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The information below outlines important safety warnings associated with the use of Vumerity (diroximel fumarate). It is crucial to understand these risks and precautions and to discuss any concerns with your healthcare provider.

• Severe Allergic Reactions: Vumerity may cause severe allergic reactions, including potentially life-threatening symptoms such as facial swelling, swelling of the tongue or throat, and anaphylaxis. Allergic reactions can occur at any time during treatment. Discontinue use and seek immediate medical assistance if you experience hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing, particularly if you have a known allergy to dimethyl fumarate (Tecfidera).

• Flushing: Commonly, Vumerity may cause flushing, which usually improves over time. Symptoms include warmth, redness, itching, or a burning sensation on the skin. While generally not serious, flushing can be uncomfortable.

• Increased Risk of Infections: Vumerity can weaken the immune system, increasing susceptibility to serious infections, such as herpes zoster (shingles) and other bacterial, fungal, or viral opportunistic infections. Rarely, it may lead to progressive multifocal leukoencephalopathy (PML), a serious brain infection. The risk is heightened if you are taking other immune-suppressing medications or have medical conditions that increase infection risk.

• Low White Blood Cell Counts (Lymphopenia): Vumerity may reduce lymphocyte levels, increasing infection risk. Regular blood tests are required before starting treatment and every 6 to 12 months thereafter to monitor blood cell levels.

• Liver Damage: Some individuals have experienced liver damage, occasionally requiring hospitalization, usually within the first few months of treatment. The liver damage typically resolves upon discontinuation of the medication. This risk is higher for those with a history of liver problems or who are taking medications that affect liver function.

• Serious Stomach and Gut Problems: Rarely, Vumerity may cause severe stomach issues, including ulcers, perforation, bleeding, and bowel obstruction, typically within the first 6 months of treatment. Contact your healthcare provider immediately if you experience new or worsening severe stomach pain, acid reflux, vomiting, constipation, or bloating.

Contraindications: Vumerity should not be used if you have an allergy to dimethyl fumarate (Tecfidera) or Vumerity itself, or if you are currently taking dimethyl fumarate (Tecfidera). Discuss these conditions with your healthcare provider before starting treatment.

When taking this medication, you may experience some common side effects, such as flushing or a warm feeling, skin redness, itching, stomach pain, diarrhea, and nausea. These effects are generally mild and often improve as your body adjusts to the medication. If they persist or worsen, it's advisable to consult a healthcare provider.

Some individuals may also report additional side effects, including vomiting, indigestion, and elevated liver enzyme levels. A decreased white blood cell count is also a possibility, which may lower your ability to fight infections. This could increase your susceptibility to infections or worsen existing ones.

In rare cases, this medication can lead to serious side effects that require immediate medical attention. These include symptoms of severe allergic reactions, such as hives, swelling of the lips or tongue, and difficulty breathing. Serious liver problems may manifest as persistent nausea, abdominal pain, yellowing of the skin or eyes, and dark urine. Blood-related issues like black or bloody stools and vomiting blood are also concerning. Additionally, there is a risk of a rare brain infection characterized by clumsiness, sudden cognitive changes, vision issues, or seizures.

If you notice any severe or unusual side effects, seek urgent medical care. It's important to stay informed about all potential side effects and discuss any concerns with your healthcare provider.