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This document provides essential safety and warning information regarding the use of Kevzara (sarilumab). It is important to review these details carefully and consult your healthcare provider if you have any questions or concerns.

• Increased Infection Risk: Kevzara (sarilumab) may impair your immune system's ability to fight infections, increasing the risk of serious or potentially life-threatening bacterial, viral, or fungal infections. It may also reactivate dormant infections such as tuberculosis (TB) or hepatitis B virus (HBV). Testing for TB and HBV is required before starting treatment, and any necessary treatment should be completed if you test positive. Those at heightened risk include individuals over 65, those with active or chronic infections, and those taking other immune-suppressing medications like methotrexate or corticosteroids.

• Blood Cell Count Issues: Treatment may lead to low blood cell counts, raising the risk of severe infections, bleeding, and anemia. If you experience symptoms like fever, fatigue, chills, cough, or difficulty breathing, contact your healthcare provider immediately. Also, seek medical advice if you notice signs of blood problems, such as pale skin, rapid heartbeat, dizziness, or blood in urine or stool.

• Gastrointestinal Concerns: Some patients on Kevzara (sarilumab) have experienced gastrointestinal issues, including tears in the stomach or bowel wall. These conditions can be severe and may require hospitalization. Inform your provider if you have a history of gut-related problems. Report any sudden stomach pain, nausea, vomiting, bloating, fever, or chills to your doctor immediately.

• Allergic Reactions: Possible allergic reactions include rashes, hives, or more severe reactions such as facial swelling, shock, or anaphylaxis. If you experience dizziness, difficulty breathing, or swelling near the eyes, lips, or tongue, seek emergency medical attention.

• Vaccination Precautions: Ensure your vaccinations are up-to-date before beginning treatment. Avoid receiving live vaccines during treatment with Kevzara (sarilumab), such as the MMR, nasal spray flu vaccine, or Varivax (varicella) vaccine, as their safety in conjunction with this medication is not well established.

In case of an overdose, seek immediate medical attention or contact poison control. Always follow your healthcare provider's instructions and notify them of any adverse effects or unusual symptoms.

When using this medication, you may experience some common side effects that are generally mild and manageable. These include irritation, redness, or pain at the injection site, which should resolve on their own. If these symptoms persist or worsen, it is advisable to consult with your healthcare provider. Additional common side effects include a low white blood cell count, high liver enzyme levels, upper respiratory tract infections, and urinary tract infections. These effects are usually not severe but should be monitored if they last or intensify.

Some users also report other side effects such as constipation, muscle pain, and itching at the injection site. While these are typically not serious, you should inform your healthcare provider if they become troublesome.

Rarely, this medication may cause serious side effects that require immediate medical attention. These include severe stomach or abdominal pain, fatigue, itchy rash, and high triglycerides. Additionally, although a very serious allergic reaction is rare, it is important to seek emergency medical help if you experience symptoms such as rash, itching or swelling of the face, tongue, or throat, severe dizziness, or trouble breathing. Always stay vigilant for any unusual symptoms and reach out to your healthcare provider if you have concerns about side effects.