teduglutide

(redirected from Gattex)

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 ?
During his time at NPS, his team was able to secure marketing approval in the US and EU for Gattex and Revestive for the treatment of intestinal failure related to short bowel syndrome.
Garceau brings 30 years of pharmaceutical development experience to Fluorinov and most recently led NPS Pharmaceuticals' (NPS) successful orphan products -- including GATTEX and NATPARA-- through regulatory filings, advisory committee reviews, registrations and approvals by the FDA and other health authorities.
Patent and Trademark Office (USPTO) on April 2nd by Hayman Capital Management regarding LIALDA (mesalamine) and GATTEX (teduglutide[rDNA origin]).
Shire would get two important new drugs Gattex (which is already in the market) and Natpara (which awaits approval from the US Food and Drug Administration (FDA)), as per the New Jersey-based NPS buyout.
States, GATTEX (teduglutide[rDNA origin]) for injection is approved for
NPS sells Gattex, a treatment for short bowel syndrome that analysts predict will garner more than $300 million in sales in 2016.
If teduglutide is approved, the company will market it as Gattex.
The company said that Nycomed will proceed with the development of Gattex, for gastrointestinal disorders, outside of the U.
NPS Pharmaceuticals is a commercial-stage rare disease-focused biopharmaceutical company, whose first product, GATTEX for injection, has been launched in the United States to treat adults with short bowel syndrome.
NPS Pharma is a commercial-stage rare disease-focused biopharmaceutical company, whose first product, GATTEX (teduglutide [rDNA origin]) for injection, has been launched in the U.
Risks associated to the company's business include, but are not limited to, the risks associated with any failure by the company to successfully commercialize Gattex, including the risk that physicians and patients may not see the advantages of Gattex and may therefore be reluctant to utilize the product, the risk that private and public payers may be reluctant to cover or provide reimbursement for Gattex, the risks associated with the company's strategy, global macroeconomic conditions, the impact of changes in management or staff levels, the effect of legislation effecting healthcare reform in the United States, as well as other risk factors described in the company's periodic filings with the U.
The acquisition is a significant step in advancing Shire's strategy to become a leading biotechnology company, said Chief executive Flemming Ornskov, With our global strength and expertise in both rare diseases and GI, Shire is uniquely positioned to drive the continued success of Gattex and, if approved, Natpara.