Eraxis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Anidulafungin

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

ERAXIS
®

_POWDER FOR INJECTION_
_anidulafungin_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ERAXIS.
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 taking ERAXIS
against the benefits it is expected to
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 ERAXIS IS USED
FOR
ERAXIS belongs to a group of
medicines called echinocandins
which work by preventing the growth
of fungal organisms causing your
infection.
ERAXIS is used to treat fungal
infections such as invasive
candidiasis and candidemia.
These are serious fungal infections in
your bloodstream or in tissues or
organs such as the food pipe or eyes.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
ERAXIS
_WHEN YOU WILL NOT BE GIVEN_
_ERAXIS_
You will not be given ERAXIS if
you have ever had an allergy to:
•
any medicine containing
anidulafungin
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines such
as Cancidas (not all brands
given).
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; skin rash,
itching or hives.
_BEFORE YOU ARE GIVEN_
_ERAXIS_
Tell your doctor if you have allergies
to any foods, preservatives or dyes or
any other medicines.
Tell your doctor if you have or have
had any of the following medical
conditions:
•
any problems affecting your liver.
Your doctor may need to monitor the
function of your liver using blood
tests. Be sure to follow your doctor's

Summary of Product characteristics

Version: pfperaxv10412 
Supersedes: pfperaxv10311 

Page 1 of 15 
PRODUCT INFORMATION 
ERAXIS
®
 (ANIDULAFUNGIN 100 MG) 
POWDER FOR INJECTION 
NAME OF THE MEDICINE 
Non-proprietary name: 
anidulafungin 
Chemical name: 
1-[(4R,5R)-4,5-Dihydroxy-N
2
-[[4"-(pentyloxy)[1,1':4',1"-
terphenyl]-4-yl]carbonyl]-L-ornithine]echinocandin B. 
CAS Number: 
166663-25-8  
ATC code: 
JO2 AX 06 
ERAXIS (anidulafungin) is a semi-synthetic lipopeptide synthesised  from
a fermentation 
product of _Aspergillus nidulans_.  
Anidulafungin is a white to off-white powder that
is practically insoluble in water and slightly 
soluble in
ethanol. The empirical formula of anidulafungin is C
58
H
73
N
7
O
17
  and  the formula 
weight is 1140.3.  
THE STRUCTURAL FORMULA IS: 

DESCRIPTION 
POWDER FOR
INJECTION. ERAXIS is a sterile, lyophilised  product for injection
that contains 
anidulafungin.  In addition to the active ingredient,
anidulafungin, ERAXIS contains the 
following inactive ingredients: fructose, mannitol,
polysorbate 80, tartaric acid and may also 
contain hydrochloric acid and/or sodium hydroxide.  
N
O
NH
O
HN
HO
OH
H
HO
H
3
C
H
H
H H
NH
O
OC
5
H
11
CH
3
OH
O
H
H
N
OH
H
O
H
N
HO
OH
H
OH
H
H
H
O
O
NH
HO
H
3
C
H
H
Version: pfperaxv10412 
Supersedes: pfperaxv10311 

Page 2 of 15 
Prior to administration,
ERAXIS powder for injection requires reconstitution with water
for 
injections (refer to DOSAGE AND ADMINISTRATION).  
PHARMACOLOGY 
MICROBIOLOGY 
Anidulafungin selectively inhibits 1,3-
β-D glucan synthase, an enzyme present in fungal, but 
not  mammalian cells. 
This results in inhibition of the formation of 1,3-
β-D-glucan, an 
essential  component of the fungal cell wall. Anidulafungin
has shown fungicidal activity 
against  _Candida_  species and activity against regions of active
cell growth of  the hyphae of 
_Aspergillus fum