Technescan HDP

TECHNESCAN HDP- oxidronate disodium injection, powder, lyophilized, for solution
Curium US LLC

DESCRIPTION

Technescan™ HDP is supplied as a lyophilized powder, packaged under nitrogen in vials for intravenous administration after reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2 •2H2 O), 0.297 mg, theoretical, stannous chloride (SnCl2 •2H2 O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl2 •2H2 O as active ingredients. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. The pH of the reconstituted drug is between 4.0 and 5.5. The contents of the vial are sterile and non-pyrogenic.

The chemical structure of oxidronate sodium is:

Chemical Structure

This radiopharmaceutical diagnostic agent, when reconstituted with ADDITIVE-FREE sodium pertechnetate Tc 99m forms a complex of unknown structure.

PHYSICAL CHARACTERISTICS

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

Table 1. Principal Radiation Emission Data 1

Radiation

Mean Percent/
Disintegration

Energy
(keV)

Gamma-2

89.07

140.5


1
Kocher, David C., “Radioactive Decay Data Tables,” DOE/TIC-11026, 108, (1981).

EXTERNAL RADIATION

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 this 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

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

* Calibration time

CLINICAL PHARMACOLOGY

During the 24 hours following injection, Technetium Tc 99m-labeled Technescan HDP is rapidly cleared from blood and other non-osseous tissues and accumulates in the skeleton and urine in humans. Blood levels are about 10% of the injected dose at one hour post-injection and continue to fall to about 6%, 4% and 3% at 2, 3 and 4 hours, respectively. When measured at 24 hours following its administration, skeletal retention is approximately 50% of the injected dose. Technescan HDP exhibits its greatest affinity for areas of altered osteogenesis and actively metabolizing bone.

INDICATIONS AND USAGE

Technescan HDP Tc 99m is a diagnostic skeletal imaging agent used to demonstrate areas of altered osteogenesis in adult and pediatric patients.

CONTRAINDICATIONS

None known.

WARNINGS

Technetium Tc 99m Oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions.

This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or who may be predisposed to hypocalcemia (i.e., alkalosis).

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