XIAFLEX collagenase clostridium histolyticum 0.9 mg lyophilised powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

collagenase clostridium histolyticum

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

collagenase clostridium histolyticum

Authorization status:

Registered

Patient Information leaflet

XIAFLEX (190917) ACMI FOR DUPUYTREN'S CONTRACTURE
1
XIAFLEX
®
(ZI-A-FLEX)
_FOR DUPUYTREN'S CONTRACTURE _
_Collagenase clostridium histolyticum - 900 micrograms powder and
diluent for solution for injection. _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about XIAFLEX.
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 having XIAFLEX
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
INJECTION, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT XIAFLEX IS USED
FOR
XIAFLEX is used for the treatment
of Dupuytren's contracture in adult
patients with a palpable cord.
Dupuytren's contracture is a disease
that causes your finger(s) to bend
inward. This bending is called a
contracture and is caused by the
abnormal formation of a cord(s)
containing collagen under your skin.
For many people, a contracture
causes significant difficulties with
performing everyday tasks like
driving, shaking hands, playing
sports, opening jars, typing or
holding objects.
_HOW IT WORKS _
XIAFLEX is injected directly into
the palpable cord(s) by your doctor
and works by breaking down the
collagen in the cord(s) and thereby
helps to remove the cause of your
contracture so that your finger(s) can
straighten.
The active substance is collagenase
clostridium histolyticum, and is
naturally produced by a bacterium
named Clostridium histolyticum.
BEFORE YOU ARE GIVEN
XIAFLEX
Do not use XIAFLEX if:
1.
You have an allergy to
collagenase clostridium
histolyticum or any of the
ingredients listed at the end of
this leaflet.
Please consult a doctor immediately
if you experience any signs or
symptoms of a serious allergic
reaction:
•
wide spread redness or rash,
•
swelling
•
tightness in the throat or difficulty
breathing
•
chest pain.
2.
You have taken anticoagulation
medicine wit

Summary of Product characteristics

XIAFLEX (190909) API
1/30
PRODUCT INFORMATION
XIAFLEX
® (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM)
LYOPHILISED POWDER FOR INJECTION
900 MICROGRAMS/VIAL
NAME OF THE MEDICINE
Active: collagenase clostridium histolyticum
CAS:_ Clostridium histolyticum _gene colG isoenzyme AUX-I: 955089-04-0
CAS:_ Clostridium histolyticum _gene colH isoenzyme AUX-II:
955089-06-2
Pharmacotherapeutic group: Other Drugs for Disorders of the Musculo-
Skeletal System – Enzymes.
DESCRIPTION
XIAFLEX is a lyophilised product for intralesional administration.
XIAFLEX
contains purified collagenase clostridium histolyticum, consisting of
two
microbial collagenases in a defined mass ratio, Collagenase AUX-I and
Collagenase AUX-II, which are isolated and purified from the
fermentation of
_Clostridium histolyticum_ bacteria. A collagenase is an enzyme that
recognises
and binds to collagen in its native conformation and cleaves the
peptide bonds
resulting in collagen breakdown. Collagenase AUX-I is a single
polypeptide
chain consisting of approximately 1000 amino acids of known sequence.
It has
an observed molecular weight of 114 kiloDaltons (kDa). It belongs to
the
class
I _Clostridium histolyticum_ collagenases. Collagenase AUX-II is a
single
polypeptide chain consisting of approximately 1000 amino acids of
known
sequence. It has an observed molecular weight of 113 kDa. It belongs
to the
class
II _Clostridium histolyticum_ collagenases.
_ _
XIAFLEX is supplied in single-use, glass vials containing 0.9 mg of
collagenase clostridium histolyticum as a sterile, lyophilised powder
for
reconstitution. Each vial also contains approximately 0.5 mg of
hydrochloric
acid, 18.5 mg of sucrose, and 1.1mg of trometamol. The reconstituted
drug
product has a pH of 7.5 – 8.5.
Sterile diluent for reconstitution is provided in the package in a
single-use
glass vial containing 3 mL of 0.3 mg/mL calcium chloride dihydrate in
0.9%
sodium chloride.
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
_MECHANISM OF ACTION _
Collagenases are proteinases that hydrolyse collagen in its