teduglutide (Rx)

Brand and Other Names:Gattex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 5mg/vial
  • 3.8mg/0.38mL (after reconstitution)

Short Bowel Syndrome

Indicated for adults with short bowel syndrome who are dependent on parenteral support

0.05 mg/kg SC qDay  

Dosage Modifications

Renal impairment

  • Mild (eGFR ≥60 mL/min/1.73 m²): No dose adjustment required
  • Moderate-to-severe (eGFR <60 mL/min/1.73 m²): 0.025 mg/kg SC qDay  

Hepatic impairment

  • Mild-to-moderate: No dose adjustment required
  • Severe: Not studied

Dosing Considerations

Within 6 months before initiating teduglutide

  • Perform colonoscopy with removal of polyps
  • Obtain baseline laboratory assessments (eg, bilirubin, alkaline phosphatase, lipase, amylase)

Colonoscopy schedule

  • Follow-up colonoscopy (or alternate imaging) recommended at end of 1 year of treatment
  • If no polyp(s) found, perform subsequent colonoscopies at least q5yr
  • If polyp(s) found, adhere to current polyp follow-up guidelines recommended

Laboratory testing

  • Perform laboratory assessments q6mo
  • If any clinically meaningful elevation observed, further diagnostic workup recommended as clinically indicated (ie, imaging of the biliary tract, liver, or pancreas)

Dosage Forms & Strengths

injection, lyophilized powder for reconstitution

  • 5mg/vial
  • 3.8mg/0.38mL (after reconstitution)

Short Bowel Syndrome

Indicated for children aged ≥1 yr with short bowel syndrome who are dependent on parenteral support

<1 year: Safety and efficacy not established

≥1 year and weight at least 10 kg: 0.05 mg/kg SC qDay  

Dosage Modifications

Renal impairment

  • Mild (eGFR ≥60 mL/min/1.73 m²): No dose adjustment required
  • Moderate-to-severe (eGFR <60 mL/min/1.73 m²): 0.025 mg/kg SC qDay  

Hepatic impairment

  • Mild-to-moderate: No dose adjustment required
  • Severe: Not studied

Dosing Considerations

Within 6 months before initiating teduglutide

  • Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase and amylase)

Colonoscopy schedule

  • Perform subsequent fecal occult blood testing annually in children and adolescents while receiving teduglutide
  • Colonoscopy/sigmoidoscopy recommended for all children and adolescents after 1 year of treatment, q5yr thereafter while on continuous treatment with teduglutide, and with new or unexplained gastrointestinal bleeding

Laboratory testing

  • Perform laboratory assessments q6mo
  • If any clinically meaningful elevation observed, further diagnostic workup recommended as clinically indicated (ie, imaging of the biliary tract, liver, or pancreas)
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Interactions

Interaction Checker

and teduglutide

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            GI stoma complication (41.9%)

            Abdominal pain (30%)

            Injection site reactions (22.4%)

            Abdominal distension (19.5%)

            Nausea (18.2%)

            Headaches (15.9%)

            Abdominal distension (13.8%)

            Upper respiratory tract infection (11.8%)

            Fluid overload (11.7%)

            Vomiting (11.7%)

            1-10%

            Flatulence (9.1%)

            Hypersensitivity (7.8%)

            Appetite disorders (6.5%)

            Sleep disturbances (5.2%)

            Cough (5.2%)

            Skin hemorrhage (5.2%)

            Postmarketing Reports

            Cardiac disorders: Cardiac arrest, cardiac failure

            Nervous system disorders: Cerebral hemorrhage

            Acceleration of neoplastic growth

            Biliary and pancreatic disease

            Intestinal obstruction

            Fluid imbalance and overload

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            Warnings

            Contraindications

            None

            Cautions

            Cholecystitis, cholangitis, cholelithiasis, and pancreatitis reported; assess bilirubin, alkaline phosphatase, and lipase and amylase within 6 months prior to starting treatment, and then every 6 months

            Intestinal obstruction reported; discontinue temporarily and restart when obstruction resolves

            Discontinuation of treatment may also result in fluid and electrolyte imbalance; monitor fluid and electrolyte status in patients who discontinue treatment

            Fluid overload and congestive heart failure observed in clinical trials

            Neoplastic growth

            • Based on pharmacologic activity and animal findings, has potential to cause hyperplastic changes, including neoplasia
            • Discontinue with active GI malignancy
            • Small bowel neoplasia observed in rats
            • Colorectal polyps
              • Colorectal polyps identified during clinical trials
              • For adults, perform colonoscopy within 6 months before initiating treatment and after 1 year of treatment
              • Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment, and if they have new or unexplained gastrointestinal bleeding
              • For children and adolescents, perform fecal occult blood testing before initiating treatment and after 1 year of treatment; colonoscopy/sigmoidoscopy required if there is unexplained blood in the stool
              • See Dosing Considerations for recommendations

            Drug interaction overview

            • Based on the pharmacodynamic effect of teduglutide, absorption of concomitantly administered oral medications may be increased
            • Monitor patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index for adverse reactions due to potential increased absorption of concomitant drug
            • Concomitant drug may require dosage reduction
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            Pregnancy & Lactation

            Pregnancy

            Available data from case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; pregnant women with short bowel syndrome are at risk for malnutrition, which is associated with adverse maternal and fetal outcomes; severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality

            Animal data

            • In animal reproduction studies, no effects on embryo-fetal development were observed with subcutaneous administration to pregnant rats and rabbits during organogenesis at exposures up to 686 times the clinical exposure at recommended human dose

            Lactation

            There is no information regarding presence in human milk, effects on the breastfed infant, or on milk production; drug is present in milk of lactating rats; systemic exposure to a breastfed infant is expected to be low; however, because of the potential for serious adverse reactions in a breastfed infant, including tumorigenicity, advise patients that breastfeeding is not recommended during treatment

            Pregnancy Categories

            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.

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            Pharmacology

            Mechanism of Action

            Analog of naturally occurring glucagonlike 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 local release of intestinal mediators that increase intestinal absorptive capacity, resulting in increased fluid and nutrient absorption

            Absorption

            Bioavailability: 88%

            Peak plasma time: 3-5 hr

            Peak plasma concentration

            • 36 ng/mL (adults)
            • 29.7 ng/mL (adolescents aged 12-17 yr)
            • 33.5 ng/mL (children aged 1-11 yr)

            AUC

            • 0.15 mcg•hr/mL (adults)
            • 154 mcg•hr/mL (adolescents aged 12-17 yr)
            • 128 mcg•hr/mL (children aged 1-11 yr)

            Distribution

            Vd: 103 mL/kg

            Metabolism

            Expected to be metabolized by hydrolytic degradation (like native BLP-2)

            Elimination

            Renal clearance: 123 mL/hr/kg (adults)

            Excretion: Primarily in urine

            Half-life

            • 1.3 hr (SBS)
            • ~2 hr (healthy volunteers)
            • 1 hr (adolescents aged 12-17 yr)
            • 0.7 hr (children aged 1-11 yr)
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            Administration

            SC Preparation

            Reconstitute each vial by slowly injecting 0.5 mL of preservative-free sterile water for injection provided; 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 vial again until all material is dissolved; if the product remains undissolved after the second attempt, do not use

            Sterile solution should appear, clear, colorless to light straw-colored

            Following reconstitution, each vial contains a maximum of 0.38 mL of the reconstituted solution, which contains 3.8 mg of teduglutide for dosing

            For single use only; does not contain preservatives; discard unused portion

            Use within 3 hr after reconstitution

            SC Administration

            For adult self-administration or by caregiver administration

            For SC injection only; do not administer IV or IM

            Alternate injection sites between thighs, arms, and quadrants of the abdomen

            Missed dose: Take as soon as possible on that day; do not take 2 doses on the same day

            Discontinuation

            • Fluid and electrolyte imbalance may occur if discontinued; monitor

            Storage

            Unopened vial

            • Before dispensing
              • Refrigerate vial at 2-8°C (35-45°F)
              • Do not freeze
              • Ancillary supplies from kit may be stored at room temperature up to 25°C (77°F)
            • After dispensing by pharmacist
              • Stored at room temperature up to 25°C (77°F); use within 90 days
              • Do not freeze

            Reconstituted vial

            • Administer within 3 hr after reconstitution; discard any unused portion
            • Do not shake or freeze the reconstituted solution
            • For single use only
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            Formulary

            FormularyPatient Discounts

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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.

            Tier Description
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.