Betiatide

Description

DESCRIPTION Kit for the Preparation of Technetium Tc99m Mertiatide is used for the preparation of technetium Tc 99m mertiatide, a diagnostic radiopharmaceutical. It is supplied as a sterile, nonpyrogenic, lyophilized powder. Each vial contains betiatide (N-[N-[N-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). After reconstitution with sterile sodium pertechnetate Tc 99m injection, the technetium Tc 99m mertiatide (disodium[N-[N-[N-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - N,N′,N″,S′]oxotechnetate (2-)) which is formed is suitable for intravenous administration. Each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (SnCl 2 ∙2H 2 O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2 ∙2H 2 O), 40 milligrams sodium tartrate dihydrate (Na 2 C 4 H 2 O 6 ∙2H 2 O), and 20 milligrams lactose monohydrate. Prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for pH adjustment. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. The contents are sealed under argon. Betiatide is light sensitive and must be protected from light. Betiatide and technetium Tc 99m mertiatide have the following structural formulas: Chemical Structure

What Is Betiatide Used For?

INDICATIONS AND USAGE Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use .) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

Dosage and Administration

DOSAGE AND ADMINISTRATION The suggested dose range employed in the average adult patient (70kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS The following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.

Contraindications

CONTRAINDICATIONS None known.

Pregnancy and Breastfeeding

Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with technetium Tc 99m mertiatide. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m mertiatide should be given to a pregnant woman only if clearly needed.

Nursing Mothers Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

How Supplied

HOW SUPPLIED Kit for the Preparation of Technetium Tc 99m Mertiatide is supplied as a lyophilized powder packaged in vials. Each reaction vial contains 1 mg betiatide, 0.05 mg (minimum) stannous chloride dihydrate (SnCl 2 ∙2H 2 O), 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate (SnCl 2 ∙2H 2 O), 40 mg sodium tartrate dihydrate (Na 2 C 4 H 2 O 6 ∙2H 2 O), and 20 mg lactose monohydrate. The pH of the reconstituted drug is between 5.0 and 6.0. No bacteriostatic preservative is present. Packages containing 5 reaction vials (NDC 45567-0655-1) are available. STORAGE Kit for the Preparation of Technetium Tc 99m Mertiatide should be stored at controlled room temperature 20°C to 25°C (68-77°F) and protected from light until use. The reconstituted vial should be stored at room temperature (15°C to 30°C) and must be used within six hours of preparation.