XELJANZ

Generic Name/API: tofacitinib

Manufacturer: PFIZER

Dosage Forms & Strength & Pack Size:
•XELJANZ Tablets: 5 mg, 10 mg tofacitinib

•XELJANZ XR Tablets: 11 mg, 22 mg tofacitinib

•XELJANZ Oral Solution: 1 mg/mL tofacitinib

Storage:

XELJANZ/XELJANZ XR

Store XELJANZ/XELJANZ XR at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Do not repackage.

 

XELJANZ Oral Solution

XELJANZ 1 mg/ mL oral solution is a clear, colorless solution that contains 1 mg of tofacitinib. It is packaged in HDPE bottles as follows:

Each bottle is packaged with one press-in bottle adapter and one 5 mL oral dosing syringe with 3.2 mL, 4 mL, and 5 mL gradations. The press-in bottle adapter and oral dosing syringe are not made with natural rubber latex.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). [See USP Controlled Room Temperature].

Store in the original bottle and carton to protect from light.

Use contents of bottle within 60 days of opening.

Discard remaining oral solution after 60 days.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

What is XELJANZ/​XELJANZ XR (tofacitinib)?

XELJANZ/​XELJANZ XR (tofacitinib) is used to treat adults who have tried TNF blockers with:

  • Moderately to severely active rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or cannot be tolerated
  • Active psoriatic arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
  • Moderately to severely active ulcerative colitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated
  • Active ankylosing spondylitis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated

XELJANZ/​XELJANZ Oral Solution is used to treat patients 2 years of age and older with:

  • Active polyarticular course juvenile arthritis when 1 or more tumor necrosis factor (TNF) blocker medicines have been used, and did not work well or cannot be tolerated

It is not known if XELJANZ/​XELJANZ XR is safe and effective in people with Hepatitis B or C.

XELJANZ/​XELJANZ XR/​XELJANZ Oral Solution is not recommended for people with severe liver problems.

It is not known if XELJANZ/​XELJANZ Oral Solution is safe and effective in children for treatment other than active polyarticular course juvenile arthritis.

It is not known if ​XELJANZ XR is safe and effective in children.

IMPORTANT SAFETY INFORMATION

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.

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.

What are other possible side effects of XELJANZ/​XELJANZ XR?

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 people with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, runny nose (nasopharyngitis), and high blood pressure (hypertension).

Common side effects in people with ulcerative colitis include nasal congestion, sore throat, runny nose (nasopharyngitis), increased cholesterol levels, headache, upper respiratory tract infections (common cold, sinus infections), increased muscle enzyme levels, rash, diarrhea, and shingles (herpes zoster).

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.

XELJANZ & Pregnancy

XELJANZ may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ. It is not known if XELJANZ will harm an unborn baby.

  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

You and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both. After you stop your treatment with XELJANZ do not start breastfeeding again until 18 hours after your last dose of XELJANZ or 36 hours after your last dose of ​XELJANZ XR.

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

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