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Teduglutide

Pronunciation

(te due GLOO tide)

Index Terms

  • ALX-0600
  • Teduglutide Recombinant
  • Teduglutide [rDNA origin]

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Subcutaneous [preservative free]:

Gattex: 5 mg

Brand Names: U.S.

  • Gattex

Pharmacologic Category

  • Glucagon-Like Peptide-2 (GLP-2) Analog

Pharmacology

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).

Distribution

0.1 L/kg

Metabolism

Similar to endogenous catabolism of GLP-2 but slower due to a single amino acid substitution (Ferrone, 2006)

Excretion

Urine

Time to Peak

Plasma: 3 to 5 hours

Half-Life Elimination

~2 hours (healthy patients); 1.3 hours (short bowel syndrome patients)

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 who are dependent on parenteral support.

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Canadian labeling: Additional contraindications (not in US 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) within the last 5 years.

Dosing: Adult

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.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: Administer 50% of the usual dose.

ESRD: Administer 50% of the usual dose.

Dosing: Hepatic Impairment

Mild-to-moderate impairment (Child-Pugh class B): No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Reconstitution

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).

Administration

SubQ: Rotate injection site between thighs, upper arms, and quadrants of the abdomen. Do not administer IM or IV

Storage

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.

Drug Interactions

Benzodiazepines: Teduglutide may increase the serum concentration of Benzodiazepines. Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Headache (16%)

Endocrine & metabolic: Hypervolemia (12%)

Gastrointestinal: Abdominal pain (30% to 38%), nausea (18% to 25%), abdominal distension (14% to 20%), vomiting (12%)

Immunologic: Antibody development (3% to 48%; 3% at month 3, 18% at month 6, 25% at month 12, 31% at month 24, and 48% at month 30)

Local: Injection site reaction (12% to 22%)

Respiratory: Upper respiratory tract infection (12% to 26%)

Miscellaneous: Intestinal stoma complication (42%)

1% to 10%:

Central nervous system: Disturbed sleep (5%)

Dermatologic: Dermal hemorrhage (5%)

Hypersensitivity: Hypersensitivity reaction (8%)

Gastrointestinal: Flatulence (9%), change in appetite (7%), intestinal obstruction (4%), intestinal polyps (2%)

Respiratory: Cough (5%)

<1% (Limited to important or life-threatening): Cardiac arrest, cardiac failure, cerebral hemorrhage, cholecystitis, cholelithiasis, cholestasis, congestive heart failure, gallbladder perforation, malignant neoplasm, pancreatic pseudocyst, pancreatitis

Warnings/Precautions

Concerns related to adverse effects:

• Colorectal polyps: Short bowel syndrome: Development of colorectal polyps has occurred. Preform 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. 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.

• 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 therapy of medications with a narrow therapeutic index.

Special populations:

• Renal function impairment: Use with caution; reduced doses required in moderate to severe renal impairment.

Other warnings/precautions:

• Discontinuation: Treatment discontinuation may result in fluid and electrolyte imbalance. Carefully monitor fluid/electrolyte status.

Monitoring Parameters

Serum bilirubin, alkaline phosphatase, lipase and amylase (baseline [within 6 months prior to initiation] and every 6 months thereafter); colonoscopy of entire colon and removal of polyps (baseline [within 6 months prior to initiation], 1 year, and ≤5 years thereafter if no polyps found); monitor fluid status in patients with cardiovascular disease; signs/symptoms of intestinal obstruction; signs/symptoms suggestive of gall bladder disease or pancreatitis; monitor fluid and electrolyte balance following therapy discontinuation

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flatulence, nausea, vomiting, headache, rhinitis, pharyngitis, cough, rhinorrhea, lack of appetite, insomnia, or injection site irritation. Have patient report immediately to prescriber signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), angina, passing out, severe abdominal pain, shortness of breath, excessive weight gain, swelling of arms or legs, severe constipation, abdominal edema, edema of stoma, bruising, or bleeding (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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