SINCALIDE

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).

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 for Injection 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.

Contains sodium metabisulfite [see Description (11)], a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

In postmarketing experience, anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions have been reported during and within one hour following administration of Sincalide for Injection [see Adverse Reactions (6)].

Sincalide for Injection is contraindicated in patients with a history of hypersensitivity to sulfites. 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)].

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.

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 stimulate 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)].

Because of Sincalide for Injection's effect on smooth muscle, pregnant patients should be advised that spontaneous abortion or premature induction of labor may occur [see Use in Specific Populations (8.1)].

Drugs that may stimulate or inhibit gallbladder motility or contractile response may interfere with the response to sincalide. Consider discontinuing these drugs prior to administration of Sincalide for Injection, when used to stimulate contraction of the gallbladder.

The safety and effectiveness in pediatric patients have not been established.

Clinical studies of Sincalide for Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

When injected intravenously, sincalide stimulates gallbladder contraction and reduction in size. The evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin. Sincalide also stimulates pancreatic secretion and intestinal motility causing pyloric contraction and slows gastric emptying.

Concurrent administration of sincalide with secretin increases both the volume of pancreatic secretion and the out-put of bicarbonate and enzymes. This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate.

Following an intravenous (bolus) injection of 0.02 mcg/kg of sincalide, maximal contraction of the gallbladder occurred in 5 to 15 minutes. Sincalide reduced gallbladder radiographic size by at least 40%, which is generally considered satisfactory contraction.

Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Anaphylaxis, Anaphylactic Shock and Other Serious Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions, including anaphylaxis and anaphylactic shock have been reported during or following administration of Sincalide for Injection. Advise patients to report immediately to a healthcare provider if they experience symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.1)].

Gastrointestinal Adverse Reactions

Advise patients that Sincalide for Injection may cause transient gastrointestinal symptoms [see Warnings and Precautions (5.3)].

Pregnancy

Advise pregnant women of the potential risk for preterm labor and spontaneous abortion [see Warnings and Precautions (5.4), Use in Specific Populations (8.1)].

Rx only

Manufactured by:

Fresenius Kabi Logo

Lake Zurich, IL 60047
www.fresenius-kabi.com/us

451763A /Revised: October 2023