A patient’s story: Managing ulcerative colitis symptoms from diagnosis to treatment

(BPT) - Content sponsored and provided by Pfizer. Tiffany partnered with Pfizer to share her experience living with moderate to severe ulcerative colitis (UC).

Tiffany, a mother of two from Westfield, Indiana, enjoyed coaching cheerleading and traveling with her daughters and team to cheer competitions when she began experiencing more frequent bowel movements and bleeding when she went to the bathroom. Eventually, these symptoms progressed, which made doing the activities she enjoyed more difficult. She wanted to be more present and visible to her cheer team during their routines, but this became challenging as she frequently needed to find the nearest bathroom.

Tiffany went to a gastroenterologist (GI) to discuss her symptoms and after a colonoscopy, she was diagnosed with moderate to severe ulcerative colitis (UC), a chronic inflammatory disease of the large intestine (also called the colon) that affects the lining and causes sores or ulcers to form. Current medicines can help manage UC symptoms but do not cure UC.[i]

Tiffany was not too familiar with UC before her diagnosis, although she knew there was some family history as her grandfather and uncle lived with the disease. She was surprised by her diagnosis and that she would need to manage her UC symptoms for the rest of her life. To learn more about the disease, she spoke to her doctor who provided her with informational packets, and she did some additional research online.

Tiffany and her GI immediately began working on a treatment plan to help manage her UC symptoms. This cycle of new medications went on for a few years. Since she had tried a tumor necrosis factor (TNF) blocker without success, Tiffany's GI discussed trying XELJANZ (tofacitinib), an oral medication for adults with moderate to severe UC.

Tiffany's doctor reviewed the potential benefits and serious side effects of XELJANZ with her and explained that it has a BOXED WARNING. They also discussed the type of monitoring and lab work that would be needed before and during treatment.

XELJANZ/XELJANZ XR can cause serious side effects and can lower your ability to fight infections like tuberculosis (TB); don't start XELJANZ if you have an infection. Before and while being treated, your doctor should check for infections like TB and do blood tests. Increased risk of death and major cardiovascular events such as heart attack, stroke, or death in patients 50 or older who have at least one heart disease risk factor. Serious, sometimes fatal infections, cancers, including lymphoma and lung cancer, cardiovascular events, immune system problems and blood clots have happened. Tell your doctor if you are a current or past smoker, have had any type of cancer, have had a heart attack, stroke or a history of blood clots.

Read more about Important Safety Information and Indication below.

After starting XELJANZ, Tiffany noticed an improvement in her UC symptoms, including less frequent bowel movements and reduced blood in her stool. Tiffany looked forward to coaching cheer and spending time with her daughters.

'I remember how happy I was at my follow-up appointment when my doctor said that with the colonoscopy results, and my symptom improvements, he thought I was in remission,' Tiffany said.

Through open communication and partnering with her doctor to find a treatment plan that works for her, Tiffany has been able to better manage her UC symptoms and focus on the activities that are important to her.

Her message to others who are living with UC is to 'keep hanging in there and working with your doctor. Try different medications until you find something that works for you. Be patient.'

To learn more about XELJANZ, visit XELJANZ.com/UC.

To share your story with UC, visit XELJANZ.com/share-your-story.

This represents Tiffany's experience and another person's experience may vary.

IMPORTANT SAFETY INFORMATION AND INDICATION

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

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

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

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

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

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

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

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

Increased risk of major cardiovascular events such as heart attack, stroke, or death in people50 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 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 of or on one side of your body
• slurred speech

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

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

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

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

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

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

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

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

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

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

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

XELJANZ & Pregnancy

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

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

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

What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR (tofacitinib) is used to treat adults with:

• Moderately to severely active ulcerative colitis when 1 or more medicines called tumor necrosis factor (TNF) blockers 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.

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

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