TM Owner Biogen
Vumerity 231mg Capsule
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Indications & Clinical Uses
- Vumerity 231 mg delayed-release capsules contain diroximel fumarate, a fumarate that acts on the immune system, taken by mouth to treat relapsing forms of multiple sclerosis (MS).
- In the US, the label covers adults with clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
- In the EU, Vumerity was authorised on 15 November 2021 for adults with relapsing-remitting MS.
- The usual regimen is 231 mg twice daily for 7 days, then 462 mg (two 231 mg capsules) twice daily, and the capsules are swallowed whole.
- It must not be used together with dimethyl fumarate (Tecfidera), a related medicine that shares the same active breakdown product.
- It is a prescription medicine from Biogen, supplied in bottles of 120 capsules in the US label reviewed.
Side Effects
- Common reactions (10% or more, and more often than placebo) were flushing (about 40%), abdominal pain (18%), diarrhea (14%) and nausea (12%); in the EU, flushing and gut problems may affect more than 1 in 10 people.
- Serious reactions include anaphylaxis and angioedema, progressive multifocal leukoencephalopathy (PML, a rare brain infection), herpes zoster (shingles) and other serious infections, lymphopenia (low lymphocyte counts), liver injury and serious gastrointestinal reactions.
- There is no boxed warning on the US label.
- Contact your healthcare provider at once if you notice new weakness, clumsiness, vision or thinking changes, a painful rash, yellow skin or eyes, dark urine, or swelling of the face or lips.
Precautions & Warnings
- Vumerity has no boxed warning in the US label.
- Do not use it if you are allergic to diroximel fumarate or dimethyl fumarate, or if you are taking dimethyl fumarate; in the EU it must not be used in people who have or might have PML.
- Blood counts, including lymphocytes, should be checked before starting and every 6 to 12 months, and liver enzymes and bilirubin should be monitored.
- Withhold treatment if PML is suspected.
- Flushing is common and may improve over time.
- Pregnancy: animal data show possible fetal harm, and a pregnancy registry exists (1-833-569-2635 or www.vumeritypregnancyregistry.com).
- Alcohol: avoid taking it with alcohol.
- Swallow the capsules whole.
- Store at 20C to 25C (68F to 77F).
Avoid Interactions
- Do not take Vumerity with dimethyl fumarate (Tecfidera) because both produce the same active metabolite; this is contraindicated.
- Avoid alcohol while taking Vumerity, as advised on the label.
- No clinically meaningful interactions are expected with liver enzyme (CYP) medicines because diroximel fumarate is not metabolized by CYP enzymes.
- Taking non-enteric-coated aspirin (up to 325 mg) about 30 minutes before a dose may reduce flushing, but only if your healthcare provider agrees.
- The label advises avoiding high-fat, high-calorie meals with the capsules.
- Tell your healthcare provider about all prescription medicines, non-prescription products, vaccines and supplements you use, especially medicines that lower immunity.
References
Frequently Asked Questions
Vumerity (diroximel fumarate) treats relapsing forms of multiple sclerosis in adults. In the US this includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In the EU it is authorised for adults with relapsing-remitting MS. It is a prescription capsule taken by mouth.
Take Vumerity (diroximel fumarate) by mouth: one 231 mg capsule twice daily for 7 days, then two 231 mg capsules (462 mg) twice daily. Swallow the capsules whole. Avoid high-fat, high-calorie meals with the capsules, and follow the dose plan your neurologist gives you.
Vumerity commonly causes flushing, abdominal pain, diarrhea and nausea. Rare serious effects include PML (a brain infection), shingles, low lymphocytes, liver injury and severe allergic reactions. Contact your healthcare provider quickly about new weakness, vision or thinking changes, yellow skin or facial swelling.
Do not take Vumerity (diroximel fumarate) with dimethyl fumarate (Tecfidera). Avoid alcohol with it, as the label advises. It is not broken down by CYP enzymes, so no CYP interactions are expected. Tell your healthcare provider about all your medicines, especially any that lower your immune defences.
Vumerity (diroximel fumarate) can lower lymphocytes and affect the liver. A complete blood count should be checked before you start and every 6 to 12 months, and liver enzymes and bilirubin should be monitored. Your provider decides the exact schedule.
Animal data show Vumerity (diroximel fumarate) may harm a fetus, so discuss pregnancy plans with your healthcare provider. A pregnancy registry is available on 1-833-569-2635 or www.vumeritypregnancyregistry.com. Tell your provider straight away if you become pregnant, or plan to, while taking it.
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