Xeljanz (Tofacitinib) What You Need to Know

Xeljanz: Uses, Dosage & Side Effects – Drugs.com

Xeljanz (Tofacitinib)  What You Need to Know

Generic Name: tofacitinib (TOE fa SYE ti nib)
Brand Names:Xeljanz, Xeljanz XR

Medically reviewed by Judith Stewart, BPharm Last updated on Mar 1, 2020.

What is Xeljanz?

Xeljanz (tofacitinib) blocks the activity of certain enzymes in the body that affect immune system function.

Xeljanz is used to treat moderate to severe rheumatoid arthritis or active psoriatic arthritis in adults who have tried methotrexate or other medications without successful treatment of symptoms. Tofacitinib is sometimes given in combination with methotrexate or other arthritis medicines.

Xeljanz is also used to treat adults with moderate to severe ulcerative colitis in adults who cannot use certain other medications, or after other treatments have failed.

Important Information

You should not use Xeljanz if you have a serious infection. Before you start treatment, your doctor may perform tests to make sure you do not have an infection.

Tofacitinib affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, trouble breathing, skin sores, diarrhea, weight loss, or burning when you urinate.

If you've ever had hepatitis B or C, using Xeljanz can cause this virus to become active or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not use Xeljanz if you are allergic to tofacitinib, or if you have any kind of infection.

To make sure Xeljanz is safe for you, tell your doctor if you have ever had:

  • liver disease (especially hepatitis B or C);
  • heart problems (especially if you are 50 or older);
  • lung disease;
  • a blood clot;
  • a chronic infection;
  • HIV, or a weak immune system;
  • a stomach or intestinal problem such as diverticulitis or an ulcer;
  • kidney disease (or if you are on dialysis);
  • diabetes; or
  • if you are scheduled to receive any vaccine.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Using Xeljanz may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

It is not known whether tofacitinib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Tofacitinib may affect your ability to have children during treatment and in the future.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of tofacitinib on the baby.

Do not breastfeed while you are using Xeljanz, and for at least 18 hours after your last dose (36 hours if you take extended-release tablets). If you use a breast pump during this time, do not feed the milk to your baby.

How should I take Xeljanz?

Before you start treatment with Xeljanz, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

A safe dose of Xeljanz is not the same for all conditions. Avoid medication errors by using only the form and strength your doctor prescribes.

You may take Xeljanz with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow the tablet whole.

Tofacitinib affects your immune system. You may get infections more easily, even serious or fatal infections.

If you've ever had shingles (herpes zoster) or hepatitis B or C, using Xeljanz can cause these viruses to become active or get worse. You may need frequent liver function tests.

Your doctor will need to examine you on a regular basis.

Store in the original container at room temperature away from moisture and heat.

Some tablets are made with a shell that is not absorbed or melted in the body. Part of this shell may appear in your stool. This is normal and will not make the medicine less effective.

Xeljanz dosing information

Usual Adult Dose for Rheumatoid Arthritis:

As monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs:-Immediate-release: 5 mg orally 2 times a day-Extended-release: 11 mg orally once a day Comments:-Do not initiate this drug if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count (ANC) is less than 1000 cells/mm3, or hemoglobin is less than 9 g/dL.-Patients treated with the 5 mg immediate-release 2 times a day may be switched to the 11-mg extended-release once a day the day following the last dose of 5 mg.

Use: For moderately to severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to methotrexate; it may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs)

Usual Adult Dose for Psoriatic Arthritis:

In combination with nonbiologic disease-modifying antirheumatic drugs:-Immediate-release: 5 mg orally 2 times a day-Extended-release: 11 mg orally once a day Comments:-Do not initiate this drug if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count (ANC) is less than 1000 cells/mm3, or hemoglobin is less than 9 g/dL.-Patients treated with the 5 mg immediate-release 2 times a day may be switched to the 11-mg extended-release once a day the day following the last dose of 5 mg.

Use: For active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to methotrexate or other DMARDs

Usual Adult Dose for Ulcerative Colitis:

-Induction: 10 mg orally 2 times a day for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response; if needed, continue 10 mg 2 times a day for a maximum of 16 weeks; discontinue 10 mg 2 times a day after 16 weeks if adequate therapeutic response is not achieved-Maintenance: 5 mg orally 2 times a day; limit use of 10 mg 2 times a day beyond induction for those with loss of response Comments:-Do not initiate this drug if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count (ANC) is less than 1000 cells/mm3, or hemoglobin is less than 9 g/dL.-Patients treated with the 5 mg immediate-release 2 times a day may be switched to the 11-mg extended-release once a day the day following the last dose of 5 mg. Use: For the treatment of adult patients with moderately to severely active

ulcerative colitis (UC) who have had an inadequate response or who are intolerant to TNF blockers

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Xeljanz?

Do not receive a “live” vaccine while using Xeljanz, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Get emergency medical help if you have signs of an allergic reaction to Xeljanz: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking high dosages of Xeljanz have developed serious or fatal blood clots in the lungs. Stop taking tofacitinib and seek emergency medical attention if you have:

  • sudden shortness of breath;
  • pain while breathing;
  • cough with pink or red mucus;
  • pain in your chest or back;
  • clammy or blue-colored skin, heavy sweating; or
  • pain, swelling, or redness in an arm or a leg.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, sweating, tiredness, muscle pain;
  • feeling short of breath;
  • skin sores with warmth, redness, or swelling;
  • increased urination, pain or burning when you urinate;
  • mouth sores, stomach pain, diarrhea; or
  • signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

  • low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • signs of hepatitis – loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • shingles – burning pain, numbness, tingling, itching, skin rash or blisters; or
  • signs of perforation (a hole or tear) in your stomach or intestines – fever, ongoing stomach pain, change in bowel habits.

Common Xeljanz side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xeljanz?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with tofacitinib, especially:

  • azathioprine;
  • cyclosporine; or
  • other drugs to treat arthritis or ulcerative colitis – abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab.

This list is not complete and many other drugs may interact tofacitinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines the reach of children, never share your medicines with others, and use Xeljanz only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 6.02.

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WHAT IS XELJANZ (tofacitinib)?

Xeljanz (Tofacitinib)  What You Need to Know

What is the most important information I should know about XELJANZ® (tofacitinib citrate)/XELJANZ® XR (tofacitinib citrate)?

XELJANZ/​XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/​XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/​XELJANZ XR, 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, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/​XELJANZ XR 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.

Before starting XELJANZ/​XELJANZ XR, tell your healthcare provider if you:

  • 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; or feeling very tired
  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have diabetes, 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 in, 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 use XELJANZ/​XELJANZ XR. 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, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/​XELJANZ XR can make you more ly to get infections or make worse any infection that you have.

Cancer and immune system problems. XELJANZ/​XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, have happened in patients taking XELJANZ/​XELJANZ XR. 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 control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Tears (perforation) in the stomach or intestines. Some people taking XELJANZ/​XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/​XELJANZ XR, and while you take XELJANZ/​XELJANZ XR, 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 receive XELJANZ/​XELJANZ XR 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 treatment for a period of time if needed because of changes in these blood test results.

Your healthcare provider should do blood tests to check your cholesterol levels 4-8 weeks after you start XELJANZ/​XELJANZ XR, and as needed after that.

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

XELJANZ/​XELJANZ XR may not be right for you. Before taking XELJANZ/​XELJANZ XR, tell your healthcare provider if you:

  • have an infection
  • have liver problems
  • have kidney problems
  • have any stomach area (abdominal) pain or been diagnosed with diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines, or narrowing within your digestive tract
  • have had a reaction to tofacitinib or any of the ingredients in XELJANZ/​XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People taking XELJANZ/​XELJANZ XR should not receive live vaccines but can receive non-live vaccines
  • have any other medical conditions
  • plan to become pregnant or are pregnant. It is not known if XELJANZ/​XELJANZ XR will harm an unborn baby Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/​XELJANZ XR. 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, 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

Tell your healthcare provider about all of the medicines you take, especially any other medicines to treat your rheumatoid arthritis.

You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab pegol (Cimzia®), golimumab (Simponi®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ/​XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.

  • Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Taking XELJANZ XR
When you take XELJANZ XR, you may see something in your stool that looks a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

What are other possible side effects of XELJANZ/​XELJANZ XR?
XELJANZ/​XELJANZ XR may cause serious side effects, including 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.

Tell your healthcare provider if you have 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, or dark urine.

Common side effects of XELJANZ/​XELJANZ XR include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).

What is XELJANZ/​XELJANZ XR?

XELJANZ/​XELJANZ XR 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 in which methotrexate did not work well.

  • It is not known if XELJANZ/​XELJANZ XR is safe and effective in people with hepatitis B or C.
  • XELJANZ/​XELJANZ XR is not for people with severe liver problems.
  • It is not known if XELJANZ/​XELJANZ XR is safe and effective in children.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

PP-XEL-USA-0949-01

Source: https://ra.xeljanz.com/about-xeljanz/what-is-xeljanz

Pfizer Announces Results from XELJANZ® (tofacitinib citrate) ORAL Strategy Study Published in The Lancet and Presented at the EULAR Annual Congress

Xeljanz (Tofacitinib)  What You Need to Know

Pfizer Inc.

(NYSE:PFE) announced today detailed results from ORAL Strategy, a head-to-head, noninferiority Phase 3b/4 study of XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) as monotherapy or in combination with methotrexate (MTX) compared to Humira® plus MTX in the treatment of moderate to severe rheumatoid arthritis (RA). ORAL Strategy also compared XELJANZ monotherapy to XELJANZ in combination with MTX. The study results were published online in The Lancet and will be presented during an oral session at the EULAR Annual European Congress of Rheumatology in Madrid, Spain (16 June).

“Our extensive RA clinical development program has demonstrated the overall efficacy and safety of XELJANZ with or without methotrexate in patients living with moderate to severe RA.

ORAL Strategy is a bold study that directly compared XELJANZ as a monotherapy or in combination with methotrexate to Humira in combination with methotrexate,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

“The totality of the ORAL Strategy results add to body of evidence for XELJANZ and further demonstrates Pfizer’s commitment to putting patients first by helping physicians make informed treatment decisions.”

Efficacy Results

The percentage of patients achieving an ACR50 response at Month 6, the primary efficacy endpoint, for each arm include:

XELJANZ 5 mg BID plus MTX: 46.0% (n=173) XELJANZ 5 mg BID monotherapy: 38.3% (n=147) Humira 40 mg every other week (EOW) plus MTX: 43.8% (n=169)

Refer to data plot showing “Differences in ACR50 Response Rate at Month 6.”

“As expected, XELJANZ in combination with methotrexate provided similar ACR50 response rates to Humira plus methotrexate,” said Dr. Roy Fleischmann, study author and clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center and Co-Medical Director, Metroplex Clinical Research Center.

“Although XELJANZ monotherapy did not demonstrate noninferiority to either combination arm, the clinical responses observed are reflective of those in the Phase 3 clinical program and affirm our understanding that XELJANZ is an important option both in combination with MTX and as monotherapy for patients who do not respond to or are intolerant to methotrexate.”

Safety Results

The safety findings in ORAL Strategy were consistent with the known adverse events (AEs) profile for XELJANZ. The most frequently reported AEs for each study group were upper respiratory tract infections, alanine aminotransferase elevation, nasopharyngitis, urinary tract infections and nausea.

Overall AEs rates were comparable between treatment arms; the majority of AEs were mild to moderate in severity. Rates of serious AEs (SAEs) and discontinuations due to AEs were generally similar between treatment arms.

Over the course of the study, the following percentages of patients experienced AEs and serious AEs across treatment groups:

AEs

XELJANZ 5 mg BID plus MTX: 61.4% (n= 231) XELJANZ 5 mg BID monotherapy: 58.9% (n=226) Humira 40 mg EOW plus MTX: 65.5% (n= 253)

SAEs

XELJANZ 5 mg BID plus MTX: 7.2% (n=27) XELJANZ 5 mg BID monotherapy: 9.1% (n=35) Humira 40 mg EOW plus MTX: 6.2% (n=24)

Top-line results for ORAL Strategy were announced in February 2017.

About Rheumatoid Arthritis (RA)

RA is a chronic, inflammatory autoimmune disease that affects approximately 17.6 million people worldwide and 1.6 million people in the U.S. It causes a range of symptoms, including pain and swelling in the joints, particularly those in the hands, feet and knees, which may lead to joint damage and eventual disability.

RA can be treated with various types of medications, including steroids, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and biologic disease-modifying antirheumatic drugs (bDMARDs). Many physicians use combination therapy with MTX when treating patients with moderate to severe RA.

However, some patients discontinue their MTX, which may result in reduced efficacy of these treatments regimens.

About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release

XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is approved in more than 80 countries around the world for the treatment of moderately to severely active rheumatoid arthritis (RA).

Since it was first approved in the United States in 2012, XELJANZ has been prescribed to more than 90,000 patients worldwide.

XELJANZ XR is the first once-daily oral JAK inhibitor approved for the treatment of moderately to severely active RA in eight countries around the world.

XELJANZ/XELJANZ XR U.S. Label Information

XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) 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 in which methotrexate did not work well.

XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs).

Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C. XELJANZ/XELJANZ XR is not for people with severe liver problems. It is not known if XELJANZ/XELJANZ XR is safe and effective in children.

Important Safety Information

XELJANZ/XELJANZ XR can lower the ability of the immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body.

Some people have died from these infections. Healthcare providers should test patients for TB before starting XELJANZ/XELJANZ XR, and monitor them closely for signs and symptoms of TB and other infections during treatment.

People should not start taking XELJANZ/XELJANZ XR if they have any kind of infection unless their healthcare provider tells them it is okay. People may be at a higher risk of developing shingles.

XELJANZ/XELJANZ XR may increase the risk of certain cancers by changing the way the immune system works.

Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ/XELJANZ XR.

The risks and benefits of treatment should be considered prior to initiating XELJANZ/XELJANZ XR in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was observed in clinical studies with XELJANZ. Use of live vaccines should be avoided concurrently with XELJANZ/XELJANZ XR. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ/XELJANZ XR therapy. 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 control (Epstein Barr virus-associated post-transplant lymphoproliferative disorder). Some people taking XELJANZ/XELJANZ XR 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. XELJANZ/XELJANZ XR should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis), or who have a narrowing within their digestive tract. Patients should tell their healthcare provider right away if they have fever and stomach-area pain that does not go away or a change in bowel habits. XELJANZ/XELJANZ XR can cause changes in certain lab test results including low blood cell counts, increases in certain liver tests, and increases in cholesterol levels. Healthcare providers should do blood tests before starting patients on XELJANZ/XELJANZ XR and while they are taking XELJANZ/XELJANZ XR, to check for these side effects. Normal cholesterol levels are important to good heart health. Healthcare providers may stop XELJANZ/XELJANZ XR treatment because of changes in blood cell counts or liver test results. Use of XELJANZ/XELJANZ XR in patients with severe hepatic impairment is not recommended. Patients should tell their healthcare providers if they plan to become pregnant or are pregnant.

It is not known if XELJANZ/XELJANZ XR will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ/XELJANZ XR, a registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.

Patients should tell their healthcare providers if they plan to breastfeed or are breastfeeding. Patients and their healthcare provider should decide if they will take XELJANZ/XELJANZ XR or breastfeed. They should not do both.

In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ/XELJANZ XR. Healthcare providers may do blood tests before and during treatment with XELJANZ/XELJANZ XR.

Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).

Please click the direct link to the full US Prescribing Information for XELJANZ/XELJANZ XR, including Boxed Warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products.

Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on at @Pfizer and @PfizerNews, LinkedIn, and us on at .com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of June 16, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about XELJANZ (tofacitinib citrate) that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; uncertainties regarding the commercial success of XELJANZ and XELJANZ XR; uncertainties regarding the commercial impact of the results of the ORAL Strategy trial; whether and when any other applications for XELJANZ or XELJANZ XR may be filed with regulatory authorities in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications and/or any other applications that are pending or may be filed for XELJANZ or XELJANZ XR, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of XELJANZ and XELJANZ XR; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

Source: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_results_from_xeljanz_tofacitinib_citrate_oral_strategy_study_published_in_the_lancet_and_presented_at_the_eular_annual_congress

XELJANZ+You Support Program

Xeljanz (Tofacitinib)  What You Need to Know

What is the most important information I should know about XELJANZ® (tofacitinib citrate)/XELJANZ® XR (tofacitinib citrate)?

XELJANZ/​XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/​XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/​XELJANZ XR, 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, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/​XELJANZ XR 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.

Before starting XELJANZ/​XELJANZ XR, tell your healthcare provider if you:

  • 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; or feeling very tired
  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have diabetes, 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 in, 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 use XELJANZ/​XELJANZ XR. 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, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/​XELJANZ XR can make you more ly to get infections or make worse any infection that you have.

Cancer and immune system problems. XELJANZ/​XELJANZ XR may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, have happened in patients taking XELJANZ/​XELJANZ XR. 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 control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Tears (perforation) in the stomach or intestines. Some people taking XELJANZ/​XELJANZ XR can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ/​XELJANZ XR, and while you take XELJANZ/​XELJANZ XR, 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 receive XELJANZ/​XELJANZ XR 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 treatment for a period of time if needed because of changes in these blood test results.

Your healthcare provider should do blood tests to check your cholesterol levels 4-8 weeks after you start XELJANZ/​XELJANZ XR, and as needed after that.

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

XELJANZ/​XELJANZ XR may not be right for you. Before taking XELJANZ/​XELJANZ XR, tell your healthcare provider if you:

  • have an infection
  • have liver problems
  • have kidney problems
  • have any stomach area (abdominal) pain or been diagnosed with diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines, or narrowing within your digestive tract
  • have had a reaction to tofacitinib or any of the ingredients in XELJANZ/​XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People taking XELJANZ/​XELJANZ XR should not receive live vaccines but can receive non-live vaccines
  • have any other medical conditions
  • plan to become pregnant or are pregnant. It is not known if XELJANZ/​XELJANZ XR will harm an unborn baby Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/​XELJANZ XR. 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, 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

Tell your healthcare provider about all of the medicines you take, especially any other medicines to treat your rheumatoid arthritis.

You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab pegol (Cimzia®), golimumab (Simponi®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ/​XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.

  • Tell your healthcare provider if you are taking medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Taking XELJANZ XR
When you take XELJANZ XR, you may see something in your stool that looks a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

What are other possible side effects of XELJANZ/​XELJANZ XR?
XELJANZ/​XELJANZ XR may cause serious side effects, including 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.

Tell your healthcare provider if you have 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, or dark urine.

Common side effects of XELJANZ/​XELJANZ XR include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).