Dosing & Uses
Dosage Forms & Strengths
- 5mg/vial (as lyophilized powder)
- 3.8mg/0.38mL (after reconstitution) is available for the dose
Short Bowel Syndrome
Indicated for adults with short bowel syndrome who are dependent on parenteral support
0.05 mg/kg SC qDay
Moderate-to-severe renal impairment (CrCl <50 mL/min) and ESRD: Decrease dose by 50%
Mild-to-moderate hepatic impairment: No dose adjustment required
Severe hepatic impairment: Not studied
For SC injection only; do not administer IV or IM
Alternate injection sites between thighs, arms, and quadrants of the abdomen
If a dose is missed, take as soon as possible on that day; do not take 2 doses on the same day
- If discontinued, may result in fluid and electrolyte imbalance
- Carefully monitor electrolyte status
SC injection preparation
- Reconstitute each vial by slowly injecting the 0.5 mL of preservative-free sterile water for injection provided in the prefilled syringe; allow vial to stand for ~30 seconds and then gently roll the vial between your palms for about 15 seconds; DO NOT SHAKE
- Allow mixed contents to stand for ~2 minutes, then inspect for any undissolved powder
- If undissolved powder observed, gently roll the vial again until all material is dissolved; if the product remains undissolved after the second attempt, do not use
- Sterile, clear, colorless to light straw-colored 5 mg/0.5 mL solution after reconstitution
- Following reconstitution, a maximum of 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn from the vial for dosing
- For single-use only; does not preservatives; discard unused portion
- Use within 3 hr after reconstitution
- Store unreconstituted vial at room temperature up to 77°F (25°C)
- Do not freeze
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
GI stoma complication (41.9%)
Abdominal pain (30%)
Injection site reactions (22.4%)
Abdominal distension (19.5%)
Abdominal distension (13.8%)
Upper respiratory tract infection (11.8%)
Fluid overload (11.7%)
Appetite disorders (6.5%)
Sleep disturbances (5.2%)
Skin hemorrhage (5.2%)
Cardiac disorders: Cardiac arrest, cardiac failure
Nervous system disorders: Cerebral hemorrhage
Teduglutide has potential to increase absorption of concomitant oral medications; monitor and adjust dose as necessary of oral medications that require titration or have a narrow therapeutic index; altered mental status reported in patients taking benzodiazepines or phenothiazines
Cholecystitis, cholangitis, cholelithiasis, and pancreatitis reported; assess bilirubin, alkaline phosphatase, lipase and amylase within 6 months prior to starting treatment, and then every 6 months
Intestinal obstruction reported; discontinue until temporarily and restart when obstruction resolves
Fluid overload and congestive heart failure observed in clinical trials
- Based on pharmacologic activity and animal findings, has potential to cause hyperplastic changes including neoplasia
- Discontinue with active GI malignancy
- Colorectal polyps identified during clinical trials
- Colonoscopy (or alternate imaging) of the entire colon with removal of polyps should be done within 6 months prior to starting treatment; follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 yr of teduglutide; if no polyp is found, subsequent colonoscopies should be done no less frequently than every 5 yr
- Small bowel neoplasia observed in rats
Pregnancy & Lactation
Pregnancy Category: B
Lactation: Unknown whether distributed in human breast milk
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Analog of naturally occurring glucagon-like peptide-2 (GLP-2); binds to the GLP-2R receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts, and enteric neurons of the submucosal and myenteric plexus
Activation of these receptors results in the local release of intestinal mediators that increases intestinal absorptive capacity, resulting in increased fluid and nutrient absorption
Peak Plasma Time: 3-5 hr
Peak Plasma Concentration: 36 ng/mL
AUC: 0.15 mcg•hr/mL
Vd: 103 mL/kg
Expected to be metabolized by hydrolytic degradation (like native BLP-2)
Half-life: 1.3 hr (SBS); ~ 2 hr (healthy volunteers)
Renal clearance: 123 mL/hr/kg
Excretion: Primarily in urine
Adding plans allows you to compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.