XELJANZ / XELJANZ XR Full Patient Information

(tofacitinib)

Full Patient 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

MEDICATION GUIDE
XELJANZ (ZEL' JANS') (tofacitinib) tablets, for oral use			XELJANZ XR (ZEL' JANS' EKS-AHR) (tofacitinib) extended-release tablets, for oral use		XELJANZ (ZEL' JANS') (tofacitinib) Oral Solution
What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution? XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects including:
1.		Serious infections. XELJANZ/XELJANZ XR/XELJANZ Oral Solution is a medicine that affects your immune system. XELJANZ/XELJANZ XR/XELJANZ Oral Solution can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, including 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 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. You should not start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). 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 and shingles. Before starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection such as:
		o fever, sweating, or chills o cough o blood in phlegm o warm, red, or painful skin or sores on your body o burning when you urinate or urinating more often than normal		o muscle aches o shortness of breath o weight loss o diarrhea or stomach pain o 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. After starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR/XELJANZ Oral Solution can make you more likely to get infections or make worse any infection that you have.
2.		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.
3.		Cancer and immune system problems. XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase your risk of certain cancers by changing the way your immune system works. • 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).
4.		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
5.		Blood clots in the lungs, veins of the legs or arms, and arteries. 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/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.
6.		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/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.
7.		Allergic reactions. • 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.
8.		Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and while you take XELJANZ/XELJANZ XR/XELJANZ Oral Solution to check for the following side effects: • 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. Your healthcare provider should routinely check certain liver tests. You should not take XELJANZ/XELJANZ XR/XELJANZ Oral Solution if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR/XELJANZ Oral Solution treatment for a period of time if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, and as needed after that. Normal cholesterol levels are important to good heart health.
See "What are the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution?" for more information about side effects.
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. 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.
What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell your healthcare provider about all of your medical conditions, including if you: • 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. • 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: o 18 hours after your last dose of XELJANZ/XELJANZ Oral Solution or o 36 hours after your last dose of XELJANZ XR Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XELJANZ/XELJANZ XR/XELJANZ Oral Solution and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take: • 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. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Take XELJANZ/XELJANZ XR/XELJANZ Oral Solution exactly as your healthcare provider tells you to take it. • 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? XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects, including: • 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:
	o feel very tired o little or no appetite o clay-colored bowel movements o chills o muscle aches o skin rash			o skin or eyes look yellow o vomiting o fevers o stomach discomfort o dark urine
Common side effects of XELJANZ/XELJANZ XR 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, and runny nose (nasopharyngitis) • high blood pressure (hypertension) • acne Common side effects of XELJANZ/XELJANZ XR in people with ulcerative colitis include: • 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 • acne • diarrhea • shingles (herpes zoster) Common side effects of XELJANZ/XELJANZ Oral Solution in people 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 • vomiting • acne Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
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. Keep XELJANZ/XELJANZ XR/XELJANZ Oral Solution and all medicines out of the reach of children.
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? Active ingredient: tofacitinib citrate Inactive ingredients: croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. What are the ingredients in XELJANZ 10 mg? Active ingredient: tofacitinib citrate Inactive ingredients: croscarmellose sodium, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. What are the ingredients in XELJANZ XR 11 mg? Active ingredient: tofacitinib citrate Inactive ingredients: cellulose acetate, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, and triacetin. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron, propylene glycol, and shellac glaze. What are the ingredients in XELJANZ XR 22 mg? Active ingredient: tofacitinib citrate Inactive ingredients: cellulose acetate, copovidone, FD&C Blue #2 Aluminum Lake, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze. What are the ingredients in XELJANZ Oral Solution? Active ingredient: tofacitinib citrate Inactive ingredients: grape flavor (natural), hydrochloric acid, lactic acid, purified water, sodium benzoate, sucralose, and xylitol. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. LAB-0535-15.0

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2024

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-1422-2.0

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: May 2024

Find XELJANZ / XELJANZ XR medical information:

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17 PATIENT COUNSELING INFORMATION

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

Serious Infections

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

Major Adverse Cardiovascular Events

Thrombosis

Hypersensitivity

Important Information on Laboratory Abnormalities

Pregnancy

Lactation

Infertility

Residual 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

MEDICATION GUIDE
XELJANZ (ZEL' JANS') (tofacitinib) tablets, for oral use			XELJANZ XR (ZEL' JANS' EKS-AHR) (tofacitinib) extended-release tablets, for oral use		XELJANZ (ZEL' JANS') (tofacitinib) Oral Solution
What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution? XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects including:
1.		Serious infections. XELJANZ/XELJANZ XR/XELJANZ Oral Solution is a medicine that affects your immune system. XELJANZ/XELJANZ XR/XELJANZ Oral Solution can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, including 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 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. You should not start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). 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 and shingles. Before starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection such as:
		o fever, sweating, or chills o cough o blood in phlegm o warm, red, or painful skin or sores on your body o burning when you urinate or urinating more often than normal		o muscle aches o shortness of breath o weight loss o diarrhea or stomach pain o 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. After starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR/XELJANZ Oral Solution can make you more likely to get infections or make worse any infection that you have.
2.		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.
3.		Cancer and immune system problems. XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase your risk of certain cancers by changing the way your immune system works. • 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).
4.		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
5.		Blood clots in the lungs, veins of the legs or arms, and arteries. 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/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.
6.		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/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.
7.		Allergic reactions. • 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.
8.		Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and while you take XELJANZ/XELJANZ XR/XELJANZ Oral Solution to check for the following side effects: • 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. Your healthcare provider should routinely check certain liver tests. You should not take XELJANZ/XELJANZ XR/XELJANZ Oral Solution if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR/XELJANZ Oral Solution treatment for a period of time if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, and as needed after that. Normal cholesterol levels are important to good heart health.
See "What are the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution?" for more information about side effects.
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. 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.
What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell your healthcare provider about all of your medical conditions, including if you: • 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. • 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: o 18 hours after your last dose of XELJANZ/XELJANZ Oral Solution or o 36 hours after your last dose of XELJANZ XR Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XELJANZ/XELJANZ XR/XELJANZ Oral Solution and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take: • 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. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Take XELJANZ/XELJANZ XR/XELJANZ Oral Solution exactly as your healthcare provider tells you to take it. • 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? XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects, including: • 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:
	o feel very tired o little or no appetite o clay-colored bowel movements o chills o muscle aches o skin rash			o skin or eyes look yellow o vomiting o fevers o stomach discomfort o dark urine
Common side effects of XELJANZ/XELJANZ XR 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, and runny nose (nasopharyngitis) • high blood pressure (hypertension) • acne Common side effects of XELJANZ/XELJANZ XR in people with ulcerative colitis include: • 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 • acne • diarrhea • shingles (herpes zoster) Common side effects of XELJANZ/XELJANZ Oral Solution in people 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 • vomiting • acne Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
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. Keep XELJANZ/XELJANZ XR/XELJANZ Oral Solution and all medicines out of the reach of children.
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? Active ingredient: tofacitinib citrate Inactive ingredients: croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. What are the ingredients in XELJANZ 10 mg? Active ingredient: tofacitinib citrate Inactive ingredients: croscarmellose sodium, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. What are the ingredients in XELJANZ XR 11 mg? Active ingredient: tofacitinib citrate Inactive ingredients: cellulose acetate, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, and triacetin. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron, propylene glycol, and shellac glaze. What are the ingredients in XELJANZ XR 22 mg? Active ingredient: tofacitinib citrate Inactive ingredients: cellulose acetate, copovidone, FD&C Blue #2 Aluminum Lake, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze. What are the ingredients in XELJANZ Oral Solution? Active ingredient: tofacitinib citrate Inactive ingredients: grape flavor (natural), hydrochloric acid, lactic acid, purified water, sodium benzoate, sucralose, and xylitol. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. LAB-0535-15.0

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2024

INSTRUCTIONS FOR USE

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

Important information about measuring XELJANZ Oral Solution:

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)

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

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.

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-1422-2.0

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: May 2024

Prescribing Information

Download Prescribing Information

Health Professional Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

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

Serious Infections

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

Major Adverse Cardiovascular Events

Thrombosis

Hypersensitivity

Important Information on Laboratory Abnormalities

Pregnancy

Lactation

Infertility

Residual 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

MEDICATION GUIDE
XELJANZ (ZEL' JANS') (tofacitinib) tablets, for oral use			XELJANZ XR (ZEL' JANS' EKS-AHR) (tofacitinib) extended-release tablets, for oral use		XELJANZ (ZEL' JANS') (tofacitinib) Oral Solution
What is the most important information I should know about XELJANZ/XELJANZ XR/XELJANZ Oral Solution? XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects including:
1.		Serious infections. XELJANZ/XELJANZ XR/XELJANZ Oral Solution is a medicine that affects your immune system. XELJANZ/XELJANZ XR/XELJANZ Oral Solution can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, including 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 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. You should not start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). 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 and shingles. Before starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection such as:
		o fever, sweating, or chills o cough o blood in phlegm o warm, red, or painful skin or sores on your body o burning when you urinate or urinating more often than normal		o muscle aches o shortness of breath o weight loss o diarrhea or stomach pain o 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. After starting XELJANZ/XELJANZ XR/XELJANZ Oral Solution, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR/XELJANZ Oral Solution can make you more likely to get infections or make worse any infection that you have.
2.		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.
3.		Cancer and immune system problems. XELJANZ/XELJANZ XR/XELJANZ Oral Solution may increase your risk of certain cancers by changing the way your immune system works. • 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).
4.		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
5.		Blood clots in the lungs, veins of the legs or arms, and arteries. 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/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.
6.		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/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.
7.		Allergic reactions. • 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.
8.		Changes in certain laboratory test results. Your healthcare provider should do blood tests before you start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and while you take XELJANZ/XELJANZ XR/XELJANZ Oral Solution to check for the following side effects: • 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. Your healthcare provider should routinely check certain liver tests. You should not take XELJANZ/XELJANZ XR/XELJANZ Oral Solution if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ/XELJANZ XR/XELJANZ Oral Solution treatment for a period of time if needed because of changes in these blood test results. You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, and as needed after that. Normal cholesterol levels are important to good heart health.
See "What are the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution?" for more information about side effects.
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. 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.
What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Before taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution, tell your healthcare provider about all of your medical conditions, including if you: • 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. • 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: o 18 hours after your last dose of XELJANZ/XELJANZ Oral Solution or o 36 hours after your last dose of XELJANZ XR Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XELJANZ/XELJANZ XR/XELJANZ Oral Solution and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take: • 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. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Take XELJANZ/XELJANZ XR/XELJANZ Oral Solution exactly as your healthcare provider tells you to take it. • 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? XELJANZ/XELJANZ XR/XELJANZ Oral Solution may cause serious side effects, including: • 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:
	o feel very tired o little or no appetite o clay-colored bowel movements o chills o muscle aches o skin rash			o skin or eyes look yellow o vomiting o fevers o stomach discomfort o dark urine
Common side effects of XELJANZ/XELJANZ XR 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, and runny nose (nasopharyngitis) • high blood pressure (hypertension) • acne Common side effects of XELJANZ/XELJANZ XR in people with ulcerative colitis include: • 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 • acne • diarrhea • shingles (herpes zoster) Common side effects of XELJANZ/XELJANZ Oral Solution in people 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 • vomiting • acne Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XELJANZ/XELJANZ XR/XELJANZ Oral Solution. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer at 1-800-438-1985.
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. Keep XELJANZ/XELJANZ XR/XELJANZ Oral Solution and all medicines out of the reach of children.
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? Active ingredient: tofacitinib citrate Inactive ingredients: croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. What are the ingredients in XELJANZ 10 mg? Active ingredient: tofacitinib citrate Inactive ingredients: croscarmellose sodium, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/Indigo Carmine Aluminum Lake, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. What are the ingredients in XELJANZ XR 11 mg? Active ingredient: tofacitinib citrate Inactive ingredients: cellulose acetate, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, and triacetin. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron, propylene glycol, and shellac glaze. What are the ingredients in XELJANZ XR 22 mg? Active ingredient: tofacitinib citrate Inactive ingredients: cellulose acetate, copovidone, FD&C Blue #2 Aluminum Lake, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze. What are the ingredients in XELJANZ Oral Solution? Active ingredient: tofacitinib citrate Inactive ingredients: grape flavor (natural), hydrochloric acid, lactic acid, purified water, sodium benzoate, sucralose, and xylitol. This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com. LAB-0535-15.0

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2024

INSTRUCTIONS FOR USE

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

Important information about measuring XELJANZ Oral Solution:

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)

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

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.

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-1422-2.0

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Approved: May 2024

Resources

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Report Adverse Event

Pfizer Safety

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Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.