treatment with an antibiotic, you
may have a fungal infection.
Candidiasis is an infection caused by
a fungus (yeast) called candida.
Invasive candidiasis is a serious type
of candidiasis which occurs in your
bloodstream (referred to as
candidaemia), or in tissues or organs
such as the lining of the abdomen
(peritonitis), the heart, kidneys, liver,
bones, muscles, joints, spleen, or
eyes.
Candidiasis can also occur in your
food pipe, also known as the
oesophagus (oesophageal
candidiasis). It may cause difficulty
or pain when swallowing.
Invasive aspergillosis is an infection
caused by a fungus, called aspergillus
(as-pur-jilus). Most of these
infections begin in the respiratory
tract (in the nose,

Summary of Product characteristics

Australian Product Information
PI v 2.1
Page | 1
AUSTRALIAN PRODUCT INFORMATION
CASPOFUNGIN AN 50 MG _(CASPOFUNGIN (AS ACETATE)) _
CASPOFUNGIN AN 70 MG _(CASPOFUNGIN (AS ACETATE))_
_ _
1 NAME OF THE MEDICINE
Caspofungin (as acetate).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
CASPOFUNGIN AN is a sterile, lyophilised product for intravenous
infusion that contains a
semisynthetic lipopeptide (echinocandin) compound synthesised from a
fermentation product
of _ Glarea lozoyensis. _ CASPOFUNGIN AN 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.
Caspofungin AN contains 50 mg or 70 mg of caspofungin acetate as the
active ingredient.
Caspofungin acetate is a hygroscopic, white to off-white powder. It is
freely soluble in water
and methanol, and slightly soluble in ethanol. The pH of a saturated
aqueous solution of
caspofungin acetate is approximately 6.6.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
CASPOFUNGIN AN is available as a white to off white lyophilised
compact powder for infusion
in single use glass vials of 50 mg and 70 mg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CASPOFUNGIN AN is indicated for:
•
Empirical therapy for presumed fungal infections in febrile,
neutropenic patients whose
fever has failed to respond to broad-spectrum antibiotics
•
Treatment of:
−
Invasive Candidiasis, including candidaemia
−
Oesophageal Candidiasis
−
Invasive Aspergillosis in patients who are refractory to or intolerant
of other therapies.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
CASPOFUNGIN AN SHOULD BE ADMINISTERED IN ADULT PATIENTS BY SLOW
INTRAVENOUS
Australian Product Information
PI v 2.1
Page | 2
INFUSION
OVER
APPROXIMATELY
1
HOUR
(refer
to
Reconstitution
section
for
dilution
recommendations).
TABLE 1
DOSING RECOMMENDATIONS IN ADULT PATIENTS
LOADING DOSE
MAINTENANCE DOSE
EMPIRICAL THERAPY
Normal hepatic function or
mild hepatic insufficiency*
70