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Narrator: What is GATTEX?

GATTEX (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children one year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). It is not known if GATTEX is safe and effective in children under one year of age.

What is the most important information I should know about GATTEX?

GATTEX may cause serious side effects, including making abnormal cells grow faster; polyps in the colon (large intestine), blockage of the bowel (intestines), swelling (inflammation), or blockage of your gallbladder or pancreas, and fluid overload.

Please see additional important safety information throughout this video.

Misa: When I was a little girl, I always wanted a Rhodesian Ridgeback, always. And now I have three beautiful Rhodesians. I find that we have something in common. They have a calmness about them. Raising and working with animals in general has always been my peace.

I was first diagnosed in those early teenage years when I just started, with Crohn's and colitis. My symptoms were excruciating pain. I mean, abdominal, crunched over, non-stop diarrhea. You start to question these things. You start to question why is this happening to me? Like, what did I do? You know, I'm only a teenager. I think at my lowest, lowest point I weighed about 87 pounds.

They would put me on some form of medication. My body didn't respond to treatments. Four or five years after the initial diagnosis they did a bowel resection and some strictureplasties. Three surgeries in, they did a total proctocolectemy, and that's what gave me my first ostomy. I have had more than 12 Crohn's and colitis related surgeries. When I heard from the doctor of my diagnosis of SBS, which is short bowel syndrome, that was a whole new open door. It's like somebody says, here, you don't have enough on your plate, take this.

I knew that short bowel syndrome was going to make me more malabsorbed. I was on parenteral support. The PS support that I was receiving was seven days a week of IV hydration with potassium. After talking to my healthcare team about treatment options that could help, my surgeon told me about GATTEX (teduglutide) a prescription medication for adults and children who are one year of age and older with SBS who need additional nutrition or fluids from IV feeding.

I wanted to learn more about GATTEX, so I talked to my doctor, and I looked for more information. I even attended a program that helped greatly. I learned about possible serious side effects. Together, we decided that treatment with GATTEX was right for me to start. A patient support manager from OnePath, a Takeda product support program, called me. They arranged for a nurse to come to my home and taught me everything I needed to know to properly administer GATTEX.

Fitting my GATTEX treatment into my schedule was important to me, so I worked with my doctor to figure out the right time of day to take it. I've also gotten the opportunity to help others with SBS through the SBS Connect mentor program, where I participate in one-on-one calls and share my story.

Since I have started GATTEX, me and my doctor are extremely pleased with where I am now today. I also feel more confident in managing my SBS. I have also been able to reduce my time on PS, which is important to me. I did experience some of the side effects. Redness around the injection site. I did have an occasional nausea, occasional bloating, distension in my abdomen. And I did communicate with my doctor. I made sure he knew all the time what was going on.

With the way I'm responding to GATTEX, I could never see myself not moving forward. There is hope out there to see my kids grow up, to strive and flourish. I don't know where I would be if I didn't have my dogs. I'm so appreciative for my life. To talk to other SBS patients like me, register for an SBS Connect call.

Narrator: GATTEX consumer adult and pediatric indication and important safety information. What is GATTEX? GATTEX (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children one year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

It is not known if GATTEX is safe and effective in children under one year of age. What is the most important information I should know about GATTEX? GATTEX may cause serious side effects, including making abnormal cells grow faster. GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer.

If you get cancer of the bowel (intestines), liver, gallbladder, or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX. Polyps in the colon (large intestine). Polyps are growths on the inside of the colon. Your healthcare provider will have your colon checked for polyps within six months before starting GATTEX and have any polyps removed.

Children and adolescents will be checked for blood in the stool before they start using GATTEX. To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the end of one year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every five years and have any new polyps removed. If cancer is found in a polyp, your healthcare provider should stop GATTEX.

Blockage of the bowel (intestines). A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell your healthcare provider right away if you have any of these symptoms of a bowel or stomal blockage, trouble having a bowel movement or passing gas, stomach area (abdomen) pain or swelling, nausea, vomiting, swelling and blockage of your stoma opening if you have a stoma. If a blockage is found, your healthcare provider may temporarily stop GATTEX.

Swelling (inflammation) or blockage of your gallbladder or pancreas. Your healthcare provider will do tests to check your gallbladder and pancreas within six months before starting GATTEX and at least every six months while you are using GATTEX. Tell your healthcare provider right away if you get stomach area (abdomen) pain and tenderness, chills, fever, a change in your stools, nausea, vomiting, dark urine, yellowing of your skin or the whites of your eyes.

Fluid overload. Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing. The most common side effects of GATTEX in adults include stomach area (abdomen) pain or swelling, nausea, cold or flu symptoms, skin reaction where the injection was given, vomiting, swelling of the hands or feet, allergic reactions.

The side effects of GATTEX in children and adolescents are similar to those seen in adults. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

What should I tell my healthcare provider before using GATTEX? Tell your healthcare provider about all your medical conditions, including if you or your child have cancer or a history of cancer; have or had polyps anywhere in your bowel (intestines) or rectum; have heart problems; have high blood pressure; have problems with your gallbladder, pancreas, kidneys; are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using GATTEX. Are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. You should not breastfeed during treatment with GATTEX. Talk to your healthcare provider about the best way to feed your baby while using GATTEX.

Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other, causing side effects. Your other healthcare providers may need to change the dose of any oral medicines (medicines taken by mouth) you take while using GATTEX.

Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine. Call your doctor for medical advice about side effects. 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. For additional safety information, see link to full Prescribing Information and Medication Guide and discuss any questions with your doctor.

Bree: Liam is nine going on thirty some days. He's very sassy. I say sassy because I feel like I rubbed off on him. He loves baseball, soccer and is even getting his blackbelt in karate. Liam has also been living with Short Bowel Syndrome, SBS, since he was very young. It's been colostomy bags, G Tubes, and surgery after surgery. Our hope is for Liam to live his life like any other nine-year-old boy.

It's been an uphill battle since my pregnancy, which was high risk. We found out at sixteen weeks that there was a mass by the umbilical cord. We finally got the results that he would be born with gastroschisis. I was nervous, I was scared. I did all the research I could. There's an abdominal wall defect during utero. The baby does not have their intestines inside their body. He eventually stopped growing.

He was born early. He had to get surgery done that first night and in the morning is when we finally met. Liam stayed in the NICU for three months. They later found his bowel was swollen and wrapped around a blood vessel. They would have to remove it. Because of his SBS, he would have to use a colostomy bag and a G Tube was inserted for feeding. He was transferred to a general pediatric floor. And there he would be spending 2 months of his life before he could finally come home.

We had to learn everything on the spot so that we could care for him. Outside of our medical team, we were now on our own. He was getting his nutrition from PS or Parenteral Support. As well as nutrition through his G Tube. It was a guessing game trying to figure out what formula he could tolerate without throwing up. And I was getting frustrated, and my son was exhausted.

When Liam was a bit older, his doctor told us about GATTEX®. We didn't know how it would affect him and we wanted to make sure that this was the right move for him, the right decision.

GATTEX is indicated for the treatment of patients 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support (PS). After discussing some of the possible side effects with GATTEX, we agreed to move forward with the treatment.

A nurse came and showed us how to administer the infusion. She taught Liam and me everything we needed to know to properly administer GATTEX. And now it's become an everyday routine. Working closely with his doctor, we have seen results that make a big difference. When first diagnosed there was a point where he spent 14 hours a day, seven days a week receiving PS.

After working closely with our doctor to monitor his condition and sometime after starting GATTEX, Liam was able to reduce his weekly volume and eventually completely wean off of PS. This time off PS gave him freedom to do more of what he loves. He must be mindful of what he eats, and we work closely with his doctor who provides guidance and help whenever needed.

Narrator: GATTEX may cause serious side effects including: making abnormal cells grow faster, polyps in the colon, blockage of the bowel, swelling or blockage of your gallbladder or pancreas and fluid overload. For more information on these serious side effects, please watch until the end of the video.

The most common side effects of GATTEX include: pain or swelling in the stomach area, nausea, cold or flu symptoms, skin reaction where the injection was given, vomiting, swelling of the hands or feet and allergic reactions. These are not all the possible side effects of GATTEX. Tell your healthcare provider if you have any side effect that bothers you or does not go away.

Tell your healthcare provider about all your medical conditions, including if you or your child: have cancer or a history of cancer, have or had polyps anywhere in your bowel or rectum, have heart problems, have high blood pressure, have problems with your gallbladder, pancreas, kidneys, are pregnant or planning to become pregnant, are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with GATTEX. Please watch until the end of the video for additional Important Safety Information.

Bree: Liam, Liam loves to learn. He’s daring. He’s brave. For a nine-year-old, I feel he's been through way more than most people can imagine. Thinking about SBS all the time, that was our focus, and it’s still our focus, but he's just a loving and affectionate kid who's still trying to figure out where he fits in the world. We are so thankful that GATTEX was a treatment option that worked for him.

To talk to other SBS caregivers like me, register for an SBS Connect call. Please watch until the end of the video for additional Important Safety Information. For the Full Gattex Prescribing Information including the Medication guide, visit www.gattex.com. Talk to your doctor.

Narrator: GATTEX consumer adult and pediatric indication and important safety information. What is GATTEX? GATTEX (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children one year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support).

It is not known if GATTEX is safe and effective in children under one year of age. What is the most important information I should know about GATTEX? GATTEX may cause serious side effects, including making abnormal cells grow faster. GATTEX can make abnormal cells that are already in your body grow faster. There is an increased risk that abnormal cells could become cancer.

If you get cancer of the bowel (intestines), liver, gallbladder, or pancreas while using GATTEX, your healthcare provider should stop GATTEX. If you get other types of cancers, you and your healthcare provider should discuss the risks and benefits of using GATTEX. Polyps in the colon (large intestine). Polyps are growths on the inside of the colon. Your healthcare provider will have your colon checked for polyps within six months before starting GATTEX and have any polyps removed.

Children and adolescents will be checked for blood in the stool before they start using GATTEX. To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the end of one year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every five years and have any new polyps removed. If cancer is found in a polyp, your healthcare provider should stop GATTEX.

Blockage of the bowel (intestines). A bowel blockage keeps food, fluids, and gas from moving through the bowels in the normal way. Tell your healthcare provider right away if you have any of these symptoms of a bowel or stomal blockage, trouble having a bowel movement or passing gas, stomach area (abdomen) pain or swelling, nausea, vomiting, swelling and blockage of your stoma opening if you have a stoma. If a blockage is found, your healthcare provider may temporarily stop GATTEX.

Swelling (inflammation) or blockage of your gallbladder or pancreas. Your healthcare provider will do tests to check your gallbladder and pancreas within six months before starting GATTEX and at least every six months while you are using GATTEX. Tell your healthcare provider right away if you get stomach area (abdomen) pain and tenderness, chills, fever, a change in your stools, nausea, vomiting, dark urine, yellowing of your skin or the whites of your eyes.

Fluid overload. Your healthcare provider will check you for too much fluid in your body. Too much fluid in your body may lead to heart failure, especially if you have heart problems. Tell your healthcare provider if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing. The most common side effects of GATTEX in adults include stomach area (abdomen) pain or swelling, nausea, cold or flu symptoms, skin reaction where the injection was given, vomiting, swelling of the hands or feet, allergic reactions.

The side effects of GATTEX in children and adolescents are similar to those seen in adults. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

What should I tell my healthcare provider before using GATTEX? Tell your healthcare provider about all your medical conditions, including if you or your child have cancer or a history of cancer; have or had polyps anywhere in your bowel (intestines) or rectum; have heart problems; have high blood pressure; have problems with your gallbladder, pancreas, kidneys; are pregnant or planning to become pregnant. It is not known if GATTEX will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using GATTEX. Are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. You should not breastfeed during treatment with GATTEX. Talk to your healthcare provider about the best way to feed your baby while using GATTEX.

Tell your healthcare providers about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. Using GATTEX with certain other medicines may affect each other, causing side effects. Your other healthcare providers may need to change the dose of any oral medicines (medicines taken by mouth) you take while using GATTEX.

Tell the healthcare provider who gives you GATTEX if you will be taking a new oral medicine. Call your doctor for medical advice about side effects. 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. For additional safety information, see link to full Prescribing Information and Medication Guide and discuss any questions with your doctor.