Teduglutide Injection
Teduglutide injection (Gattex) is a GLP-2 analog used to treat Short Bowel Syndrome in adults and children aged 1 year and older who depend on parenteral (IV nutritional) support.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Teduglutide Injection: Patient Information Guide
A plain-language walkthrough of Teduglutide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Teduglutide injection (sold as Gattex) is approved for one main condition:
- Short Bowel Syndrome (SBS) in adults: Gattex is indicated for adults with SBS who depend on parenteral support (nutrition delivered through a vein) because their intestine cannot absorb enough on its own.
- Short Bowel Syndrome (SBS) in children aged 1 year and older: Gattex is also indicated for pediatric patients 1 year of age and older with SBS who are dependent on parenteral support.
⚙️How it works▾
Teduglutide is a synthetic (lab-made) analog — a close copy — of a natural hormone your gut produces called GLP-2 (glucagon-like peptide-2). GLP-2 is normally released by cells in the lower intestine after eating. Teduglutide binds to GLP-2 receptors on intestinal cells, nerve cells, and supporting cells in the gut wall. This triggers the release of growth-promoting signals — including IGF-1 (insulin-like growth factor-1) and KGF (keratinocyte growth factor) — that rebuild and thicken the intestinal lining, increase blood flow to the gut, and reduce gastric acid production. The result is a larger, healthier absorptive surface that can take in more fluid and nutrients from food.
💊How it's taken▾
Gattex is given as a subcutaneous injection (a small shot just under the skin) once daily. Injection sites should be rotated — using the abdomen, thighs, or upper arms in turn — to avoid irritation at any one spot. The medication comes as a powder that must be mixed with the sterile water supplied before each use; once mixed, it must be used within 3 hours and any unused portion discarded.
- Adults may self-inject or have a caregiver administer it; self-injection in children has not been tested.
- The 5 mg kit is not recommended for children weighing less than 10 kg (about 22 lbs).
- Patients with moderate to severe kidney disease or end-stage renal disease require a reduced dose — follow your prescriber's instructions exactly.
- If a dose is missed, take it as soon as possible on that same day. Never take two doses in one day.
🤒Side effects — in detail▾
The most common side effects of Gattex (occurring in at least 10% of patients in clinical studies) include:
- Abdominal pain or cramping
- Nausea
- Upper respiratory tract infections (colds, sinusitis, sore throat)
- Abdominal bloating or distension
- Injection site reactions (redness, swelling, bruising, pain at the shot site)
- Vomiting
- Fluid retention or swelling (edema)
- Allergic reactions (rash, flushing, itching, eyelid swelling)
More serious reactions that require prompt medical attention include intestinal obstruction (blockage), polyps or GI cancer, gallbladder disease, pancreatitis, fluid overload or heart failure, and severe changes in mental status if taking certain medications alongside Gattex. Contact your doctor right away if you experience any of these.
⚠️Warnings & precautions▾
- Polyp and tumor growth: Teduglutide promotes growth of intestinal cells, which can accelerate the development of polyps (benign growths) and potentially cancers in the GI tract. Adults must have colonoscopy and upper GI endoscopy before starting and after 1 year of treatment, then every 5 years. If GI cancer is diagnosed, Gattex must be stopped immediately.
- Intestinal obstruction: Blockages in the intestine or at a stoma (surgical opening) have occurred. If this happens, Gattex should be temporarily stopped until the obstruction clears.
- Gallbladder and pancreatic disease: Gattex has been linked to gallstones, gallbladder inflammation (cholecystitis), and pancreatitis. Lab tests (bilirubin, liver enzymes, lipase, amylase) are needed every 6 months.
- Fluid overload and heart problems: Because Gattex improves fluid absorption, excess fluid can build up — leading to swelling, shortness of breath, and in some cases heart failure. Patients with heart disease need extra monitoring.
- Stronger absorption of oral medications: Gattex may cause oral drugs to be absorbed more powerfully than usual. Drugs with a narrow safe range (like certain sedatives) may need dose adjustments. One patient on a benzodiazepine fell into a coma shortly after starting Gattex.
- Stopping Gattex: Discontinuing treatment can cause fluid and electrolyte imbalances. Monitor for dehydration or electrolyte problems after stopping.
🔀What it interacts with▾
Because Gattex improves how well the intestine absorbs substances, it can make oral medications work more powerfully — sometimes dangerously so. Key interactions to know:
- Benzodiazepines (e.g., diazepam, lorazepam, and similar sedatives/anti-anxiety drugs): One patient developed a coma linked to extremely high levels of a benzodiazepine after starting Gattex. Use together requires very careful monitoring and possible dose reduction of the benzodiazepine.
- Oral drugs with a narrow therapeutic index (meaning the difference between an effective dose and a harmful dose is small): These may be absorbed more than intended, increasing the risk of toxicity. Your prescriber may need to lower the dose of the other drug.
- Any oral drug that requires titration (gradual dose adjustment): Should be watched closely for stronger-than-expected effects when starting or continuing Gattex.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Active or history of GI cancer: Gattex must be stopped if gastrointestinal malignancy (cancer of the gut, liver, bile ducts, or pancreas) develops; use with caution in those at elevated cancer risk.
- Kidney disease: A dose reduction is required for adults and children with moderate to severe kidney impairment or end-stage renal disease. Tell your doctor about any kidney problems before starting.
- Gallbladder or pancreatic disease: These conditions can worsen with Gattex; baseline and ongoing lab monitoring is required.
- Heart disease or history of fluid retention: Gattex can cause fluid overload; people with underlying cardiovascular disease need especially close monitoring.
- Pregnancy: Limited human data are available; animal studies showed no harm to the fetus. However, untreated Short Bowel Syndrome can itself cause serious pregnancy complications. Discuss risks and benefits with your doctor.
- Breastfeeding: Breastfeeding is not recommended while taking Gattex because of the potential for serious side effects — including tumor-promoting effects — in a nursing infant.
- Children under 1 year: Safety and effectiveness have not been established in infants under 1 year of age. Gattex is not approved for this age group.
- Children weighing less than 10 kg: The Gattex 5 mg kit is not recommended for pediatric patients below this weight.
- Older adults (75+): Experience is limited in people 75 years and older; use with appropriate caution and monitoring.
🚑If you take too much▾
The highest dose studied in clinical development was 80 mg per day for 8 days, and no unexpected serious reactions were seen at that level. If an overdose is suspected, the person should be carefully monitored by a medical professional. Contact poison control or emergency services right away if you think too much has been given.
📡Pharmacodynamics — effects in the body▾
In clinical studies, Gattex improved the gut's ability to absorb fluid by approximately 750 to 1,000 mL (about 3 to 4 cups) per day, compared to baseline. It also increased the height of intestinal villi (tiny finger-like projections that absorb nutrients) and the depth of intestinal crypts (the pockets between villi that help regenerate the lining) — in other words, it physically rebuilds and enlarges the absorptive surface of the gut. At a dose five times higher than the standard dose, Gattex did not cause any meaningful changes to heart rhythm (QT interval), suggesting a low cardiac electrical risk at recommended doses.
🔬Pharmacokinetics — how your body processes it▾
When injected subcutaneously (under the skin), Gattex is well absorbed — about 88% of the dose reaches the bloodstream — with peak blood levels occurring 3 to 5 hours after the injection. It is distributed through the body in a volume similar to blood volume and does not accumulate with daily dosing. Teduglutide is broken down into small peptides and amino acids (the building blocks of proteins) and is primarily cleared by the kidneys, with a half-life of roughly 2 hours in healthy adults and about 1.3 hours in people with Short Bowel Syndrome — meaning it clears the body relatively quickly. Children aged 1 to 17 years have similar peak drug levels (Cmax) to adults but somewhat lower overall exposure (AUC), which increases as children get older.
📦How to store it▾
Store GATTEX 5 mg Strength one-vial kits refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Store GATTEX 5 mg Strength one-vial kits at room temperature up to 25°C (77°F).
📄 Written from Teduglutide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Teduglutide Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Gattex do, and will it cure my Short Bowel Syndrome? ▾
How do I give myself this injection, and does it hurt? ▾
Why do I need a colonoscopy before and during treatment? ▾
Are there any medications I need to be careful about while taking Gattex? ▾
What side effects should I just watch and which ones mean I need to call my doctor right away? ▾
Is Gattex safe if I'm pregnant or breastfeeding? ▾
Is Teduglutide Injection available over the counter? ▾
When was Teduglutide Injection first available? ▾
Who makes Teduglutide Injection? ▾
💬 Answers drafted from Teduglutide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Teduglutide Injection comes
Teduglutide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Gattex is used to treat Short Bowel Syndrome (SBS) in adults who are dependent on parenteral (IV) nutritional support
- Gattex is used to treat Short Bowel Syndrome (SBS) in children 1 year of age and older who are dependent on parenteral support
- Gattex is injected subcutaneously (under the skin) once daily — rotate injection sites among the abdomen, thigh, and upper arm with each dose
- Gattex must be reconstituted (mixed) with the sterile water provided before each use; gently roll the vial, do not shake, and use within 3 hours of mixing
- Gattex is for adult self-administration or caregiver administration; self-injection in children has not been tested, and the 5 mg kit is not recommended for children weighing less than 10 kg
- If a Gattex dose is missed, take it as soon as possible on that same day — never take two doses on the same day
📊 Teduglutide Injection across the U.S. market
How Teduglutide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Teduglutide Injection is used
A general measure of how commonly Teduglutide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Teduglutide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Teduglutide Injection prescribed? Of the 1,596 medications we measure, Teduglutide Injection ranks #1,052 by Medicaid prescriptions — more than 34% of them.
Utilization by Teduglutide Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
teduglutide 5 MG Injection
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1364472
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Teduglutide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Teduglutide Injection NDCs with Medicaid activity.
🔍 Compare Teduglutide Injection products
A representative set of FDA-listed product records for Teduglutide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 5 mg/0.5 mL | — | Patheon Italia S.p.A. × 2 listings | DRUG FOR FURTHER PROCESSING | View NDC → |
| 5 mg/0.5 mL | Subcutaneous | Takeda Pharmaceuticals America, Inc. × 2 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Teduglutide Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Teduglutide Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Teduglutide Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Teduglutide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1364468 1 dose form · 1 strength
-
Dose form (SCDF) Injection RxCUI 1719758In current FDA listingsClinical drug / strength (SCD) 5 MGRxCUI 1364472
Look up RxCUI 1364468 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Teduglutide Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Teduglutide Injection belongs to the GLP-2 Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.