Technetium Tc 99m Oxidronate

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.

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. (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 .)

General Technetium Tc 99m oxidronate contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe drug handling to protect patients and healthcare providers from unintentional radiation exposure. (See DOSAGE AND ADMINISTRATION, Radiation Safety-Drug Handling .) To minimize radiation dose to the bladder, encourage patients to drink fluids before and after administration and to void immediately before the examination and as often thereafter as possible for the next 4 to 6 hours.

The following adverse reactions associated with the use of Technescan HDP have been reported: hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting, and injection site reactions.

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. In patients with high levels of these cations caused by concomitant medications, particularly patients receiving iron infusions, consider performing an imaging study with technetium Tc 99m oxidronate injection once the cation levels have normalized (e.g., after 3 to 5 half-lives of the cation). (See WARNINGS .) Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate carcinogenic or mutagenic potential or whether technetium Tc 99m oxidronate affects fertility in males and females. Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m oxidronate. It is also not known whether technetium Tc 99m oxidronate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. All radiopharmaceuticals, including Tehnescan HDP, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technescan HDP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m oxidronate and the gestational timing of exposure. Nursing Mothers Technetium-99m is excreted in human milk during lactation, therefore formula feedings should be substituted for breast feedings. Pediatric Use Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in pediatric patients. The relatively higher effective dose and radiation exposure of the epiphyses in growing bone should be considered in pediatric patients. (See DOSAGE AND ADMINISTRATION , Radiation Dosimetry ). Geriatric Use This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Animal reproduction studies have not been conducted with technetium Tc 99m oxidronate. It is also not known whether technetium Tc 99m oxidronate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. All radiopharmaceuticals, including Tehnescan HDP, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technescan HDP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m oxidronate and the gestational timing of exposure.

Technetium-99m is excreted in human milk during lactation, therefore formula feedings should be substituted for breast feedings.

Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in pediatric patients. The relatively higher effective dose and radiation exposure of the epiphyses in growing bone should be considered in pediatric patients. (See DOSAGE AND ADMINISTRATION , Radiation Dosimetry ).

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.