Vumerity

Vumerity is a prescription medication 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.

Vumerity belongs to a group of drugs called immunomodulators. While the exact way it works is not known, Vumerity is thought to adjust the immune response to be less inflammatory and may have antioxidant properties that could be protective against damage to the brain and spinal cord.

Vumerity delayed-release capsules are taken twice daily by mouth. Avoid taking Vumerity with a high-fat, high-calorie meal or snack.

Common side effects include flushing, rash and stomach problems.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vumerity. See the "Vumerity Precautions" section.

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 healthcare provider if you have any of these symptoms and they bother you or do not go away. Ask your healthcare provider if taking aspirin before taking Vumerity may reduce flushing.

These are not all the possible side effects of Vumerity.

Call your healthcare provider for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take:

• Tecfidera (dimethyl fumarate)

This is not a complete list of Vumerity drug interactions. Ask your doctor or pharmacist for more information.

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 healthcare provider right away if you get any of these symptoms of PML:

  • weakness on one side of the body that gets worse

  • clumsiness in your arms or legs

  • vision problems

  • changes in thinking and memory

  • confusion

  • personality changes

• herpes zoster infections (shingles), including central nervous system infections

• other serious infections

• decreases in your white blood cell count Your healthcare provider 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 healthcare provider should do blood tests to check your liver function before you start taking Vumerity and during treatment if needed. Tell your healthcare provider 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

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

• are taking dimethyl fumarate (Tecfidera)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vumerity, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking and while you take Vumerity, tell your healthcare provider 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 healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with Vumerity. In animal studies, pregnant and lactating animals were given this medication and the babies showed medical issues including increased incidences of skeletal abnormalities, increased mortality, decreased body weights, neurobehavioral impairment. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vumerity crosses into human milk. Because many medications can cross into human milk and because the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vumerity.

Take this medication exactly as prescribed by your healthcare provider.

Swallow Vumerity capsules whole. Do not crush, chew, or sprinkle contents on 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 grams of fat.

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

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

The recommended starting dose on days 1 to 7 is one Vumerity capsule (231 mg) by mouth 2 times a day. After 7 days, the recommended dose is 2 capsules (462 mg)  by mouth 2 times a day.

If you take too much Vumerity, call your healthcare provider or go to the nearest hospital emergency room right away.

• 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.