Dimethylfumarat Genericon 240 mg magensaftresistente Hartkapseln - Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete

Summary of risk management plan for DimeFum 120 mg magensaftresistente Kapseln, DimeFum 240 mg magensaftresistente Kapseln (dimethyl fumarate)

This is a summary of the risk management plan (RMP) for DimeFum 120 mg/ 240 mg magensaftresistente Kapseln. The RMP details important risks of DimeFum 120 mg/ 240 mg magensaftresistente Kapseln, how these risks can be minimised, and how more information will be obtained about DimeFum 120 mg/ 240 mg magensaftresistente Kapseln´s risks and uncertainties (missing information).

DimeFum 120 mg/ 240 mg magensaftresistente Kapseln´s summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how DimeFum 120 mg/ 240 mg magensaftresistente Kapseln should be used.

Important new concerns or changes to the current ones will be included in updates of DimeFum 120 mg/ 240 mg magensaftresistente Kapseln`s RMP.

• I. The medicine and what it is used for

DimeFum 120 mg/ 240 mg magensaftresistente Kapseln is authorised for the treatment of adult and paediatric patients aged 13 years and older patients with relapsing remitting multiple sclerosis (RRMS) (see SmPC for the full indication).

It contains dimethyl fumarate as the active substance and it is for oral use as 120 mg, 240 mg, gastro-resistant capsules, hard.

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

Important risks of DimeFum 120 mg/ 240 mg magensaftresistente Kapseln, together with measures to minimise such risks and the proposed studies for learning more about DimeFum 120 mg/ 240 mg magensaftresistente Kapseln´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 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 is not yet available, it is listed under ‘missing information’ below.

• II.A List of important risks and missing information

Important risks of DimeFum 120 mg/ 240 mg magensaftresistente Kapseln 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 DimeFum 120 mg/ 240 mg magensaftresistente Kapseln. 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	Progressive Multifocal Leukoencephalopathy (PML) Decreases in leukocyte and lymphocyte counts Drug-induced liver injury
Important potential risks	Serious and opportunistic infections (other than PML and herpes zoster) Malignancies Effects on pregnancy outcome Interaction with nephrotoxic medications leading to renal toxicity
Missing information	Long term efficacy and safety Safety profile in patients over the age of 55 years Safety profile in patients with moderate to severe renal impairment Safety profile in patients with hepatic impairment Safety profile in patients with severe active GI disease Increased risk of infection in patients concomitantly taking anti-neoplastic or immunosuppressive therapies

• II.B Summary of important risks

The safety information in the proposed Product Information is aligned to the reference medicinal product.

• 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 DimeFum 120 mg/ 240 mg magensaftresistente Kapseln.

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

There are no studies required for DimeFum 120 mg/ 240 mg magensaftresistente Kapseln.

The MAH of the originator has 3 studies ongoing in the Post-authorisation development plan:

• Study 109MS401:

• – Purpose of the study: Characterise the long-term risk-benefit profile of Tecfidera in patients with MS who are prescribed Tecfidera under routine clinical care.

• Study 109MS402:

– Purpose of the study: Determine any effects of exposure of Tecfidera on the outcome of pregnancies.

• Study 109MS306 Part 2: