Teduglutide

What is Teduglutide?

• Teduglutide (GATTEX) is a glucagon-like peptide-2 (GLP-2) analog used for the treatment of short bowel syndrome.

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Teduglutide

What are the uses of this medicine?

This medicine is 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).

How does this medicine work?

• Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine.
• GLP-2 is known to increase intestinal and portal blood flow and inhibit gastric acid secretion.
• Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus.
• Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Based upon the pharmacodynamic effect of GATTEX, there is a potential for increased absorption of concomitant oral medications.
• The concomitant drug may require a reduction in dosage.

Is this medicine FDA approved?

• Teduglutide is designated as an orphan drug by the US FDA on 12/8/2020.

How should this medicine be used?

Within 6 months prior to initiating treatment with GATTEX:

• Adults: Perform a colonoscopy with removal of polyps.
• Pediatric patients: Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy.
• Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase).

Recommended dosage:

• The recommended dosage of GATTEX for both adults and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection.

Dosage Adjustment for Renal Impairment

• For adult and pediatric patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate less than 60 mL/min/1.73 m2) the recommended dosage is 0.025 mg/kg once daily.

Administration:

• 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 5 mg 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.
• 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: 5 mg teduglutide in a single-dose vial supplied with 0.5 mL Sterile Water for Injection in a single-dose prefilled syringe.

This medicine is available in fallowing brand namesː

• GATTEX , Revestive

What side effects can this medication cause?

The most common side effects of this medicine 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

GATTEX may cause serious side effects, including:

• Making abnormal cells grow faster
• Polyps in the colon (large intestine)
• Fluid overload

What special precautions should I follow?

• Based on the pharmacologic activity and findings in animals, GATTEX has the potential to cause hyperplastic changes including neoplasia. In adults and pediatric patients, colonoscopy is recommended after 1 year of treatment. Perform subsequent colonoscopies no less frequently than every 5 years. In case of intestinal malignancy, discontinue GATTEX. The decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.
• Intestinal obstruction has been reported in clinical studies and postmarketing. In patients who develop intestinal or stomal obstruction, temporarily discontinue GATTEX while the patient is clinically managed. GATTEX may be restarted when the obstructive presentation resolves, if clinically indicated.
• Cholecystitis, cholangitis, and cholelithiasis have been reported. Obtain bilirubin, alkaline phosphatase, lipase, amylase every 6 months. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and reassess continued GATTEX treatment.
• Fluid overload and congestive heart failure have been observed in clinical studies, which were deemed to be related to enhanced fluid absorption associated with GATTEX. If fluid overload occurs, adjust parenteral support, and reassess continued GATTEX treatment.
• Monitor patients on concomitant oral medications (e.g., benzodiazepines) for adverse reactions related to the concomitant drug; dosage reduction of the other drug may be required.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No unexpected systemic adverse reactions were seen.

Treatment of overdosage:

• In the event of overdose, the patient should be carefully monitored by the medical professional.

Can this medicine be used in pregnancy?

• Available data from case reports with GATTEX use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness in pediatric patients less than 1 year of age have not been established.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Manufactured for:

Shire-NPS Pharmaceuticals, Inc. 300 Shire Way Lexington, MA

• GATTEX is a registered trademark of Shire-NPS Pharmaceuticals, Inc., a Takeda company.

What should I know about storage and disposal of this medication?

• Store GATTEX powder 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.

• Dailymed label info on Teduglutide
• FDA Teduglutide

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