Xiapex 0.9mg powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Collagenase clostridium histolyticum

Available from:

Swedish Orphan Biovitrum Ltd

INN (International Name):

Collagenase clostridium histolyticum

Dosage:

900microgram

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intralesional

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5013457027648

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
XIAPEX 0.9 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
collagenase _clostridium histolyticum _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Xiapex is and what it is used for
2.
What you need to know before you are given Xiapex
3.
How Xiapex is used
4.
Possible side effects
5.
How to store Xiapex
6.
Contents of the pack and other information
1.
WHAT XIAPEX IS AND WHAT IT IS USED FOR
Xiapex is used for the treatment of two different conditions:
DUPUYTREN’S CONTRACTURE IN ADULT
PATIENTS WITH A PALPABLE CORD and PEYRONIE’S DISEASE IN ADULT MEN.
•
DUPUYTREN’S CONTRACTURE
This 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 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.
•
PEYRONIE’S DISEASE
This is a condition where adult men have a ‘plaque’ that can be
felt and a curve to their penis. The
disease can cause a change in the shape of the erect penis due to the
abnormal build-up of scar tissue,
known as a plaque, within the stretchy fibres of the penis. The plaque
may interfere with the ability to
get a straight erection because the plaque will not stretch as much as
the rest of the penis. Men with
Peyronie’s disease may have an erection that is curved or bent.
The active substance in Xiapex is collagenase _clostridium
histolyticum_, and this collagenase is
produced using the microorganism _Clostridium histolyticum_. Xiapex is
injected by your doctor int

Summary of Product characteristics

OBJECT 1
XIAPEX 0.9 MG POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 02-Jan-2018 | Swedish
Orphan Biovitrum Ltd
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 sections 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
medicinal 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 solvent required and the volume of reconstituted Xiapex to be
administered into the Dupuytren's cord
differs depending on the type of joint being treated (for the
reconstitution instructions, see section 6.6,
Table 13).
• For cords affecting MP joints each dose is administered in an
injection volume of 0.25 ml.
• F