IKERVIS 1 mg/mL eye drops, emulsion

  • Name:

    IKERVIS 1 mg/mL eye drops, emulsion

  • Company:
    info
  • Active Ingredients:

    Ciclosporin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/07/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 16/7/2019

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Santen UK Limited

Santen UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name IKERVIS 1 mg/mL eye drops, emulsion Active Ingredients Ciclosporin
Medicine Name Saflutan 15 micrograms/ml eye drops, solution Active Ingredients Tafluprost
Medicine Name SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container Active Ingredients Tafluprost
Medicine Name Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Active Ingredients Tafluprost, Timolol Maleate
Medicine Name Timoptol 0.25% and 0.5% w/v Eye Drops Solution Active Ingredients Timolol Maleate
Medicine Name TRUSOPT 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
Medicine Name TRUSOPT Preservative-Free 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
1 - 0 of 9 items.Total: Infinity pages

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 16 July 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 16 July 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

4.3     Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Ocular or peri-ocular malignancies or premalignant conditions

Active or suspected ocular or peri-ocular infection.

4.4     Special warnings and precautions for use

 

IKERVIS has not been studied in patients with a history of ocular herpes and should therefore be used with caution in such patients.

Contact lenses

Patients wearing contact lenses have not been studied. Careful monitoring of patients with severe keratitis is recommended. Contact lenses should be removed before instillation of the eye drops at bedtime and may be reinserted at wake-up time.

Concomitant therapy

There is limited experience with IKERVIS in the treatment of patients with glaucoma. Caution should be exercised when treating these patients concomitantly with IKERVIS, especially with beta-blockers which are known to decrease tear secretion.

Co-administration of Ikervis with eye drops containing corticosteroids may potentiate the effects of Ikervis on the immune system. Therefore, caution should be exercised when corticosteroids are administered concomitantly with Ikervis (see section 4.5).

Effects on the immune system

MedicinalOphthalmic medicinal products, which affect the immune system, including ciclosporin, may affect host defences against local infections and malignancies. Therefore, regular examination of the eye(s) is recommended, e.g. at least every 6 months, when Ikervis is used for years.

Co-administration of IKERVIS with eye drops containing corticosteroids could potentiate the effects of IKERVIS on the immune system (see section 4.5).

Excipient

IKERVIS contains cetalkonium chloride which may cause eye irritation.

10.     DATE OF REVISION OF THE TEXT

July 2016

07/2019

Updated on 12 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 February 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 31 January 2018 SmPC

Reasons for updating

  • 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 4.8 AE reporting details changed for UK  
....

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see contact details below).

 

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

 

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

 

 

Updated on 31 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 18 January 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section
  • Change to section 4 - how to report a side effect

Updated on 14 October 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 14 October 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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



4.2     Posology and method of administration

 

Paediatric population

There is no relevant use of IKERVIS in children and adolescents aged below 18 in the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes

4.8       Undesirable effects

In four five clinical studies including 532 patients who received IKERVIS and 398 who received IKERVIS vehicle (control), IKERVIS was administered at least once a day in both eyes, for up to one year. The most common adverse reactions were eye pain (19.2%), eye irritation (17.8%), lacrimation (6. 42%), ocular hyperaemia (5.5%) and eyelid erythema (1.7%) which were usually transitory and occurred during instillation.

The majority of adverse reactions reported in clinical studies with the use of IKERVIS were ocular and mild to moderate in severity.

 

 

5.1     Pharmacodynamic properties

Clinical efficacy and safety.....

The severity of keratitis, assessed using CFS, improved significantly from baseline at Month 6 with IKERVIS compared to vehicle (mean change from baseline was -1.76481 with IKERVIS vs. -1.41848 with vehicle, p=0.037). The proportion of IKERVIS-treated patients with a 3-grade improvement in CFS score at Month 6 (from 4 to 1) was 28.8%, compared to 9.6% of vehicle-treated subjects, but this was a post-hoc analysis, which limits the robustness of this outcome. The beneficial effect on keratitis was maintained in the open phase of the study, from Month 6 and up to Month 12.  

The mean change from baseline in the 100-point OSDI score was ‑13.6 with IKERVIS and ‑14.1 with vehicle at Month 6 (p=0.858). In addition, no improvement was observed for IKERVIS compared to vehicle at Month 6 for other secondary endpoints, including ocular discomfort score, Schirmer test, use of concomitant artificial tears, investigator’s global evaluation of efficacy, tear break-up time, lissamine green staining, quality of life score, and tear osmolarity.

A reduction in the ocular surface inflammation assessed with Human Leukocyte Antigen-DR (HLA-DR) expression (an exploratory endpoint), was observed at Month 6 in favour of IKERVIS (p=0.021).
.......

At completion of the SANSIKA study (12 month study), patients were asked to enter the Post SANSIKA study. This study was an open-label, non-randomized, one-arm, 24-month study extension of the Sansika Study. In Post SANSIKA study patients alternatively received IKERVIS treatment or no treatment depending on CFS score (patients received IKERVIS when there was a worsening of keratitis).

This study was designed to monitor the long-term efficacy and relapse rates in patients who have previously received IKERVIS.

The primary objective of the study was to assess the duration of the improvement following IKERVIS treatment discontinuation once the patient was improved with respect to the baseline of the SANSIKA study (i.e. at least 2 grade improvement on the modified Oxford scale).

67 patients were enrolled (37.9% of the 177 patients having ended Sansika). After the 24-month period, 61.3% of 62 patients included in the primary efficacy population did not experience a relapse based on CFS scores. Percentage of patients who experienced a severe keratitis recurrence was 35% and 48% in patients treated 12 months and 6 months with IKERVIS respectively in the SANSIKA study.

Based on the first quartile (the median could not be estimated due to the small number of relapses), time to relapse (back to CFS grade 4) was ≤224 days and ≤175 days in patients previously treated 12 months and 6 months with IKERVIS, respectively. Patients spent more time on CFS grade 2 (Median 12.7 weeks/year) and grade 1 (Median 6.6 weeks/year) than CFS grade 3 (Median 2.4 weeks/year), CFS grades 4 and 5 (Median time 0 week/year).

Assessment of DED symptoms by VAS showed a worsening of patient’s discomfort from the time treatment was first stopped to the time it was restarted except pain which remained relatively low and stable.  The median global VAS score increased from the time treatment was first stopped (23.3%) to the time treatment was restarted (45.1%).

No significant changes have been observed in the other secondary endpoints (TBUT, lissamine green staining and Schirmer test, NEI-VFQ and EQ-5D) over the course of the extension study.

 

 

10.     DATE OF REVISION OF THE TEXT

 

July 2016

Updated on 9 March 2016 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 8 March 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 March 2016 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

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