MDP Multidose Kit

Warnings
Precautions

WARNINGS

Anaphylactic/anaphylactoid reactions that may be life-threatening have occurred with the use of technetium Tc99m medronate. Manifestations include: shock, hypotension, loss of consciousness, dyspnea, cyanosis, wheezing, generalized rash, and pruritus. Advanced life support equipment and trained personnel should be readily available.

This class of compound 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 clinical significance of this information is unknown as no cases of hypocalcemia have been reported.

Reports indicate impairment of brain scans using sodium pertechnetate Tc99m injection which have been preceded by a bone scan using an agent containing stannous ions. This impairment may result in false-positive or false-negative brain scans. It is recommended that brain scans precede bone imaging procedures. Alternately, a brain-imaging agent such as technetium Tc99m pentetate injection may be employed.

PRECAUTIONS

General

The contents of the kit before preparation are not radioactive. However, after the sodium pertechnetate Tc99m injection is added, adequate shielding of the final preparation must be maintained.

Contents of the vial are intended only for use in the preparation of technetium Tc99m medronate injection and are NOT to be administered directly to the patient.

Technetium Tc99m medronate injection, as well as other radioactive drugs, must be handled with care. Once sodium pertechnetate Tc99m injection 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.

To minimize radiation dose to the bladder, the patient should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next 4-6 hours.

Technetium Tc99m medronate injection contains no bacteriostatic preservative. The preparation should be formulated within 6 hours prior to clinical use. Optimal imaging results are obtained 1 to 4 hours after administration. Technetium Tc99m medronate injection should be discarded 6 hours after reconstitution. The solution should not be used if cloudy. Image quality may be adversely affected by patient obesity, old age, and impaired renal function.

The finding of an abnormal concentration of radioactivity implies the existence of underlying pathology, but further study is required to distinguish benign from malignant lesions.

The components of the kit are sterile and pyrogen-free. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.

Technetium Tc99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, sodium pertechnetate Tc99m containing oxidants should not be used.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether technetium Tc99m medronate injection affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with technetium Tc99m medronate injection. It is also not known whether technetium Tc99m medronate injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc99m medronate injection 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 Tc99m 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.

Last reviewed on RxList: 10/3/2007
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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