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This document outlines vital safety information regarding the use of dimethyl fumarate (Tecfidera). It is crucial to understand potential risks and necessary precautions. Contact your healthcare provider if you have any concerns or questions.

• Severe Allergic Reactions: Be aware that severe allergic reactions to dimethyl fumarate, including life-threatening conditions such as facial or neck swelling and anaphylaxis, are possible. Symptoms include difficulty breathing, hives, or swelling of the tongue or throat. Seek immediate medical attention if these occur.

• Serious Infections: Dimethyl fumarate may weaken your immune system, making you more susceptible to opportunistic infections (OIs), which are typically harmless to healthy individuals but can be severe for those with compromised immunity. The risk increases if you are taking other immune-weakening drugs or have certain medical conditions.

• Low White Blood Cell Counts (Lymphopenia): This medication can decrease lymphocyte levels, heightening the risk of infections. Regular blood tests are required before and during treatment to ensure your blood cell levels remain safe.

• Liver Damage: Some patients have experienced liver damage, sometimes necessitating hospitalization. This risk is particularly pronounced during the initial months of treatment, especially for those with pre-existing liver issues or who are on other liver-affecting medications. Typically, liver damage subsides after discontinuing the drug.

• Flushing: Flushing, characterized by warmth, redness, itching, or a burning sensation, may occur but generally improves over time. To mitigate this, you can take aspirin (up to 325 mg) 30 minutes prior to your dose if advised by your doctor, and consume the medication with food.

• Serious Stomach and Intestinal Problems: Although rare, some individuals have reported severe gastrointestinal issues such as ulcers, perforation, bleeding, and bowel obstruction, particularly within six months of starting treatment. Contact your healthcare provider if you experience new or worsening symptoms such as stomach pain, nausea, vomiting, or bloating.

Please note there are no specific contraindications associated with this medication. Always follow your healthcare provider’s guidance and report any unusual symptoms immediately.

When taking this medication, you might experience some common side effects that are usually mild. These include flushing or a warm sensation, stomach pain, diarrhea, nausea, vomiting, itchiness, and rash. Such effects often diminish as your body adjusts to the drug. Taking the medication with food may help reduce flushing. If these symptoms persist or worsen, it is important to consult your healthcare provider.

In addition to the common side effects, there are other potential reactions like skin redness, upset stomach, indigestion, elevated liver enzymes in blood tests, and a reduced white blood cell count. These effects may occur in some individuals, and if they become severe, you should seek advice from your healthcare provider.

There are also rare but serious side effects that require immediate medical attention. Signs of liver damage such as persistent nausea or vomiting, yellowing of the skin or eyes, and dark urine should not be ignored. Serious infections may manifest as a persistent sore throat, fever, chills, or cough. Stomach or gut issues can include rectal bleeding, bloody stools, or vomit that resembles coffee grounds. Moreover, there is a risk of a rare brain infection characterized by clumsiness, loss of coordination, or sudden changes in thinking and speech.

Finally, although very rare, severe allergic reactions can occur. Symptoms like trouble breathing, severe dizziness, or swelling of the face, tongue, or throat indicate the need for urgent medical care. If you notice any side effects not mentioned here, it's important to reach out to your healthcare provider for further guidance.