Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Biogen Netherlands B.V., Prins Mauritslaan 13, 1171 LP Badhoevedorp, The Netherlands
Vumerity is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (see section 5.1 for important information on the populations for which efficacy has been established).
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis.
The starting dose is 231 mg twice a day. After 7 days, the dose should be increased to the recommended maintenance dose of 462 mg twice a day (see section 4.4).
Temporary dose reductions to 231 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended dose of 462 mg twice a day should be resumed.
If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses. Otherwise, the patient should wait until the next scheduled dose.
Based on uncontrolled study data, the safety profile of diroximel fumarate in patients ≥55 years of age seems to be comparable to patients <55 years of age. Clinical studies with diroximel fumarate had limited exposure to patients aged 65 years and above and did not include sufficient numbers of patients aged 65 years and above to determine whether they respond differently than younger patients (see section 5.2). Based on the mechanism of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
No dose adjustment is necessary in patients with renal impairment (see section 5.2). Long-term safety of diroximel fumarate has not been studied in patients with moderate or severe renal impairment (see sections 4.4 and 5.2).
No dose adjustment is necessary for patients with hepatic impairment (see sections 4.4 and 5.2). Diroximel fumarate has not been studied in patients with hepatic impairment.
The safety and efficacy of Vumerity in children and adolescents aged 10 to less than 18 years have not yet been established.
There is no relevant use of Vumerity in children aged less than 10 years for the indication of relapsing remitting multiple sclerosis.
For oral use.
Vumerity should be swallowed whole and intact. The capsules should not be crushed or chewed and the contents should not be sprinkled on food because the enteric-coating of the capsule contents prevents irritant effects on the gut.
Vumerity can be taken with or without food (see section 5.2). For those patients who may experience flushing or gastrointestinal adverse reactions, taking with food may improve tolerability (see sections 4.4 and 4.8).
In reported cases of overdose, the symptoms described were consistent with the known adverse reaction profile of the product. There are no known therapeutic interventions to enhance elimination of diroximel fumarate nor is there a known antidote. In the event of overdose, it is recommended that symptomatic supportive treatment be initiated as clinically indicated.
2 years.
Store below 25°C.
Store in the original bottle in order to protect from moisture.
HDPE bottle with a polypropylene child-resistant closure and a silica gel desiccant.
Pack size:
Packs of 120 (1 bottle) or 360 (3 bottles) gastro-resistant hard capsules.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
