XIAPEX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Available from:

MEGAPHARM LTD

ATC code:

M09AB02

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM 0.9 MG/VIAL

Administration route:

INTRA-LESIONAL

Prescription type:

Required

Manufactured by:

SWEDISH ORPHAN BIOVITRUM, SWEDEN

Therapeutic area:

COLLAGENASE CLOSTRIDIUM HISTOLYTICUM

Therapeutic indications:

Xiapex is indicated for the treatment of Dupuytren’s contracture in adult patients with a palpable cord.The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Authorization date:

2015-05-03

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by physician’s prescription only
XIAPEX
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION:
ACTIVE INGREDIENT:
Collagenase clostridium histolyticum 0.9 mg/vial.
For the full list of excipients, see section: "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains essential information about
this medicine. If you have any further questions, refer to the
physician or the pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them, even if it seems to
you that their illness is similar.
WHAT IS THIS MEDICINE INTENDED FOR?
_ _
Dupuytren's contracture
Xiapex is intended for the treatment of Dupuytren’s contracture in
adult patients with a palpable cord._ _
Peyronie's disease
Xiapex is intended for the treatment of adult men with Peyronie’s
disease with a palpable plaque and curvature deformity
of at least 30 degrees at the start of therapy.
THERAPEUTIC GROUP: The medicine contains an enzyme called Collagenase
clostridium histolyticum produced by
Clostridium histolyticum bacteria.
_ _
Peyronie's disease is a condition associated with the formation of
palpable scar tissue made of collagen, called a plaque,
on the penis. The plaque may cause changes in the shape of the penis
during erection, since the plaque will not undergo
stretching as the rest of the penis. Men with Peyronie's disease will
have a bent and curved penis during erection.
Dupuytren’s contracture is a condition associated with formation of
an abnormal collagen cord under the skin of the
finger/s, causing them to be contracted and bent towards the inner
region of the hand. For many people, this condition
imposes difficulties on daily tasks such as driving, hand shaking,
sports, opening jars, typing or holding objects.
Xiapex is injected by your physician directly into the cord formed in
the hand/finger or int

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xiapex
0.9 mg powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 0.9 mg of collagenase
_clostridium histolyticum_
*.
*A formulation of two collagenase enzymes co-expressed and harvested
from anaerobic fermentation
of a phenotypically selected strain of C
_lostridium histolyticum _
bacterium.
Excipients with known effect
Sodium injected per joint in the treatment of Dupuytren’s
contracture:
Metacarpophalangeal (MP) joints: 0.9 mg.
Proximal interphalangeal (PIP) joints: 0.7 mg.
Sodium injected per plaque in the treatment of Peyronie’s disease:
0.9 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is a white lyophilised powder.
The solvent is a clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xiapex is indicated for:
•
The treatment of Dupuytren’s contracture in adult patients with a
palpable cord.
•
The treatment of adult men with Peyronie’s disease with a palpable
plaque and curvature
deformity of at least 30 degrees at the start of therapy (see section
4.2 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Dupuytren’s contracture_
_ _
Xiapex must be administered by a physician appropriately trained in
the correct administration of the
product and experienced in the diagnosis and management of
Dupuytren’s disease.
Posology
The recommended dose of Xiapex is 0.58 mg per injection into a
palpable Dupuytren’s cord. The
volume of reconstituted Xiapex to be administered into the
Dupuytren’s cord differs depending on the
type of joint being treated (see section 6.6, Table 10).
2
Approximately 24 hours after injection, a finger extension procedure
may be performed, as necessary,
to facilitate cord disruption. If a satisfactory response has not been
achieved, the injection and finger
extension procedures may be repeated after approximately 4 weeks.
Inj