Medically reviewed by Drugs.com. Last updated on Apr 3, 2020.
(te due GLOO tide)
- Teduglutide Recombinant
- Teduglutide [rDNA origin]
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Subcutaneous [preservative free]:
Gattex: 5 mg
Brand Names: U.S.
- Glucagon-Like Peptide-2 (GLP-2) Analog
Teduglutide is an analog of glucagon-like peptide-2 (GLP-2), which is secreted in the distal intestine. Endogenous GLP-2 increases intestinal and portal blood flow while inhibiting gastric acid secretion, thereby reducing intestinal losses and improving intestinal absorption. Teduglutide binds and activates GLP-2 receptors, resulting in release of mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).
Similar to endogenous catabolism of GLP-2 but slower due to a single amino acid substitution (Ferrone 2006)
Time to Peak
Plasma: SubQ: 3 to 5 hours
Children 1 to 11 years: 0.7 ± 0.2 hours
Children 12 to 17 years: 1 ± 0.01 hours
Adults: 1.3 hours
Special Populations: Renal Function Impairment
Teduglutide exposure is increased in patients with moderate or severe renal impairment or ESRD.
Special Populations: Hepatic Function Impairment
Teduglutide exposure is decreased in patients with moderate hepatic impairment.
Use: Labeled Indications
Short bowel syndrome: Treatment of short bowel syndrome in adults and pediatric patients ≥1 year of age who are dependent on parenteral support.
There are no contraindications listed in the US manufacturer's labeling.
Canadian labeling: Hypersensitivity to teduglutide or any component of the formulation; active gastrointestinal (GI) malignancy (GI tract, hepatobiliary, pancreatic); history of GI tract malignancies (including the hepatobiliary system and pancreas) within the last 5 years.
Short bowel syndrome: SubQ: 0.05 mg/kg once daily
Missed doses: If a dose is missed, take as soon as possible on that day; do NOT take 2 doses on the same day.
Refer to adult dosing.
Short bowel syndrome (requiring parenteral support): Children and Adolescents weighing ≥10 kg: SubQ: 0.05 mg/kg/dose once daily; reductions in parenteral nutrition requirements (including calorie and volume) and advancement of enteral nutrition were observed as early as week 4 of teduglutide therapy in an open-label trial (Carter 2017).
Reconstitute each vial with 0.5 mL of preservative-free SWFI (provided in syringe); let stand for 30 seconds and then roll vial between palms for 15 seconds. Do not shake. Allow vial to stand for an additional ~2 minutes; if undissolved material remains, roll between palms again. If particles are not dissolved after second attempt, discard vial. Once reconstituted, each vial provides 3.8 mg/0.38 mL (concentration is 10 mg/mL).
SubQ: Rotate injection site between thighs, upper arms, and quadrants of the abdomen. Do not administer IM or IV. Following patient training and instructions on self-administration, adult patients may self-administer treatment.
Prior to dispensing, store intact vials refrigerated at 2°C to 8°C (36°F to 46°F); do not freeze. The carton of ancillary supplies should be stored at 25°C (77°F). After dispensing, store vials at 25°C (77°F); once dispensed, vials must be used within 90 days. Once reconstituted, store at <25°C (77°F); do not shake or freeze; use within 3 hours. Discard any unused portion.
Benzodiazepines: Teduglutide may increase the serum concentration of Benzodiazepines. Monitor therapy
Endocrine & metabolic: Fluid retention (1% to 12%)
Gastrointestinal: Abdominal pain (30%), nausea (23%), abdominal distension (20%), vomiting (12%)
Immunologic: Antibody development (3% to 54%; incidence increased with prolonged use)
Local: Injection site reaction (13%)
Respiratory: Upper respiratory tract infection (21%)
Miscellaneous: Intestinal stoma complication (42%)
1% to 10%:
Cardiovascular: Peripheral edema (10%), cardiac failure (3%)
Central nervous system: Sleep disturbance (5%)
Dermatologic: Dermal hemorrhage (5%)
Gastrointestinal: Flatulence (9%), decreased appetite (7%), intestinal stenosis (<5%; including colonic), pancreatic disease (<5%; duct stenosis), cholecystitis (4%), intestinal obstruction (≤4%), gallbladder perforation (1%)
Hypersensitivity: Hypersensitivity reaction (10%)
Infection: Influenza (7%)
Respiratory: Cough (5%), dyspnea (<5%)
Frequency not defined:
Cardiovascular: Edema, flushing, jugular vein distention
Dermatologic: Erythema of skin, pruritus, skin rash
Gastrointestinal: Cholelithiasis, cholestasis, colonic polyp, pancreatic pseudocyst, pancreatitis, rectal polyp
Hematologic & oncologic: Hematoma
Ophthalmic: Eyelid edema
<1%, postmarketing, and/or case reports: Cholangitis, malignant neoplasm
Concerns related to adverse effects:
• Colorectal polyps: Short bowel syndrome: Development of colorectal polyps has occurred. In adults, perform a baseline colonoscopy of the entire colon with polyp removal ≤6 months prior to initiation of therapy. Follow-up colonoscopy (or alternative imaging) should be performed at 1 year and at least every 5 years, thereafter. In children and adolescents, perform fecal occult blood testing at baseline and annually; if unexplained blood detected, perform colonoscopy/sigmoidoscopy. Additionally, perform colonoscopy/sigmoidoscopy after 1 year, every 5 years thereafter during therapy, or for new or unexplained GI bleeding. Discontinue teduglutide in patients who develop colorectal cancer.
• Fluid overload: Increased fluid absorption and subsequent fluid overload/congestive heart failure has been reported; consider modification of parenteral support in patients who develop fluid overload, especially in patients with underlying cardiovascular disease. If significant cardiac deterioration develops, reassess the need for continued teduglutide treatment.
• Gallbladder/biliary tract disease: Cholecystitis, cholangitis, and cholelithiasis have been reported; monitor serum bilirubin and alkaline phosphatase ≤6 month prior to initiation of therapy and at least every 6 months for duration of therapy. If clinically meaningful changes are detected, perform gallbladder/biliary tract imaging and reassess the need for continued teduglutide treatment.
• Intestinal obstruction: Temporarily discontinue treatment in patients that develop intestinal or stomal obstruction; teduglutide may be resumed (if clinically indicated) once the obstruction is resolved.
• Malignancy: Teduglutide may increase the risk of hyperplastic changes, including neoplasia. In patients at increased risk for malignancy, consider treatment only if benefits outweigh the risks. Discontinue treatment in patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic); evaluate risk versus benefit in patients with active non-GI malignancy. Monitor for small bowel neoplasia; remove any benign neoplasm. Discontinue in patients who develop small bowel cancer.
• Pancreatitis: Pancreatitis has been reported; monitor serum lipase and amylase ≤6 months prior to initiation of therapy and at least every 6 months for duration of therapy. If clinically meaningful changes are detected, evaluate for pancreatitis and reassess the need for continued teduglutide treatment.
Concurrent drug therapy issues:
• Oral medications: Teduglutide may increase absorption of oral medications; monitor for adverse effects of concomitant oral medications, particularly those with a narrow therapeutic index.
• Renal function impairment: Use with caution; reduced doses required in moderate to severe renal impairment and end-stage renal disease (ESRD).
• Discontinuation: Treatment discontinuation may result in fluid and electrolyte imbalance. Carefully monitor fluid/electrolyte status.
In all patients, serum bilirubin, alkaline phosphatase, lipase, and amylase (baseline [within 6 months prior to initiation] and every 6 months thereafter); monitor fluid status in patients with cardiovascular disease; signs/symptoms of intestinal obstruction; signs/symptoms suggestive of gallbladder disease or pancreatitis; monitor fluid and electrolyte balance following therapy discontinuation. In adults, perform colonoscopy of entire colon with removal of polyps at baseline (within 6 months prior to initiation), 1 year, and ≤5 years thereafter if no polyps found; follow current guidelines if polyps are found. In children/adolescents, test fecal occult blood at baseline (within 6 months prior to initiation) and yearly during treatment; perform colonoscopy/sigmoidoscopy if unexplained blood in stool at baseline and after 1 year of treatment, every 5 years thereafter during treatment, or if new or unexplained GI bleeding occurs.
Information related to use of teduglutide in pregnancy is limited.
Short bowel syndrome may cause maternal malnutrition, which is associated with adverse fetal effects, including congenital malformations, intrauterine growth restriction, low birth weight, perinatal mortality and preterm birth.
What is this drug used for?
• It is used to treat short bowel syndrome.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Passing gas
• Common cold symptoms
• Flu-like signs
• Lack of appetite
• Injection site irritation
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Pancreatitis like severe abdominal pain, severe back pain, severe nausea, or vomiting
• Gallstones like pain in the upper right abdominal area, right shoulder area, or between the shoulder blades; yellow skin; or fever with chills
• Severe abdominal pain
• Shortness of breath
• Excessive weight gain
• Swelling of arms or legs
• Severe constipation
• Abdominal swelling
• Swelling of stoma
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about teduglutide
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- En Español
- 1 Review
- Drug class: miscellaneous GI agents
Other brands: Gattex