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This document outlines essential safety and warning information for Bafiertam (monomethyl fumarate). Patients and healthcare professionals are encouraged to review these details carefully and consult a healthcare provider if there are any questions or concerns.

• Serious Allergic Reactions: Bafiertam may cause severe allergic reactions shortly after the first dose. Symptoms include hives, rash, facial or eye swelling, difficulty breathing or swallowing, vomiting, and diarrhea. If any of these occur, discontinue use and seek immediate medical attention.

• Brain Infection (Progressive Multifocal Leukoencephalopathy - PML): This medication can compromise your immune system, increasing the risk of PML, a serious brain infection caused by the John Cunningham virus (JCV). This is particularly concerning for individuals with pre-existing conditions such as cancer or HIV. Early symptoms of PML include unilateral weakness, clumsiness, personality changes, and confusion. Promptly inform your healthcare provider if these symptoms arise as further testing or brain imaging may be necessary.

• Serious Infections: Bafiertam may increase susceptibility to opportunistic infections (OIs) due to immune suppression. These infections may become more frequent or severe in individuals with weakened immune systems. Common OIs include herpes zoster (shingles), yeast infections, and tuberculosis. Notify your provider of any illness while taking this medication, as it may require discontinuation to allow your immune system to recover.

• Low White Blood Cell Counts (Lymphopenia): The medication may reduce lymphocyte levels, raising the risk of serious infections. Regular blood tests before and during treatment are essential to monitor white blood cell counts. If lymphocyte levels fall too low, temporary cessation of the medication may be necessary. Consult your provider if symptoms of infection, such as fever or persistent cough, develop.

• Liver Injury: Bafiertam can cause liver damage, potentially leading to hospitalization. The risk is highest within the first six months of treatment. Early liver injury signs are often detectable only through blood tests, necessitating regular liver function monitoring. Discontinue use and seek medical help if you experience symptoms like jaundice, abdominal pain, fatigue, loss of appetite, or nausea.

Contraindications: Bafiertam should not be used if you are currently taking dimethyl fumarate (Tecfidera) or Vumerity (diroximel fumarate). Consult your healthcare provider if any contraindications apply.

When taking this medication, some individuals may experience common side effects such as flushing, stomach pain, diarrhea, and nausea. These symptoms are generally mild and often improve as your body adjusts. If they persist or worsen, it is advisable to consult your healthcare provider. Occasionally, other side effects like vomiting, bloating, itchy skin, rash, redness, and warmth of the skin can occur. Some patients have also reported experiencing protein in urine, fatigue, and signs of liver injury, such as loss of appetite and yellowing of the skin and eyes.

This medication may lower your immune system's ability to fight infections, increasing the likelihood of infections, which can present with symptoms like fever, cough, and runny nose. It is essential to seek medical advice if you notice any signs of infection. In rare cases, severe side effects may arise, including liver damage indicated by persistent nausea, vomiting, dark urine, and jaundice. Additionally, there is a risk of a rare but serious brain infection, signaled by symptoms such as clumsiness, loss of coordination, memory issues, and difficulty speaking or walking.

Severe allergic reactions to this medication are also rare but require immediate medical attention if you experience symptoms such as rash, swelling of the face, tongue, or throat, severe dizziness, or difficulty breathing. Although these serious side effects are uncommon, it is crucial to be vigilant and seek urgent medical care if they occur. Always communicate with your healthcare provider about any side effects you experience, ensuring your safety and well-being.