FREQUENTLY ASKED QUESTIONS

What is short bowel syndrome (SBS)?

SBS is a rare, serious, and chronic intestinal disorder. There are many causes of SBS. It can occur after part of the intestine is surgically removed because of disease or injury. Some people are born with conditions that require surgery that leads to the removal of the intestine. SBS prevents the body from absorbing nutrients, water, and electrolytes effectively—a condition called malabsorption. Learn more.

What is parenteral support (PS)?

Parenteral support (PS) is any kind of nutrition and/or fluids that are given through a vein (intravenously). Since SBS increases the risk of malnutrition, dehydration, and electrolyte disturbances, doctors often prescribe a form of parenteral support. Based on personal needs, PS can include a mix of ingredients, such as proteins, carbohydrates, fats, vitamins, and minerals. Although PS is a life-saving intervention, long-term use of PS has been linked to kidney and liver issues as well as other health complications. It’s important to discuss long-term treatment expectations and impacts with your healthcare provider. Learn more about PS and SBS management.

What is GATTEX?

GATTEX® (teduglutide) for subcutaneous injection is a prescription medicine used in adults and children 1 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 1 year of age. Learn more here.

Who is GATTEX right for?

GATTEX is for people 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support (PS). It is not known if GATTEX is safe and effective in children under 1 year of age.

The GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg. Use this questionnaire to discuss with your doctor if GATTEX could be right for you or your child.

Can I take GATTEX if I have kidney problems (renal impairment)?

For adults and children with moderate or severe kidney problems, including advanced kidney disease, the recommended amount of GATTEX is 0.025 mg/kg once a day. Consult your doctor to see if GATTEX is appropriate for you.

What could be possible with GATTEX?

GATTEX has been clinically proven to reduce both the volume and duration of parenteral support (PS). For some people, it has even led to complete independence from PS. This could mean more time to focus on the activities you enjoy with less time spent on infusions. Explore results from real adult patients and real pediatric patients or hear from some of the people it’s helped.

In a 6-month study, 27 out of 43 adults treated with GATTEX reduced weekly PS volume by 20% or more vs 13 out of 43 on placebo, and 21 out of 39 achieved at least 1 day off PS per week vs 9 out of 39 on placebo. In a 24-month extension study, 10 out of 30 adults previously on GATTEX no longer needed PS after 30 months of treatment.

In a 6-month trial, pediatric patients treated with GATTEX reduced weekly PS volume by ≥20% (18/26), achieved a reduction of ≥1 day off PS per week (10/26), and weaned off PS completely (3/26).

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

How long does it take to see results?

Every patient is different and the time it takes to reduce weekly PS volume can vary. Explore results in adults. See results in children. These links provide information from clinical studies in adults and children. In addition, tracking treatment is an excellent way to keep an eye on your own results or the results of someone you’re caring for who is taking GATTEX.

What might success look like?

Success looks different for each individual, but for some, managing their SBS may mean:

• Reduce or even eliminate the need for PS
• Maintain proper nutrition and hydration
• Enhance nutrient and fluid absorption
• Improve sleep, work, and social routines

To hear real stories from some of the people GATTEX has helped and their experiences navigating the ups and downs of SBS, visit our Support and Resources page, where you can also find out about the mentorship program SBS Connect. SBS Connect is a program to talk with real people with SBS.

What are the side effects of GATTEX?

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

In clinical studies of adults, the most common (≥10%) side effects of GATTEX were:

• 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 pediatric patients are similar to those seen in adults.

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Is insurance support available?

Yes, insurance support is available. There is also a co-pay program where eligible, commercially insured patients could pay as low as $0 for treatment. Additional terms and conditions apply. Find out more here.

Why are treatment goals important?

Pursuing goals can be a key part of managing treatment. Takeda Patient Support specialists and members of your care team can assist you in identifying areas that may need adjustments, and noting topics to discuss with the doctor. Tracking treatment is an excellent way to monitor progress toward goals while on or caring for someone on GATTEX.

What if I’m concerned about performing the injections? How do I know if I did it right?

Before beginning GATTEX, each patient or caregiver can receive injection instruction from a healthcare professional. This can be in-person or virtual. GATTEX also provides Instructions for Use here and an instructional injection video here. Patients and caregivers can also find an injection guide in the welcome kit provided by Takeda Patient Support. If you still have questions about how to inject GATTEX, reach out to your Takeda Patient Support contact for additional support.

What might my care team look like?

Though every care team may be different, a care team for treating short bowel syndrome could include:

• Primary healthcare provider
• Gastrointestinal surgeon
• Gastroenterologist
• Dietitian
• Parenteral support and/or GATTEX pharmacist

Your care team may include a number of other healthcare professionals.

How do I store GATTEX?

Store GATTEX 5 mg kits at room temperature up to 77 °F (25 °C).

• Do not freeze GATTEX
• Use the GATTEX powder by the expiration date on the “Use By” sticker on the kit
• Use GATTEX within 3 hours after mixing it
• Throw away any unused GATTEX that has been mixed, even if there is medicine left in the vial
• Do not store any GATTEX you have mixed

What might a GATTEX routine look like?

In building your personal routine, here are a few things to consider:

• GATTEX is taken once daily as an injection
• Rotate the injection site; do not inject in the same spot as the day prior
• Create a specific time to inject
• Build an activity into your treatment routine
  • Watch a certain show
  • Listen to a podcast or music

These tips can help a daily injection feel more like a natural part of daily life. You can also check out SBS Connect, a mentorship program through GATTEX, to speak with someone who has personal experience with GATTEX. Learn more about injection and how to properly store GATTEX here.

Is there a GATTEX mentorship program?

Yes, there is. You can explore SBS Connect and talk with adults or caregivers who have personally experienced short bowel syndrome (SBS) and what it’s like to be dependent on parenteral support (PS). Connect with a mentor to share relatable experiences and stories, talk one on one, and receive peer support.

With SBS Connect, you can discuss:

• Day-to-day life with SBS
• Experiences with SBS treatment
• How caregivers provide support
• Setting personal treatment expectations

Discover more.

What happens if I miss a dose of GATTEX?

If you miss a dose, take it as soon as you remember that day. Take your next dose the next day at the same time you take it every day. Do not take 2 doses on the same day. If you use more than 1 dose, call your healthcare provider right away.

Are there medicine interactions I should know about with GATTEX? What should I avoid while taking GATTEX?

Based upon the effect of GATTEX on the body, there is a potential for increased absorption of oral medications taken at the same time. In addition, altered mental status has been observed in patients taking GATTEX and benzodiazepines in the adult clinical studies. Before starting GATTEX, tell your doctor if there are any other medications that you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, to avoid any potential interactions. 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.

Before using GATTEX, tell your healthcare provider if you are pregnant or plan to become pregnant. Tell your healthcare provider right away if you become pregnant while using GATTEX. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby while using GATTEX. Breastfeeding is not recommended during treatment with GATTEX.

What about traveling while on GATTEX?

You are free to travel if your doctor gives you or your child with SBS the okay to do so. The GATTEX Welcome Kit, provided to people starting GATTEX, contains a printable TSA letter to have signed by your doctor. This can help you to carry the necessary materials such as needles and the medication itself on planes. Reach out to Takeda Patient Support if you did not receive a Welcome Kit or if you need a replacement.

Can I breastfeed while on GATTEX?

Before using GATTEX, tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if GATTEX passes into your breast milk. Breastfeeding is not recommended during treatment with GATTEX.

Talk to your healthcare provider about the best way to feed your baby while using GATTEX.

I’m having a difficult time administering GATTEX to my child. What can I do?

Consulting with your pediatrician or care team is always recommended. There is also a community of SBS mentors that have faced many of the same obstacles who are willing to share what works for them.

How can I help if my child complains of discomfort?

Caring for a child with SBS, especially one that might not be able to communicate yet, can be challenging. Reach out to your pediatrician for assistance. There is also a community you can join that’s always ready with support.