Gattex One-Vial (teduglutide)
Short Bowel Syndrome-glucagon-like peptide-2 (GLP-2) analog Subcutaneous Kit
Last reviewed · Source: First Databank (FDB) drug data
Overview
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.
Teduglutide is a biosynthetic analog of human glucagon-like peptide-2 (GLP-2), a pleiotropic hormone that enhances intestinal mucosal growth and affects intestinal function. In response to food from enteroendocrine L-cells located predominantly in the terminal ileum and colon, GLP-2 is secreted. GLP-2 has been shown to promote growth of intestinal epithelial cells by stimulating crypt cell proliferation and inhibiting apoptosis of crypt and villi cells, thereby increasing the functional mucosal surface area.
Additionally, GLP-2 has been shown to increase intestinal transit time, inhibit motility and gastric emptying, increase intestinal and portal blood flow, inhibit gastric acid secretion, increase or maintain intestinal barrier function, and enhance fluid and nutrient absorption. Teduglutide is prepared from cultures of a modified strain of Escherichia coli using recombinant DNA technology. The drug is identical to human GLP-2 except for the substitution of glycine for alanine at position 2 of the 33-amino acid peptide; this substitution enhances receptor binding and confers resistance to degradation by dipeptidyl peptidase-4 (DPP-4), which prolongs the half-life from about 7 minutes (for human GLP-2) to about 1-3 hours.
Binding of teduglutide to GLP-2 receptors located mainly in the small and large intestines in enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons of the submucosal and myenteric plexus results in activation of the receptors and local release of multiple mediators, including insulin-like growth factor I (IGF-I), nitric oxide, and keratinocyte growth factor (KGF). Changes in intestinal morphology (increases in villus height and crypt depth) and increased plasma concentrations of citrulline, a biomarker of mucosal mass, have been reported in teduglutide-treated patients with short bowel syndrome.
Teduglutide is readily absorbed from subcutaneous injection sites; the absolute bioavailability of the drug is approximately 88% and peak plasma concentrations are attained about 3-5 hours after subcutaneous administration in healthy individuals. Although the single amino acid substitution at position 2 renders teduglutide resistant to degradation by DPP-4, teduglutide is expected to be degraded to small peptides and amino acids via catabolic pathways similar to those of endogenous GLP-2. The metabolic pathway of teduglutide has not been investigated in humans, and no inhibition or induction of the cytochrome P-450 (CYP) enzyme system has been observed during in vitro studies.
Like GLP-2, teduglutide appears to be eliminated mainly by the kidneys. Teduglutide has a mean terminal half-life of approximately 2 hours in healthy individuals and 1.3 hours in patients with short bowel syndrome.
USES: Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2).
It works by helping to improve intestinal absorption of fluids and nutrients.
Generic name: teduglutide
Pronunciation: (TE-due-GLOO-tide)
Drug class: Short Bowel Syndrome-glucagon-like peptide-2 (GLP-2) analog
Therapeutic class: Gastrointestinal Therapy Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Gattex One-Vial
Indications
The following indications are listed for Gattex One-Vial:
- Short Bowel Syndrome
Also known as: Short Gut Syndrome.
Dosing
No dosing information is available for this tab.
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.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Gattex 5 Mg Vial | Maintenance | 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 | 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 | Inject 0.05 mg/kg by subcutaneous route once daily in the abdomen, thighs, or upper arms rotating injection sites daily. |
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been conducted with teduglutide to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
- Biliary tract malignancy
- Lactation
- Malignant neoplasm of pancreas
- Primary malignant neoplasm of gastrointestinal tract
- 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
- Chronic heart failure
- Hyperbilirubinemia
- Kidney disease with likely reduction in glomerular filtration rate (GFr)
Adverse reactions
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.
More Frequent
- Hypersensitivity drug reaction
Rare or 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
More Frequent
- Abdominal distension
- Acute abdominal pain
- Body fluid retention
- Headache disorder
- Hypervolemia
- Injection site sequelae
- Nausea
- Upper respiratory infection
- Vomiting
Less Frequent
- Appetite changes
- Cough
- Flatulence
- Hemorrhage
- Sleep disorder
Rare or Very Rare
- Dyspnea
- Injection site erythema
- Injection site inflammation
Precautions
No enhanced messaging available.
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.
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.
No dosage adjustment is necessary in geriatric patients >65 years of age.
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.
ICD codes
| Code | Type | Description |
|---|---|---|
| Short bowel syndrome | ||
| K90.82 | ICD10CM | Short bowel syndrome |
| K90.829 | ICD10CM | Short bowel syndrome, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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