teduglutide

teduglutide (rDNA origin)

(te-due-gloo-tide) ,

Gattex

(trade name)

Classification

Therapeutic: temporary class
Pregnancy Category: B

Indications

Treatment of short bowel syndrome in adult 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 effects

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

Contraindications/Precautions

Contraindicated in: Lactation: Breastfeeding should be avoided.
Use Cautiously in: Patients with history of or ↑ risk of gastrointestinal malignancy; Underlying cardiovascular disease (fluid overload may be problematic); CCr <50 mL/min (dose ↓ required); Biliary and pancreatic disease; Geriatric: Elderly patients may be ↑ sensitive to drug effects; Obstetric: Use during pregnancy only if clearly needed; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • sleep disturbances

Respiratory

  • cough

Gastrointestinal

  • accelerated intestinal malignancy (life-threatening)
  • intestinal obstruction (life-threatening)
  • abdominal distention (most frequent)
  • abdominal pain (most frequent)
  • nausea (most frequent)
  • stoma complications (most frequent)
  • appetite disorders
  • cholangitis
  • cholecystitis
  • cholelithiasis
  • flatulence
  • pancreatitis

Fluid and Electrolyte

  • fluid overload (most frequent)

Local

  • injection site reactions (most frequent)

Metabolic

  • hypersensitivity reactions

Interactions

Drug-Drug interaction

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

Route/Dosage

Subcutaneous (Adults) 0.05 mg/kg once daily.

Renal Impairment

Subcutaneous (Adults) CCr <50 mL/min—0.025 mg/kg once daily.

Availability

Lyophilized powder for reconstitution: 5 mg/vial with 0.5 mL Sterile Water for Injection in a pre-filled syringe

Nursing implications

Nursing 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.
  • 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 Nursing Diagnoses

Imbalanced nutrition: less than body requirements (Indications)

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.
  • Subcutaneous: 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) 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.
References in periodicals archive ?
General medications to treat short bowel syndrome include antibiotics to prevent bacterial overgrowth, H2 blockers to treat too much gastric acid secretion, proton pump inhibitors to treat too much gastric acid secretion, choleretic agents to improve bile flow and prevent liver disease, bile-salt binders to decrease diarrhea, anti-secretin agents to reduce gastric acid in the intestine, hypomotility agents to increase the time it takes food to travel through the intestines, leading to increased nutrient absorption, growth hormones to improve intestinal absorption, teduglutide to improve intestinal absorption.
Teduglutide has a safety profile (5), but adverse events are mostly related to hyperplastic and hypertrophic effects.
For example, NPS Pharma is a global biopharmaceutical company headquartered in New Jersey that engaged Almac to support the launch of their lead product, teduglutide [rDNA origin]) in Europe, which was first approved in the EU in August 2012, under the brand name Revestive, for adult short bowel syndrome (SBS).
There are four gastrointestinal agents: crofelemer (Fulyzaq; antidiarrheal), linaclotide (Linzess; laxative), teduglutide (Gattex; short bowel syndrome), and the combination of sodium picosulfate, magnesium oxide, and citric acid (Prepopik; osmotic laxative).
Teduglutide, an analogue of human glucagon-like peptide-2 administered subcutaneously, was recommended for approval in adults with short bowel syndrome.
M2 PHARMA-January 6, 2014-NPS Pharmaceuticals starts global registration study of teduglutide in paediatric patients with Short Bowel Syndrome
M2 EQUITYBITES-January 6, 2014-NPS Pharmaceuticals starts global registration study of teduglutide in paediatric patients with Short Bowel Syndrome
jointly announced today that the European Commission (EC) has granted European market authorization for the medicinal product teduglutide (trade name in Europe: RevestiveA) as a once-daily treatment for adult patients with short bowel syndrome.
M2 PHARMA-March 19, 2013-NPS Pharmaceuticals and Takeda sign fresh agreements for rights to Teduglutide and 1-84(C)2013 M2 COMMUNICATIONS
M2 EQUITYBITES-March 19, 2013-NPS Pharmaceuticals and Takeda sign fresh agreements for rights to Teduglutide and 1-84(C)2013 M2 COMMUNICATIONS http://www.
Due to the complexities of short bowel syndrome and the need for individualized management strategies, patients should be referred to major centers with experience in short bowel syndrome, particularly during the early stages of teduglutide treatment.
M2 PHARMA-March 28, 2011-Nycomed files for European approval of teduglutide in SBS(C)2011 M2 COMMUNICATIONS