Technetium Tc 99m Medronate 25 mg Injection, Powder, For Solution, 30-count — NDC 65174-660-30 (Billing 65174-0660-30)

WARNINGS 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 contents of the kit before preparation are not radioactive.

However, after the sodium pertechnetate Tc-99m is added, adequate shielding of the final preparation must be maintained. Preliminary reports indicate impairment of brain images using Sodium Pertechnetate Tc 99m Injection which have been preceded by bone imaging using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain images.

It is recommended, where feasible, that brain imaging using Sodium Pertechnetate Tc 99m Injection precede bone imaging procedures. Alternatively, a brain imaging agent such as technetium Tc-99m pentetate may be employed. The biodistribution of technetium Tc 99m medronate 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. )

ADVERSE REACTIONS Several cases of allergic dermatological reactions have been reported in association with the use of Technetium Tc 99m Medronate. Several reactions have also been reported in association with other radiopharmaceuticals of the diphosphonate class, particularly Technetium Tc 99m Medronate. These are usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea, fever, and vomiting.

One death secondary to cardiac arrhythmia following the administration of Technetium Tc 99m Medronate has been reported. In addition, one case of cardiac arrest in a patient also undergoing pulmonary function testing one and one-half hours after the performance of a bone scan using Technetium Tc 99m Medronate has been reported.

PRECAUTIONS Contents of the reaction vial are intended only for use in the preparation of Technetium Tc 99m Medronate and are NOT to be administered directly to the patient. To minimize the radiation dose to the bladder, the patient should be encouraged to increase fluid intake and to void as often as possible after the injection of Technetium Tc 99m Medronate, and for 4 to 6 hours after the imaging procedure. The preparation contains no bacteriostatic preservative.

Both the powdered and reconstituted forms of MDP-25 should be stored at 25°C (77°F); excursions permitted between 15° and 30°C (59° to 86°F). The reconstituted product should be stored in a suitable lead shield. The solution should not be used if it is cloudy.

Optimal imaging results are obtained 1 to 4 hours after administration. The image quality may be adversely affected by obesity, old age and impaired renal function. General The components of the kit are sterile and non-pyrogenic.

It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation. Technetium Tc 99m Medronate as well as other radioactive drugs must be handled with care. Once sodium pertechnetate Tc-99m is added to the vial, appropriate safety measures should be used to minimize external radiation to clinical occupational personnel.

Care should also be taken to minimize radiation exposure to patients in a manner consistent with proper patient management. The technetium Tc-99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, sodium pertechnetate Tc-99m containing oxidants should not be employed.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. Drug Interactions The biodistribution of technetium Tc 99m medronate 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 medronate 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 Medronate affects fertility in males or females.

Pregnancy Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Medronate. It is also not known whether Technetium Tc 99m Medronate can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women.

Technetium Tc-99m should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses. Nursing Mothers Technetium Tc-99m is excreted in human milk during lactation.

Therefore, formula feedings should be substituted for breast feedings. Pediatric Use Safety and effectiveness in pediatric patients have not been established.