teduglutide

General

**REMS Drug**

Pronunciation:
te-due-gloo-tide

Trade Name(s)

• Gattex
• Revestive 

Ther. Class.

glucagon-like peptide-2 (GLP-2) analogues

Indications

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

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 Effect(s):

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

Pharmacokinetics

Absorption: 88% absorbed following SUBQ administration.

Distribution: Unknown.

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

Half-life: 2 hr.

TIME/ACTION PROFILE (↓ in parenteral nutrition/IV volume need)

Contraindication/Precautions

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.

Adverse Reactions/Side 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

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

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

Route/Dosage

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

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

Availability

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

Assessment

• Obtain an upper GI endoscopy and colonoscopy of entire colon with removal of polyps within 6 mo prior to starting teduglutide. Follow-up upper GI endoscopy and colonoscopy are recommended at end of 1 yr on teduglutide. Repeat every 5 yr or more often as needed.  If polyps found,  follow recommended guidelines.  If GI cancer diagnosed,  discontinue teduglutide. Pedi:  Perform fecal occult blood test within 6 mo of starting and annually during therapy.  If unexplained blood found, perform upper GI endoscopy and colonoscopy/sigmoidoscopy. Perform colonoscopy/sigmoidoscopy after 1 yr and every 5 yr thereafter during therapy. Consider upper GI endoscopy during treatment as well.  If GI cancer diagnosed,  discontinue teduglutide.
• Monitor for fluid overload, especially in patients with underlying cardiovascular disease; may require adjustment in parenteral support and reassessment of need for therapy.

Lab Test Considerations:

Monitor bilirubin, alkaline phosphatase, lipase, and amylase within 6 mo of starting and every 6 mo thereafter during therapy.  If clinically meaningful gallbladder, biliary tract, or pancreatic changes occur,  further diagnostic workup is recommended.

Implementation

•  Reconstitution: Slowly inject 0.5 mL preservative-free sterile water for injection from prefilled syringe into vial. Allow vial to stand for 30 sec; then gently roll between palms for 15 sec. Do not shake. Allow mixed contents to stand for 2 min. Inspect for undissolved powder and gently roll again until dissolved. If product remains undissolved after second attempt, do not use. Solution should be clear and colorless to light straw; do not administer if discolored or contains precipitates.  Concentration: 10 mg/mL. Administer within 3 hr of reconstitution. Store in refrigerator; do not freeze. Discard unused solution.
• SUBQ Inject SUBQ once daily into thigh, arm, or abdomen. Rotate sites daily. Do not inject IM or IV.
• Discontinuation may result in fluid and electrolyte imbalance; monitor closely.

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.

Evaluation/Desired Outcomes

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