Kit For the Preparation of Technetium Tc99m Mertiatide

KIT FOR THE PREPARATION OF TECHNETIUM TC99M MERTIATIDE- betiatide injection, powder, lyophilized, for solution
Sun Pharmaceutical Industries, Inc.

Rx Only.

Diagnostic-For Intravenous Use

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 (SnCl2 ∙2H2 O) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (SnCl2 ∙2H2 O), 40 milligrams sodium tartrate dihydrate (Na2 C4 H2 O6 ∙2H2 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 StructureChemical Structure

PHYSICAL CHARACTERISTICS

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging is listed in Table 1.

Table 1: Principal Radiation Emission Data *
Radiation M Mean % per Disintegration Energy (keV)
*
Kocher, David C., “Radioactive Decay Tables,” DOE/TIC-11026, 108 (1981).

Gamma-2

89.07

140.5

The specific gamma ray constant for Technetium Tc 99m is 0.78 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for Technetium Tc 99m is 0.017 cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of 0.25 cm of Pb will decrease the external radiation exposure by a factor of about 1000.

Table 2: Radiation Attenuation by Lead Shielding
Shield Thickness (Pb) cm Coefficient of Attenuation

0.017

0.5

0.08

10-1

0.16

10-2

0.25

10-3

0.33

10-4

To correct for physical decay of the radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3.

Table 3: Physical Decay Chart: Technetium Tc 99m, Half-life 6.02 Hours
Hours Fraction Remaining Hours Fraction Remaining
*
Calibration Time

0*

1.000

7

0.447

1

0.891

8

0.398

2

0.794

9

0.355

3

0.708

10

0.316

4

0.631

11

0.282

5

0.562

12

0.251

6

0.501

CLINICAL PHARMACOLOGY

Following intravenous injection of technetium Tc 99m mertiatide, the appearance, concentration, and excretion of the tracer in the kidney can be monitored to assess renal function. Although technetium Tc 99m mertiatide is highly plasma protein bound following intravenous injection, the protein binding is reversible and the tracer is rapidly excreted by the kidneys via active tubular secretion and glomerular filtration. Following intravenous injection of technetium Tc 99m mertiatide in normal volunteers, 89% of the tracer was plasma protein bound. In healthy subjects with normal renal function (mean serum creatinine 1.2 mg/dL) technetium Tc 99m mertiatide was rapidly cleared from the blood. The plasma clearance was approximately 0.3 liters/minute and the amount of technetium Tc 99m mertiatide excreted in the urine in three hours was nearly 90% of the dose. In a study performed in three patients with renal impairment (serum creatinine greater than 6.3 mg/dL), there was decreased blood clearance and a decrease in the amount excreted in the urine over three hours. In these patients, 78% of the tracer was plasma protein bound after intravenous injection. The mean plasma clearance of technetium Tc 99m mertiatide was 0.03 liters/minute and 21.3% was excreted in three hours on average. In both healthy subjects and patients with renal impairment, the plasma concentration-time profile showed a biexponential decline.

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.

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