NephroScan

NEPHROSCAN- succimer injection, powder, lyophilized, for solution
Theragnostics Inc

1 INDICATIONS AND USAGE

NEPHROSCAN, after radiolabeling with technetium Tc 99m, is indicated for use as an aid in the scintigraphic evaluation of renal parenchymal disorders in adult and pediatric patients including term neonates.

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety – Drug Handling

After radiolabeling, handle Technetium Tc 99m Succimer Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2)]. Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Succimer Injection.

Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.

2.2 Patient Preparation

Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Technetium Tc 99m Succimer Injection and to continue to drink and void frequently following administration to reduce radiation exposure [see Warnings and Precautions (5.2)].

2.3 Recommended Dosage

Adults

The recommended amount of radioactivity of Technetium Tc 99m Succimer Injection for renal parenchymal imaging in adults is 74 MBq to 222 MBq (2 mCi to 6 mCi) by intravenous injection (bolus).

Pediatric Patients

The recommended amount of radioactivity of Technetium Tc 99m Succimer Injection for renal parenchymal imaging in pediatric patients is 1.85 MBq/kg (0.05 mCi/kg) of body weight with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi) by intravenous injection (bolus). Weight based pediatric dosing is shown in Table 1.

Table 1 Recommended Radioactivity of Technetium Tc 99m Succimer Injection for Pediatric Patients by Body Weight

Body Weight (kg)	Recommended Radioactivity MBq (mCi)	Body Weight (kg)	Recommended Radioactivity MBq (mCi)
less than 11 kg	19 MBq (0.5 mCi)	25 to 26	49 MBq (1.3 mCi)
11 to 12	21 MBq (0.6 mCi)	27 to 28	52 MBq (1.4 mCi)
13 to 14	26 MBq (0.7 mCi)	29 to 30	56 MBq (1.5 mCi)
15 to 16	30 MBq (0.8 mCi)	31 to 32	59 MBq (1.6 mCi)
17 to 18	33 MBq (0.9 mCi)	33 to 34	63 MBq (1.7 mCi)
19 to 20	37 MBq (1 mCi)	35 to 36	67 MBq (1.8 mCi)
21 to 22	41 MBq (1.1 mCi)	37 to 38	70 MBq (1.9 mCi)
23 to 24	44 MBq (1.2 mCi)	39 or greater	74 MBq (2 mCi)

2.4 Drug Preparation

Prepare Technetium Tc 99m Succimer Injection according to the following procedure using asceptic technique:

a)

Wear waterproof gloves.

b)

Place the kit vial in lead shielding and disinfect the stopper (allow disinfectant to dry).

c)

Use a sterile syringe to transfer 5 mL sodium pertechnetate Tc 99m injection obtained from a technetium Tc 99m generator with a maximum activity of 1,480 MBq (40 mCi) to the vial. The volume of sodium pertechnetate Tc 99m injection may be adjusted to 5 mL prior to adding to the kit vial using 0.9% sodium chloride injection, USP.

d)

Use the same syringe to withdraw the appropriate gas volume from the vial for pressure compensation.

e)

Lightly shake the vial to completely dissolve the powder. Ensure the stopper is well moistened.

f)

Incubate the vial for 10 minutes at controlled room temperature 20°C to 25°C (68°F to 77°F).

g)

Measure the product activity in a dose calibrator; complete the radiolabeled product vial label and affix to the vial shield.

h)

Check radiochemical purity according to the method in 2.5 Radiochemical Purity Determination [see Dosage and Administration (2.5)].

i)

Use Technetium Tc 99m Succimer Injection within 4 hours and store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

2.5 Radiochemical Purity Determination

Determine the radiochemical purity of Technetium Tc 99m Succimer Injection as follows:

a)

Activate a 65 × 95-mm silica gel thin-layer chromatographic (TLC) plate by heating at 100°C to 110°C (212°F to 230°F) for 30 minutes.

b)

Cool the silica gel TLC plate and immediately apply 1 microL of Technetium Tc 99m Succimer Injection about 17 mm from one end of the TLC plate and allow to dry. If necessary, the Technetium Tc 99m Succimer Injection may be diluted with 0.9% sodium chloride injection USP, to a radioactive concentration of 18.5 MBq to 370 MBq (0.5 mCi to 10 mCi) per mL.

c)

Develop the TLC plate over a period of about 30 minutes to 45 minutes by ascending chromatography, using a solution of n-butanol saturated with 0.3 N hydrochloric acid (see Note 1). Air-dry the developed TLC Plate.

d)

Determine the radioactive distribution on the TLC plate by scanning the chromatogram with a radiochromatographic scanner having a suitably collimated radiation detector.

e)

The radioactivity associated with technetium Tc 99m succimer is at Rf between 0.45 and 0.7, hydrolyzed Tc 99m is located at the origin (Rf 0 to 0.15) and the unbound Tc 99m is located at the solvent front (Rf 1)

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f)

Calculate radiochemical purity using the following formula:

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g)

Technetium Tc 99m Succimer Injection preparation with not less than 85% radiochemical purity is suitable for administration. Discard preparation with less than 85% radiochemical purity.

Note 1: To prepare the n-butanol saturated with 0.3 N hydrochloric acid solution, place 50 mL of 0.3 N HCl and 50 mL of n-butanol in an Erlenmeyer flask. Place the mixture in an ultrasonic bath for 2 hours, during which time the solution heats up to about 50°C. Cool the solution to room temperature. After about 30 minutes to 45 minutes the phase separation of the mixture will complete. Collect the upper phase of the mixture and discard the lower phase. The solution is stable for up to 7 days when stored at controlled room temperature 20°C to 25°C (68°F to 77°F).