Xeljanz

The active ingredient in Xeljanz is tofacitinib citrate. It belongs to a group of biologic medications known as disease-modifying anti-rheumatic drugs (DMARD). Specifically, Xeljanz is a Janus kinase (JAK) inhibitor. It regulates an overactive immune system by suppressing its activity. As a JAK inhibitor, it does this by disrupting JAK pathways and enzymes from inside the cell, which plays a role in the inflammatory response.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Xeljanz. However, the following is a synopsis of the general guidelines for the use of Xeljanz:

• Take this medication orally exactly as directed by your physician. It is typically taken once (Xeljanz XR) or twice daily (Xeljanz).
• Regular laboratory monitoring is recommended due to potential changes in lymphocytes, neutrophil count, hemoglobin, liver enzymes, and lipids.
• Live vaccines should not be taken by individuals on this medication, but they can receive non-live vaccines instead.

The most common side effects of Xeljanz seen in clinical trials as compared to placebo include:

• Shingles (herpes zoster).
• Upper respiratory tract infection.
• Increased blood pressure (hypertension).
• Diarrhea.
• Weight loss.
• Stomach pain.
• Runny nose (nasopharyngitis).
• Abnormal blood tests.
• Increased cholesterol levels.
• Fever.
• Headache.
• Nausea.
• Vomiting.

Some individuals may experience serious side effects while using Xeljanz. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction - hives, swelling, itching.
• Serious infections - fever, chills, trouble breathing, cough, diarrhea, stomach pain, burning when you urinate, urinating less or more often.
• Increased risk of malignancy, including lymphomas and other tumors.
• Major adverse cardiovascular events.
• Thrombosis (blood clot) in your heart, lung, or leg.
• Gastrointestinal perforation (tears) - happens more often when used with nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.
• Liver damage - nausea, stomach pain, yellowing of your skin or whites of your eyes.

These are not all of the possible adverse reactions of Xeljanz. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Xeljanz, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Signs of an infection.
• History of tuberculosis (TB).
• Diabetes.
• Chronic lung disease.
• HIV.
• Weak immune system.
• Lived in Ohio, Mississippi River Valleys, or the Southwest.
• Hepatitis B or C.
• Current or past smoker.
• Cancer.
• Heart attack.
• Stroke.
• Anemia (low red blood cell count).
• Have had blood clots.
• Liver problems.
• Kidney problems.
• Diverticulitis (ulcers in the stomach or intestines).
• Recently received a vaccine.
• Pregnant.
• Breastfeeding.

Boxed Warning

• Increased risk of developing certain cancers, such as lymphoma, lung cancer, or skin cancer.
• Increased risk of serious and possibly fatal infections.
• Increased risk of death and major cardiovascular events in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor.

• Previous hypersensitivity/allergic reaction to tofacitinib or any other excipients.
• Lymphocyte, neutrophil, or hemoglobin levels are below the recommended level.
• Present active serious or localized infection.
• Severe liver disease.

Xeljanz can start working relatively quickly, but it can take up to 3-6 months for full benefits to be felt.

When Xeljanz is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Immunosuppressive medications (etanercept, adalimumab, azathioprine) - taking Xeljanz with these medications increases the risk of infection.
• Moderate CYP3A4 inhibitors/strong CYP2C19 inhibitors (fluconazole).
• Strong CYP3A4 inducers (rifampin).
• Strong CP3A4 inhibitors (ketoconazole).
• Tacrolimus.
• Medications affecting certain liver enzymes from working.

Xeljanz is available in a variety of dosage forms, including:

• Xeljanz tablets - 5 mg, 10 mg.
• Xeljanz extended-release tablets - 11 mg, 22 mg.
• Xeljanz oral solution - 1 mg/L.

Store this medication at room temperature and keep it out of reach of children.

Pfizer Inc. is the pharmaceutical company that manufactures Xeljanz.

There are lower-cost generics available of the brand name Xeljanz.

Do not stop or adjust your use of this medication without first consulting your doctor. Stopping this medication abruptly can worsen the symptoms of the condition being treated.

Xeljanz use during pregnancy can harm your unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Xeljanz should not be taken when breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.