Use of Teduglutide (Revestive) in adult patients

Introduction

This leaflet is for adult patients with short bowel syndrome (SBS) who are being treated or considered for treatment with teduglutide, also known by the brand name Revestive. The aim of this patient information leaflet is to outline the use, benefits and possible disadvantages of teduglutide to enable patients to make an informed decision about their treatment.

What is Teduglutide?

Teduglutide acts like a hormone naturally produced by the body and it may reduce or stop the need for parenteral nutrition by increasing the ability of the small bowel to absorb fluids and nutrients.

Teduglutide is used in a specific way and patients must be carefully monitored. It has been approved for use by the National Institute for Health & Care Excellence (NICE) in patients who:

• are on PN three or more days a week for at least 2 years
• have not had cancer in the last five years
• do not have any active disease (for example inflammatory bowel disease, fistulae).

Patients may not be suitable if they have recently had surgery or are expected to have bowel surgery soon.You may be required to have a gastroscopy and/or a colonoscopy before starting your treatment with teduglutide. This is to detect and remove any polyps in your bowel. A CT scan of your abdomen and pelvis may also be performed before or within three months of starting treatment. Initially you will need to be reviewed regularly (either virtually or face to face), this is to advise and guide you through any side effects caused by the changes in your body, and to monitor any required changes to your PN. As treatment progresses the frequency of attending clinics and reviews will be reduced as you become more stable on the new drug.

Like your parenteral nutrition, Teduglutide will be prescribed by CUH.

How you are given Teduglutide

Teduglutide is a subcutaneous (below the skin) injection given once a day.

Teduglutide is a white powder in a glass vial that needs to be mixed with water for injection from a pre-filled syringe. You will receive training on how to mix them together and give the injection by a homecare company nurse.

Being on teduglutide requires close monitoring, especially in the first 6 weeks of treatment. Therefore, this will take some of your time, and you should plan for this.

In addition, you will be required to have regular tests including blood and urine. If you do not agree to these tests, we will not be able to safely prescribe Teduglutide for you.

Benefits to you

Up to two thirds of patients have found that they are able to reduce the volume of PN they need, or they have reduced the number of nights per week that they require PN. Patients have reported that reducing the number of nights they need PN has improved their quality of life. If you respond well to tteduglutide, you will need to continue taking it for the long-term.

Risks to you

Some people have side effects from the drug:

• Gastro-intestinal symptoms include abdominal pain, nausea or vomiting, protrusion of stoma (your stoma bag size may need to be changed)
• Injection site reactions from the daily injections
• Fluid retention (if you respond to the drug, you will need less PN)
• Pancreatitis
• Cold or flu symptoms
• If you experience side effects from the drug, we may decide to reduce the dose or stop the drug. Your doctor will discuss this with you.

As teduglutide can affect the growth of cells there may be an increased risk of gastrointestinal cancer if you take the drug. However, whilst on Teduglutide you will be closely monitored once a year with a colonoscopy or scan during the first two years of treatment. Further information about the drug is included in the link below. If you have any questions, you can also ask your medical team.

When should teduglutide be stopped?

• If you develop any malignancy
• If you develop recurrent bowel obstruction episodes requiring hospital admission
• If your parenteral support is not sufficiently reduced as a result of taking the drug. We would be expecting at least a 20% or 1-day per week reduction in parenteral support after 6-12 months of treatment. If that is not the case, the drug will be stopped.
• There is little information available regarding the safe use of teduglutide in pregnancy and/or lactation, therefore teduglutide should be avoided during pregnancy and breastfeeding.

Patient responsibilities

To ensure safety, patients taking teduglutide are expected to:

• Undertake a daily injection
• Have blood tests taken as requested
• Collect urine when needed
• Have colonoscopy or imaging as required
• Fill in a patient diary
• Report any problems or side effects as soon as possible
• Attend telephone review and clinic appointments

Alternatives

The alternative to treatment with Teduglutide is to continue with your current treatment for short bowel syndrome. This usually consists of supportive therapy with parenteral nutrition and or fluids and medications such as Loperamide and oral rehydration therapy.

Contacts/ Further Information

Patient information for teduglutide from the PINNT website. (opens in a new tab)

Takeda brochures

Starting on teduglutide (Revestive®) brochure will be provided.

References/ Sources of evidence

Special thanks to Newcastle NHS Trust for allowing us to adapt their protocol for use.