XELJANZ / XELJANZ XR Patient Counseling Information
(tofacitinib)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Serious Infections
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may lower the ability of their immune system to fight infections. Advise patients not to start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution if they have an active infection. Instruct patients to contact their healthcare provider immediately during treatment if symptoms suggesting infection appear in order to ensure rapid evaluation and appropriate treatment [see Warnings and Precautions (5.1)].
Advise patients that the risk of herpes zoster, some cases of which can be serious, is increased in patients treated with XELJANZ/XELJANZ XR [see Warnings and Precautions (5.1)].
Malignancies and Lymphoproliferative Disorders
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase their risk of certain cancers, and that lymphoma and other cancers have been observed in patients taking XELJANZ. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see Warnings and Precautions (5.3)].
Major Adverse Cardiovascular Events
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase their risk of major adverse cardiovascular events (MACE) defined as myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions (5.4)].
Thrombosis
Advise patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call their healthcare provider right away if they experience any symptoms of thrombosis (sudden shortness of breath, chest pain worsened with breathing, swelling of leg or arm, leg pain or tenderness, red or discolored skin in the affected leg or arm) [see Warnings and Precautions (5.5)].
Hypersensitivity
Advise patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call their healthcare provider right away if they experience any symptoms of allergic reactions while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution [see Warnings and Precautions (5.7)].
Important Information on Laboratory Abnormalities
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may affect certain lab test results, and that blood tests are required before and during XELJANZ/XELJANZ XR/XELJANZ Oral Solution treatment [see Warnings and Precautions (5.8)].
Pregnancy
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed during treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution and for at least 18 hours after the last dose of XELJANZ/XELJANZ Oral Solution or 36 hours after the last dose of XELJANZ XR [see Use in Specific Populations (8.2)].
Infertility
Advise females of reproductive potential that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)]. It is not known if this effect is reversible.
Residual Tablet Shell
Patients receiving XELJANZ XR may notice an inert tablet shell passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the inert tablet shell.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
For medical information about XELJANZ/XELJANZ XR/XELJANZ Oral Solution, please visit www.pfizermedinfo.com or call 1-800-438-1985.
LAB-0445-26.0
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Health Professional Information
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Serious Infections
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may lower the ability of their immune system to fight infections. Advise patients not to start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution if they have an active infection. Instruct patients to contact their healthcare provider immediately during treatment if symptoms suggesting infection appear in order to ensure rapid evaluation and appropriate treatment [see Warnings and Precautions (5.1)].
Advise patients that the risk of herpes zoster, some cases of which can be serious, is increased in patients treated with XELJANZ/XELJANZ XR [see Warnings and Precautions (5.1)].
Malignancies and Lymphoproliferative Disorders
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase their risk of certain cancers, and that lymphoma and other cancers have been observed in patients taking XELJANZ. Instruct patients to inform their healthcare provider if they have ever had any type of cancer [see Warnings and Precautions (5.3)].
Major Adverse Cardiovascular Events
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase their risk of major adverse cardiovascular events (MACE) defined as myocardial infarction, stroke, and cardiovascular death. Instruct all patients, especially current or past smokers or patients with other cardiovascular risk factors, to be alert for the development of signs and symptoms of cardiovascular events [see Warnings and Precautions (5.4)].
Thrombosis
Advise patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call their healthcare provider right away if they experience any symptoms of thrombosis (sudden shortness of breath, chest pain worsened with breathing, swelling of leg or arm, leg pain or tenderness, red or discolored skin in the affected leg or arm) [see Warnings and Precautions (5.5)].
Hypersensitivity
Advise patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call their healthcare provider right away if they experience any symptoms of allergic reactions while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution [see Warnings and Precautions (5.7)].
Important Information on Laboratory Abnormalities
Inform patients that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may affect certain lab test results, and that blood tests are required before and during XELJANZ/XELJANZ XR/XELJANZ Oral Solution treatment [see Warnings and Precautions (5.8)].
Pregnancy
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed during treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution and for at least 18 hours after the last dose of XELJANZ/XELJANZ Oral Solution or 36 hours after the last dose of XELJANZ XR [see Use in Specific Populations (8.2)].
Infertility
Advise females of reproductive potential that XELJANZ/XELJANZ XR/XELJANZ Oral Solution may impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)]. It is not known if this effect is reversible.
Residual Tablet Shell
Patients receiving XELJANZ XR may notice an inert tablet shell passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the inert tablet shell.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
For medical information about XELJANZ/XELJANZ XR/XELJANZ Oral Solution, please visit www.pfizermedinfo.com or call 1-800-438-1985.
LAB-0445-26.0
Health Professional Information
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