Vumerity

Vumerity (diroximel fumarate) is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Exactly how Vumerity works in treating multiple sclerosis is not known.

It is not known if Vumerity is safe and effective in children.

Use Vumerity (diroximel fumarate) exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using Vumerity.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you take Vumerity with food, avoid foods that are high in calories or fat. Your meal or snack should not contain more than 700 calories or more than 30 grams of fat.

Do not drink alcohol when you take your Vumerity dose.

Diroximel fumarate can lower your blood cell counts. You will need frequent medical tests, and your next dose may be delayed based on the results.

Store at room temperature away from moisture and heat.

You should not use Vumerity if you have had a severe allergic reaction to diroximel fumarate, or if you also use dimethyl fumarate (Tecfidera).

You should not use Vumerity if:

• you have had a severe allergic reaction to diroximel fumarate or dimethyl fumarate (Tecfidera); or
• you also use dimethyl fumarate.

To make sure Vumerity is safe for you, tell your doctor if you have ever had:

• liver disease;
• kidney disease;
• infections; or
• low white blood cell (WBC) counts.

Tell your doctor if you are pregnant or breastfeeding.

Vumerity is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction to Vumerity: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diroximel fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Call your doctor at once if you have signs of liver problems, such as:

• right-sided upper stomach pain;
• loss of appetite;
• tiredness;
• dark urine; or
• jaundice (yellowing of the skin or eyes).

Common Vumerity side effects may include:

• indigestion, nausea, vomiting, stomach pain;
• diarrhea; or
• flushing (sudden warmth, redness, or tingly feeling);

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Multiple Sclerosis:

Initial dose: 231 mg orally 2 times a day for 7 days, then increase to 462 mg orally 2 times a day Maintenance dose: 462 mg orally 2 times a day; temporary dose reductions to 231 mg 2 times a day may be considered for individuals who do not tolerate the maintenance dose; within 4 weeks the recommended dose of 462 mg 2 times a day should be resumed; consider discontinuing therapy in patients unable to tolerate return to the maintenance dose Comments: -Administration of nonenteric coated aspirin (up to 325 mg) 30 minutes prior to this drug may reduce the incidence/severity of flushing. Use: For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with Vumerity active ingredient diroximel fumarate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.