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This safety information is essential for understanding the potential risks and precautions associated with the use of Tremfya (guselkumab). Please read the following points carefully and consult your healthcare provider if you have any questions or concerns:

• Severe Allergic Reactions: Tremfya (guselkumab) may cause severe allergic reactions in some individuals. Seek immediate medical attention if you experience symptoms such as difficulty breathing, swelling of the face or mouth, skin rash, hives, or persistent itching.

• Infections: Using Tremfya (guselkumab) can increase your susceptibility to infections. To minimize risk, practice good hand hygiene and avoid close contact with individuals who are ill. If you notice signs of an infection, including fever, persistent cough, difficulty breathing, night sweats, or confusion, contact your healthcare provider without delay. You may need to pause the medication until you have fully recovered from the infection. Do not take Tremfya (guselkumab) if you currently have an active infection. Increased risk factors include having active, long-term, or frequent infections, conditions that predispose you to infections, or taking other immunosuppressive medications.

• Vaccines: It is important to be up-to-date with your vaccinations prior to beginning treatment with Tremfya (guselkumab). Once treatment starts, you should avoid receiving live vaccines such as the MMR (measles, mumps, and rubella vaccine) or Varivax (chickenpox vaccine). Consult your healthcare provider or pharmacist before getting any vaccines while on Tremfya (guselkumab) to ensure they are safe for you.

Please discuss any concerns about these warnings with your healthcare provider to ensure safe and effective use of Tremfya (guselkumab).

When taking this medication, some individuals may experience mild side effects such as upper respiratory infections like the common cold or sore throat, headaches, and joint pain. Injection site reactions, including redness, swelling, and itching, may also occur, but these are generally mild and should resolve on their own. If these or any other minor side effects persist or worsen, it is advisable to consult a healthcare provider for reassurance and guidance.

There are other side effects that some users have reported, which include diarrhea, stomach flu, fungal infections, herpes infections, migraines, and hives. While these are less common, it is important to monitor their severity and consult a healthcare provider if they become bothersome.

Serious side effects, though rare, demand immediate medical attention. These include severe allergic reactions characterized by skin rash, hives, intense itching, swelling of the face or tongue, trouble breathing, and chest tightness. This medication may also lower your ability to fight infections, increasing the risk of serious infections. Symptoms such as persistent fever, cough, night sweats, confusion, extreme tiredness, chills, and muscle aches require prompt medical evaluation. Additionally, signs of liver disease like persistent nausea or vomiting, loss of appetite, abdominal pain, yellowing of the skin or eyes, and dark urine should be reported to a healthcare provider immediately. If you notice any other unusual effects, seeking medical advice is recommended.