Gattex

Gattex is used to treat Short Bowel Syndrome (SBS) in adults and children aged 1 year and older who rely on parenteral (intravenous) nutritional support. Gattex is given as a once-daily injection under the skin (subcutaneous). It works by improving the intestine's ability to absorb nutrients and aims to reduce or eliminate dependence on IV nutrition.

Before prescribing Gattex, healthcare providers are required to complete educational training and a knowledge assessment as part of the Gattex Risk Evaluation and Mitigation Strategy (Gattex REMS) program.

This ensures providers can properly inform patients and caregivers about the following potential risks:

• Tumor and polyp growth. Gattex may accelerate the growth of existing tumors or promote polyp development
• Gastrointestinal obstruction (a blockage in the digestive tract)
• Biliary and pancreatic disorders (conditions affecting the gallbladder, bile ducts, or pancreas).

Gattex (teduglutide) gained FDA approval on December 21, 2012. There is no generic.

Use Gattex exactly as your healthcare provider tells you to.

• Your healthcare provider or nurse should show you how to prepare, measure your dose, and give your injection of Gattex. Self-administration is not recommended in pediatric patients.
• Gattex comes as a 5 mg kit. Use of the Gattex kit is not recommended in pediatric patients weighing less than 22 pounds (10 kg).

Gattex is given 1 time each day, at the same time of day.

• Inject your dose of Gattex under the skin (subcutaneous injection) in your stomach area (abdomen), upper legs (thighs), or upper arms. Do not inject Gattex into a vein or muscle.
• Use a different injection site each time you use Gattex.
• Gattex comes as a powder for injection in a vial that is used only 1 time (single-dose vial). The powder must be mixed with Sterile Water for Injection (a diluent) provided in a prefilled syringe before you inject it.
• Gattex must be injected within 3 hours after you mix it with the diluent.

Read the Instructions for Use for detailed instructions for preparing and injecting a dose of Gattex

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, or kidneys.
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

It is not known if Gattex is safe and effective in children under 1 year of age. Use of the Gattex kit is not recommended in children < 10 kg (22 lb).

Pregnancy

It is not known if Gattex will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while using Gattex.

Breastfeeding

It is not known if Gattex passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby.

Common Side Effects

The most common side effects of Gattex injection in adults and children are:

• Stomach area (abdomen) pain or swelling
• Nausea
• Cold or flu symptoms
• Skin reaction where the injection was given (such as redness, pain, swelling, itching, or hives)
• Vomiting
• Swelling of the hands or feet
• Allergic reactions.

Serious Side Effects and Warnings

Gattex may cause the following serious side effects:

• 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 Intestines. Polyps are growths on the inside of the intestines. Some polyps can be precancerous or cancerous. Before you start Gattex, your healthcare provider will: Adults: Have your colon and upper intestines checked for polyps within 6 months before starting Gattex, and remove any polyps if found Pediatrics: Check for blood in the stool within 6 months before starting Gattex. If there is blood found in the stool, have your colon and upper intestines checked for polyps. Have any polyps removed.

To keep using Gattex, your healthcare provider should:

• Adults: Have your colon and upper intestines checked for new polyps at the end of 1 year of using Gattex. If no polyps are found, your healthcare provider should check you for polyps as needed and at least every 5 years. Any new polyps should be removed. Pediatrics: Check for blood in the stool every year while using Gattex. If there is blood found in the stool, have your colon and upper intestines checked for polyps. H

If cancer is found in a polyp, your healthcare provider should stop Gattex.

• Blockage of the Bowel/Intestines (Bowel Obstruction). A bowel blockage prevents 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 stoma 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.
• Swelling (Inflammation) or Blockage of Your Gallbladder or Pancreas. Swelling (inflammation) or blockage of your gallbladder or pancreas can occur. Your healthcare provider will check your gallbladder and pancreas before starting Gattex and at least every 6 months while you are receiving it. 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 and Heart Failure Risk. 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 right away if you get swelling in your feet and ankles, you gain weight very quickly (water weight), or you have trouble breathing.

Notes:

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all of the possible side effects of Gattex. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Gattex (teduglutide) is a synthetic version of GLP-2, a natural intestinal hormone. It works by binding to GLP-2 receptors in the intestinal lining, triggering the release of insulin-like growth factor (IGF-1), nitric oxide, and keratinocyte growth factor (KGF) that promote tissue growth and enhance nutrient absorption.

Gattex belongs to the drug class called glucagon-like peptide-2 (GLP-2) analogs.

Dose of Gattex for Short Bowel Syndrome (SBS) (Adults and Pediatrics)

• 0.05 mg/kg subcutaneously once a day.

Dosage Adjustment for Moderate to Severe Renal Impairment and End-Stage Renal Disease (eGFR ≤60 mL/min/1.73 m2)

• 0.025 mg/kg subcutaneously once a day.

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. Do not stop taking Gattex without consulting your healthcare provider.

Tell your healthcare providers about all the medicines you take, including prescription and 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.

• Gattex improves intestinal absorption, which may increase the absorption of other oral medications.
• Dosage adjustments of other medicines may be necessary, particularly benzodiazepines and other drugs with a narrow therapeutic index.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get anew medicine.

• Store Gattex powder at room temperature up to 77°F (25°C).
• Do not freeze.
• Use the powder in the Gattex kit 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.

Eligible patients may pay as little as $0 per Gattex prescription if they meet eligibility requirements.

Takeda Patient Support provides a range of product support services throughout Gattex treatment, such as

• Accessing Gattex
• Enrollment in the Takeda Patient Support Co-Pay Assistance Program, if you qualify
• Arrange for nursing support if you have questions about your condition and your prescribed treatment
• Provide you with tips and timely information throughout your treatment.

Also see Gattex Prices, Coupons, Copay Cards & Patient Assistance for more information.

Clinical trials showed Gattex significantly reduces IV nutrition requirements in Short Bowel Syndrome patients.

• In adult trials (STEPS NCT00172185, NCT00798967), 63% achieved at least 20% reduction in IV needs versus 30% with placebo.
• Pediatric trials (NCT01952080, NCT02682381) 69% of children reduced their weekly PS volume by 20% or more from baseline at 6 months, with an average reduction of 42% (23 mL/kg/day PS volume from baseline).

Active ingredient: teduglutide

Inactive ingredients: dibasic sodium phosphate heptahydrate, L-histidine, mannitol, and monobasic sodium phosphate monohydrate. Sterile Water for Injection is provided as a diluent.

Available as the Gattex kit containing 5 mg teduglutide in a single-dose vial supplied with 0.5 mL sterile Water for Injection in a single-dose prefilled syringe.

Gattex is distributed by Takeda Pharmaceuticals America, Inc., Cambridge, MA 02142.