Revestive (Teduglutide)

What Is Revestive and What Is It Used For?

Revestive contains the active substance teduglutide, a synthetic analogue of the naturally occurring human hormone glucagon-like peptide-2 (GLP-2). This hormone is produced by specialized cells (L-cells) in the lower part of the small intestine and plays a crucial role in maintaining the health and function of the intestinal lining. Teduglutide mimics the action of native GLP-2 but is engineered to be more resistant to enzymatic breakdown, giving it a longer duration of action.

Short bowel syndrome (SBS) is a complex malabsorptive condition that typically results from the surgical removal (resection) of a significant portion of the small intestine. This can occur due to a variety of underlying conditions, including Crohn's disease, mesenteric vascular disease, radiation enteritis, volvulus (intestinal twisting), necrotizing enterocolitis (especially in newborns), or traumatic injury. When too much of the small intestine is missing, the remaining bowel is unable to absorb sufficient nutrients, fluids, and electrolytes from food alone.

Patients with SBS often require parenteral nutrition (PN) — the delivery of nutrients directly into the bloodstream through an intravenous catheter — to survive. While PN is lifesaving, long-term use is associated with significant complications including catheter-related bloodstream infections, liver disease (intestinal failure-associated liver disease, or IFALD), venous thrombosis, metabolic bone disease, and reduced quality of life. The central goal of SBS treatment is intestinal rehabilitation: maximizing the absorptive capacity of the remaining bowel to reduce or eliminate PN dependence.

Revestive addresses this goal at the physiological level. By binding to GLP-2 receptors on intestinal cells, teduglutide triggers a cascade of effects: it stimulates the proliferation of crypt cells (the stem cells of the intestinal lining), inhibits programmed cell death (apoptosis) of intestinal epithelial cells, increases villus height and crypt depth, and enhances intestinal blood flow. The net result is an expansion of the absorptive surface area and improved nutrient and fluid uptake from the remaining intestine.

In pivotal clinical trials, Revestive demonstrated a statistically significant reduction in parenteral nutrition volume requirements compared to placebo. Some patients were able to completely wean off PN during the study period. The European Medicines Agency (EMA) first approved Revestive in 2012 for adults with SBS, and later expanded the indication to include children and adolescents aged 1 year and older (subsequently extended to 4 months and older). In the United States, teduglutide is marketed under the brand name Gattex and has a similar approved indication.

What Should You Know Before Taking Revestive?

Contraindications

Revestive must not be used in the following situations:

• Allergy to teduglutide or any of the excipients in the formulation, or to tetracycline residues (trace amounts may be present from the manufacturing process).
• Active cancer (malignancy) or suspected malignancy of any type.
• History of gastrointestinal cancer within the preceding 5 years, including cancers of the liver, gallbladder, bile ducts, and pancreas. Because teduglutide stimulates cell proliferation, there is a theoretical concern that it could promote the growth of pre-existing or residual malignant cells.

Warnings and Precautions

Before starting Revestive, your doctor should be informed about all existing medical conditions. Special caution is needed in the following circumstances:

• Severely impaired liver function: Dose adjustments or intensified monitoring may be necessary, as teduglutide's effects on intestinal absorption could alter the metabolism of co-administered drugs processed by the liver.
• Cardiovascular disease: Patients with hypertension (high blood pressure) or heart failure should be closely monitored. Signs to watch for include sudden weight gain, facial swelling, ankle edema, and shortness of breath. Revestive can increase fluid absorption, potentially exacerbating fluid overload in patients with compromised cardiac function.
• Impaired kidney function: The dose of Revestive may need to be reduced, as teduglutide is primarily cleared through the kidneys. Patients with moderate to severe renal impairment (creatinine clearance below 50 mL/min) should receive half the standard dose.
• Other serious uncontrolled medical conditions: The prescribing physician will consider the overall risk-benefit balance before initiating treatment.

Required Medical Monitoring

Several important medical evaluations are mandatory before and during treatment with Revestive:

• Fecal occult blood test: Required before starting treatment to check for hidden blood in the stool.
• Colonoscopy: A full colonoscopy must be performed before starting Revestive to screen for polyps (abnormal growths). If polyps are found, they must be removed and assessed before the prescriber decides whether to proceed with treatment. Follow-up colonoscopies are required at regular intervals during ongoing treatment.
• Fluid and electrolyte monitoring: As Revestive improves intestinal absorption, the volume and composition of parenteral nutrition and intravenous fluids must be carefully adjusted to avoid fluid overload or dehydration.
• Gallbladder and pancreas surveillance: The doctor should monitor for signs and symptoms of gallbladder problems (cholecystitis, cholelithiasis), bile duct obstruction, and pancreatitis throughout treatment.
• Small intestine function monitoring: Regular assessment of intestinal adaptation and absorptive capacity is part of standard care.

Pregnancy and Breastfeeding

Revestive is not recommended during pregnancy. There are no adequate and well-controlled studies of teduglutide in pregnant women. Animal reproduction studies have not demonstrated clear evidence of harm, but as a precautionary measure, Revestive should only be used during pregnancy if the potential benefit to the mother clearly outweighs the potential risk to the fetus.

It is unknown whether teduglutide is excreted in human breast milk. A decision must be made whether to discontinue breastfeeding or discontinue Revestive therapy, taking into account the importance of the medication to the mother. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss their options with their healthcare provider before using this medication.

Driving and Operating Machinery

Revestive may cause dizziness in some patients. If dizziness occurs, patients should avoid driving, cycling, or operating heavy machinery until the symptom resolves. This effect is generally transient and mild.

How Does Revestive Interact with Other Drugs?

Because Revestive works by enhancing the absorptive capacity of the gastrointestinal tract, it has the potential to affect how other orally administered medications are absorbed. As the intestinal lining grows and functions more efficiently, the rate and extent of absorption of many drugs may change. This is not a traditional pharmacokinetic drug interaction (like those involving liver enzymes) but rather a physiological consequence of improved intestinal function.

Patients with short bowel syndrome are often on complex medication regimens, and even modest changes in drug absorption can have clinically significant effects, particularly for medications with a narrow therapeutic index — those where small changes in blood levels can lead to either treatment failure (too low) or toxicity (too high).

Medications Requiring Close Monitoring

It is critical that patients inform their healthcare provider about all medications they are taking, including prescription drugs, over-the-counter medicines, herbal supplements, and vitamins. The doctor may need to adjust the dose of concomitant medications as intestinal adaptation progresses during Revestive treatment. In some cases, additional blood tests or therapeutic drug monitoring may be required to ensure safe and effective co-administration.

What Is the Correct Dosage of Revestive?

Revestive is administered as a once-daily subcutaneous injection. The dose is calculated based on the patient's body weight, and the prescribing physician will determine the exact volume (in milliliters) of reconstituted solution to be injected. The medication is supplied as a powder that must be reconstituted (mixed) with a provided solvent immediately before use.

Standard Dosing

How to Prepare and Inject Revestive

Revestive requires reconstitution before injection. The powder in the vial is mixed with the solvent provided in a pre-filled syringe. Patients and caregivers should receive thorough training from a healthcare professional before self-administering the injection at home. The key steps are:

1. Assemble the pre-filled syringe: Attach the reconstitution needle (22G) to the pre-filled syringe containing the solvent.
2. Reconstitute the powder: Clean the vial top with an alcohol swab. Inject the solvent into the vial. Let stand for 30 seconds, then gently roll between your palms for 15 seconds. Do not shake. Let stand for another 2 minutes until fully dissolved.
3. Prepare the injection syringe: Attach a clean injection syringe (0.5 or 1 mL) to the reconstitution needle in the vial. Draw up the solution. Attach a fine injection needle (26G) and remove air bubbles. Adjust to the prescribed dose volume.
4. Inject the solution: Clean the injection site (abdomen or thigh) with an alcohol swab. Pinch the skin and insert the needle at a 45-degree angle. Inject slowly. Remove the needle and dispose of all sharps safely.

Missed Dose

If a dose is missed, it should be injected as soon as possible on the same day. Never administer two doses on the same day. Do not inject a double dose to compensate for a forgotten dose. Simply resume the regular dosing schedule the following day.

Overdose

If more Revestive than prescribed is accidentally injected, contact the prescribing physician, pharmacist, or local poison control center immediately. Overdose symptoms may include nausea, fluid retention, and exacerbation of known side effects. There is no specific antidote; treatment would be supportive and symptomatic.

What Are the Side Effects of Revestive?

Like all medicines, Revestive can cause side effects, although not everybody gets them. The side effects listed below are based on clinical trial data and post-marketing surveillance. The frequency categories follow the standard medical classification system. It is important to be aware of both common and serious side effects so that prompt medical attention can be sought when necessary.

Side Effects in Children and Adolescents

The side effect profile in children and adolescents is generally similar to that observed in adults. Clinical experience in children under 4 months of age is limited, and Revestive is not recommended for use in this age group. Parents and caregivers should monitor for any new or worsening symptoms and report them to the treating physician.

Reporting Side Effects

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance. Healthcare professionals and patients are encouraged to report suspected adverse reactions through their national pharmacovigilance system (e.g., the FDA MedWatch program in the United States, the Yellow Card Scheme in the United Kingdom, or the EMA EudraVigilance system in the European Union).

How Should You Store Revestive?

Proper storage of Revestive is essential to maintain the medication's effectiveness and safety. The unreconstituted powder and pre-filled solvent syringe should be stored in a refrigerator (2–8°C / 36–46°F). The medication must never be frozen, as freezing can damage the teduglutide protein and render it inactive.

Once the powder has been reconstituted with the solvent, the resulting solution should ideally be used immediately. However, from a microbiological perspective, chemical and physical stability of the reconstituted solution has been demonstrated for up to 24 hours at room temperature (not exceeding 25°C / 77°F). If the reconstituted solution is not used within this timeframe, it must be discarded.

Before injection, always visually inspect the reconstituted solution. The solution should appear clear and colorless. Do not use the solution if it appears cloudy, discolored, or contains visible particles. Check the expiration date on the carton, vial, and pre-filled syringe before use — the expiry date refers to the last day of the stated month.

Keep Revestive out of sight and reach of children. Do not dispose of medications in wastewater or household waste. Used needles and syringes should be placed in a puncture-resistant sharps disposal container. Contact your pharmacist for advice on proper disposal methods in your area.

What Does Revestive Contain?

Revestive is supplied as a powder and solvent for solution for injection. The formulation is designed for reconstitution immediately before subcutaneous administration.

Active Ingredient

The active substance is teduglutide. Teduglutide is a 33-amino acid peptide analogue of human glucagon-like peptide-2 (GLP-2), produced by recombinant DNA technology in Escherichia coli. It differs from native GLP-2 by a single amino acid substitution (alanine to glycine at position 2), which confers resistance to degradation by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in a significantly longer half-life.

• 1.25 mg vial: Contains 1.25 mg teduglutide as powder. After reconstitution with 0.5 mL solvent, the concentration is 2.5 mg/mL. Primarily designed for pediatric dosing.
• 5 mg vial: Contains 5 mg teduglutide as powder. After reconstitution with 0.5 mL solvent, the concentration is 10 mg/mL. Primarily designed for adult dosing.

Other Ingredients (Excipients)

The powder contains the following inactive ingredients:

• L-histidine (buffer)
• Mannitol (stabilizer)
• Sodium dihydrogen phosphate monohydrate (buffer)
• Disodium hydrogen phosphate heptahydrate (buffer)

The solvent contains water for injections.

Appearance and Packaging

The powder is white and the solvent is a clear, colorless liquid. Revestive is supplied in packages containing 28 vials of powder and 28 pre-filled syringes of solvent, providing a one-month supply for daily dosing. Items not included in the package but required for preparation and injection include reconstitution needles, injection syringes, fine injection needles, alcohol swabs, and a sharps disposal container.

Revestive is manufactured by Takeda Pharmaceuticals and holds marketing authorization in the European Union and other countries worldwide. The marketing authorization holder is Takeda Pharmaceuticals International AG Ireland Branch, Dublin, Ireland.

References & Sources

This article is based on the following peer-reviewed sources, regulatory documents, and international clinical guidelines:

1. European Medicines Agency (EMA). Revestive (teduglutide) — Summary of Product Characteristics (SmPC). Last updated 2025. Available at: ema.europa.eu/medicines/human/EPAR/revestive
2. U.S. Food and Drug Administration (FDA). Gattex (teduglutide) Prescribing Information. Revised 2024. Available at: FDA drug label
3. Jeppesen PB, Pertkiewicz M, Messing B, et al. Teduglutide reduces need for parenteral support among patients with short bowel syndrome with intestinal failure. Gastroenterology. 2012;143(6):1473-1481.e3. doi:10.1053/j.gastro.2012.09.007
4. Schwartz LK, O'Keefe SJ, Fujioka K, et al. Long-term teduglutide for the treatment of patients with intestinal failure associated with short bowel syndrome. Clin Transl Gastroenterol. 2016;7:e142. doi:10.1038/ctg.2015.69
5. Carter BA, Cohran VC, Cole CR, et al. Outcomes from a 12-week, open-label, multicenter clinical trial of teduglutide in pediatric short bowel syndrome. J Pediatr. 2017;181:102-111.e5. doi:10.1016/j.jpeds.2016.10.027
6. Pironi L, Arends J, Bozzetti F, et al. ESPEN guidelines on chronic intestinal failure in adults. Clin Nutr. 2016;35(2):247-307. doi:10.1016/j.clnu.2016.01.020
7. World Health Organization (WHO). WHO Model List of Essential Medicines. 23rd list, 2023. Geneva: WHO.
8. Bines JE, Taylor RG, Justice F, et al. Influence of diet complexity on intestinal adaptation following massive small bowel resection in a preclinical model. J Gastroenterol Hepatol. 2002;17(11):1170-1179.

Editorial Team

All medical content on iMedic follows evidence-based medicine principles with Evidence Level 1A (systematic reviews and meta-analyses of randomized controlled trials) as the gold standard. Our editorial process includes fact-checking against primary sources, peer review by subject-matter experts, and regular content updates to reflect the latest clinical evidence and regulatory changes.