XELJANZ / XELJANZ XR (tofacitinib)

What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

• Your healthcare provider should test you for TB before starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution and during treatment.
• Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution.

• think you have an infection or have symptoms of an infection such as:

• fever, sweating, or chills
• cough
• blood in phlegm
• warm, red, or painful skin or sores on your body
• burning when you urinate or urinating more often than normal

• muscle aches
• shortness of breath
• weight loss
• diarrhea or stomach pain
• feeling very tired

• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you take XELJANZ/XELJANZ XR/XELJANZ Oral Solution. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B or C.

• Lymphoma and other cancers including skin cancers can happen in people taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution. 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. 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 skin cancers. Tell your healthcare provider if you have ever had any type of cancer.
• 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).

• 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

• Stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and tell your healthcare provider right away if you develop signs and symptoms of a blood clot, such as sudden shortness of breath or difficulty breathing, chest pain, swelling of the leg or arm, leg pain or tenderness, or redness or discoloration in the leg or arm.

• 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/XELJANZ XR/XELJANZ Oral Solution can get tears in their stomach or intestines. 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 and stomach-area pain that does not go away, and a change in your bowel habits.

• Symptoms such as swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) that may mean you are having an allergic reaction have been seen in people taking XELJANZ/XELJANZ XR. Some of these reactions were serious. If any of these symptoms occur while you are taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, stop XELJANZ/XELJANZ XR/XELJANZ Oral Solution and call your healthcare provider right away.

• changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
• low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
• low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

What is XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

• XELJANZ/XELJANZ XR/XELJANZ Oral Solution is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults 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.
• XELJANZ/XELJANZ XR is used to treat adults with active psoriatic arthritis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated.
• XELJANZ/XELJANZ XR is used to treat adults with active ankylosing spondylitis when 1 or more TNF blocker medicines have been used and did not work well or cannot be tolerated.
• XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active ulcerative colitis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated.
• XELJANZ/XELJANZ Oral Solution is used to treat people 2 years of age and older with active polyarticular course juvenile arthritis when 1 or more TNF blocker medicines have been used, and did not work well or cannot be tolerated.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

• have an infection. See " What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution?"
• 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 in the veins of your legs, arms, or lungs, or clots in the arteries in the past.
• have liver problems.
• have kidney problems.
• have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines.
• have had a reaction to tofacitinib or any of the ingredients in XELJANZ/XELJANZ XR/XELJANZ Oral Solution.
• have recently received or are scheduled to receive a vaccine. People who take XELJANZ/XELJANZ XR/XELJANZ Oral Solution should not receive live vaccines. People taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution can receive non-live vaccines.
• plan to become pregnant or are pregnant. XELJANZ/XELJANZ XR/XELJANZ Oral Solution may affect the ability of females to get pregnant. It is not known if this will change after stopping XELJANZ/XELJANZ XR/XELJANZ Oral Solution. It is not known if XELJANZ/XELJANZ XR/XELJANZ Oral Solution will harm an unborn baby.
  • Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR/XELJANZ Oral Solution. 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/XELJANZ XR/XELJANZ Oral Solution, 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.
• plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR/XELJANZ Oral Solution or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution do not start breastfeeding again until:
  • 18 hours after your last dose of XELJANZ/XELJANZ Oral Solution or
  • 36 hours after your last dose of XELJANZ XR

• any other medicines to treat your rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis or polyarticular course juvenile arthritis. You should not take 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), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution. Taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution with these medicines may increase your risk of infection.
• 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.

How should I take XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

• Take XELJANZ/XELJANZ Oral Solution 2 times a day with or without food.
• Take XELJANZ XR 1 time a day with or without food.
• Swallow XELJANZ XR tablets whole and intact. Do not crush, split, or chew.
• When you take XELJANZ XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
• If you take too much XELJANZ/XELJANZ XR/XELJANZ Oral Solution, call your healthcare provider or go to the nearest hospital emergency room right away.
• For the treatment of psoriatic arthritis, take XELJANZ/XELJANZ XR in combination with methotrexate, sulfasalazine or leflunomide as instructed by your healthcare provider.
• XELJANZ XR should not be used instead of XELJANZ Oral Solution.

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

• See " What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution?"
• Hepatitis B or C activation infection in people who carry the virus in their blood. 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/XELJANZ XR/XELJANZ Oral Solution. Your healthcare provider may do blood tests before you start treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution and while you are taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:

• 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
• dark urine

• upper respiratory tract infections (common cold, sinus infections)
• headache
• diarrhea
• nasal congestion, sore throat, and runny nose (nasopharyngitis)
• high blood pressure (hypertension)

• nasal congestion, sore throat, and runny nose (nasopharyngitis)
• increased cholesterol levels
• headache
• upper respiratory tract infections (common cold, sinus infections)
• increased muscle enzyme levels
• rash
• diarrhea
• shingles (herpes zoster)

• upper respiratory tract infections (common cold, sinus infections)
• nasal congestion, sore throat, and runny nose (nasopharyngitis)
• headache
• fever
• nausea
• vomiting

How should I store XELJANZ/XELJANZ XR/XELJANZ Oral Solution?

• Store XELJANZ/XELJANZ XR at room temperature between 68°F to 77°F (20°C to 25°C).
• Store XELJANZ Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle and carton to protect from light.
• Safely throw away XELJANZ Oral Solution that is out of date or no longer needed. Use XELJANZ Oral Solution within 60 days of opening the bottle. Throw away (discard) remaining oral solution after 60 days.

General information about the safe and effective use of XELJANZ/XELJANZ XR/XELJANZ Oral Solution.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XELJANZ/XELJANZ XR/XELJANZ Oral Solution for a condition for which it was not prescribed. Do not give XELJANZ/XELJANZ XR/XELJANZ Oral Solution to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about XELJANZ/XELJANZ XR/XELJANZ Oral Solution. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about XELJANZ/XELJANZ XR/XELJANZ Oral Solution that is written for health professionals.

What are the ingredients in XELJANZ 5 mg?

What are the ingredients in XELJANZ 10 mg?

What are the ingredients in XELJANZ XR 11 mg?

What are the ingredients in XELJANZ XR 22 mg?

What are the ingredients in XELJANZ Oral Solution?

LAB-0535-13.0

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

INSTRUCTIONS FOR USE

XELJANZ® (ZEL' JANS')
(tofacitinib)
Oral Solution

Read this Instructions for Use before you start taking XELJANZ Oral Solution and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important information about measuring XELJANZ Oral 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.

How should I store XELJANZ?

• Store XELJANZ Oral Solution at room temperature between 68°F to 77°F (20°C to 25°C).
• Always store XELJANZ Oral Solution in the original bottle and carton to protect from light.

Keep XELJANZ and all medicines out of the reach of children.

Use XELJANZ Oral Solution within 60 days of opening the bottle. Throw away (discard) remaining XELJANZ Oral Solution after 60 days.

To help you remember when to throw away your bottle of XELJANZ Oral Solution, you can write the date when you first start to use it on the carton and below:

Date of first use ____ / ____ / ____.

Before each use:

Wash your hands with soap and water and place the items from the carton on a clean, flat surface.

Each carton of XELJANZ Oral Solution contains:

• 1 press-in bottle adapter
• 1 bottle of XELJANZ Oral Solution
• 1 oral dosing syringe

Step 1. Remove bottle from carton

Open the carton and remove the bottle of XELJANZ Oral Solution.

Step 2. Open bottle

Open the bottle by pushing down on the child-resistant cap and turning it to the left (counter-clockwise) as shown. Remove the seal off the top of the bottle (first time only).

Do not throw away the child-resistant cap.

Note: The bottle does not need to be shaken before use.

Step 3. Insert press-in bottle adapter (first time only)

Remove the press-in bottle adapter and oral dosing syringe from the plastic overwrap. With the bottle on a flat surface, push the ribbed end of the press-in bottle adapter all the way into the neck of the bottle with your thumbs while holding the bottle firmly.

Note: Do not remove the press-in bottle adapter from the bottle after it is inserted.

Step 4. Remove air from oral dosing syringe

Push the oral dosing syringe plunger all the way down to the tip of the syringe barrel to remove excess air.

Step 5. Insert the oral dosing syringe

Insert the oral dosing syringe tip into the upright bottle through the opening of the press-in bottle adapter until it is firmly in place.

Step 6. Withdraw dose from bottle

With the oral dosing syringe in place, turn the bottle upside down. Pull down on the plunger until the bottom of the plunger is even with the markings on the oral dosing syringe for your prescribed dose of oral solution.

If you see air bubbles in the oral dosing syringe, fully push the plunger in so that the oral solution flows back into the bottle. Then withdraw your prescribed dose of oral solution.

Step 7. Remove oral dosing syringe

Turn the bottle upright and place the bottle on a flat surface. Remove the oral dosing syringe from the press-in bottle adapter and bottle by pulling straight up on the oral dosing syringe barrel.

Step 8. Check the dose

Check that the correct dose was drawn up into the oral dosing syringe.

If the dose is not correct, insert the oral dosing syringe tip firmly into the press-in bottle adapter. Fully push in the plunger so that the oral solution flows back into the bottle. Repeat Step 6 and Step 7.

Step 9. Take the dose of XELJANZ

Place the tip of the oral dosing syringe into the inside of the cheek.

Slowly push the plunger all the way down to give all of the medicine in the oral dosing syringe. Make sure there is time to swallow the medicine.

Step 10. Close the bottle

Close the bottle tightly by turning the child-resistant cap to the right (clockwise), leaving the press-in bottle adapter in place.

Place the bottle back into the carton.

Close the carton to protect XELJANZ Oral Solution from light.

Step 11. Clean oral dosing syringe

Remove the plunger from the barrel by pulling the plunger and the barrel away from each other.

Rinse both with water after each use.

Allow to air dry. When the barrel and plunger are dry, put the oral dosing syringe back together by inserting the plunger into the barrel.

Store the oral dosing syringe with the XELJANZ Oral Solution.

Do not throw away the oral dosing syringe.

LAB-1422-1.0

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: September 2020

Full Patient Information