* CAPITALS indicate life-threatening. Underline indicate most frequent.
May ↑absorption of orally administered medications; cautiously monitor drugs with narrow therapeutic indices or drugs requiring careful titration.
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.
Lyophilized powder for injection: 5 mg/vial with 0.5 mL sterile water for injection in a pre-filled syringe
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.
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.
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.
Improved gastrointestinal absorption of fluids and nutrients with a decreased need for parenteral nutrition/IV support.
teduglutide is a sample topic from the Davis's Drug Guide.
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