teduglutide

General

**REMS Drug**

Pronunciation:
te-due-gloo-tide


Trade Name(s)

  • Gattex
  • Revestive Canadian Tradename

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 subcutaneous 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)

ROUTEONSETPEAKDURATION
subcutwithin 1 mounknownunknown

Contraindication/Precautions

Contraindicated in:

  • 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.

Adverse Reactions/Side Effects

F and E: fluid overload

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

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.

Availability

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

Assessment

  • Obtain a colonoscopy of entire colon with removal of polyps within 6 mo prior to starting teduglutide. Follow-up colonoscopy is recommended at end of 1 yr on teduglutide. If no polyps found, repeat at least every 5 yrs. If polyps found follow recommended guidelines. For pediatric patients, perform fecal occult blood testing annually; if there is unexplained blood in stool, perform colonoscopy/sigmoidoscopy. Perform colonoscopy/sigmoidoscopy after 1 yr of therapy, every 5 yrs during therapy, and if new or unexplained bleeding occurs.
  • Monitor for fluid overload, especially in patients with underlying cardiovascular disease; may require adjustment in parenteral support.

Lab Test Considerations:

Monitor bilirubin, alkaline phosphatase, lipase, and amylase within 6 mo of starting and every 6 mo after starting therapy. If clinically meaningful ↑ occurs further diagnostic work-up is recommended.

Potential Diagnoses

Implementation

  • Reconstitute each vial with 0.5 mL of preservative-free Sterile Water for Injection slowly injected from pre-filled syringe. Allow vial to stand for 30 seconds, then gently roll between palms for 15 seconds; 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 solutions that are discolored or contain a precipitate. Vial contains 0.38 mL of reconstituted solution with up to 3.8 mg of teduglutide. Administer within 3 hrs of reconstitution. Store in refrigerator; do not freeze. Discard unused solution.
  • SC Inject subcut once daily in thighs, arms, and quadrants of the 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 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.

Evaluation/Desired Outcomes

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

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