Xeljanz XR (Tofacitinib)

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Fact	Details
Brand Name	Xeljanz XR
Generic Name	Tofacitinib
Dosage Form	Extended-Release Tablets
Strengths Available	11 mg
Indications	– Rheumatoid Arthritis (RA): For adult patients with moderate to severe RA who have had an inadequate response or intolerance to methotrexate.
	– Psoriatic Arthritis (PsA): For adult patients with active PsA who have had an inadequate response or intolerance to methotrexate or other DMARDs (Disease-Modifying Anti-Rheumatic Drugs).
	– Ulcerative Colitis (UC): For adult patients with moderate to severe UC who have had an inadequate response or intolerance to TNF blockers.
Mechanism of Action	Xeljanz XR works as a Janus kinase (JAK) inhibitor, which reduces the activity of the immune system by interfering with the JAK-STAT signaling pathway, ultimately decreasing inflammation and immune response.
Administration Route	Oral
Dosage and Administration	– Recommended Dosage: 11 mg once daily, taken at the same time each day.
	– Administration: Xeljanz XR should be taken with or without food. The tablet should be swallowed whole and not split, crushed, or chewed to maintain the extended-release property.
Contraindications	– Severe Hepatic Impairment: Xeljanz XR is contraindicated in patients with severe liver problems.
	– Hypersensitivity: Contraindicated in patients with known hypersensitivity to tofacitinib or any components of the formulation.
Common Side Effects	– Infections: Upper respiratory tract infections such as the common cold, bronchitis.
	– Gastrointestinal: Diarrhea, nausea.
	– Nervous System: Headache, dizziness.
	– Hypertension: Elevated blood pressure.
Serious Side Effects	– Infections: Serious infections leading to hospitalization or death, including tuberculosis and other bacterial, fungal, viral, and opportunistic infections.
	– Cardiovascular Events: Increased risk of major adverse cardiovascular events (MACE), including heart attack and stroke.
	– Thrombosis: Risk of blood clots in the lungs (pulmonary embolism) or legs (deep vein thrombosis).
	– Malignancies: Increased risk of developing cancers such as lymphoma and lung cancer.
	– Gastrointestinal Perforations: Risk of perforations in the stomach or intestines.
Warnings and Precautions	– Infections: Monitor patients for infections before and during treatment. Avoid use in patients with active infections.
	– Malignancy Risk: Regular monitoring for malignancies is recommended, especially in patients with a history of malignancy.
	– Liver Enzyme Monitoring: Regular liver enzyme tests are recommended to monitor for liver damage.
	– Lipid Monitoring: Monitor lipid levels, as increases in cholesterol have been observed.
	– Blood Count Monitoring: Regular complete blood count (CBC) is recommended to monitor for decreases in white blood cells, red blood cells, and platelets.
Drug Interactions	– Immunosuppressants: Avoid concomitant use with other potent immunosuppressive drugs such as azathioprine and cyclosporine.
	– CYP3A4 Inhibitors: Caution with use of potent CYP3A4 inhibitors like ketoconazole, which may increase tofacitinib levels.
	– CYP3A4 Inducers: Caution with use of CYP3A4 inducers like rifampin, which may decrease tofacitinib levels, reducing its effectiveness.
Pregnancy and Lactation	– Pregnancy: Xeljanz XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown potential risks.
	– Lactation: It is unknown whether tofacitinib is excreted in human milk. Caution is advised when administering to breastfeeding women. Consider the benefits of breastfeeding and the potential risks to the infant.
Pediatric Use	Safety and efficacy in pediatric patients have not been established. Therefore, Xeljanz XR is not recommended for use in children.
Geriatric Use	Older adults (aged 65 and above) may have an increased risk of infections and cardiovascular events. Careful monitoring is recommended.
Storage	Store Xeljanz XR tablets at room temperature, between 20°C to 25°C (68°F to 77°F). Protect from moisture and light.
Approval Status	Xeljanz XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of RA, PsA, and UC.
Manufacturer	Pfizer