teduglutide

Contraindicated in:

Lactation: Lactation.

Use Cautiously in:

History of or ↑ risk of 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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

Drug-drug:

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

Availability ⬆ ⬇

Lyophilized powder for injection: 5 mg/vial with 0.5 mL sterile water for injection in a prefilled syringe

Route/Dosage ⬆ ⬇

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

Renal Impairment

SC (Adults and Children ≥1 yr): CCr <60 mL/min: 0.025 mg/kg once daily.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

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.

Therapeutic effects:

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

Classifications ⬆ ⬇

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

Pharmacokinetics ⬆ ⬇

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.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(↓ in parenteral nutrition/IV volume need)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within 1 mo	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient in correct technique for injection and disposal of equipment. Take missed doses as soon as remembered in same day; do not take two 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. If severe reaction or rash occur, notify health care professional.
Inform patient of risk of accelerated neoplastic growth and colorectal polyps. Advise patient to report significant changes in bowel habits and blood in stool.
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 during teduglutide therapy.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Emphasize the importance of routine lab tests, colonoscopy, and upper GI endoscopy to monitor for adverse effects.

Pronunciation ⬆ ⬇

Code ⬆

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)

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Indications ⬇

Contraind./Precautions ⬆ ⬇