Vumerity

Generic name: diroximel fumarate
Drug class: Selective immunosuppressants

Medically reviewed by  A Ras MD.

What is Vumerity?

Vumerity is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. It is not known if Vumerity is safe and effective in children.

Description

VUMERITY contains diroximel fumarate. The chemical name of diroximel fumarate is 2-Butenedioic acid (2E)-, 1-[2-(2,5-dioxo-1-pyrrolidinyl)ethyl] 4-methyl ester, which has a molecular formula of C11H13NO6 and molecular weight of 255.22. Diroximel fumarate has the following structure:

Diroximel fumarate is a white to off-white powder that is slightly soluble in water.

VUMERITY is provided as delayed-release capsules for oral administration. Each capsule contains 231 mg of diroximel fumarate and the following inactive ingredients: crospovidone, colloidal silicon dioxide, magnesium stearate (non-bovine), methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, talc, and triethyl citrate.

The capsule shell contains carrageenan, hypromellose, potassium chloride, and titanium dioxide. It is printed with black ink that contains iron oxide, potassium hydroxide, propylene glycol, and shellac.

 Mechanism of Action

The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.

Who should not take Vumerity?

Do not take Vumerity if you:

• have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to diroximel fumarate, dimethyl fumarate, or any of the ingredients in Vumerity. See “What are the ingredients in Vumerity?” below for a complete list of ingredients.
• are taking dimethyl fumarate.

What should I tell my healthcare provider before taking Vumerity?

Before taking and while you take Vumerity, tell your doctor about all of your medical conditions, including if you:

• have liver problems.
• have kidney problems.
• have or have had low white blood cell counts or an infection.
• are pregnant or plan to become pregnant. It is not known if Vumerity will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Vumerity passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Vumerity.

Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Vumerity?

• Take Vumerity exactly as your doctor tells you to take it.
• The recommended starting dose on days 1 to 7 is one capsule by mouth 2 times a day. After 7 days, the recommended dose is 2 capsules by mouth 2 times a day.
• If taken with food, avoid taking Vumerity with a high-fat, high-calorie meal or snack.
  • Your meal or snack should contain no more than 700 calories and no more than 30 g of fat.
• Swallow Vumerity whole. Do not crush, chew, or sprinkle capsule contents on food.
• If you take too much Vumerity, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking Vumerity?

Do not drink alcohol at the time you take a Vumerity dose.

What are the possible side effects of Vumerity?

Vumerity may cause serious side effects including:

• allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking Vumerity and get emergency medical help right away if you get any of these symptoms.
• PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your doctor right away if you get any of these symptoms of PML:
  • weakness on one side of the body that gets worse
  • vision problems
  • confusion
  • clumsiness in your arms or legs
  • changes in thinking and memory
  • personality changes
• herpes zoster infections (shingles), including central nervous system infections.
• other serious infections
• decreases in your white blood cell count. Your doctor should do a blood test to check your white blood cell count before you start treatment with Vumerity and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that.
• liver problems. Your doctor should do blood tests to check your liver function before you start taking Vumerity and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment.
  • severe tiredness
  • loss of appetite
  • pain on the right side of your stomach
  • have dark or brown (tea color) urine
  • yellowing of your skin or the white part of your eyes

The most common side effects of Vumerity include:

• flushing, redness, itching, or rash
• nausea, vomiting, diarrhea, stomach pain, or indigestion
• Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking Vumerity with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking Vumerity may reduce flushing.

These are not all the possible side effects of Vumerity. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
For more information go to dailymed.nlm.nih.gov

General information about the safe and effective use of Vumerity

Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use Vumerity for a condition for which it was not prescribed. Do not give Vumerity to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about Vumerity that is written for healthcare professionals.

How should I store Vumerity?

• Store Vumerity at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Vumerity and all medicines out of the reach of children.

What are the ingredients in Vumerity?

Active ingredient: diroximel fumarate

Inactive ingredients: crospovidone, colloidal silicon dioxide, magnesium stearate (non-bovine), methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, talc, and triethyl citrate.

Capsule Shell: carrageenan, hypromellose, potassium chloride, and titanium dioxide.

Capsule Shell Ink: iron oxide, potassium hydroxide, propylene glycol, and shellac.

Label

Principal Display Panel – 106 Capsule Bottle Label

• 106 Capsules
• RX Only
• NDC 64406-020-01
• VUMERITY™ (diroximel fumarate) delayed-release capsules
• 231 mg starter dose bottle
• Swallow capsule whole.
• Each capsule contains 231 mg of diroximel fumarate.
• Information and support:
• 1-800-456-2255
• VUMERITY.com
• 54477-01
• Biogen®