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    Other Products for Functional Bowel Disorders

    DEA CLASS

    Rx

    DESCRIPTION

    Recombinant glucagon-like peptide-2 (GLP-2) analog
    Used in patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition
    Potential increased risk of developing cancer, polyps, and intestinal obstruction

    COMMON BRAND NAMES

    Gattex

    HOW SUPPLIED

    Gattex Subcutaneous Inj Pwd F/Sol: 5mg

    DOSAGE & INDICATIONS

    For the treatment of short bowel syndrome in patients who are dependent on parenteral support:.
    Subcutaneous dosage
    Adults

    0.05 mg/kg/day SC once daily. Alternate sites for subcutaneous injection among the 4 quadrants of the abdomen, the thighs, or the arms. Do not administer intravenously or intramuscularly. In a phase 3 trial designed to measure impact on parenteral nutrition requirements, 83 patients with SBS dependent on parenteral nutrition were randomized to teduglutide 0.05 mg/kg/day SC, 0.1 mg/kg/day SC, or placebo for 24 weeks. Patients were classified as having a clinically significant response if their weekly parenteral nutrition needs decreased by > 20% by week 20, and if the reduced requirements were maintained through week 24. More patients in the 0.05 mg/kg/day group responded compared to the 0.1 mg/kg/day group (46% vs. 25%); only the results from the low-dose group achieved statistical significance as compared to placebo (p = 0.007). Additionally 2 patients in the low-dose group and 1 patient in the high-dose group were independent from parenteral nutrition by the end of the study. An open label, 28-week extension of this study found that the required volume of parenteral nutrition continued to be reduced in patients receiving teduglutide for the duration of the study. In another phase 3 trial, 63% of patients treated with teduglutide 0.05 mg/kg/day SC once daily achieved at least a 20% reduction in weekly parenteral nutrition and IV volumes compared to 30% of placebo-treated patients (p = 0.002). At 24 weeks, mean parenteral nutrition volumes decreased by 4.4 L/week and 2.3 L/week in teduglutide and placebo recipients, respectively (p < 0.001), and 54% of teduglutide recipients were able to decrease infusion days by 1 or more days/week, compared to 23% of placebo recipients (p = 0.005).

    MAXIMUM DOSAGE

    Adults

    0.05 mg/kg/day SC.

    Geriatric

    0.05 mg/kg/day SC.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    CrCl >= 50 ml/min: No dosage adjustment necessary.
    CrCl < 50 ml/min: Reduce the dose by 50%.

    ADMINISTRATION

     
    NOTE: Due to a risk for accelerated neoplastic growth, teduglutide is available only through a restricted distribution system (GATTEX REMS Program) composed of certified prescribers and pharmacies. This system aims to inform healthcare providers and patients of potential drug associated risks, and to ensure compliance with the required colonoscopy monitoring prior to and during treatment.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

    Subcutaneous Administration

    Reconstitution:
    Slowly inject the 0.5 ml of preservative-free Sterile Water for Injection provided in the prefilled syringe into the vial containing teduglutide.
    Allow the vial containing teduglutide and water to stand for approximately 30 seconds and then gently roll the vial between your palms for about 15 seconds. Do not shake the vial. Allow the mixed contents to stand for about 2 minutes.
    If undissolved powder is observed, gently roll the vial again until all material is dissolved. Do not shake the vial.
    If the product remains undissolved after the second attempt, do not use.
    Teduglutide does not contain any preservatives and is for single-use only. Discard any unused portion. The product should be used within 3 hours after reconstitution.
     
    Subcutaneous Injection:
    Calculate the approximate teduglutide dose, withdraw into a syringe, and administer as a subcutaneous injection. Do not administer intravenously or intramuscularly.
    If a dose is missed, it should be administered as soon as possible on the same day. Two doses should not be administered on the same day.
    Alternate sites for injection, including the thighs, arms, and the quadrants of the abdomen.

    STORAGE

    Gattex:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Discard unused portion. Do not store for later use.
    - Do not freeze
    - Do not freeze reconstituted product
    - Prior to dispensing, store in refrigerator (36 to 46 degrees F)
    - Reconstituted product should be used within 3 hours
    - Store unreconstituted product at or below 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Gastric cancer, neoplastic disease

    In patients at increased risk for neoplastic disease, consider use of teduglutide only if the benefits outweigh the risks. Based on the pharmacologic activity and findings in animals, teduglutide has the potential to cause hyperplastic changes including neoplasia. In patients with active gastrointestinal malignancy or gastric cancer (GI tract, hepatobiliary, pancreatic), teduglutide should be discontinued. In patients with active non-gastrointestinal malignancy, the decision to continue teduglutide should be made based on risk-benefit considerations. In addition, during clinical trials colorectal polyps were identified. Therefore, colonoscopy of the entire colon with removal of polyps should be done within 6 months prior to starting treatment with teduglutide. A follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of teduglutide, with subsequent colonoscopies every 5 years or more often as needed. If a polyp is found, adherence to current polyp follow-up guidelines is recommended. If a patient is diagnosed with colorectal cancer, discontinue therapy with teduglutide. Patients should also be monitored clinically for small bowel neoplasias; if a benign neoplasm is found, it should be removed. In case of small bowel cancer, discontinue therapy with teduglutide.

    GI obstruction

    In clinical trials, GI obstruction has been reported. In patients who develop intestinal or stomal obstruction, temporarily discontinue teduglutide while the patient is clinically managed. Teduglutide may be restarted when the obstructive presentation resolves, if clinically indicated.

    Biliary tract disease, gallbladder disease

    Cholecystitis, cholangitis, and cholelithiasis, have been reported in clinical studies. In order to identify the onset or worsening of gallbladder disease or biliary tract disease, patients should undergo laboratory assessment of bilirubin and alkaline phosphatase within 6 months prior to starting teduglutide and at least every 6 months while on teduglutide. If clinically meaningful changes are evident, further evaluation including imaging of the gallbladder and/or biliary tract is recommended; the need for continued teduglutide treatment should be reassessed.

    Pancreatitis

    Pancreatitis has been reported in clinical studies. In order to identify the onset or worsening of pancreatic disease, patients should undergo laboratory assessment of lipase and amylase within 6 months prior to starting teduglutide and at least every 6 months while on teduglutide. If clinically meaningful changes are evident, further evaluation such as imaging of the pancreas is recommended; the need for continued teduglutide treatment should be reconsidered.

    Cardiac disease, electrolyte imbalance, heart failure

    Teduglutide should be used cautiously in patients with cardiac disease and congestive heart failure. Fluid overload and congestive heart failure have been reported in clinical trials, as a result of enhanced fluid absorption associated with teduglutide. Fluid overload may lead to electrolyte imbalance. If fluid overload occurs, adjust parenteral support and reassess teduglutide treatment If significant cardiac deterioration develops while on teduglutide, reconsider the need for continued teduglutide treatment. In addition, discontinuation of treatment with teduglutide in any patient may result in fluid and electrolyte imbalance. Therefore, monitor patients’ fluid and electrolyte status carefully.

    Pregnancy

    Teduglutide is classified in FDA pregnancy risk category B. There are no adequate and well-controlled studies in pregnant women. Reproduction studies in pregnant rats and rabbits at subcutaneous doses up to 50 mg/kg/day (about 1000 times the recommended daily human dose of 0.05 mg/kg) did not reveal any evidence of impaired fertility or harm to the fetus due to teduglutide. In addition, in a pre-and postnatal development study in rats using the same study dose, adverse effects on pre-and postnatal development were not evident. According to the manufacturer, teduglutide should be given to a pregnant woman only if clearly needed.

    Breast-feeding

    According to the manufacturer, teduglutide or breast-feeding should be discontinued because of the potential for serious adverse reactions in nursing infants from teduglutide and because of the potential for tumorigenicity. It is not known whether teduglutide is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    Renal failure, renal impairment

    In patients with moderate and severe renal impairment (creatinine clearance < 50 ml/min), including renal failure, dose reduction of teduglutide is recommended.

    ADVERSE REACTIONS

    Severe

    GI obstruction / Delayed / 1.0-10.0
    cholecystitis / Delayed / 1.0-10.0
    heart failure / Delayed / 2.6-2.6
    pancreatitis / Delayed / Incidence not known

    Moderate

    antibody formation / Delayed / 0-38.0
    edema / Delayed / 11.7-11.7
    secondary malignancy / Delayed / Incidence not known
    cholelithiasis / Delayed / Incidence not known
    cholestasis / Delayed / Incidence not known

    Mild

    abdominal pain / Early / 30.0-30.0
    injection site reaction / Rapid / 22.4-22.4
    nausea / Early / 18.2-18.2
    headache / Early / 15.9-15.9
    infection / Delayed / 11.8-11.8
    vomiting / Early / 11.7-11.7
    flatulence / Early / 9.1-9.1
    cough / Delayed / 5.2-5.2

    DRUG INTERACTIONS

    Alprazolam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Amitriptyline; Chlordiazepoxide: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Benzodiazepines: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Carbamazepine: (Moderate) Teduglutide may increase absorption of carbamazepine because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of cabamazepine is recommended.
    Chlordiazepoxide: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Chlordiazepoxide; Clidinium: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Clonazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Clorazepate: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Cyclosporine: (Moderate) Teduglutide may increase absorption of cyclosporine because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of cyclosporine is recommended.
    Dextromethorphan; Quinidine: (Moderate) Teduglutide may increase absorption of quinidine because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of quinidine is recommended.
    Diazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Digoxin: (Moderate) Teduglutide may increase absorption of digoxin because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of digoxin is recommended.
    Disopyramide: (Moderate) Teduglutide may increase absorption of disopyramide because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of disopyramide is recommended.
    Estazolam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Ethosuximide: (Moderate) Teduglutide may increase absorption of ethosuximide because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of ethosuximide is recommended.
    Flecainide: (Moderate) Teduglutide may increase absorption of flecainide because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of flecainide is recommended.
    Flurazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Lithium: (Moderate) Teduglutide may increase absorption of lithium because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of lithium is recommended.
    Lorazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Midazolam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Oxazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Phenytoin: (Moderate) Teduglutide may increase absorption of phenytoin because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of phenytoin is recommended.
    Procainamide: (Moderate) Teduglutide may increase absorption of procainamide because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of procainamide is recommended.
    Quazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Quinidine: (Moderate) Teduglutide may increase absorption of quinidine because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of quinidine is recommended.
    Sirolimus: (Moderate) Teduglutide may increase absorption of sirolimus because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of sirolimus is recommended.
    Tacrolimus: (Moderate) Teduglutide may increase absorption of tacrolimus because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of tacrolimus is recommended.
    Temazepam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Theophylline, Aminophylline: (Moderate) Teduglutide may increase absorption of theophylline because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of theophylline, aminophylline is recommended.
    Thyroid hormones: (Moderate) Monitor thyroid status and for symptoms of increased thyroid effect. Based upon the pharmacodynamic effect of teduglutide, there is a potential for increased absorption of concomitant oral medications, which should be considered if these drugs require titration or have a narrow therapeutic index, such as orally administered thyroid hormones.
    Triazolam: (Moderate) Teduglutide may increase absorption of benzodiazepines or other psychotropic agents because of it's pharmacodynamic effect of improving intestinal absorption. In studies with teduglutide, one of the subjects was receiving concomitant treatment with prazepam and experienced dramatic deterioration in mental status progressing to coma during her first week of teduglutide therapy. Upon admission to the ICU, her benzodiazepine level was reported as >300 mcg/L. Both drugs were discontinued, and the coma resolved 5 days later. Careful monitoring and possible dose adjustment of the psychotropic agent is recommended.
    Valproic Acid, Divalproex Sodium: (Moderate) Teduglutide may increase absorption of valproic acid, divalproex sodium because of it's pharmacodynamic effect of improving intestinal absorption. Careful monitoring and possible dose adjustment of valproic acid is recommended.
    Warfarin: (Moderate) Although an interaction is possible, these drugs may be used together. Teduglutide may increase the actions of warfarin. Your prescriber will monitor your therapy closely. Report any unusual effects to your prescriber.

    PREGNANCY AND LACTATION

    Pregnancy

    Teduglutide is classified in FDA pregnancy risk category B. There are no adequate and well-controlled studies in pregnant women. Reproduction studies in pregnant rats and rabbits at subcutaneous doses up to 50 mg/kg/day (about 1000 times the recommended daily human dose of 0.05 mg/kg) did not reveal any evidence of impaired fertility or harm to the fetus due to teduglutide. In addition, in a pre-and postnatal development study in rats using the same study dose, adverse effects on pre-and postnatal development were not evident. According to the manufacturer, teduglutide should be given to a pregnant woman only if clearly needed.

    According to the manufacturer, teduglutide or breast-feeding should be discontinued because of the potential for serious adverse reactions in nursing infants from teduglutide and because of the potential for tumorigenicity. It is not known whether teduglutide is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine in response to a meal. GLP-2 is known to increase intestinal and portal blood flow, inhibit gastric acid secretion, and decrease gastric motility. GLP-2 appears to induce its effects most readily in the small bowel; however high doses may elicit changes in the colon as well. GLP-2 induces proliferation of the small bowel mucosa by stimulating crypt compartment cell proliferation and inhibiting apoptosis of enterocytes. Small bowel villus height and diameter are also increased; these trophic actions increase the surface area of the small intestine allowing for increased absorption of nutrients. Teduglutide binds to the glucagon-like peptide-2 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 the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).

    PHARMACOKINETICS

    Teduglutide is given via subcutaneous (SC) administration. In healthy subjects, teduglutide has a volume of distribution (103 ml/kg) similar to blood volume. Although the metabolic pathway of teduglutide has not been studied in humans, teduglutide is expected to be degraded into small peptides and amino acids via catabolic pathways, similar to the catabolism of endogenous GLP-2. The plasma clearance of teduglutide in healthy subjects was approximately 123 ml/hr/kg, which is similar to the GFR suggesting that teduglutide is primarily cleared by the kidney.The mean terminal half-life of teduglutide is approximately 2 hours in healthy subjects and 1.3 hours in patients with short bowel syndrome (SBS).
     
    In a dose-ranging study of 17 adults with SBS, the ability of teduglutide to improve intestinal absorption was assessed using daily SC doses of 0.03, 0.10, 0.15 mg/kg (n=2—3 per dose group) over 21 days. All doses studied, except 0.03 mg/kg once daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption of approximately 750—1000 ml/day, and increased villus height and crypt depth of the intestinal mucosa.

    Subcutaneous Route

    In healthy subjects, SC administration of teduglutide had an absolute bioavailability of 88% and reached maximum plasma concentrations at 3—5 hours after administration. Following a 0.05 mg/kg SC dose in patients with SBS, the median peak concentration (Cmax) was 36 ng/ml and the median area under the curve (AUC) was 0.15 mcg x hr/ml. No accumulation of teduglutide was observed following repeated SC administrations.The Cmax and AUC of teduglutide was dose proportional over the dose range of 0.05—0.4 mg/kg.