|Gattex® (Teduglutide [rDNA origin]) for Injection
Gattex® (teduglutide [rDNA origin]) for injection is the first prescription medicine for the long-term treatment of adults with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
It’s important to remember that individual results may vary and that you should talk with your doctor about whether Gattex is right for you.
In clinical studies, about six months after starting Gattex, patients, on average, reduced their parenteral support use by 4.4 liters per week compared to 2.3 liters with placebo. Some were even able to stop parenteral support altogether.
Gattex is not approved for the treatment of pediatric SBS patients. Visit our Pipeline page to learn more about the study of teduglutide.
Devera checked into the hospital for a routine operation. Eight surgeries later, she was diagnosed with Short Bowel Syndrome. Watch her story.
Text on screen: See how Devera is managing her Short Bowel Syndrome. [Link to full video at Gattex.com.]
NPS Advantage is our support program that assists patients and healthcare providers in overcoming challenges that may prevent access to NPS Pharma therapies, including:
Aside from a clinical trial, a drug typically may not be distributed prior to its approval by government regulators, such as the US Food and Drug Administration or European Medicines Agency. However, there are rare exceptions for select patients with serious or immediately life-threatening diseases who have no comparable or suitable treatment alternatives. When this situation occurs in the US, FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial2. Similarly, in the EU, Named Patient (or Compassionate Use) Programs create access to particular treatments prior to marketing authorization for patients with life-threatening, chronic or seriously disabling conditions. Compassionate use programs are coordinated and implemented by the EU Member States, which decide independently how and when to open such programs according to national rules and legislation.3
|Medical Information Requests
If you are a healthcare professional seeking additional information, please click here to access our
medical request form. To report suspected side effects, contact NPS Pharmaceuticals at 1-855-5GATTEX (1-855-542-8839) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If you are a medical professional looking for information about our clinical trials, please visit our Healthcare Practitioners section, which also contains information about investigator-initiated trials, our patient registries, and educational support. [Link to Healthcare Practitioners section.]
|Important Safety Information
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)
To keep using GATTEX, your healthcare provider should have your colon checked for new polyps at the end of 1 year of using GATTEX. If no polyp is found, your healthcare provider should check you for polyps as needed and at least every 5 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)
If blockage is found, your healthcare provider may temporarily stop GATTEX.
Swelling (inflammation) or blockage of your gallbladder or pancreas
Increased absorption of concomitant oral medication
The most common side effects of GATTEX include:
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 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 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. To report suspected side effects, contact NPS Pharmaceuticals at 1-855-5GATTEX (1-855-542-8839) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This page is intended for US residents only.
|Kathryn has three feet of small intestine, which does not allow her to absorb the nutrients she needs to live.