Dosing & Uses
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
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)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (38)
- alprazolam
teduglutide increases levels of alprazolam by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- carbamazepine
teduglutide increases levels of carbamazepine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- chlordiazepoxide
teduglutide increases levels of chlordiazepoxide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- chlorpromazine
teduglutide increases levels of chlorpromazine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- clonazepam
teduglutide increases levels of clonazepam by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- clonidine
teduglutide increases levels of clonidine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- clorazepate
teduglutide increases levels of clorazepate by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- colchicine
teduglutide increases levels of colchicine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- cyclosporine
teduglutide increases levels of cyclosporine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- diazepam
teduglutide increases levels of diazepam by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- digoxin
teduglutide increases levels of digoxin by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- disopyramide
teduglutide increases levels of disopyramide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- ethosuximide
teduglutide increases levels of ethosuximide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- flecainide
teduglutide increases levels of flecainide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- fluphenazine
teduglutide increases levels of fluphenazine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- haloperidol
teduglutide increases levels of haloperidol by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- levothyroxine
teduglutide increases levels of levothyroxine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- lithium
teduglutide increases levels of lithium by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- lorazepam
teduglutide increases levels of lorazepam by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- loxapine
teduglutide increases levels of loxapine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- midazolam
teduglutide increases levels of midazolam by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- minoxidil
teduglutide increases levels of minoxidil by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- oxazepam
teduglutide increases levels of oxazepam by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- phenytoin
teduglutide increases levels of phenytoin by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- pimozide
teduglutide increases levels of pimozide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- prazosin
teduglutide increases levels of prazosin by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- primidone
teduglutide increases levels of primidone by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- procainamide
teduglutide increases levels of procainamide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- prochlorperazine
teduglutide increases levels of prochlorperazine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- quinidine
teduglutide increases levels of quinidine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- sirolimus
teduglutide increases levels of sirolimus by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- tacrolimus
teduglutide increases levels of tacrolimus by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- theophylline
teduglutide increases levels of theophylline by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- thioridazine
teduglutide increases levels of thioridazine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- thiothixene
teduglutide increases levels of thiothixene by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- trifluoperazine
teduglutide increases levels of trifluoperazine by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- valproic acid
teduglutide increases levels of valproic acid by sedation. Use Caution/Monitor. Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
- warfarin
teduglutide increases levels of warfarin by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.
Minor (0)
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
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
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Gattex 30-Vial subcutaneous - | 5 mg kit |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
teduglutide subcutaneous
TEDUGLUTIDE - INJECTION
(TE-due-GLOO-tide)
COMMON BRAND NAME(S): Gattex
USES: Teduglutide is used by patients with Short Bowel Syndrome (SBS) who need intravenous (IV) nutrition and fluids. It may help to decrease the amount of intravenous nutrition needed by the patient. Teduglutide is similar to a natural hormone in your body (GLP-2). It works by helping to improve intestinal absorption of fluids and nutrients.
HOW TO USE: Read the Medication Guide and the Instructions For Use Leaflet provided by your pharmacist before you start using teduglutide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not shake the vial. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once daily. The dosage is based on your medical condition, weight, and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.
SIDE EFFECTS: Decreased appetite, trouble sleeping, cough, flu-like symptoms, or pain/redness/swelling at injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: nausea/vomiting that doesn't stop, swelling ankles/feet, unusual tiredness, sudden weight gain, severe constipation, stomach/abdominal pain or swelling, yellowing eyes/skin, dark urine, black/tarry stool, vomit that looks like coffee grounds.This medication may increase the risk of cancer. Your doctor will monitor you closely with lab and medical tests. See also Notes section.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using teduglutide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, cancer, gallbladder disease, disease of the pancreas (pancreatitis), intestinal or rectal polyps, heart problems (such as heart failure).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as colonoscopy, fecal occult blood testing, lipase/amylase levels, liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, use it as soon as you remember if it is on the same day. If it is the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose or use 2 doses on the same day to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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