Fingolimod Ascend 0,5 mg Hartkapseln - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

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)

Fingolimod Ascend 0,5 mg Hartkapseln

Administrative Information:

Wirkstoff	Fingolimodhydrochlo­rid
ATC-Code	L04AA27
Darreichungsform	Hartkapsel
Art der Anwendung	zum Einnehmen
Inhaber der Zulassung	Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41 60439 Frankfurt am Main Deutschland
Zulassungsnummer	7001767.00.00
Datum der Zulassung	15.08.2022
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	0.3 / 24.01.2022
Datum der Genehmigung des RMPs	15.08.2022

Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels 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 dieses Arzneimittel so sicher wie möglich angewendet wird.

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. Arzneimittel gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.

Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 27. September 2022 veröffen­tlicht.

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PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN

Summary of risk management plan for Fingolimod 0.5 mg hard capsules ( fingolimod)

This is a summary of the risk management plan (RMP) for Fingolimod 0.5 mg hard capsules. The RMP details important risks of Fingolimod 0.5 mg hard capsules, how these risks can be minimised, and how more information will be obtained about Fingolimod 0.5 mg hard capsules’s risks and uncertainties (missing information).

Fingolimod 0.5 mg hard capsules’s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Fingolimod 0.5 mg hard capsules should be used.

Important new concerns or changes to the current ones will be included in updates of Fingolimod 0.5 mg hard capsules' RMP.

• I. The medicine and what it is used for

Fingolimod 0.5 mg hard capsules is indicated 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:.

• – Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1 of the SmPC)

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 by oral route.

• II. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of Fingolimod 0.5 mg hard capsules, together with measures to minimize such 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 Fingolimod 0.5 mg hard capsules, 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, 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 Fingolimod 0.5 mg hard capsules is not yet available, it is listed under ‘missing information’ below.

• II.A List of important risks and missing information:

Important risks of Fingolimod 0.5 mg hard capsules 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 Fingolimod 0.5 mg hard capsules. 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);

Important identified risks	Bradyarrhythmia (including conduction defects and bradycardia complicated by hypotension) occurring post-first dose Liver transaminase elevation Macular edema Opportunistic infections including PML, VZV, herpes viral infections other than VZV, fungal infection Reproductive toxicity Skin cancer (Basal cell carcinoma, Kaposi’s sarcoma, Malignant melanoma, Merkel cell carcinoma, Squamous cell carcinoma) Convulsions Lymphoma
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

  Important identified risks: Bradyarrhythmia (including conduction defects and bradycardia complicated by hypotension) occurring post-first dose
  Risk minimisation measures	Routine risk minimisation measures: SmPC sections 4.2, 4.4, 4.5, 4.7, 4.8, 4.9 and 5.1 PIL sections 2 and 4 Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

  Important identified risks: Liver transaminase elevation
  Risk minimisation measures	Routine risk minimisation measures:
  	SmPC sections 4.4, and 4.8. PIL sections 2 and 4 Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

  Important identified risks: Macular edema
  Risk minimisation measures	Routine risk minimisation measures:
  	SmPC sections 4.4, and 4.8. PIL sections 2 and 4 Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

  Important identified risks: Opportunistic infections including PML, VZV, herpes viral infections other than VZV, fungal infection
  Risk minimisation measures	Routine risk minimisation measures: SmPC sections 4.3, 4.4, 4.5 and 4.8. PIL sections 2 and 4 Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

  Important identified risks: Reproductive toxicity
  Risk minimisation	Routine risk minimisation measures:
  measures	SmPC sections 4.3, 4.4 and 4.6. PIL section 2

  Important identified risks: Reproductive toxicity
  	Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide Pregnancy-specific patient reminder card

  Important identified risks: Skin cancer (Basal cell carcinoma, Kaposi’s sarcoma, Malignant melanoma, Merkel cell carcinoma, Squamous cell carcinoma)
  Risk minimisation measures	Routine risk minimisation measures: SmPC sections 4.4, and 4.8. PIL sections 2 and 4 Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

  Important identified risks: Convulsions
  Risk minimisation measures	Routine risk minimisation measures:
  	SmPC sections 4.4, and 4.8. PIL sections 2 and 4 Additional risk minimisation measures:
  	Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

  Missing information: Long-term use in pediatric patients, including impact on growth and development (including cognitive development)
  Risk minimisation measures	Routine risk minimisation measures: SmPC sections 4.2, 4.4 and 5.2. PIL section 2 Additional risk minimisation measures: Educational materials for physicians and patients: - Physician’s chec­klist Patient/Paren­t/Caregiver guide

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 Fingolimod 0.5 mg hard capsules.

II.C.2 Other studies in post-authorisation development plan

There are no studies required for Fingolimod 0.5 mg hard capsules.

Ascend GmbH

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