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This document provides key safety information regarding the use of Kesimpta (ofatumumab). It is crucial to review the following points and discuss any concerns with your healthcare provider.

• Increased Risk of Infections: Kesimpta (ofatumumab) may reduce your body's ability to combat infections, increasing the likelihood of bacterial, viral, or fungal infections. This risk is heightened if you are currently taking or have recently taken other medications that suppress the immune system. Additionally, Kesimpta (ofatumumab) can reactivate certain viruses, such as the hepatitis B virus (HBV), present in your body, which can be dangerous. If you develop an infection, your healthcare provider may advise discontinuing Kesimpta (ofatumumab) until the infection is resolved. This is particularly important for those with active or chronic infections, conditions that increase infection risk, or those on immunosuppressive drugs.

• Injection Reactions: After taking Kesimpta (ofatumumab), you may experience reactions related to the injection, including fever, headache, muscle pain, chills, and fatigue. These reactions are more common within the first day of the initial dose but can occur with subsequent doses. To ensure your safety, your first injection should be administered in a hospital or clinic setting, where medical help is readily available in case of severe reactions.

• Potential Harm to Unborn Babies: Animal studies suggest that Kesimpta (ofatumumab) may harm unborn babies; therefore, it is advised for females who are or could become pregnant to avoid using this medication. Use effective contraception during treatment and for at least six months following the last dose. If you are pregnant or planning to become pregnant, consult your healthcare provider to discuss safer alternatives for you and your baby.

Contraindications:

• Do not use Kesimpta (ofatumumab) if you have an active hepatitis B infection, as this medication may pose serious health risks in such cases. Always speak to your healthcare provider if you have any concerns or questions regarding its use.

When using this medication, some individuals may experience common side effects, which are generally mild and include redness, swelling, itching, or pain at the injection site. You might also notice fever, headaches, muscle aches, chills, and general tiredness. These reactions often become milder with subsequent doses. If they persist or worsen, it is important to consult your healthcare provider. Sore throat, runny nose, and symptoms akin to respiratory tract infections can occur, as well as urinary tract infection symptoms like pain while urinating.

In rare instances, this medication can lead to more severe side effects. It may suppress your immune system, increasing the risk of serious infections characterized by a persistent sore throat, fever, chills, or cough. Additionally, it can cause liver disease, particularly for those with a history of hepatitis B, potentially leading to nausea, vomiting, loss of appetite, stomach pain, jaundice, or dark urine. There is also a rare risk of developing progressive multifocal leukoencephalopathy (PML), a serious brain infection. Symptoms include clumsiness, loss of coordination, confusion, memory loss, difficulty talking, seizures, and vision changes.

Severe allergic reactions are very rare but serious. Seek immediate medical assistance if you experience symptoms like a rash, swelling of the face or throat, severe dizziness, or trouble breathing. If you notice other side effects not mentioned here, contact your healthcare provider.