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Simponi (golimumab) is a medication that can impact your immune system. Below are important safety considerations and warnings associated with its use. Please review this information and discuss it with your healthcare provider to ensure it is suitable for you.

• Increased Risk of Infections: Simponi may reduce your body’s ability to fight infections, increasing your risk of serious infections, including bacterial, viral, and fungal infections. This risk is heightened if you are older than 65, have pre-existing conditions, or are on other immune-suppressing medications, such as steroids or methotrexate. Inform your healthcare provider about your medical history, especially if you have been in regions with high rates of tuberculosis (TB) or fungal infections, such as the Ohio and Mississippi River valleys and the southwestern United States.

• Risk of Cancer: There is a slight risk of developing certain cancers, including lymphoma, leukemia, and skin cancer, with the use of TNF blockers like Simponi. This risk is higher in individuals under 18, those taking other immunosuppressive drugs, or those with severe inflammatory conditions. Your healthcare provider will evaluate your risk before starting treatment and will monitor you during use. Report any unusual symptoms such as swollen glands, unexplained weight loss, or persistent fever.

• Heart Failure: Simponi can cause new or worsened heart failure. If you have a history of heart failure, your healthcare provider will monitor you closely. Discontinue use and contact your healthcare provider immediately if you experience symptoms such as shortness of breath, swelling in the legs, or irregular heartbeat.

• Nervous System Issues: Rarely, Simponi may cause new or worsened neurological problems, including nerve damage or multiple sclerosis. If you have a history of neurological issues, notify your healthcare provider. Seek medical advice if you experience symptoms such as dizziness, muscle weakness, or vision changes.

• Lupus-like Syndrome: Simponi can induce a lupus-like syndrome, presenting with flu-like symptoms and muscle or joint pain. Discontinue use and consult your healthcare provider if these symptoms occur.

• Low Blood Cell Counts: There have been reports of low blood cell counts in people taking Simponi, which can lead to serious infections, anemia, or bleeding issues. If you notice signs of infection or blood problems, such as fever, fatigue, or pale skin, contact your healthcare provider immediately.

• Drug Interactions: Simponi should not be used with Kineret (anakinra) or Orencia (abatacept) due to the increased risk of severe infections without additional benefits. Inform your healthcare provider if you are using these medications.

• Allergic Reactions: Serious allergic reactions, including anaphylaxis, have occurred with Simponi. Seek immediate medical attention if you experience rash, hives, breathing difficulties, or swelling of the face or lips. Inform your healthcare provider if you have a known latex or rubber allergy.

In case of an overdose, seek emergency medical attention promptly. Always follow your healthcare provider's instructions regarding the use of Simponi to minimize potential risks and adverse effects.

When using this medication, some common side effects may include upper respiratory tract infections, injection site reactions such as pain and bruising, viral infections, elevated liver enzymes, and high blood pressure. These effects are often mild, but if they persist or worsen, it is advisable to consult your healthcare provider for guidance.

In addition to common side effects, other less frequent reactions might occur, such as constipation, dizziness, bronchitis, tingling sensations, and various infections. While these are generally not serious, any significant discomfort or persistence of these symptoms should be discussed with a healthcare professional.

Rare but serious side effects require immediate medical attention. These include symptoms of severe infections like fever, difficulty breathing, and chills; heart failure signs such as shortness of breath and swelling in the lower extremities; and potential indicators of cancer, including unexpected weight loss and swollen lymph nodes. Additionally, severe allergic reactions, characterized by hives, facial swelling, and difficulty breathing, necessitate urgent care.

Finally, while most individuals using this medication do not experience severe side effects, it is important to remain vigilant and seek medical help for any concerning symptoms.

Golimumab, sold under the brand name Simponi, can interact with several other medications. It is important to inform your healthcare provider about all the drugs and supplements you are currently taking, including prescription, over-the-counter, vitamins, and herbal products.

Some medications that may interact with golimumab include other TNF-blockers like adalimumab, certolizumab, etanercept, and infliximab. Additionally, drugs that suppress the immune system, such as abatacept, anakinra, and cyclosporine, can also interact with golimumab.

Furthermore, avoid using live vaccines, such as those for flu (inhaled through the nose), BCG, adenovirus, dengue, measles, mumps, rubella, polio, rotavirus, smallpox, typhoid, varicella, yellow fever, and zoster, while on golimumab. These vaccines can increase the risk of serious infections due to their live bacteria or virus content. If your doctor prescribes any of these medications alongside golimumab, they may adjust dosages or administration frequency to ensure your safety.