Xiapex 0.9 mg powder and solvent for solution for injection
- Name:
Xiapex 0.9 mg powder and solvent for solution for injection
- Company:
Swedish Orphan Biovitrum Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/12/19
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 17/12/2019
Click on this link to Download PDF directly
Swedish Orphan Biovitrum Ltd
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| Medicine Name ALPROLIX powder and solvent for solution for injection | Active Ingredients Eftrenonacog Alfa |
| Medicine Name ELOCTA powder and solvent for solution for injection | Active Ingredients efmoroctocog alfa |
| Medicine Name Fomepizole EUSA Pharma 5 mg/mL | Active Ingredients Fomepizole sulphate |
| Medicine Name Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe | Active Ingredients Anakinra |
| Medicine Name Orfadin 2mg, 5mg, 10mg and 20mg Capsules | Active Ingredients Nitisinone |
| Medicine Name Orfadin 4mg/ml Oral Suspension | Active Ingredients Nitisinone |
| Medicine Name Xiapex 0.9 mg powder and solvent for solution for injection | Active Ingredients Collagenase clostridium histolyticum |
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 17 December 2019 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
How to report a side effect
Updated on 17 December 2019 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4 has been updated with:
- reported cases of finger necrosis
- reported cases of digital phalangeal fractures
- advise to wait for at least 4 weeks after the second injection of a treatment cycle before resuming sexual activity taking care to ensure that any pain and swelling has ceased and to be cautious when resuming sexual activity.
Section 4.8 has been updated with new adverse reactions listed under frequency not known
Updated on 2 July 2019 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 2 July 2019 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 25 June 2019 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 25 June 2019 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SmPC section 4.4 and 5.1 has been updated with long term safety data for Peyronie’s disease.
Updated on 24 July 2018 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 December 2017 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4. Clinical particulars
4.8 Undesirable effects
Inserted: Cold intolerance of the treated fingers
10. DATE OF REVISION OF THE TEXT
Inserted: 08/12/2017
Deleted: 05/2016
Updated on 19 December 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 15 December 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 15 December 2017 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 7 July 2016 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
$04.8 Undesirable effects$0$0Peyronie’s disease$0$0Summary of the safety profile$0$0The overall safety profile was similar in the two Phase 3 double‐blind placebo controlled studies (832 male patients,$0$0551 patients received Xiapex) and in an open‐label Phase 3 study (189 male patients) of patients who had previously$0$0received placebo in the controlled studies. In the two Phase 3 double‐blind placebo controlled studies, Most adverse$0$0reactions were local events of the penis and groin and the majority of these events were of mild or moderate severity,$0$0and most (79%) resolved within 14 days of the injection. The adverse reaction profile was similar after each injection,$0$0regardless of the number of injections administered. The most frequently reported adverse drug reactions (≥25%)$0$0during the Xiapex controlled clinical studies (832 male patients, 551 patients received Xiapex) were penile haematoma,$0$0penile swelling and penile pain. Severe penile haematoma including severe injection site haematoma were reported$0$0with the frequency very common.$0$05.1 Pharmacodynamic properties$0$0An open label phase 3 study, AUX‐CC‐806, evaluated the safety and efficacy of Xiapex. The study inclusion and exclusion$0$0criteria as well as the treatment schedule and the co‐primary efficacy endpoints were the same as in the pivotal AUXCC‐$0$0803 and AUX‐CC‐804 studies. Patients were however followed up to 36 weeks. A total of 189 patients were enrolled$0$0and treated with Xiapex. All patients had participated in and completed the studies AUX‐CC‐803 or AUX‐CC‐804, in$0$0which they had received placebo.$0$0The median age of the patients included was 60, ranging between 33 and 77 years. The median duration of disease was$0$04.9 years (range 2.0 to 27.9 years). Erectile dysfunction was reported in 52.9% of patients, and 27.5% reported previous$0$0trauma to penis.$0$0Tables 11‐12 provide the results of the co‐primary efficacy endpoints measured in the open label phase 3 study AUX‐CC‐$0$0806.$0$0Table 11 and 12 have been added:$0$02$0$0Table 11. Mean Percent Change from Baseline in Curvature Deformity at Week 36 (LOCF) (mITT* Population)$0$0– study AUX‐CC‐806$0$0Xiapex$0$0N=126$0$0Baseline value$0$0Mean (SD)$0$0Min, Max$0$046.9 (12.00)$0$030, 85$0$0Week 36 value (LOCF)$0$0Mean (SD)$0$0Min, Max$0$029.9 (15.56)$0$00, 80$0$0% change from baseline$0$0Mean (SD)$0$0Min, Max$0$095% CI of mean**$0$0‐36.3 (30.72)$0$0‐100, 100$0$0‐41.6, ‐30.9$0$0*The mITT population was defined as all randomized subjects who had both a penile curvature deformity$0$0measurement and a PDQ assessment at baseline and at one or more subsequent time points.$0$0**Based on the 95% CI of the mean not including zero, the percent change from baseline was considered$0$0statistically significant.$0$0Table 12. Mean Change from Baseline in Peyronie’s Disease Bother Score at Week 36 (LOCF) (mITT* Population)$0$0– study AUX‐CC‐806$0$0Xiapex$0$0N=126$0$0Baseline value$0$0Mean (SD)$0$0Min, Max$0$06.3 (3.60)$0$01, 15$0$0Week 36 value (LOCF)$0$0Mean (SD)$0$0Min, Max$0$03.9 (3.65)$0$00, 16$0$0Change from baseline$0$0Mean (SD)$0$0Min, Max$0$095% CI of mean**$0$0‐2.4 (3.34)$0$0‐12, 7$0$0‐3.0, ‐1.8$0$0*The mITT population was defined as all randomized subjects who had both a penile curvature deformity$0$0measurement and a PDQ assessment at baseline and at one or more subsequent time points.$0$0**Based on the 95% CI of the mean not including zero, the mean change from baseline was considered$0$0statistically significant.$0$0As an exploratory analysis, female sexual partners completed two questionnaires at both the screening visit and$0$0week 36: the PDQ for Female Sexual Partners (an adaptation of Peyronie’s disease bother and psychological symptom$0$0domains of the PDQ for men, scoring from 0‐12) and the Female Sexual Function Index (FSFI, scale from 2‐36, where a$0$0higher score represents better sexual functioning). Altogether 30 female partners participated in the study. At baseline,$0$0the mean (SD) Female PDQ score was 4.7 (3.61) and 2.7 (3.06) at week 36, i.e. a change from baseline of ‐2.0. The mean$0$0(SD) FSFI score was 20.56 (10.08) at baseline and 26.72 (7.73) at week 36, a change from baseline of 7.54.$0$010. DATE OF REVISION OF THE TEXT$0$005/2016$0
Updated on 6 July 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 27 April 2016 SmPC
Reasons for updating
- Removal of black triangle
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
removal of black triangle
Updated on 26 April 2016 PIL
Reasons for updating
- Removal of black triangle
Updated on 28 January 2016 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The changes involved include two separate variation submissions and approval. The first being II59 update which included the 'multicord' data (two concurrent injections during a treatment visit and a variable time for the finger extension procedure between 24-72 hours), the Periodic Safety Update Report (7) was also implemented in the text revision 22 October 2015. The following sections of the SmPC were revised: 4.2, 4.4, 4.8, 5.1, 5.2, 6.6 and the PIL updated.
Xiapex has received positive opinion for the 5 years renewal (second submission). The SmPC sections that have been revised: 4.2 (replacement of texts), 4.6 (minor editorial change) 4.8 (very minor changes), 5.2 and 6.6 (minor editorial change) and some minor changes to the PIL as well as including a new picture for PD (enlarged arrow). Revision of text date January 2016.
For further information contact Sobi
Updated on 27 January 2016 PIL
Reasons for updating
- Change to date of revision
Updated on 12 May 2015 SmPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Additional information added to section 4.4 Special warnings and precautions for use
Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren’s contracture
Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased
risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex. This is particularly
important for cords situated at the PIP joint of the fifth finger.
Most patients experiencing tendon/ligament rupture or injury have gone on to have successful surgical repair. Early
diagnosis and prompt evaluation and treatment are important because tendon rupture/ligament injury may potentially
affect overall hand function.
Cases of skin laceration requiring skin graft after finger extension procedures have been reported post‐marketing. Signs
or symptoms that may reflect serious injury to the treated finger/hand after injection or manipulation should be
promptly evaluated because surgical intervention may be required. A higher rate for skin laceration has been shown
following two concurrent injections in the same hand in a controlled post‐marketing trial.
revision of text date
appendix V reporting
Tendon rupture or other serious injury to the injected finger/hand in the treatment of Dupuytren’s contracture
Care should be taken when injecting Xiapex into cords contracting the PIP joints as clinical studies indicate an increased
risk of tendon rupture and ligament injury associated with treatment of PIP contractures with Xiapex. This is particularly
important for cords situated at the PIP joint of the fifth finger.
Most patients experiencing tendon/ligament rupture or injury have gone on to have successful surgical repair. Early
diagnosis and prompt evaluation and treatment are important because tendon rupture/ligament injury may potentially
affect overall hand function.
Cases of skin laceration requiring skin graft after finger extension procedures have been reported post‐marketing. Signs
or symptoms that may reflect serious injury to the treated finger/hand after injection or manipulation should be
promptly evaluated because surgical intervention may be required. A higher rate for skin laceration has been shown
following two concurrent injections in the same hand in a controlled post‐marketing trial.
revision of text date
appendix V reporting
Updated on 5 May 2015 PIL
Reasons for updating
- Change to date of revision
Updated on 24 February 2015 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
New indication added. therefore most sections have been updated. please refer to company for further information
Updated on 18 February 2015 PIL
Reasons for updating
- Change to, or new use for medicine
Updated on 16 February 2015 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
xiapex has a new indication. Nearly sections have changed, please contact Sobi for full details
Updated on 11 November 2014 SmPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
None provided
Updated on 7 November 2014 PIL
Reasons for updating
- New PIL for new product