(BPT) - Content sponsored and provided by Pfizer. Samantha partnered with Pfizer to share her experience living with moderate to severe ulcerative colitis (UC).
Samantha, an e-commerce marketer from California, was excited to celebrate a new chapter in her life as a mother. But soon after giving birth to her son she noticed blood in her stool. At the time, she thought it may have been a result of childbirth recovery. However, as Samantha began to use the bathroom more frequently and see blood in her stool each time, she realized something was not right.
She discussed these recurring symptoms with her doctor, who then referred her to a gastroenterologist for further testing and a colonoscopy. Her gastroenterologist diagnosed Samantha 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 can help manage UC symptoms, but do not cure UC.[i]
Samantha had never heard of the disease before her diagnosis and had no family history with the condition. It took her a while to fully come to terms with the fact that she would be living with UC for the rest of her life. 'There were moments when I was very overwhelmed,' she says. 'I wasn't sure if things were going to get better or if I was doing everything I needed to do to help improve my symptoms.'
Samantha worked with her gastroenterologist on a treatment plan and was prescribed several different medications over the years to help manage her symptoms of moderate to severe UC, including a tumor necrosis factor (TNF) blocker that eventually did not work well enough to manage her UC symptoms. Continuing to experience UC symptoms, Samantha often felt she needed to be close to a bathroom, and the thought of driving to work or attending her son's sporting events worried her.
'I was a single mom at the time, and I didn't want to disappoint my son,' she says. 'It was really difficult for me to feel like I couldn't take him to the park or play outside without looking for the closest bathroom.'
One day, Samantha was researching UC treatment options online and read about XELJANZ® (tofacitinib), an oral medication for adults with moderate to severe UC who have used 1 or more medicines called TNF blockers that did not work well or cannot be tolerated. She was interested in learning more about XELJANZ since it was an option available as a pill and asked her gastroenterologist about it as a potential treatment option.
Samantha's gastroenterologist reviewed the possible 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 or XELJANZ XR can cause serious side effects and can lower your ability to fight infections; don't start Xeljanz if you have an infection. Before and during treatment, your doctor should check for infections like tuberculosis, and do blood tests. Serious, sometimes fatal infections, cancers including lymphoma, and lung cancer, blood clots and serious heart-related events have happened. People 50 or older with heart disease risk factors had an increased risk of death. Tell your doctor if you had a heart attack, other heart problems, stroke or a history of blood clots.
Read more Important Safety Information and Indication below.
After Samantha was prescribed XELJANZ, she went online to learn more about XELSOURCE and potential savings options for which she may qualify. 'I like how easy the information is to navigate online,' she said.
Samantha began seeing improvements in her symptoms about a month after starting treatment on XELJANZ for her moderate to severe UC. She was going to the bathroom less frequently and had less blood in her stool. Samantha discussed her symptom improvement with her gastroenterologist at a follow-up appointment, expressing how happy she was to be feeling better.
'I look forward to cheering on my son at his sporting events, taking him to our favorite botanical garden, and going on walks with my dog and family,' she says.
With a busy life as a working mother, Samantha finds it helpful to create a predictable routine so she remembers to take XELJANZ every day as prescribed. She appreciates that XELJANZ is a pill and finds that keeping it next to her bed with a glass of water is a helpful reminder to take it first thing every morning before helping her son get ready for school.
By working with her gastroenterologist, Samantha was able to find a treatment option that works for her. She hopes that sharing her story will inspire others with moderate to severe UC to discuss their disease management plan with their doctors if they feel it is not working well enough for them.
'It's important to listen to your body, write down questions you may have to ask 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 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
- 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 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
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 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 starting and while you are taking XELJANZ. Your doctor should also check certain liver tests. You should not take 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®)
- ixekizumab (Taltz®)
- 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: 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 in people 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 tumor necrosis factor (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.
[i] Crohn's & Colitis Foundation. What is Ulcerative Colitis? https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/overview
PP-XUC-USA-2030 August 2022