Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Gilycora 0,25 mg Hartkapseln
Zusammenfassung des Risikomanagement-Plans gemäß § 34
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Gilycora 0,25 mg Hartkapseln
Gilycora 0,5 mg Hartkapseln
Administrative Information:
| Wirkstoff | Fingolimodhydrochlorid |
| ATC-Code | L04AA27 |
| Darreichungsform | Hartkapsel |
| Art der Anwendung | zum Einnehmen |
| Inhaber der Zulassung | Coripharma ehf. Reykjavikurvegur 78–80 220 HAFNARFJÖRDUR Island |
| Zulassungsnummern | 7002148.00.00 7002149.00.00 |
| Datum der Zulassung | 08.01.2022 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 1.5 / 21.12.2021 |
| Datum der Genehmigung des RMPs | 08.01.2022 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) der o. g. Arzneimittel ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass diese Arzneimittel so sicher wie möglich angewendet werden.
Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).
Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimitteln gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 04. Februar 2022 veröffentlicht.
-
(1)
-
(2)
Part VI: Summary of the risk management plan
Summary of risk management plan for Gilycora (fingolimod)
This is a summary of the risk management plan (RMP) for Gilycora. The RMP details important risks of Gilycora, <how these risks can be minimised>, and how more information will be obtained about Gilycora's risks and uncertainties (missing information).
Gilycora's summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Gilycora should be used.
-
I. The medicine and what it is used for
Gilycora is authorised for use as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult patients and paediatric patients aged 10 years and older (see SmPC for the full indication):
-
– Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy
Or
-
– Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
It contains fingolimod as the active substance and it is given orally.
-
II. Risks associated with the medicine and activities to minimise or further characterise the risks
Important risks of Gilycora, together with measures to minimise such risks and the proposed studies for learning more about Gilycora's risks, are outlined below.
Measures to minimise the risks identified for medicinal products can be:
- Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals;
- Important advice on the medicine's packaging;
- The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly;
- The medicine's legal status — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.
Together, these measures constitute routine risk minimisation measures.
In the case of Gilycora, these measures are supplemented with additional risk minimisation measures mentioned under relevant important risks, below.
In addition to these measures, information about adverse reactions is collected continuously and regularly analysed, including PSUR assessment, so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.
If important information that may affect the safe use of Gilycora is not yet available, it is listed under ʻmissing informationʼ below.
-
II.A List of important risks and missing information
Important risks of Gilycora are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely taken. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Gilycora. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine);
| List of important risks and missing information | |
| Important identified risks |
|
| Important potential risks | – Other malignant neoplasms |
| Missing information | – Long-term use in pediatric patients, including impact on growth and development (including cognitive development) |
-
II.B Summary of important risks
Risks that have corresponding additional risk minimisation activities or additional pharmacovigilance activities:
| Important identified risk Bradyarrhythmia (including conduction defects and bradycardia complicated by hypotension) occurring post-first dose | |
| Risk minimisation measures | Routine risk minimisation measures
Additional risk minimisation measures:
|
| Important identified risk Liver transaminase elevation | |
| Risk minimisation measures | Routine risk minimisation measures
Additional risk minimisation measures:
|
| Important identified risk Macular edema | |
| Risk minimisation measures | Routine risk minimisation measures
Additional risk minimisation measures:
|
| Important identified risk Opportunistic infections including PML, VZV, herpes viral infections other than VZV, fungal infection | |
| Risk minimisation measures | Routine risk minimisation measures - Routine risk communication in summary of product |
| Important identified risk Opportunistic infections including PML, VZV, herpes viral infections other than VZV, fungal infection | |
| characteristics and patient information leaflet Additional risk minimisation measures:
| |
| Important identified risk Reproductive toxicity | |
| Risk minimisation measures | Routine risk minimisation measures
Additional risk minimisation measures:
|
| Important identified risk Skin cancer (Basal cell carcinoma, Kaposiʼs sarcoma, Malignant melanoma, Merkel cell carcinoma, Squamous cell carcinoma) | |
| Risk minimisation measures | Routine risk minimisation measures
Additional risk minimisation measures:
|
| Important identified risk Convulsions | |
| Risk minimisation measures | Routine risk minimisation measures - Routine risk communication in summary of product characteristics and patient information leaflet |
| Important identified risk Convulsions | |
| Additional risk minimisation measures:
| |
| Missing information Long-term use in pediatric patients, including impact on growth and development (including cognitive development) | |
| Risk minimisation measures | Routine risk minimisation measures
Additional risk minimisation measures:
|
II.C Post-authorisation development plan
II.C.1 Studies which are conditions of the marketing authorisation
There are no studies which are conditions of the marketing authorisation or specific obligation of Gilycora.
II.C.2 Other studies in post-authorisation development plan
There are no studies required for Gilycora.
Fingolimod 0.25 mg and 0.5 mg capsules hard – RMP v. 1.5
Page 22/48