retion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. (1) accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. (1)

ntaneous abortion. (5.4, 8.1) 5.1 anaphylaxis, anaphylactic shock and other hypersensitivity reactions in postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during and within one hour following administration of sincalide [see adverse reactions (6)]. due to the potential for anaphylaxis, appropriate medical support should be readily available when sincalide for injection is administered. if anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. observe patients closely during and after the infusion. do not reinitiate sincalide for injection in patients who have experienced symptoms of hypersensitivity [see contraindications (4)]. 5.2 evacuation of gallstones stimulation of gallbladder contraction in patients with small gallbladder stones could lead to the evacuation of the stones from the gallbladder, resulting in their lodging in the cystic duct or in the common bile duct. 5.3 adverse reactions with intravenous injection administration of sincalide for injection as an intravenous injection may cause adverse reactions such as nausea, vomiting, abdominal pain or cramping, dizziness, and flushing [see adverse reactions (6)] . these reactions are generally transient. to reduce the risk of adverse reactions with intravenous injection when used to simulate contraction of the gallbladder or accelerate transit of a barium meal through the small intestine, administer sincalide for injection as an intravenous infusion over 50 or 30 minutes, respectively [see dosage and administration (2.1)]. 5.4 preterm labor or spontaneous abortion based on limited human data and mechanism of action, advise pregnant patients that sincalide for injection may cause preterm labor or spontaneous abortion [see use in specific populations (8.1)].

a intravenous injection. (2.1) if satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second dose of 0.04 mcg/kg over 30 to 60 seconds. (2.1) alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions : 0.12 mcg/kg diluted in 100 ml 0.9% sodium chloride injection usp and infused over 30 minutes. (2.1, 2.2, 5.3) 2.1 recommended dosage and administration instructions the recommended dosage and administration of sincalide for injection by indication is shown in table 1. for preparation instructions see dosage and administration (2.2) . table 1: recommended adult dosage and administration of sincalide for injection by treatment indication to stimulate contraction of the gallbladder sincalide for injection 0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. if satisfactory contraction does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30 to 60 seconds. ​alternatively, consider an intravenous infusion to reduce gastrointestinal adverse reactions ​[see warnings and precautions (5.3 ) ] : ​ 0.12 mcg/kg diluted in 100 ml of 0.9% sodium chloride injection usp and infused over 50 minutes at a rate of 2 ml per minute to stimulate pancreatic secretion in combination with secretin for injection secretin for injection: 0.25 units/kg as intravenous infusion over 60 minutes sincalide for injection: 30 minutes after initiation of secretin infusion, administer sincalide for injection 0.02 mcg/kg diluted in 30 ml of 0.9% sodium chloride injection usp and infused over 30 minutes at a rate of 1 ml per minute. to accelerate the transit of a barium meal through the small intestine after the barium meal is beyond the proximal jejunum, administer sincalide for injection 0.04 mcg/kg over 30 to 60 seconds via intravenous injection. if satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second dose of 0.04 mcg/kg over 30 to 60 seconds. ​ ​alternatively, consider an intravenous infusion to reduce gastrointestinal adverse reactions ​[see warnings and precautions (5.3)] ​ : ​0.12 mcg/kg diluted in 100 ml 0.9% sodium chloride injection usp and infused over 30 minutes. 2.2 preparation instructions for intravenous injection reconstitute sincalide for injection aseptically by adding 5 ml of sterile water for injection usp to the vial. inspect the reconstituted solution visually for particulate matter and discoloration after reconstitution and prior to administration. withdraw the prescribed dose of the reconstituted solution from the vial and administer as an intravenous injection over 30 to 60 seconds, as shown in table 1. discard the unused portion. store the reconstituted solution at room temperature. discard after 8 hours . for single use only; discard unused portion. for intravenous infusion reconstitute sincalide for injection aseptically by adding 5 ml of sterile water for injection usp to the vial. after reconstitution, withdraw the prescribed dose of the solution from the vial. discard unused portion. dilute the reconstituted solution in 30 ml or 100 ml of 0.9% sodium chloride injection usp, depending on the indication, as described in table 1. inspect the sincalide solutions visually for particulate matter and discoloration after reconstitution, dilution and prior to administration. store the diluted solution at room temperature. discard after 1 hour

ness, nausea, diaphoresis, syncope and hypotension (generally self-limiting). other: nausea, vomiting, flushing, hypertension, urge to defecate, diarrhea, sneezing. most common adverse reactions (≥20%) are: abdominal discomfort or pain, and nausea. (6) to report suspected adverse reactions, contact fosun pharma usa inc. at 1-866-611-3762 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data there were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (gestation days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. no effects on embryo-fetal development were observed in sprague-dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from gestation days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. in a separate study at a higher dose of 90 mcg/kg administered subcutaneously to cfy rats from gestation day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays. 8.2 lactation risk summary there are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sincalide for injection and any potential adverse effect on the breastfed infant from sincalide for injection or from the underlying condition. 8.4 pediatric use the safety and effectiveness in pediatric patients have not been established. animal data direct injection of sincalide in neonatal rats reduced milk consumption with the youngest rats exhibiting the greatest sensitivity to this effect. although safety margins relative to maternal doses cannot be calculated since rat pups were injected directly, the safety margin in the youngest rat pups was less than 0.1 on a body surface area bases compared to the maximum adult clinical dose. at higher doses administered subcutaneously in neonatal rats, transient behavioral changes and small effects on physical developmental milestones such as ear opening, eye opening, and incisor appearance were observed (at doses 10 to 200-fold higher than the maximum recommended human dose on a body surface area basis). 8.5 geriatric use clinical studies of sincalide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

h defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data there were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (gestation days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. no effects on embryo-fetal development were observed in sprague-dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from gestation days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. in a separate study at a higher dose of 90 mcg/kg administered subcutaneously to cfy rats from gestation day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays.