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This document outlines essential safety warnings and precautions for the use of Xeljanz (tofacitinib). It is crucial to understand these risks and discuss any concerns with your healthcare provider.

• Serious Infections: Xeljanz (tofacitinib) can compromise your immune system, increasing susceptibility to serious infections like tuberculosis, shingles, and hepatitis. Regular monitoring for infections by your healthcare provider is recommended. Inform your provider immediately if you experience symptoms such as fever, chills, body aches, painful urination, or a cough. Higher risk factors include current or recurrent infections, conditions increasing infection risk, residence in or travel to TB-prevalent areas, and concurrent use of immune-suppressing medications.

• Increased Mortality Risk in Rheumatoid Arthritis Patients: Individuals aged 50 or older with rheumatoid arthritis and at least one cardiovascular risk factor, taking Xeljanz (tofacitinib), showed a higher mortality rate compared to another RA treatment in a clinical study. Discuss potential risks and benefits with your provider if you fall into this category, especially if you have high blood pressure, cholesterol, or blood sugar.

• Cancer Risk: Cases of cancer, such as lymphoma, lung, and skin cancer, have been reported in Xeljanz (tofacitinib) users. Regular cancer risk assessments will be conducted by your provider. Discuss any cancer concerns, particularly if you have a history of cancer or smoke.

• Cardiovascular Events: Xeljanz (tofacitinib) may increase the risk of blood clots, potentially causing life-threatening events like heart attacks or strokes. This risk is higher in those aged 50 and above with cardiovascular risk factors. Talk to your provider if you have high blood pressure, cholesterol, blood sugar, a smoking history, or past blood clots.

• Gastrointestinal Issues: Some patients have reported gut tears during Xeljanz (tofacitinib) treatment, though a direct causation is not established. If you use NSAIDs or have a history of diverticulitis, you may be at increased risk. Seek immediate medical help for symptoms like stomach pain or blood in stools.

• Allergic Reactions: Rare but serious allergic reactions can occur. Immediate medical attention is required for symptoms such as facial or throat swelling, breathing difficulties, or rashes.

• Blood Cell Count Reduction: Xeljanz (tofacitinib) can lower red and white blood cell counts, increasing the risk of anemia and infection. Regular blood tests will be conducted to monitor your blood cell levels. Report symptoms of anemia or infection, such as fatigue, headache, pale skin, rapid heartbeat, fever, chills, cough, or body aches, to your provider.

• Liver Health: Elevated liver enzymes, indicating liver damage, may occur with Xeljanz (tofacitinib) use. Frequent liver function tests will be performed. Notify your provider of any signs of liver issues, such as nausea, stomach pain, or yellowing of the skin or eyes.

No specific contraindications have been identified for Xeljanz (tofacitinib). Always consult your healthcare provider for personalized advice and information.

Common side effects:

• Upper respiratory tract infections
• Nose and throat infections
• Diarrhea
• Headaches

Less common but important to monitor:

• High cholesterol
• Muscle damage
• Rash
• Stomach infections
• Anemia

Serious side effects:

• Fever
• Nausea
• High blood pressure
• Any other form of infection

Tofacitinib is processed in the body primarily by an enzyme called CYP3A4. This means that other substances affecting this enzyme can change how tofacitinib works. Here's what you should know:

Medications That Increase Tofacitinib Levels:

• Strong CYP3A4 Inhibitors: Drugs like Ketoconazole can raise tofacitinib levels in your body. If you're taking such medications, your doctor may adjust your tofacitinib dose to prevent side effects.

• Combination of Moderate CYP3A4 and Strong CYP2C19 Inhibitors: Medications like Fluconazole can also increase tofacitinib levels. In such cases, a dose adjustment may be necessary.

Medications That Decrease Tofacitinib Levels:

• Strong CYP3A4 Inducers: Drugs such as Rifampin can lower tofacitinib levels, potentially making it less effective. It's generally recommended to avoid combining tofacitinib with these medications.

Other Important Considerations:

• Immunosuppressive Drugs: Combining tofacitinib with other immune-suppressing medications like Azathioprine, Tacrolimus, or Cyclosporine can increase the risk of infections. Such combinations are usually not recommended.

• Live Vaccines: While on tofacitinib, it's advisable to avoid live vaccines, as they may not be safe or effective.

• Grapefruit Juice: Regular consumption of grapefruit juice can increase tofacitinib levels, potentially leading to more side effects. It's best to avoid grapefruit juice while taking this medication.

Always inform your healthcare provider about all medications, supplements, and dietary habits to ensure tofacitinib is safe and effective for you.