Considering a Different Treatment For Your Child’s Active Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)?

What is XELJANZ?

XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ (tofacitinib) is used to treat patients 2 years of age and older with active polyarticular course juvenile idiopathic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated.

What is XELJANZ Oral Solution?

XELJANZ Oral Solution is used to treat patients 2 years of age and older with active polyarticular course juvenile idiopathic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated. XELJANZ Oral Solution 1 mg/mL is a grape flavored, clear, colorless solution. Always use the oral dosing syringe that comes with XELJANZ Oral Solution to measure and take your prescribed dose. Ask your healthcare provider or pharmacist to show you how to measure your prescribed dose if you are not sure. Take XELJANZ Oral Solution 2 times a day with or without food.

What is the Most Important Information I should know about XELJANZ/​XELJANZ Oral Solution?

The safety information below applies to all marketed formulations of XELJANZ. Specific risks associated with certain dosing are noted.

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Do not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. Serious infections have happened in people taking XELJANZ. These serious infections include tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting and during treatment with XELJANZ. You should not start taking XELJANZ if you have any kind of infection unless your healthcare professional tells you it is okay.

Before and after starting XELJANZ, tell your doctor if you are being treated for an infection, have infections that keep coming back, or have symptoms of an infection, including:

• fever, sweating, or chills
• cough
• blood in phlegm
• warm, red, or painful skin or sores on your body
• burning when you urinate
• urinating more often than normal
• muscle aches
• shortness of breath
• weight loss
• diarrhea or stomach pain
• feeling very tired

Increased risk of death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily.

Cancer. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen. People taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily have a higher risk of certain cancers including lymphoma and lung cancer, especially if you are a current or past smoker. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People with ulcerative colitis taking the higher dose of XELJANZ (10 mg twice daily) or XELJANZ XR (22 mg one time each day) have a higher risk of serious infections, shingles, or skin cancers.

Immune system problem. Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily, especially if you are a current or past smoker.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking XELJANZ, including:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded
• weakness in one part or on one side of your body
• slurred speech

Blood clots in the lungs (pulmonary embolism, PE), veins of the legs (deep vein thrombosis, DVT), and arteries (arterial thrombosis) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking XELJANZ 5 mg twice daily or XELJANZ 10 mg twice daily. Blood clots in the lungs have also happened in people with ulcerative colitis. Some people have died from these blood clots.

• Stop taking XELJANZ and tell your healthcare provider right away if you have any signs and symptoms of blood clots such as sudden shortness of breath, difficulty breathing, chest pain, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the leg or arm.

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever, stomach-area pain that does not go away, and a change in your bowel habits.

Serious allergic reactions can occur. Stop using XELJANZ and call your healthcare provider right away if you have swelling of your lips, tongue, throat, or get hives.

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver function test levels are too high. Changes in lab test results may cause your healthcare provider to stop your XELJANZ treatment for a time. Your cholesterol levels should be checked 4 to 8 weeks after you start receiving XELJANZ.

These are not all of the possible side effects of XELJANZ/XELJANZ Oral Solution. Learn more and read the Medication Guide.

How should I store XELJANZ Oral Solution?

Store XELJANZ Oral Solution at room temperature between 20°C to 25°C (68°F to 77°F). Always store XELJANZ in its original bottle and carton in order to protect from light. Keep XELJANZ and all medicines out of the reach of children.

What should I tell my child’s (2 or older) healthcare provider before starting with XELJANZ/XELJANZ Oral Solution?

Before you use XELJANZ, tell your healthcare provider if you:

• Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection
• Have TB, or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
• Have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
• Live or have lived in certain areas (such as Ohio and Mississippi River Valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections
• Have or have had Hepatitis B or C
• Are a current or past smoker
• Have had any type of cancer
• Have had a heart attack, other heart problems or stroke
• Have had blood clots
• Have liver or kidney problems
• Have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
• Have recently received or plan to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines
• Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. You should not take XELJANZ and breastfeed
• Have had a reaction to tofacitinib or any of the ingredients
• Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any of the following medicines while taking XELJANZ since this may increase your risk of infection:
  • tocilizumab (Actemra^®)
  • etanercept (Enbrel^®)
  • adalimumab (Humira^®)
  • infliximab (Remicade^®)
  • rituximab (Rituxan^®)
  • abatacept (Orencia^®)
  • anakinra (Kineret^®)
  • certolizumab (Cimzia^®)
  • golimumab (Simponi^®)
  • ustekinumab (Stelara^®)
  • secukinumab (Cosentyx^®)
  • vedolizumab (Entyvio^®)
  • ixekizumab (Taltz^®)
  • sarilumab (Kevzara^®)
  • azathioprine, cyclosporine, or other immunosuppressive drugs
• Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

These are not all of the possible side effects of XELJANZ/XELJANZ Oral Solution. Learn more and read the Medication Guide.

What are possible side effects of XELJANZ/XELJANZ Oral Solution?

See Most Important Information I should know about XELJANZ/XELJANZ Oral Solution

If you are a carrier of the Hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ. Your healthcare provider may do blood tests before starting and while using treatment with XELJANZ. Tell your healthcare provider if you have any signs of these symptoms: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.

Common side effects in children (2 & older) with polyarticular course juvenile arthritis include upper respiratory tract infections (common cold, sinus infections), nasal congestion, sore throat, and runny nose (nasopharyngitis), headache, fever, nausea, and vomiting.

These are not all of the possible side effects of XELJANZ/XELJANZ Oral Solution. Learn more and read the Medication Guide.