What Xiapex contains
The active substance is collagenase clostridium histolyticum
. Each vial of Xiapex contains 0.9 mg of collagenase clostridium histolyticum
. The other ingredients are sucrose, trometamol and hydrochloric acid.
The solvent contains calcium chloride dihydrate, sodium chlorideand water for injections.
What Xiapex looks like and contents of the pack
Xiapex is supplied as a white powder in a 3 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
The solvent that is used to dissolve the powder is supplied as a clear liquid in a 5 ml type I clear glass vial with rubber stopper, aluminium seal and flip-off plastic cap.
Xiapex is supplied in a single use pack containing 1 vial of Xiapex powder and 1 vial of 3 ml solvent.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien Pfizer S.A.N.V. TélTel 32 02 554 62 11 LuxembourgLuxemburg Pfizer S.A. TélTel 32 02 554 62 11
, . 359 2 970 4333 Magyarország Pfizer Kft. Tel. 36 1 488 37 00
eská republika Pfizer s.r.o. Tel 420 283 004 111 Malta V.J. Salomone Pharma Ltd. Tel 356 21 22 01 74
Danmark Pfizer ApS Tlf 45 44 20 11 00 Nederland Pfizer bv Tel 31 010 406 43 01
Deutschland Pfizer Pharma GmbH Tel 49 030 550055 51000 Norge Pfizer AS Tlf 47 67 52 61 00
Eesti Pfizer Luxembourg SARL Eesti filiaal Tel 372 6 405 328 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0
Pfizer Hellas A.E. 30 210 6785800 Polska Pfizer Polska Sp. z o.o. Tel. 48 22 335 61 00
España Pfizer S.A. Tel 34 91 490 99 00 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 5500
France Pfizer Tél 33 01 58 07 34 40 România Pfizer România S.R.L. Tel 40 021 207 28 00
Ireland Pfizer Healthcare Ireland Slovenija Pfizer Luxembourg SARL, Pfizer, podrunica za svetovanje s podroja farmacevtske dejavnosti, Ljubljana Tel 386 01 52 11 400 Tel 1800 633 363 toll free 44 01304 616161
Ísland Icepharma hf Sími 354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizaná zloka Tel 421-2-3355 5500
Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 SuomiFinland Pfizer Oy PuhTel 358 09 43 00 40
Geo. Pavlides Araouzos Ltd, 35722818087 Sverige Pfizer AB Tel 46 08 550 520 00
Latvija United Kingdom Pfizer Luxembourg SARL filile Latvij Tel 371 670 35 775 Pfizer Limited Tel 44 01304 616161
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. +3705 2514000
This leaflet was last approved in
-------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Instructions for use and handling
1. Preparation - Reconstitution procedure
The single dose vial containing Xiapex and the single dose vial containing the solvent for solution for injection for reconstitution must be refrigerated. Prior to use, the vial containing Xiapex and the vial containing the solvent for solution for reconstitution must be removed from the refrigerator and allowed to stand at room temperature for at least 15 minutes and no longer than 60 minutes .
Using an aseptic technique, the following procedure for reconstitution must be followed:
1. Confirm the joint to be treated (metacarpophalangeal [MP] or proximal interphalangeal [PIP]) as the volume of solvent required for reconstitution is determined by the type of joint (PIP joint requires a smaller volume for injection).
2. Remove the flip-off plastic caps from both vials and swab the rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the solvent for reconstitution with sterile alcohol (no other antiseptics must be used).
3. Use only the supplied solvent for reconstitution; it contains calcium which is required for the activity of Xiapex. Using a sterile syringe calibrated with 0.01 ml graduations, withdraw the appropriate amount of solvent supplied in order to deliver as follows:
0.39 ml of solvent for cords affecting a MP joint or 0.31 ml of solvent for cords affecting a PIP joint
4. Inject the solvent slowly into the sides of the vial containing the lyophilised powder of Xiapex. Do not invert the vial or shake the solution. Slowly swirl the solution to ensure that all of the lyophilised powder has gone into solution. Remove and discard the syringe and needle used for reconstitution.
5. Inspect the solution visually for particulate matter and discoloration prior to administration. The reconstituted solution of Xiapex must be clear. If the solution contains particles, is cloudy or discoloured, do not inject it.
6. Reconstituted Xiapex can be kept at ambient room temperature (20ºC-25ºC) for up to one
hour or refrigerated (2ºC-8-C) for up to 4 hours prior to administration. If refrigerated, the reconstituted solution must be allowed to return to ambient room temperature (20ºC-25ºC) for approximately 15 minutes before use.
2. Injection procedure
Administration of a local anaesthetic medicinal product prior to injection of Xiapex is not recommended, as it may interfere with proper placement of the injection.
1. Reconfirm the cord to be injected. The site chosen for injection must be the area where the contracting cord is maximally separated from the underlying flexor tendons and where the skin is not intimately adhered to the cord.
2. Prepare the skin with an antiseptic and allow it to dry.
3. Using a sterile, hubless syringe with 0.01 ml graduations and a permanently fixed, 26 or 27 gauge, 12 or 13 mm needle (not supplied), withdraw the adequate volume of reconstituted solution for a 0.58 mg dose of Xiapex required for injection to deliver:
0.25 ml of reconstituted Xiapex for cords affecting a MP joint or 0.20 ml of reconstituted Xiapex for cords affecting a PIP joint.
4. Use caution with cords as they approach the PIP flexion crease area. If injecting into a cord affecting the PIP joint of the fifth (little) finger, care must be taken to inject as close to the palmar digital crease as possible and not to insert more than 2 mm to 3 mm in depth. For PIP joints do not inject more than 4 mm distal to the palmar digital crease.
5. With your non-dominant hand, secure the patient?s hand to be treated while simultaneously applying tension to the cord. With your dominant hand, place the needle into the cord, using caution to keep the needle within the cord. Avoid having the needle tip pass completely through the cord to help minimise the potential for injection of Xiapex into tissues other than the cord. After needle placement, if there is any concern that the needle is in the flexor tendon, apply a small amount of passive motion at the distal interphalangeal (DIP) joint. If insertion of the needle into a tendon is suspected or paresthesia is noted by the patient, withdraw the needle and reposition it into the cord. If the needle is in the proper location, there will be some resistance noted during the injection procedure. See Figure 1 below for an illustration of the injection technique.
6. After confirming that the needle is correctly placed in the cord, inject approximately one-third of the dose.
7. Next, keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it in a slightly more distal location (approximately 2-3 mm) to the initial injection in the cord and inject another one-third of the dose.
8. Again keeping the needle under the skin at all times, withdraw the needle tip from the cord and reposition it a third time proximal to the initial injection (approximately 2-3 mm) and inject the final portion of the dose into the cord (see Figure 2).
The figures 1 and 2 below are for illustrative purposes only and may not be representative of the precise location of anatomical structures in an individual patient.
Figure 1: Illustration of the injection technique.
Figure 2: Three step injection of Xiapex into the cord.
9. Wrap the patient?s treated hand with a soft, bulky, gauze dressing.
10. Discard the unused portion of the reconstituted solution and solvent after injection. Do not store, pool, or use any vials containing unused reconstituted solution or solvent.
11. Patients should be instructed: - Not to flex or extend the fingers of the injected hand to reduce extravasation of Xiapex out of the cord until the finger extension procedure is completed. - Not attempt to disrupt the injected cord by self manipulation at any time. - To elevate the injected hand as much as possible until the day after the finger extension procedure. - To promptly contact their doctor if there is evidence of infection (e.g., fever, chills, increasing redness or oedema) or trouble bending the finger after the swelling goes down (symptoms of tendon rupture). - To return to see their physician the next day for an examination of the injected hand and a possible finger extension procedure to disrupt the cord.
3. Finger extension procedure
1. At the follow-up visit the day after injection, determine if the contracture has resolved. If a cord contracture remains, a passive finger extension procedure will be performed in an attempt to disrupt the cord.
2. Local anaesthesia may be used, if needed, during the finger extension procedure.
3. While the patient?s wrist is in the flexed position, apply moderate stretching pressure to the injected cord by extending the finger for approximately 10 to 20 seconds. For cords affecting the PIP joint, perform the finger extension procedure when the MP joint is in the flexed position.
4. If the first finger extension procedure does not result in disruption of the cord, a second and third attempt can be performed at 5- to 10-minute intervals. No more than 3 attempts are recommended to disrupt a cord.
5. If the cord has not disrupted after 3 attempts of extension, a follow-up visit may be scheduled approximately 4 weeks after the injection. If, at that subsequent visit the contracted cord persists, an additional injection and finger extension procedure may be performed.
6. Following the finger extension procedure(s) and fitting patient with a splint (with treated joint in maximum extension), patients should be instructed to:
- Not perform strenuous activity with the injected hand until advised to do so. - Wear the splint at bedtime for up to 4 months.
- Perform a series of finger flexion and extension exercises several times a day for several months.