Vumerity (diroximel)

• Vumerity (diroximel) 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.

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

• 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.

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

Concomitant Dimethyl Fumarate

Vumerity is contraindicated in patients currently taking dimethyl fumarate, which is also metabolized to monomethyl fumarate. Vumerity may be initiated the day following discontinuation of dimethyl fumarate

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

• 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.