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: 18/03/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 18/3/2020

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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 18 March 2020 PIL

Reasons for updating

  • XPIL Updated

Free text change information supplied by the pharmaceutical company

correction of typos and removal of HPRA address in section 4 to align with published leaflet

Updated on 18 March 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

2.       What you need to know before you use IKERVIS

....

IKERVIS contains cetalkonium chloride

This medicine contains 0.05 mg cetalkonium chloride in 1 mL. You should remove contact lenses before using this medicine and you can reinsert them when you wake up. Cetalkonium chloride may also cause eye irritation. If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

....

4.       Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported:

The most common side effects are in and around the eyes.

Very common (may affect more than 1 in 10 people)

  • Pain when the drops are put into the eye.Eye pain,
  • Eye irritation

Common (may affect up to 1 in 10 people)

  • Irritation, redness, and increase in tears when the drops are put into the eye,
  • rRedness of the eyelid,
  • wWatery eyes,
  • eEye redness,
  • bBlurred vision,
  • . Swelling of the eyelid,
  • rRedness of the conjunctiva (thin membrane covering the front part of the eye),eEye irritation, eEye p
  • Iching in the eye

Uncommon (may affect up to 1 in 100 people)

Uncommon side effects related to the eye:

  • Discomfort in or around the eye when the drops are put into the eye, including feeling that there is something in the eye,.
  • Irritation or swelling of the conjunctiva (thin membrane covering the front part of the eye),
  • eEye allergy,
  • tTear disorder,
  • eEye discharge,
  • Irritation or inflammation of the conjunctiva (thin membrane covering the front part of the eye),
  • iInflammation of the iris (coloured part of the eye) or eyelid,
  • dDeposits in the eye,
  • aAbrasion to the outer layer of the cornea,wWhitish patches on the cornea,
  •  cRed or swollen eyelids,
  • Cyst in the eyelid,
  • Immune response or scarring in the cornea,
  •   iItching in the eyelid,or in the eye,
  • Bacterial infection or inflammation of the cornea (transparent front part of the eye),
  • Painful rash around the eye caused by the herpes zoster virus,.
  • Headache

6.       Contents of the pack and other information

.....

Manufacturer

EXCELVISION

Rue de la Lombardière

ZI la Lombardière

F-07100 Annonay

France

 

SANTEN Oy

Kelloportinkatu 1

33100 Tampere

Niittyhaankatu 20

33720 Tampere

Finland

This leaflet was last revised in March 2020  07/2019

Updated on 18 March 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

4.4          Special warnings and precautions for use

…..

Concomitant therapy

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

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

….

Cetalkonium chloride content

IKERVIS contains cetalkonium chloride which may cause eye irritation.

 Contact lenses should be removed prior to application and may be reinserted at wake-up timewait at least 15 minutes before reinsertion. Cetalkonium chloride is known to discolour soft contact lenses.

 Cetalkonium chloride mayhas been reported to cause eye irritation., symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

……

4.8     Undesirable effects

Summary of the safety profile

In 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 are were eye pain (19.02%), eye irritation (17.58%), ocular hyperaemia (5.5%), lacrimation increased (6.44.9%) and eyelid erythema (1.7%) which were are usually transitory and occurred during instillation. These adverse reactions are consistent with those that have been reported during post-marketing experience.

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

Tabulated list of adverse reactions

The following adverse reactions listed below were observed in clinical studies or during post-marketing experience. They are ranked according to system organ class and classified according to the following convention: very common (³1/10), common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

System Organ Class

Frequency

Adverse reactions

Infections and infestations

Uncommon

Keratitis bacterial,

 Hherpes zoster ophthalmic.

Eye disorders

Very common

Eye pain,

Eye irritation

Common

Erythema of eyelid,

 lLacrimation increased,

oOcular hyperaemia,

vVision blurred,

eEyelid oedema,

cConjunctival hyperaemia, eEye irritation,

eEye pain.

Eye pruritus

Uncommon

Conjunctival oedema,

lLacrimal disorder,

eEye discharge,

eEye pruritus,

cConjunctival irritation,

cConjunctivitis,

fForeign body sensation in eyes,

dDeposit eye,

kKeratitis,

bBlepharitis,

cCorneal decompensation,

cChalazion,

cCorneal infiltrates,

cCorneal scar,

eEyelid pruritus,

iIridocyclitis.

Ocular discomfort

General disorders and administration site conditions

Uncommon

Instillation site reactionInstillation site discomfort,

iInstillation site pruritus,

iInstillation site foreign body sensation.

Nervous system disorders

Uncommon

Headache

Description of selected adverse reactions

Instillation siteEye pain

waaA frequently reported local adverse reaction associated with the use of IKERVIS during clinical trials. It is likely to be attributable to ciclosporin.

One case of severe epithelial erosion of the cornea identified as corneal decompensation by the investigator resolved without sequeleae was reported

Generalised and localised infections

Patients receiving immunosuppressive therapies, including ciclosporin, are at increased risk of infections. Both generalised and localised infections can occur. Pre-existing infections may also be aggravated (see section  4.3). Cases of infections have been reported uncommonly in association with the use of IKERVIS.

As precautionary measure, action should be taken t To reduce the systemic absorption, (see section  4.2).

….

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19 March 2015

Date of latest renewal: 09 March 2020

10.     DATE OF REVISION OF THE TEXT

16 March 2020 07/2019

 

 

 

 

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

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

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

Reasons for updating

  • New SmPC for new product

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

Updated on 31 January 2018 SPC

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 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 SPC

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 14 October 2016 PIL

Reasons for updating

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

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 SPC

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