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The safety information for Benlysta (belimumab) is crucial for ensuring the well-being of those prescribed this medication. Please review the following information and discuss any concerns with your healthcare provider.

• Increased Infection Risk: Benlysta (belimumab) can compromise your immune system, increasing the likelihood of serious infections such as pneumonia, urinary tract infections (UTIs), and bronchitis. If you experience symptoms like fever, cough, difficulty breathing, or chills, contact your healthcare provider immediately. Your medical team should be informed of your medical history and current medications to evaluate the safety of Benlysta (belimumab) for you.

• Allergic Reactions: There is a potential for severe allergic reactions, including anaphylaxis, especially when administered intravenously. Symptoms may include rash, hives, and difficulty breathing, and can occur within hours or even a week after infusion. If you experience these symptoms, seek medical assistance immediately.

• Mood Changes: Some patients have reported depression and suicidal thoughts while taking Benlysta (belimumab). It's essential to monitor any changes in mood or behavior and inform your healthcare provider promptly. If symptoms are severe, discontinuation of the medication may be necessary.

• Vaccine Precautions: Do not receive live vaccines within 30 days before or during treatment with Benlysta (belimumab), as the medication might interfere with the vaccine's efficacy. Ensure all vaccinations are current prior to starting treatment, and inform your healthcare provider or pharmacist that you are taking Benlysta (belimumab) before receiving any vaccines.

Please adhere strictly to these guidelines and maintain open communication with your healthcare provider to ensure safe and effective use of Benlysta (belimumab).

When using this medication, some common side effects may occur, though they are generally mild. These include nausea, diarrhea, fever, common cold symptoms, bronchitis, difficulty sleeping, and reactions at the injection site such as pain, redness, or itching. Additionally, some individuals may experience pain in the arms or legs, depression, migraine, and sore throat. If these symptoms persist or worsen, it is advisable to consult your healthcare provider for guidance.

There are also other side effects that may occur, such as bladder infections or urinary tract infections, and symptoms resembling the stomach flu. While these are less common, it is important to monitor how you feel and report any concerns to a healthcare professional.

More serious side effects, although rare, require immediate medical attention. These include severe infections characterized by confusion, fever, difficulty breathing, weakness, and other symptoms like a burning sensation during urination. Additionally, a serious allergic reaction may present with difficulty breathing, hives, a fast heartbeat, and swelling of the face or tongue. Depression and thoughts of self-harm are also serious and should be addressed by seeking medical help promptly.

In rare cases, the medication may lower your immune response, increasing the risk of serious infections or even cancer, including skin cancer. If you notice new skin lesions, changes in moles, or symptoms like night sweats and unexplained weight loss, contact a healthcare provider immediately. Furthermore, there is a small risk of developing a rare brain infection known as progressive multifocal leukoencephalopathy (PML), which can cause symptoms such as clumsiness, confusion, or vision changes. If you experience these, seek urgent medical assistance.

Always be attentive to how your body responds to the medication and communicate any unexpected effects to your healthcare provider for advice and support.