Label: TECHNESCAN HDP- technetium tc 99m oxidronate injection, powder, lyophilized, for solution

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•2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2•2H2O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl2•2H2O 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:

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

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 Data1

1

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

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

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

* Calibration time

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.

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

None known.

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).

The biodistribution of technetium Tc 99m oxidronate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS,Drug Interactions.)

Hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting and injection site reactions, have been infrequently reported with Technetium Tc 99m Oxidronate use.

The estimated absorbed radiation doses from an intravenous injection of Technetium Tc 99m-labeled Technescan HDP are shown in Table 4.

Table 4. Estimated Absorbed Radiation Dose*

*  Based on data in MIRD Dose Estimate Report No. 14. Bladder initially voided at 2.0 hours and then every 4.8 hours thereafter.

** See Dosage and Administration section.

All procedures should be conducted using waterproof gloves. Use shielded syringe during transport and administration of Tc 99m solutions.

1. Remove plastic disc from Technescan HDP vial and cleanse top by swabbing with alcohol. Note: If dose is for a single adult patient or for a pediatric patient, see unit dose preparation method below.
2. Place vial in lead vial shield. Add 3 to 6 mL of sodium pertechnetate Tc 99m solution and secure with a fitted lead cover. In choosing the amount of Tc 99m radioactivity to be used, the number of doses desired, the activity of each dose [recommended adult dose is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi)] and radioactive decay must be taken into account. The recommended maximum amount of Tc 99m radioactivity to be added to the vial is 11.1 gigabecquerels (300 mCi). Note: The contents of the vial are now radioactive. Maintain adequate shielding using the lead vial shield and fitted lead cover during the life of the radioactive preparation.
3. Shake the vial gently, for approximately 30 seconds, to ensure complete dissolution.
4. Record the time, date of preparation and the activity of the Tc 99m labeled Technescan HDP on the radioassay information label and affix to the vial.
5. Use within eight (8) hours of preparation. Refrigeration of the radiolabeled complex is not necessary. Discard unused material in accordance with Nuclear Regulatory Commission or Agreement State regulations pertaining to the disposal of radioactive wastes.

Technescan HDP is supplied as a lyophilized powder packaged in vials. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2•2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2•2H2O) with 0.343 mg, maximum, tin chloride [stannous and stannic] dihydrate as SnCl2•2H2O. In addition, each vial contains 0.84 mg gentisic acid as a stabilizer and 30.0 mg sodium chloride. Kits containing 5 vials (NDC 69945-091-20) or 30 vials (NDC 69945-091-40) are available. The drug can be stored at controlled room temperature 20º to 25ºC (68º to 77ºF) both prior to and following reconstitution with ADDITIVE-FREE sodium pertechnetate Tc 99m.

This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.

Manufactured by: Curium US LLC
2703 Wagner Place
Maryland Heights, MO 63043

Made in USA

©2025 Curium US LLC. Technescan™, Curium™, and the Curium logo are trademarks of a Curium company.

A091I0

R05/2025

CURIUM™

Technescan™ HDP Kit for the Preparation of Technetium Tc 99m Oxidronate
Sterile, Non-Pyrogenic, for IV Injection with Sodium Pertechnetate Tc 99m

Rx only

Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl2 ● 2H2O), 0.297 mg, theoretical, stannous chloride (SnCl2 ● 2H2O), with 0.343 mg, maximum tin chloride [stannous and stannic] dihydrate as SnCl2 ● 2H2O.  In addition, each vial contains 0.84 mg gentisic acid (stabilizer) and 30.0 mg sodium chloride.  The pH is adjusted with HCI and/or NaOH.  Contents are lyophilized and sealed under nitrogen. Use within 8 hours of preparation.

Manufactured by:
Curium US LLC
Maryland Heights, MO 63043

Made in USA

CURIUM™

A091V0

R12/2018