• Short bowel syndrome in patients who are dependent on parenteral nutrition.

Contraindicated in:

• Lactation: Lactation.

Use Cautiously in:

• History of or ↑ risk of GI malignancy
• Underlying cardiovascular disease (fluid overload may be problematic)
• CCr <50 mL/min (↓ dose)
• Biliary and pancreatic disease
• OB: Use only if potential maternal benefit justifies potential fetal risk
• Pedi: Children <1 yr (safety and effectiveness not established)
• Geri: Older adults may be highly sensitive to drug effects.

F and E: fluid overload.

GI: abdominal distention, abdominal pain , nausea, stoma complications, ACCELERATED INTESTINAL MALIGNANCY, appetite disorders, cholangitis, cholecystitis, cholelithiasis, flatulence, INTESTINAL OBSTRUCTION, pancreatitis.

Local: injection site reactions.

Neuro: headache, sleep disturbances.

Resp: cough.

Misc: hypersensitivity reactions.

Drug-Drug:

• May ↑absorption of orally administered medications; cautiously monitor drugs with narrow therapeutic indices or drugs requiring careful titration.

• Lyophilized powder for injection: 5 mg/vial with 0.5 mL sterile water for injection in a pre-filled syringe;

• SC (Adults and Children ≥1 yr): 0.05 mg/kg once daily.

Gattex

• Increases intestinal and portal blood flow, inhibits gastric acid secretion.
• Binding to receptors causes release of insulin-like growth factor, nitric oxide and keratinocyte growth factor.

• Improved gastrointestinal absorption of fluids and nutrients with a decreased need for parenteral nutrition/IV support.

Therapeutic Classification: glucagon-like peptide-2 (GLP-2) analogues

Absorption: 88% absorbed following SUBQ administration.

Distribution: Unknown.

Metabolism/Excretion: Probably degraded into small peptides and amino acids; primarily renally eliminated.

Half-life: 2 hr.

Revestive

(↓ in parenteral nutrition/IV volume need)

• Instruct patient in correct technique for injection and disposal of equipment. Take missed doses as soon as remembered in same day; do not take 2 doses in one day. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
• Advise patient that injection site reaction may occur, but if severe reaction or severe rash occurs, notify health care professional.
• Inform patient of risk of accelerated neoplastic growth, colorectal polyps, and small bowel neoplasia. Advise patient to report signs and symptoms.
• Advise patient to notify health care professional if signs and symptoms of intestinal obstruction (abdominal pain, swelling of stoma) or blockage of gallbladder or pancreas (abdominal pain and tenderness, chills, fever, change in stools, nausea, vomiting, dark urine, yellowing of skin or whites of eyes) occur. May require temporary discontinuation of teduglutide.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications. Oral medications may be absorbed more completely and may require dose adjustment.
• Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
• Emphasize the importance of routine lab tests and colonoscopies to monitor for adverse effects.

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NDC Code^*

• 68875- Shire-NPS Pharmaceuticals, Inc.
  • 68875-0101- Gattex
    • 68875-0101-2- 30 VIAL in 1 CARTON (68875-0101-2) >.5 mL in 1 VIAL (68875-0101-1)

• 68875- Shire-NPS Pharmaceuticals, Inc.
  • 68875-0102- Gattex
    • 68875-0102-1- 1 KIT in 1 CARTON (68875-0102-1) *.5 mL in 1 SYRINGE, PLASTIC *.7 mL in 1 PACKET *.5 mL in 1 VIAL (68875-0101-1)

• 68875- Shire-NPS Pharmaceuticals, Inc.
  • 68875-0103- Gattex
    • 68875-0103-1- 1 KIT in 1 CARTON (68875-0103-1) *.5 mL in 1 SYRINGE, PLASTIC *.7 mL in 1 PACKET *.5 mL in 1 VIAL (68875-0101-1)