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When using the Simlandi 2 Pen, it's crucial to be aware of certain risks to ensure safe and effective treatment:

Serious Infections: Simlandi can weaken your immune system, increasing the likelihood of serious infections, including tuberculosis (TB), bacterial sepsis, and invasive fungal infections. Before starting treatment, your doctor should test you for latent TB and monitor you for signs of infection during therapy. If you develop a serious infection, discontinue Simlandi and seek medical attention.

Malignancies: There have been reports of lymphoma and other cancers, some fatal, in patients, particularly children and adolescents, treated with TNF blockers like Simlandi. A rare type of cancer called hepatosplenic T-cell lymphoma has occurred in young adults with inflammatory bowel disease treated with TNF blockers. Discuss the risks and benefits of Simlandi with your doctor, especially if you have a history of cancer.

Hypersensitivity Reactions: Serious allergic reactions, including anaphylaxis, have been reported. If you experience symptoms such as hives, difficulty breathing, or swelling of the face, discontinue Simlandi and seek immediate medical attention.

Hepatitis B Virus Reactivation: If you are a carrier of hepatitis B, using Simlandi may reactivate the virus, potentially leading to serious liver problems. Your doctor should monitor you for signs of hepatitis B during and for several months after treatment.

Neurologic Reactions: Rare cases of new or worsening central nervous system disorders, such as multiple sclerosis or Guillain-Barré syndrome, have been associated with TNF blockers. Exercise caution if you have a history of these conditions, and inform your doctor if you develop symptoms like vision problems, weakness, or numbness.

Hematological Reactions: Instances of decreased blood cell counts, including conditions like pancytopenia and aplastic anemia, have been reported. Seek medical attention if you experience symptoms such as persistent fever, bruising, bleeding, or pallor.

Heart Failure: Worsening or new onset of congestive heart failure has been observed with TNF blockers. Use Simlandi cautiously if you have heart failure, and monitor for symptoms like shortness of breath or swelling of the ankles.

Autoimmunity: Treatment with Simlandi may lead to the formation of autoantibodies and, in rare cases, a lupus-like syndrome. If you develop symptoms such as persistent joint pain or a rash on your cheeks or arms that worsens with sun exposure, discontinue Simlandi and consult your doctor.

Immunizations: Avoid live vaccines while using Simlandi. Ensure that pediatric patients are up to date with all immunizations before starting therapy. If you are pregnant, be aware that Simlandi can cross the placenta during the third trimester and may affect the immune response in your newborn. Discuss vaccination plans for your baby with your doctor.

Always consult your healthcare provider to fully understand the risks associated with Simlandi and to determine if it's the right treatment for you.

Simlandi is a medication used to treat various inflammatory conditions by modulating the immune system. While it can be effective, it's important to be aware of potential side effects associated with its use. Common Side Effects: Many individuals using Simlandi may experience mild side effects, including:

• Injection Site Reactions: Redness, itching, pain, or swelling at the injection site.
• Upper Respiratory Infections: Symptoms such as a stuffy nose, sinus pain, sneezing, or sore throat.
• Headaches
• Skin Rash These side effects are generally mild and tend to resolve on their own. However, if they persist or worsen, it's advisable to consult your healthcare provider. Serious Side Effects: Although less common, Simlandi can cause serious side effects that require immediate medical attention:
• Serious Infections: Simlandi can increase the risk of serious infections, including tuberculosis (TB) and other bacterial, viral, or fungal infections. Symptoms may include fever, chills, muscle aches, cough, shortness of breath, weight loss, or night sweats.
• Hepatitis B Reactivation: In individuals who carry the hepatitis B virus, Simlandi may cause the virus to become active again. Signs include muscle aches, fatigue, dark urine, yellowing of the skin or eyes, loss of appetite, vomiting, and stomach discomfort.
• Allergic Reactions: Severe allergic reactions may occur, presenting as hives, difficulty breathing, or swelling of the face, lips, eyes, or mouth.
• Nervous System Issues: Symptoms such as numbness, tingling, vision problems, weakness in the arms or legs, or dizziness may indicate nervous system problems.
• Blood Disorders: A decrease in blood cells that help fight infections or stop bleeding can occur. Signs include persistent fever, easy bruising or bleeding, or looking very pale.
• Heart Failure: New or worsening heart failure may develop, with symptoms like shortness of breath, sudden weight gain, or swelling of the ankles or feet.
• Liver Problems: Indicators include extreme fatigue, yellowing of the skin or eyes, poor appetite, vomiting, or pain on the right side of the stomach.
• Psoriasis: Some individuals may develop new psoriasis or experience worsening of existing psoriasis, characterized by red scaly patches or raised bumps filled with pus. If you experience any of these serious side effects, contact your healthcare provider immediately. Important Considerations: Before starting Simlandi, inform your doctor if you have any existing infections, a history of hepatitis B, nervous system disorders, heart conditions, or if you are scheduled to receive any vaccines. Regular monitoring and open communication with your healthcare provider can help manage potential risks associated with Simlandi. Remember, while Simlandi can be beneficial in managing certain conditions, being informed about its potential side effects ensures safer and more effective treatment.

When using Simlandi, it's important to be aware of potential interactions with other medications and treatments:

• Biologic Disease-Modifying Antirheumatic Drugs (DMARDs): Combining Simlandi with other biologic DMARDs, such as abatacept or anakinra, is not recommended. This combination may increase the risk of serious infections without providing additional benefits.

• Live Vaccines: Avoid receiving live vaccines while on Simlandi, as the medication can weaken your immune system, making live vaccines less effective and increasing the risk of infection.

• Cytochrome P450 Substrates: Simlandi may affect the metabolism of drugs processed by the liver enzyme CYP450. If you're taking medications like Warfarin, Cyclosporine, or Theophylline, your doctor may need to monitor and adjust your dosages accordingly.

• Dextromethorphan: Simlandi may decrease the blood levels and effectiveness of dextromethorphan, a common ingredient in cough suppressants. If you're using dextromethorphan, inform your doctor, as a dosage adjustment may be necessary.

Always inform your healthcare provider about all medications, supplements, and vaccines you are taking or plan to take. This ensures they can provide guidance on potential interactions and adjust your treatment plan as needed.