MEDICAL DISCLAIMER: Educational research guidelines only. Lyophilized peptides are investigational chemical compounds and are NOT approved for human consumption, diagnosis, or therapy. Consult a licensed physician before any research application.
Teduglutide Dosage Chart, Schedule & Reconstitution Protocol
Quickstart Highlights
Teduglutide (Gattex, Revestive) is a DPP-4-resistant analog of glucagon-like peptide-2 (GLP-2) and a GLP-2 receptor agonist approved for short bowel syndrome (SBS) in patients dependent on parenteral support. It binds intestinal GLP-2 receptors to release IGF-1, KGF, and nitric oxide, expanding mucosal surface area, boosting intestinal blood flow, and slowing gastric emptying so the gut absorbs more fluid and nutrients (PMID 22982184). The standard dose is 0.05 mg/kg subcutaneously once daily, about 3.5 mg for a 70 kg adult, halved to 0.025 mg/kg in moderate-to-severe renal impairment. In the 24-week STEPS trial, 63% of treated patients cut parenteral support by 20% or more versus 30% on placebo (PMID 22982184). Because it is trophic to the bowel, it requires pre-treatment colonoscopy and periodic monitoring for polyps, biliary, and pancreatic disease. It is prescription-only; the figures here are educational, not medical advice.
Reconstitute: Add 0.5 mL bacteriostatic water → 10 mg/mL concentration.
Typical dose: 0.05 mg/kg/day SC (~3.5 mg/day for a 70 kg adult)
Easy measuring: At 10 mg/mL, 1 unit = 0.01 mL = 0.1 mg (100 mcg) on a U-100 insulin syringe.
Storage: Lyophilized single-dose vials are stored at controlled room temperature, 20-25 °C, protected from light; do not freeze. Once reconstituted, the solution should be used within about 3 hours and is kept at room temperature (the commercial product is not refrigerated or frozen after mixing). For the educational bacteriostatic-water model, refrigerate any retained solution at 2-8 °C and discard per single-use guidance.
Half-life: ~2 hours in healthy subjects (~1.3 h in SBS); biological half-life 2-3 h versus ~7 min for native GLP-2, with ~88% subcutaneous bioavailability and no accumulation.
Route: Subcutaneous injection once daily (abdomen, thigh, or upper arm), rotating sites; 5 mg vial reconstituted with 0.5 mL diluent to 10 mg/mL, used within ~3 hours.
Status: Prescription biologic. FDA-approved as Gattex (adults 2012; children ≥1 year 2019) and EMA-approved as Revestive (2012) for short bowel syndrome.
About Teduglutide
Teduglutide (brand names Gattex in the US and Revestive in the EU) is a recombinant 33-amino-acid analog of glucagon-like peptide-2 (GLP-2) and a selective GLP-2 receptor agonist used to treat short bowel syndrome (SBS) in patients who depend on parenteral support [1][2]. It differs from native human GLP-2 by a single substitution, alanine to glycine at position 2, which blocks dipeptidyl peptidase-4 (DPP-4) degradation and lengthens its biological half-life from roughly 7 minutes to 2-3 hours [3]. Unlike most oral or topical compounds catalogued on this site, teduglutide's real-world route is already subcutaneous, so the reconstitution figures below closely mirror clinical practice.\n\nThe approved Teduglutide dosage is 0.05 mg/kg injected subcutaneously once daily, about 3.5 mg/day for a 70 kg adult. This guide models the commercial 5 mg single-dose vial reconstituted with 0.5 mL of diluent (10 mg/mL), the same concentration used clinically, so doses land cleanly on a U-100 insulin syringe: a 70 kg dose (3,500 mcg) is 35 units, a 50 kg dose (2,500 mcg) is 25 units, and a 90 kg dose (4,500 mcg) is 45 units. Patients with moderate-to-severe renal impairment (eGFR below 60 mL/min/1.73 m²) take half the dose, 0.025 mg/kg [1]. Note that the licensed product is reconstituted with single-use sterile water for injection supplied in a prefilled syringe rather than bacteriostatic water.\n\nFrequency: Once daily at the same time each day, rotating injection sites among the abdomen, thighs, and upper arms; the reconstituted solution is used within about 3 hours. Teduglutide is FDA- and EMA-approved by prescription, and this page is an educational dosing reference, not medical advice.
Quick Protocol Navigation
Reconstitution Instruction & Mixing Step-by-Step
Lyophilized powder must be reconstituted carefully. Agitating peptide chains can shear disulfide bonds and render the peptide biologically inert.
Draw 0.5 mL of diluent (sterile water for injection clinically; bacteriostatic water in this educational model) into a sterile syringe — this matches the single-use prefilled diluent syringe packaged with the commercial 5 mg Gattex/Revestive vial.
Inject the 0.5 mL slowly down the inner wall of the 5 mg teduglutide vial; do not aim the stream at the powder cake and do not shake — vigorous agitation can denature the peptide and cause foaming.
Let the vial stand for about 30 seconds, then gently roll it between your palms until the powder is fully dissolved and the solution is clear and colorless; the result is 10 mg/mL, i.e. 100 mcg per insulin-syringe unit.
Draw the prescribed volume based on body weight: 3,500 mcg ≈ 35 units for a 70 kg adult, 2,500 mcg ≈ 25 units at 50 kg, 4,500 mcg ≈ 45 units at 90 kg, and 1,750 mcg ≈ 18 units for the renal-adjusted 0.025 mg/kg dose.
Swab a rotating subcutaneous site (abdomen, thigh, or upper arm), inject within about 3 hours of reconstitution, and discard any remainder — the licensed product is single-use and not preserved for multi-dose storage.
Interactive Teduglutide Syringe Calculator
Currently visualizing the 5 mg vial reconstituted with 0.5 mL bacteriostatic water. Adjust the target dose to dynamically render syringe units.
Reconstitution Calculation: 5mg dry powder in 0.5mL water yields 10.00 mg/mL. To evaluate a 250mcg dose, pull to 2.5 units (3 syringe ticks).
U-100 Syringe Representation
Educational reference visual. Assumes standard U-100 insulin syringe where 1.0 mL volume = 100 units.
Titration & Dose Escalation Schedules
| Phase | Dose per injection | Units (per injection) |
|---|---|---|
| Standard 0.05 mg/kg — 50 kg adult | 2500 mcg (2.5 mg) | 25 units (0.25 mL) |
| Standard 0.05 mg/kg — 70 kg adult (~3.5 mg) | 3500 mcg (3.5 mg) | 35 units (0.35 mL) |
| Standard 0.05 mg/kg — 90 kg adult | 4500 mcg (4.5 mg) | 45 units (0.45 mL) |
| Renal impairment (eGFR <60): 0.025 mg/kg — 70 kg | 1750 mcg (1.75 mg) | 18 units (0.17 mL) |
Administration guidelines: Refer to guidelines | 0.5 mL Reconstitution
Research Supplies Quantity Planner
Scientific mathematical planning of syringes, bacteriostatic water and dry vials needed for extended research blocks using the 5 mg vial.
Peptide Vials (Teduglutide, 5 mg each):
- check8 weeks at 0.05 mg/kg/day for a ~70 kg adult (3.5 mg/dose, single-use vials) ≈ 56 vials
- check12 weeks ≈ 84 vials
- check16 weeks ≈ 112 vials — each 5 mg vial is single-dose and discarded after one injection, so usage scales 1 vial per day regardless of body weight up to ~100 kg
Insulin Syringes (U-100):
- checkOnce-daily dosing: 7 syringes per week
- check8 weeks ≈ 56 syringes; 12 weeks ≈ 84 syringes
- check16 weeks ≈ 112 syringes — at 10 mg/mL each unit is 100 mcg, so a 70 kg dose is ~35 units, well within one syringe
Bacteriostatic Water (30 mL bottles): Use 0.5 mL per vial for reconstitution.
- check8 weeks (56 vials × 0.5 mL) ≈ 28 mL ≈ 1 bottle
- check12 weeks ≈ 42 mL ≈ 2 bottles
- check16 weeks ≈ 56 mL ≈ 2 bottles — note the licensed product instead ships single-use 0.5 mL sterile water syringes rather than multi-dose bacteriostatic water
Alcohol Swabs:
- check1-2 swabs per dose (vial top + injection site)
- check8 weeks ≈ 60-115 swabs; 12 weeks ≈ 85-170 swabs
- check16 weeks ≈ 115-225 swabs; rotate injection sites and keep extras for site prep
Mechanism of Action (MOA)
Teduglutide is a 33-amino-acid recombinant analog of glucagon-like peptide-2 (GLP-2), an intestinotrophic hormone secreted by enteroendocrine L-cells of the distal ileum and colon after a meal [3]. Native GLP-2 is rapidly inactivated by dipeptidyl peptidase-4 (DPP-4), which cleaves the N-terminal His-Ala dipeptide; teduglutide replaces the position-2 alanine with glycine, rendering it resistant to DPP-4 and extending its biological half-life from roughly 7 minutes to about 2-3 hours [3][4]. This single change is what makes once-daily dosing feasible.\n\nMechanistically, teduglutide binds the GLP-2 receptor, a G-protein-coupled receptor expressed on subepithelial myofibroblasts, enteric neurons, and enteroendocrine cells rather than on the absorptive enterocytes themselves [1][3]. Receptor activation drives the local release of downstream mediators, principally insulin-like growth factor-1 (IGF-1), keratinocyte growth factor (KGF), and nitric oxide. The net trophic effect is increased villus height and crypt depth, expansion of the mucosal absorptive surface area, enhanced intestinal and portal blood flow, slowed gastric emptying, and reduced gastric acid secretion [1][3]. Together these actions raise the gut's capacity to absorb fluid, electrolytes, and macronutrients, which in short bowel syndrome translates into a reduced requirement for parenteral nutrition and intravenous fluids.\n\nPharmacokinetics: teduglutide is administered subcutaneously with high absolute bioavailability of approximately 88%. After a 0.05 mg/kg dose in SBS patients, peak plasma concentrations (Cmax) of roughly 36 ng/mL are reached at a Tmax of about 3-5 hours [1][4]. Exposure increases dose-proportionally across 0.05 to 0.4 mg/kg, and total exposure is similar whether injected into the abdomen, arm, or thigh. The terminal half-life is approximately 2 hours in healthy subjects and about 1.3 hours in SBS patients, and the drug does not accumulate with repeated daily dosing [1][4]. Plasma clearance (~123 mL/hr/kg) approximates the glomerular filtration rate, indicating that teduglutide is cleared primarily by the kidney; consequently, the dose is halved to 0.025 mg/kg in patients with moderate-to-severe renal impairment or end-stage renal disease [1].\n\nBecause teduglutide is a true peptide given subcutaneously, the reconstitution scheme on this page reflects how the medicine is actually prepared and delivered, unlike the educational subcutaneous models used elsewhere on this site for oral or topical compounds. The trophic, pro-proliferative mechanism that makes teduglutide effective is also the basis for its principal safety signal: because it promotes mucosal cell growth, it carries warnings for acceleration of neoplastic growth, colorectal polyps, intestinal obstruction, and gallbladder, biliary, and pancreatic disease, which is why colonoscopy and laboratory monitoring are required before and during therapy [1].
Clinical Trial Efficacy Highlights
- starIn the pivotal 24-week, double-blind, placebo-controlled phase 3 STEPS trial (Jeppesen et al., Gastroenterology 2012), 63% (27 of 43) of adults with SBS-intestinal failure receiving teduglutide 0.05 mg/kg/day achieved a 20% or greater reduction in weekly parenteral support at weeks 20 and 24, versus 30% (13 of 43) on placebo (p = 0.002), with a mean parenteral-volume reduction of about 4.4 L/week on teduglutide [2].
- starThe earlier randomized phase 3 dose-finding study summarized by Jeppesen (Therap Adv Gastroenterol 2012) reported a responder rate of 46% (16 of 35) at 0.05 mg/kg/day versus 6% (1 of 16) on placebo, and several patients achieved complete independence from parenteral support, including individuals who had been dependent for 6.5 and 25 years [3].
- starIn the long-term STEPS-2 extension (Schwartz et al., Clinical and Translational Gastroenterology 2016), patients treated continuously for up to 30 months showed a 93% response rate among completers and a mean parenteral-support reduction of about 7.6 L/week (66%); 13 patients (20% of completers) achieved full enteral autonomy and stopped parenteral support entirely [6].
- starThe 24-week phase 3 pediatric trial (Kocoshis et al., JPEN 2020) randomized children 1-17 years with SBS-IF to teduglutide 0.025 or 0.05 mg/kg/day or standard of care; all 59 enrolled patients completed the study, and teduglutide produced significant reductions in parenteral support relative to baseline, supporting the 2019 FDA expansion to children 1 year and older [5].
- starPopulation pharmacokinetic modeling across healthy participants and SBS and Crohn's disease patients (Marier et al., J Clin Pharmacol 2010) confirmed a one-compartment model with weight-dependent clearance and a terminal half-life on the order of 1-3 hours, providing the quantitative basis for weight-based (mg/kg) rather than fixed dosing [4].
- starAcross the controlled program, the most consistently demonstrated benefit was a clinically meaningful reduction in parenteral nutrition days and volume, with a subset of patients gaining one or more additional days per week free of parenteral support, an outcome strongly tied to quality of life in this population [2][6].
- starRegulatory bodies judged the cumulative phase 3 evidence sufficient for approval: the FDA approved Gattex for adults in December 2012 and for children 1 year and older in 2019, and the EMA approved Revestive in August 2012 for patients 1 year and above who have stabilized after intestinal adaptation [1][7].
Side Effects & Tolerability Profile
Clinical subjects transiently report mild side effects. Slowly escalating the titration dose represents the single most effective intervention to limit side effects.
- warningThe most common adverse reactions (incidence 10% or higher) in controlled trials were abdominal pain (~30%), nausea (~23%), upper respiratory tract infection (~21%), abdominal distension (~20%), and injection-site reactions such as pain, swelling, or rash (~13%); vomiting and peripheral edema are also frequent [1].
- warningAcceleration of neoplastic growth is the principal warning: because teduglutide is trophic to the bowel, it may promote growth of existing malignancy. The drug must be discontinued if active gastrointestinal cancer is detected, and treatment in patients with a history of GI cancer requires careful risk-benefit assessment [1].
- warningColorectal polyps: a colonoscopy (or alternative imaging) to detect and remove polyps is required before starting therapy and periodically during treatment (for example at the end of year 1, then at least every 5 years), reflecting the proliferative mechanism [1].
- warningIntestinal or stomal obstruction can occur; teduglutide should be temporarily discontinued during an acute obstructive episode and only resumed after the obstruction resolves [1].
- warningBiliary and pancreatic disease: gallbladder disease (cholecystitis, cholelithiasis), biliary obstruction, and pancreatitis have been reported. Liver enzymes are checked at baseline and laboratory monitoring (including bilirubin, lipase, and amylase) is recommended roughly every 6 months, with clinical evaluation if abnormalities appear [1].
- warningFluid overload: by enhancing fluid absorption, teduglutide can cause fluid retention that may precipitate or worsen congestive heart failure, so parenteral support should be reduced and adjusted rather than continued unchanged, and cardiovascular status monitored [1].
- warningRenal clearance dominates elimination, so patients with moderate-to-severe renal impairment or end-stage renal disease require a 50% dose reduction to 0.025 mg/kg/day; dose is also individualized in pediatric patients [1][4].
- warningRegulatory status: teduglutide is a prescription-only biologic (FDA-approved Gattex 2012/2019; EMA-approved Revestive 2012) administered under specialist supervision. It is not an over-the-counter or research-only supplement, and the figures here are educational, not a substitute for the prescribing information or clinical care [1][7].
Subcutaneous Injection Technique
Most research peptides require subcutaneous injection into fatty tissue. Never inject directly into a blood vessel or deep muscle tissue unless clinically detailed.
1. Site Selection
Common locations include the abdomen (2 inches from navel), outer upper arms, or thighs.
2. Sanitization
Thoroughly clean the selected site, stopper and vial top using 70% isopropyl alcohol prep swabs.
3. Angle & Push
Pinch the skin and insert the needle at a 45 to 90-degree angle. Depress plunger smoothly.
4. Site Rotation
Rotate injection sites continuously to avoid lipodystrophy or tissue scarring.
Frequently Asked Questions
What is the typical Teduglutide dosage?expand_more
The approved Teduglutide dosage is 0.05 mg/kg of body weight injected subcutaneously once daily, which works out to about 3.5 mg/day for a 70 kg adult, 2.5 mg/day at 50 kg, and 4.5 mg/day at 90 kg. The dose is the same from the start (there is no titration ramp), but it is halved to 0.025 mg/kg/day in patients with moderate-to-severe renal impairment or end-stage renal disease because the drug is cleared mainly by the kidneys. Pediatric patients aged 1 year and older are also dosed at 0.05 mg/kg once daily.
Is Teduglutide FDA approved?expand_more
Yes. The FDA approved teduglutide as Gattex in December 2012 for adults with short bowel syndrome (SBS) who depend on parenteral support, and in 2019 expanded the approval to children 1 year of age and older. It is also EMA-approved in the EU as Revestive (authorized August 2012). Teduglutide is a prescription-only biologic used under specialist supervision; it is not an over-the-counter supplement, and this page is an educational reference rather than medical advice.
How is Teduglutide reconstituted and administered?expand_more
The commercial 5 mg single-dose vial is reconstituted with 0.5 mL of preservative-free sterile water for injection (supplied in a prefilled syringe), giving a 10 mg/mL solution. Add the diluent slowly down the vial wall, let it sit briefly, then gently roll, never shake, until clear. Draw the weight-based dose, inject subcutaneously into the abdomen, thigh, or upper arm within about 3 hours, rotate sites, and discard any remainder. On a U-100 insulin syringe at 10 mg/mL, each unit equals 100 mcg, so a 3,500 mcg dose is 35 units.
What is the half-life of Teduglutide?expand_more
Teduglutide has a terminal half-life of roughly 2 hours in healthy subjects and about 1.3 hours in patients with short bowel syndrome. Its biological half-life of 2-3 hours is far longer than the roughly 7-minute half-life of native GLP-2 because the alanine-to-glycine substitution at position 2 resists DPP-4 breakdown. Subcutaneous bioavailability is about 88%, peak levels occur around 3-5 hours, and the drug does not accumulate with daily dosing, so once-daily injection maintains the intestinotrophic effect despite the short measured half-life.
What are the main Teduglutide side effects and warnings?expand_more
The most common side effects are abdominal pain, nausea, abdominal distension, upper respiratory infection, vomiting, peripheral edema, and injection-site reactions. Because teduglutide promotes intestinal cell growth, it carries important warnings for acceleration of neoplastic growth and colorectal polyps (a colonoscopy is required before treatment and periodically during it), intestinal or stomal obstruction, gallbladder/biliary and pancreatic disease, and fluid overload that can worsen heart failure. Regular laboratory and imaging monitoring is part of standard care.
Related Guides & Tools
Step-by-step references for reconstituting, measuring, and storing Teduglutide, plus the universal dosing calculator.
Academic References & Study Citations
GATTEX (teduglutide) for injection, for subcutaneous use — US Prescribing Information (DailyMed/FDA), Takeda Pharmaceuticals. Dosage 0.05 mg/kg once daily; renal dose reduction; warnings and pharmacokinetics. View Scientific Paper →
Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure (STEPS). Gastroenterology. 2012;143(6):1473-1481.e3. View Scientific Paper →
Jeppesen PB. Teduglutide, a novel glucagon-like peptide 2 analog, in the treatment of patients with short bowel syndrome. Therap Adv Gastroenterol. 2012;5(3):159-171. View Scientific Paper →
Marier JF, Mouksassi MS, Gosselin NH, et al. Population pharmacokinetics of teduglutide following repeated subcutaneous administrations in healthy participants and in patients with short bowel syndrome and Crohn's disease. J Clin Pharmacol. 2010;50(1):36-49. View Scientific Paper →
Kocoshis SA, Merritt RJ, Hill S, et al. Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study. JPEN J Parenter Enteral Nutr. 2020;44(4):621-631. View Scientific Paper →
Schwartz LK, O'Keefe SJD, Fujioka K, et al. Long-Term Teduglutide for the Treatment of Patients With Intestinal Failure Associated With Short Bowel Syndrome (STEPS-2). Clin Transl Gastroenterol. 2016;7(2):e142. View Scientific Paper →
European Medicines Agency. Revestive (teduglutide) — EPAR / medicine overview. Marketing authorization valid throughout the EU since 30 August 2012, for short bowel syndrome in patients aged 1 year and above. View Scientific Paper →