Technetium Tc 99M Oxidronate

Description

DESCRIPTION Drug Characteristics Technescan™ HDP (kit for the preparation of technetium Tc 99m oxidronate injection) is a radioactive diagnostic drug for intravenous use after radiolabeling with sodium pertechnetate Tc 99m injection. Each vial contains 3.15 mg oxidronate sodium and 0.258 mg, minimum, stannous chloride (SnCl 2

What Is Technetium Tc 99M Oxidronate Used For?

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.

Dosage and Administration

DOSAGE AND ADMINISTRATION Radiation Safety – Drug Handling After radiolabeling of Technescan HDP, the reaction vial contains Technetium Tc 99m Oxidronate Injection. Handle Technetium Tc 99m Oxidronate Injection with appropriate safety measures to minimize radiation exposure. (See PRECAUTIONS, General .) Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Oxidronate Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers 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. Recommended Dosage Adults The recommended amount of radioactivity of Technetium Tc 99m Oxidronate Injection in adults is 555 MBq (15 mCi) with a range of 370 MBq to 740 MBq (10 mCi to 20 mCi). The maximum dose of oxidronate sodium in adults is 2 mg. Pediatric Patients The recommended amount of radioactivity of Technetium Tc 99m Oxidronate Injection in pediatric patients is 7.4 MBq/kg to 13 MBq/kg (0.20 mCi/kg to 0.35 mCi/kg). The recommended minimum and maximum activity in pediatric patients are 37 MBq (1 mCi) and 740 MBq (20 mCi), respectively. The maximum dose of oxidronate sodium in pediatric patients is 2 mg. Administration Instructions Measure the patient dose with a dose calibrator just prior to administration. Administer the dose intravenously by slow injection 1 hour to 4 hours before imaging. To minimize radiation dose to the bladder, encourage the patients to drink fluids before and after administration of Technetium Tc 99m Oxidronate Injection and to void immediately before the examination and as often thereafter as possible for the next 6 hours. (See PRECAUTIONS, General .) Directions for Drug Preparation Procedural Precautions The contents of the vial are intended only for use in the preparation of Technetium Tc 99m Oxidronate Injection and are NOT to be administered directly to the patient. The components of the kit are sterile and non-pyrogenic. Follow the directions carefully and adhere to strict aseptic procedures during preparation. Sodium pertechnetate Tc 99m injection that contains an oxidizing agent or 0.9% sodium chloride injection containing preservatives is not suitable for use in the preparation of Technetium Tc 99m Oxidronate Injection. Wear waterproof gloves during the entire preparation procedure and during subsequent patient dose withdrawals from the reaction vial. Make all transfers of sodium pertechnetate Tc 99m injection using an adequately shielded syringe. Keep the prepared Technetium Tc 99m Oxidronate Injection in the lead vial shield with fitted lead cover in place during the useful life of the radioactive preparation. Make all withdrawals and injection of the Technetium Tc 99m Oxidronate Injection with an adequately shielded syringe....

Side Effects (Adverse Reactions)

ADVERSE REACTIONS 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.

Drug Interactions

Drug Interactions 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.

Contraindications

CONTRAINDICATIONS None known.

Pregnancy and Breastfeeding

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.

Overdosage

OVERDOSAGE In the event of the administration of an overdose of Technetium Tc 99m Oxidronate Injection, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.

How Supplied

HOW SUPPLIED Technescan HDP (kit for the preparation of technetium Tc 99m oxidronate injection) contains 3.15 mg oxidronate sodium as a white lyophilized powder in a multiple-dose vial. Technescan HDP is available as: