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Drug overview for GATTEX (teduglutide):
Generic name: TEDUGLUTIDE (TE-due-GLOO-tide)
Drug class: Short Bowel Syndrome-glucagon-like peptide-2 (GLP-2) analog
Therapeutic class: Gastrointestinal Therapy Agents
Teduglutide is a biosynthetic (recombinant DNA origin) analog of human glucagon-like peptide-2 (GLP-2), a pleiotropic hormone that enhances intestinal mucosal growth and affects intestinal function.
No enhanced Uses information available for this drug.
Generic name: TEDUGLUTIDE (TE-due-GLOO-tide)
Drug class: Short Bowel Syndrome-glucagon-like peptide-2 (GLP-2) analog
Therapeutic class: Gastrointestinal Therapy Agents
Teduglutide is a biosynthetic (recombinant DNA origin) analog of human glucagon-like peptide-2 (GLP-2), a pleiotropic hormone that enhances intestinal mucosal growth and affects intestinal function.
No enhanced Uses information available for this drug.
DRUG IMAGES
GATTEX 5 MG 30-VIAL KIT
The following indications for GATTEX (teduglutide) have been approved by the FDA:
Indications:
Short bowel syndrome
Professional Synonyms:
Short gut syndrome
Indications:
Short bowel syndrome
Professional Synonyms:
Short gut syndrome
The following dosing information is available for GATTEX (teduglutide):
No enhanced Dosing information available for this drug.
Administer teduglutide by subcutaneous injection only; do not administer IV or IM. Adult patients may self-administer teduglutide if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug after appropriate training. Self-administration in pediatric patients is not recommended.
Parents or an adult caregiver may administer the drug to pediatric patients if trained by a healthcare provider. Administer subcutaneous injections into the abdomen, thighs, and upper arms; rotate injection sites. If a dose is missed, administer the missed dose as soon as possible on the same day; do not administer 2 doses to make up for a missed dose.
Parents or an adult caregiver may administer the drug to pediatric patients if trained by a healthcare provider. Administer subcutaneous injections into the abdomen, thighs, and upper arms; rotate injection sites. If a dose is missed, administer the missed dose as soon as possible on the same day; do not administer 2 doses to make up for a missed dose.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GATTEX 5 MG VIAL | Maintenance | Adults inject 0.05 mg/kg by subcutaneous route once daily in the abdomen, thighs, or upper arms rotating injection sites daily. |
| GATTEX 5 MG 30-VIAL KIT | Maintenance | Adults inject 0.05 mg/kg by subcutaneous route once daily in the abdomen, thighs, or upper arms rotating injection sites daily. |
| GATTEX 5 MG ONE-VIAL KIT | Maintenance | Adults inject 0.05 mg/kg by subcutaneous route once daily in the abdomen, thighs, or upper arms rotating injection sites daily. |
No generic dosing information available.
The following drug interaction information is available for GATTEX (teduglutide):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for GATTEX (teduglutide):
Drug contraindication overview.
*None.
*None.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Biliary tract malignancy |
| Lactation |
| Malignant neoplasm of pancreas |
| Primary malignant neoplasm of gastrointestinal tract |
There are 14 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Biliary calculus |
| Cholangitis |
| Cholecystitis |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Colorectal polyp |
| Edema |
| Elevated serum amylase |
| Elevated serum lipase |
| Gastrointestinal obstruction |
| Malignancy |
| Polyp of intestine |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
| Hyperbilirubinemia |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for GATTEX (teduglutide):
Adverse reaction overview.
The most common adverse effects reported in >=10% of patients receiving teduglutide in clinical trials include abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.
The most common adverse effects reported in >=10% of patients receiving teduglutide in clinical trials include abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.
There are 14 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypersensitivity drug reaction |
None. |
| Rare/Very Rare |
|---|
|
Biliary calculus Cardiac arrest Cholangitis Cholecystitis Chronic heart failure Colorectal polyp Gastrointestinal obstruction Intestinal stenosis Malignancy Neoplasm Pancreatic duct stenosis Pancreatitis Polyp of intestine |
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Acute abdominal pain Body fluid retention Headache disorder Hypervolemia Injection site sequelae Nausea Upper respiratory infection Vomiting |
Appetite changes Cough Flatulence Hemorrhage Sleep disorder |
| Rare/Very Rare |
|---|
|
Dyspnea |
The following precautions are available for GATTEX (teduglutide):
Safety and efficacy of teduglutide have not been established in pediatric patients <1 year of age. Use of teduglutide in pediatric patients >=1 year of age is based on evidence from well-controlled studies in adults and additional efficacy, safety, pharmacokinetic, and pharmacodynamic data in pediatric patients in this age group. Across two studies of 24-week and 12-week duration, 41 pediatric patients >=1 year of age were treated with teduglutide 0.05
mg/kg daily. In these studies and corresponding extension studies, 29 pediatric patients received teduglutide prospectively for up to 94 weeks; adverse reactions in pediatric patients were similar to those seen in adults. In pharmacokinetic studies, similar peak plasma concentrations of teduglutide were noted across all age groups, including pediatric and adult groups. However, pediatric patients had lower systemic exposure compared to adults.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
mg/kg daily. In these studies and corresponding extension studies, 29 pediatric patients received teduglutide prospectively for up to 94 weeks; adverse reactions in pediatric patients were similar to those seen in adults. In pharmacokinetic studies, similar peak plasma concentrations of teduglutide were noted across all age groups, including pediatric and adult groups. However, pediatric patients had lower systemic exposure compared to adults.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Case reports describing use of teduglutide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Malnutrition, a risk in pregnant women with untreated short bowel syndrome, is associated with known adverse maternal and fetal outcomes, including preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations, and perinatal mortality. Animal reproduction studies demonstrated no effects on embryo-fetal development after subcutaneous administration of teduglutide to pregnant rats and rabbits at exposures up to 686 and 657 times, respectively, the clinical exposure at the recommended human dose.
It is not known whether teduglutide is distributed into human milk; however, the drug is distributed into milk in rats. Because of the potential for serious adverse reactions to teduglutide in nursing infants and because of the tumorigenic potential of the drug in animal studies, breast-feeding is not recommended during treatment with teduglutide.
In clinical studies, 14% of patients who received teduglutide at the recommended dosage of 0.05 mg/kg daily were >=65 years of age and 4% were >=75 years of age. Although no overall differences in safety or efficacy were observed between geriatric patients and younger adults, the possibility of increased sensitivity to the drug in some geriatric patients cannot be ruled out. No age-related differences in the pharmacokinetics of teduglutide have been identified in geriatric individuals compared with younger adults.
The following prioritized warning is available for GATTEX (teduglutide):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GATTEX (teduglutide)'s list of indications:
| Short bowel syndrome | |
| K90.82 | Short bowel syndrome |
| K90.829 | Short bowel syndrome, unspecified |
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