Usual Adult Dose for Short Bowel Syndrome

0.05 mg/kg via subcutaneous injection once a day

Comments:

• Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
• IV and IM administration should be avoided.
• Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

Usual Pediatric Dose for Short Bowel Syndrome

1 year and older: 0.05 mg/kg via subcutaneous injection once a day

Comments:

• Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants.
• IV and IM administration should be avoided.
• Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.
• The manufacturer recommends against use of the 5 mg kit in patients weighing less than 10 kg.
• Self-administration has not been studied in pediatric patients.

Renal Dose Adjustments

Mild Renal Dysfunction (estimated glomerular filtration rate [eGFR] 60 mL/min/1.73 m2 and greater): Data not available
Moderate to Severe Renal Dysfunction (eGFR less than 60 mL/min/1.73 m2) and End-Stage Renal Disease (ESRD): 0.025 mg/kg via subcutaneous injection once a day

Liver Dose Adjustments

Mild to Moderate Liver Dysfunction (Child-Pugh grades A and B): No adjustment recommended.
Severe Liver Dysfunction (Child-Pugh grade C): Data not available

Dose Adjustments

Active Malignancies:

• Gastric malignancy (gastrointestinal tract, hepatobiliary, pancreatic) development during treatment: Treatment should be discontinued.
• Non-gastrointestinal malignancy: The decision to continue treatment should be determined when benefit outweighs the risk.

• Within 6 months prior to starting treatment: A colonoscopy of entire colon should be performed, with polyp removal (if found).
• Colonoscopy or alternative imaging should be performed after the first year of treatment, and then at least 5-year intervals thereafter if a polyp is not found.
• If polyps are found: Current recommended follow-up guidelines should be followed.
• If colorectal cancer is diagnosed: Treatment should be discontinued.

• Within 6 months prior to starting treatment: Fecal occult blood testing should be performed; colonoscopy/sigmoidoscopy should be performed in patients with unexplained blood in the stool.
• Fecal occult blood testing should be performed yearly thereafter during treatment.
• Colonoscopy/sigmoidoscopy is recommended after 1 year and every 5 years thereafter in patients receiving continuous treatment, and in those with new/unexplained gastrointestinal bleeding.

• Concomitant drug levels: Narrow therapeutic index and/or drugs requiring titration should be monitored closely, and may require dose reductions.

• Fluid/electrolyte balance should be performed more frequently in the first months of treatment and during discontinuation.
• Patients with significant cardiovascular disease deterioration: The continued need for treatment should be reassessed.
• Dehydration occurring during treatment: Parenteral support should be carefully decreased; abrupt discontinuation should be avoided. The fluid status should be evaluated after reducing parenteral support.

• Baseline laboratory levels should be obtained (e.g., alkaline phosphatase, amylase, bilirubin, lipase) within 6 months before starting treatment, and should be obtained every 6 months thereafter.
• Recurrent Intestinal Obstructions: Patients should be reassessed for the continued need for treatment.
• Bile ducts, gallbladder, pancreas, and small bowel: Signs/symptoms should be monitored, with additional imaging and/or laboratory investigations performed as needed. Patients with gallbladder/bile duct-related symptoms and/or pancreatic adverse events should be reassessed for the continued need for treatment.

• If a benign neoplasm is detected: The neoplasm should be removed.
• If small bowel cancer occurs: Treatment should be discontinued.

Precautions

CONTRAINDICATIONS: None.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for GATTEX. It includes elements to assure safe use (ETASU). For additional information: www.accessdata.fda.gov/scripts/cder/rems/index.cfm

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Injection sites should be alternated, and may include the thighs, arms, and abdominal quadrants. Some experts state that the thighs may be used if abdominal tissue is hardened, scarred, and/or hampered by pain.
• IV and IM administration should be avoided.
• Missed doses should be taken as soon as possible on that day; patients should not take 2 doses on the same day.

• Consult the manufacturer product information.

• Consult the manufacturer product information.

• Some experts recommend recording the name and lot number of the product every time this drug is administered to the patient to maintain a link between the patient and lot of the product.
• Discontinuation of treatment should be managed carefully as it may result in fluid and electrolyte imbalance.
• Administration of this drug may trigger the development of antibodies, which is consistent with the potentially immunogenic properties of medicinal products containing peptides. Antibody formation appears to have no impact on short term (up to 2.5 years) efficacy and safety, although the long-term impact is unknown.

• CARDIOVASCULAR: Fluid overload, electrolyte status
• GASTROINTESTINAL: Small bowel and pancreas function
• HEPATIC: Gallbladder and biliary tract function; laboratory assessments of bilirubin, alkaline phosphatase, lipase, and amylase (within 6 months prior to treatment initiation, and every 6 months thereafter; further diagnostic workup recommended if clinically meaningful elevation is seen)
• METABOLIC: Weight (at each patient visit)
• ONCOLOGIC: Entire colon imaging with removal of polyps (within 6 months prior to starting treatment, and at the end of 1 year of treatment)
• If no polyp is found: Colon imaging at least every 5 years