Technetium Tc 99m Oxidronate

FDA Drug Profile — Technescan HDP

Drug Details

Generic Name
Technetium Tc 99m Oxidronate
Brand Names
Technescan HDP
Application Number
NDA018321
Sponsor
Curium US LLC
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
OXIDRONATE DISODIUM

Indications and Usage

INDICATIONS AND USAGE Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.

Warnings

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. (See ADVERSE REACTION S .) Technetium Tc 99m oxidronate is known to complex cations such as calcium. Particular caution should be used with patients who have or who may be predisposed to hypocalcemia. 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 .)