Patient Stories

Sheila:
Some people are afraid of needles or injections.

I wouldn't be nervous about the infusion, um, it's, it's not hard.

Dan:
Yeah, it's not that scary. Uh, you go, and you get the line in, and um after the IV line's in and the, the bag's hooked up, it just takes about 30 minutes and the infusion center I went to, they had a little TV... so I was able to watch the news when I was getting my infusion done.

Kate:
Sometimes you end up meeting people who happen to be there at the same time... and it's nice to see those familiar faces again. I made a friend who had Crohn's disease... and we would actually be infusion buddies. So we would schedule our infusions at the same time and then go have lunch together.

Ron:
So you, you do have to go in for infusions every eight weeks... and that, that little bit of fear and anticipation of having to go in and have a needle stuck in you... The advice is... it's all worth it... If this medication works for you, it's worth it.

ENTYVIO is a prescription medicine used in adults with moderately to severely active ulcerative colitis or Crohn's disease when certain other medications have not worked well enough or cannot be tolerated.

Important Safety Information about ENTYVIO^® (vedolizumab)

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
• Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see accompanying full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO^® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis
• moderately to severely active Crohn's disease

VO:
ENTYVIO (vedolizumab) is a prescription medicine used to treat adults with moderately to severely active ulcerative colitis or Crohn's disease.

Dan:
The first thing I do on an infusion day is make a cup of coffee and then I start to get ready for my ENTYVIO treatment.

Jen:
It takes me about 30 minutes to drive to my infusion center. I use the time to transition from my busy life and relax mentally.

Dan:
I get my ENTYVIO at-home infusion kit and my collapsible IV pole out from underneath my bed where I store them.

Jen:
When I walk through the infusion center door, I'm always greeted by smiling faces. The staff treats me like family.

Dan:
I take my ENTYVIO dose out of the refrigerator and I lay everything on the table so that it's ready to go.

Jen:
I'm escorted down the hall to my own private room and the nurse ensures I have everything I need to feel comfortable.

Dan and Jen (simultaneously):
I sit down in my chair, and I'm ready to receive my infusion.

Dan:
I'm Daniel. I've been living with moderate to severe ulcerative colitis since 2006. I like to stay as active as I possibly can, and I always knew that I would need a treatment plan and a management plan that would work well with my active lifestyle.

Jen:
I'm Jen, and I was diagnosed with Crohn's disease in 2001 and ulcerative colitis in 2017. I'm a mother of two children, and they're my world. I knew I needed to be my own best advocate and find options that work with my schedule.

Cassidy:
I'm Cassidy and I'm a nurse working with patients receiving infusion therapies. Infusions can be unfamiliar and seem scary at first. It is important that patients know their options and what the infusion process can look like.

Cassidy:
Some of these infusions can be administered here at an infusion center…

Cassidy:
…or here in the patient's home. It is my job as an infusion nurse to ensure that patients receive the same quality of care regardless of their infusion setting.

Jen:
My doctor prescribed me ENTYVIO to treat my moderately to severely active Crohn's disease when other options weren't working.

We talked about the potential serious side effects, as well as common side effects including common cold, headache, joint pain and nausea.

These are not all the side effects of ENTYVIO.

My doctor also talked to me about the importance of monitoring for any side effects and working with my healthcare team to manage them.

After prescribing ENTYVIO, my doctor and I felt it would be right for me to receive my infusions at a center.

We looked into different infusion centers in my area and found one that was right for me.

My doctor's office set up my first appointment and together we completed my initial paperwork.

Dan:
For about two years, I had been receiving my ENTYVIO infusions at the hospital to treat my moderate to severe ulcerative colitis.

This followed an induction period to help me start ENTYVIO. When starting ENTYVIO, my healthcare provider told me about the potential serious side effects including infusion-related and serious allergic reactions, increased risk of getting a serious infection, PML in people with weakened immune systems, and liver problems.

When my insurance provider switched my treatment so that I would receive at-home infusions, I was hesitant at first. My provider helped me to arrange getting my medication delivered to me in the mail.

Soon I realized how easy the process could be, and how easy it was for me to not have to leave my home to get my infusion.

Cassidy:
The team of nurses at an infusion center work together to provide continuous care to our patients.

My patients like having access to all the inperson resources available in the infusion center, such as pharmacists, treatment consultants, and planners.

Jen:
Although I was nervous at first about possible complications with my infusion process, the atmosphere at the infusion center quickly put my mind at ease.

It's nice to know that I'm in a fully equipped medical center with a skilled clinical team should any challenges occur during my ENTYVIO infusions.

I know that there are strict protocols in place to provide a sterile and safe environment.

Cassidy:
At-home infusions provides patients a way to receive their treatment who otherwise would not have had access to an infusion center.

A visiting nurse in an at-home setting works to provide patients with the same resources over the phone that they otherwise would have access to in the infusion center, for example, answering patients' questions about their treatment.

Dan:
Any concerns I had about arranging the logistics of getting my ENTYVIO infusion at home are long gone.

I've had the same nurse since I started my at-home ENTYVIO infusions.

When she arrives, she disinfects her work area and prepares my medication.

During the 30 minutes that it takes to actually get the infusion, my nurse will monitor me during that time, and we'll also talk about each other's lives. After my infusion is done, my nurse will monitor me just to make sure there's no complications.

Jen:
I like that every aspect of my infusion is taken care of by my nurse at the infusion center.

During my infusion, I just sit back and mentally unwind. I'm grateful for the little breaks that my visits to the infusion center give me to decompress from my hectic life as a mother.

My nurse monitors me after my infusion, then afterwards, I just get up and go. I'm lucky that my infusion center handles all of my insurance paperwork. I don't have to worry about a thing.

Dan:
I've found that the ENTYVIOConnect program can be a great support system. It's available even when my infusion nurse can't be. They can help guide me through my treatment journey, navigate insurance coverage questions, and remind me of upcoming treatments. They help ease the stress of managing my at-home infusions.

This is just my experience, but each patient's experience may be different.

Dan and Jen (simultaneously):
My ENTYVIO infusion setting is right for me.

Important Safety Information

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
  • Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
  • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
  • People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
  • Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see accompanying full Prescribing Information, including the Medication Guide for ENTYVIO at ENTYVIO.com and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Ron:
So, this is the... this is the first medication that I ever went on that was an infusion. Um, others were injections or oral. I had no expectation of... of... you know, returning to what we'll call before the disease, um, but was hopeful that it would at least reduce the symptoms.

Dan:
After being on ENTYVIO for two to three months, I knew something was changing. It wasn't anything I could notice on a daily basis... but when I had looked back to when I started the medication...

I looked... said, "Hey I just drove by the restroom on a three-hour road trip here and I didn't even think about stopping. That hasn't happened before." It was kind of at that time I could tell things were different.

Kate:
Mine was really, um, a gradual climb. It was not immediate, it was not overnight, but it definitely after a couple of months, I was noticing that I was feeling much better and my symptoms were much, uh, much lighter than they had been before. I noticed I was, uh, using the bathroom less and less, um, and yeah, it was, it was nice.

Sheila:
I mean, you have to laugh at yourself... your parents tell you that when you're little, if you slip and fall just laugh it off, get up.

And I think it's the same thing for me with this disease and getting through it... even in remission, things don't always act normal, you still have an underlying chronic condition.

Don't let it define you, don't let it stop you, don't let it upset you, it is what it is and let's just move to the next step.

Ron:
And to not be chained to a bathroom anymore is just you know really been liberating... um... just really amazing.

ENTYVIO is a prescription medicine used in adults with moderately to severely active ulcerative colitis or Crohn's disease when certain other medications have not worked well enough or cannot be tolerated.

Important Safety Information about ENTYVIO^® (vedolizumab)

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
• Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see accompanying full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO^® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis
• moderately to severely active Crohn's disease

Ron:
It's really critical to find a doctor that's willing to be a partner with you. He understands the medical side, you understand your body side.

Kate:
If something is working for you then I would say stay the course, if, as long as you and your doctor are satisfied with things. Um, but if your symptoms are starting to, uh, worsen, I would say certainly talk with your doctor and, and if your doctor doesn't have the answer, there's no harm in getting a second opinion.

Jen:
So I have met some patients who are, have been with the same GI since diagnosis and if it's not the right fit and you don't, you can't have your own voice and you can't, you know, bounce ideas and, and say, what about this and suggest things in your own health journey, you have to take the initiative.

Dan:
After seven years of trying the same old, same old and feeling the same way, I decided that it was time for a change.

I went to my doctor and I said look... there has to be an option that will work for me.

Sheila:
So we went through over a decade of me trusting the doctor to do what's best for me.

And it was always a mutual decision, he'd never just told me to do this or told me to do that. I was lucky that I had a very, very good doctor who talked to me, and was able to recommend ENTYVIO for me.

ENTYVIO is a prescription medicine used in adults with moderately to severely active ulcerative colitis or Crohn's disease when certain other medications have not worked well enough or cannot be tolerated.

Important Safety Information about ENTYVIO^® (vedolizumab)

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
• Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see accompanying full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO^® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis
• moderately to severely active Crohn's disease

Kate:
I think it's important to tell new people... that A, it's not your body's fault, it's not your fault for what's happening to you. And B, to get as much support as you can, whether that takes the form of a support group in person, if there is one local to you, or online.

Sheila:
So if you don't face the reality of it, then you can't get past it. You have to be able to admit to yourself, did I really just go to the bathroom ten times in the last five hours? And I have to talk about this. I have to get to that next place that says, how do I not have that happen, and where do I go from here?

Dan:
My best advice is just share your story with someone else and let them encourage you to, to kind of find that courage from within and take that first step. For me that was a bit of a mind shift to learn to be my own advocate and to really push for the best healthcare that I could get.

Ron:
We're all unique and we, we need to really to get to know our body because the doctor, he doesn't know your body. He's got all these opportunities to try different things but he doesn't know your body in particular, so you have to help educate him. And, you know, it's really critical to find a doctor that's willing to be a partner with you.

Sheila:
Focus on what you can control. And that is your medication... communication with your doctor.

Kate:
Humor has been an, a really important, um, when I tell my story I sometimes end it by saying that um, you know laughter really is the best medicine. And it has been for me and I'm grateful to be able laugh at things now.

ENTYVIO is a prescription medicine used in adults with moderately to severely active ulcerative colitis or Crohn's disease when certain other medications have not worked well enough or cannot be tolerated.

Important Safety Information about ENTYVIO^® (vedolizumab)

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
• Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see accompanying full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO^® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis
• moderately to severely active Crohn's disease

Sheila:
It's nice to have someone to talk to, and that can be in a lot of different forms... I was very lucky in that my husband was very, my boyfriend at the time, he didn't run away. But, it also helped to seek out, um, either a support group or someone else to talk to so that you can have someone else that can relate to the everyday struggles.

Dan:
You need to talk about it. For me, being a young male, it wasn't a comfortable conversation for me to have when I was first diagnosed, but part of my journey was learning to talk about my ulcerative colitis.

Ron:
You'll be surprised at how many people around you actually have the same or similar issues but are afraid to talk about it. And because I was open and honest with people, they were well then willing to talk about it too.

Kate:
If you can find someone with Crohn's or colitis, um, and you will find that your journeys, even though they may be wildly different in some ways will, will probably have some similar threads and hopefully you can help each other out with, uh, with that journey.

Jen:
My mom has been there for every needle poke, she's held my hand throughout everything and she's phenomenal but it's, it's meeting others who have this and feeling okay, I'm not alone. I'm not, you know, there's more, it's strength in numbers.

ENTYVIO is a prescription medicine used in adults with moderately to severely active ulcerative colitis or Crohn's disease when certain other medications have not worked well enough or cannot be tolerated.

Important Safety Information about ENTYVIO^® (vedolizumab)

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
• Infusion-related and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
• ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
• People with weakened immune systems can get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). Although unlikely while receiving ENTYVIO, a risk of PML cannot be ruled out. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
• Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see accompanying full Prescribing Information, including the Medication Guide, for ENTYVIO and talk with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Uses of ENTYVIO^® (vedolizumab)

ENTYVIO is a prescription medicine used in adults for the treatment of:

• moderately to severely active ulcerative colitis
• moderately to severely active Crohn's disease