Create a plan: Working with a doctor to help manage a chronic inflammatory condition

Stephanie was excited about starting her first job as a dog groomer. However, her plans changed during a family vacation to Lake Tahoe, when she began experiencing more frequent bowel movements and blood in her stool. While Stephanie didn’t know what was happening to her at the time, she could tell that something was not right.

Initially, Stephanie’s doctor thought she might be suffering from an infection. Yet her symptoms kept recurring, and three months later, she was using the restroom up to 20 times a day. A colonoscopy finally helped diagnose Stephanie 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. Medicines do not cure UC but can help manage symptoms.^[1]

Stephanie began working with her gastroenterologist on a disease management plan to help manage her UC symptoms. Despite trying various medications, including a TNF blocker that eventually stopped working well enough for her, she continued to experience UC symptoms.

“When my symptoms weren’t improving, I had to move back home with my family,” Stephanie said. “It really felt like I was starting over.”

After multiple flares, Stephanie and her doctor determined it was time to explore other treatment options. Stephanie heard about XELJANZ^® (tofacitinib), an oral medication for adults with moderate to severe UC in whom medicines called tumor necrosis factor (TNF) blockers did not work well or cannot be tolerated. She decided to bring it up with her doctor during her next appointment.

Stephanie’s gastroenterologist reviewed the potential side effects of XELJANZ with her. They also discussed the type of monitoring and lab work that would be needed before and during treatment. Her gastroenterologist also explained that XELJANZ has a BOXED WARNING.

XELJANZ/XELJANZ XR can cause serious side effects and can lower your ability to fight infections like TB; don’t start XELJANZ if you have an infection. Before and while being treated, get tested for TB. Taking a higher than recommended dose of XELJANZ for RA can increase risk of death. This was found in a study of RA patients age 50 and older with heart disease risk factor(s). Serious, sometimes fatal infections, cancers, including lymphoma, and blood clots have happened. Tell your doctor if you have a history of blood clots.

Read more Important Safety Information and Indication below.

At her one-month follow-up appointment, Stephanie was thrilled to tell her doctor how much better she was feeling and that she had noticed improvements in some of her symptoms, including less frequent bowel movements. By working with her gastroenterologist, Stephanie found a treatment plan to help manage her symptoms.

“I look forward to doing things like socializing with my friends and walking my dog,” Stephanie said.

Although her life may be different now, Stephanie believes that partnering with her doctor and persevering throughout her journey, even when things got challenging, were crucial factors in adjusting to life with UC. Her advice to others who may be in a similar situation?

“Anybody who's newly diagnosed with UC should know, it doesn't have to be the end of your world. You don't have to become your disease. If you feel like your symptoms aren't improving, or something isn't right, talk to your doctor and advocate for yourself.”

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

IMPORTANT SAFETY INFORMATION AND INDICATION

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

Before and after starting XELJANZ, tell your doctor if you have an infection or 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 with rheumatoid arthritis who have at least 1 heart disease (cardiovascular) risk factor and who are taking a higher than recommended dose of XELJANZ/XELJANZ XR. The recommended dose in patients with rheumatoid arthritis and psoriatic arthritis is XELJANZ 5 mg twice daily or XELJANZ XR 11 mg one time each day.

Cancer. 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, can happen. Tell your healthcare provider if you have ever had any type of cancer.

Higher dose. People 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).

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 patients with rheumatoid arthritis who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a higher than recommended dose of XELJANZ/XELJANZ XR. Blood clots in the lungs have also happened in patients with ulcerative colitis. Some people have died from these blood clots.

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

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

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

Changes in certain lab test results. Your doctor should do blood tests to check your white and red blood cells before 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
  • 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