Technetium Tc 99m Pyrophosphate

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Diagnostic–For Intravenous Use

TechneScan™ PYP™ (kit for the preparation of Technetium TC 99M Pyrophosphate Injection) is a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous administration after reconstitution with sterile sodium pertechnetate Tc 99m injection or sterile 0.9% sodium chloride injection.

Each 10 milliliter reaction vial contains 11.9 milligrams sodium pyrophosphate, 3.2 milligrams (minimum) stannous chloride (SnCl2•2H2O) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (SnCl2•2H2O) in lyophilized form under an atmosphere of nitrogen. Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present.

The precise structures of the stannous-pyrophosphate and technetium-stannous-pyrophosphate complexes are not known at this time.

When injected intravenously, Technetium TC 99M Pyrophosphate has a specific affinity for areas of altered osteogenesis. It is also concentrated in the injured myocardium, primarily in areas of irreversibly damaged myocardial cells.

One to two hours after intravenous injection of Technetium TC 99M Pyrophosphate, an estimated 40 to 50 percent of the injected dose had been taken up by the skeleton, and approximately 0.01 to 0.02 percent per gram of acutely infarcted myocardium. Within a period of one hour, 10 to 11 percent remains in the vascular system, declining to approximately 2 to 3 percent twenty-four hours post injection. The average urinary excretion was observed to be about 40 percent of the administered dose after 24 hours.

TechneScan PYP also has an affinity for red blood cells. When administered 15 to 30 minutes prior to the intravenous administration of sodium pertechnetate Tc 99m (in vivo red blood cell labeling), approximately 75 percent of the injected radioactivity remains in the blood pool providing excellent images of the cardiac chambers. When the modified in vivo/in vitro red blood cell labeling method is used, comparable percentages of the injected radioactivity are obtained.

Toxicology data are available upon request.

Reports indicate impairment of brain images using sodium pertechnetate Tc 99m, which have been preceded by a bone image. The impairment may result in false positives or false negatives. It is recommended, where feasible, that brain imaging precede bone imaging procedures.

Preliminary reports indicate impairment of blood pool images in patients receiving sodium heparin for anticoagulant therapy. This is characterized by a reduction in the amount of injected radioactivity remaining in the blood pool.

TechneScan PYP should be injected by direct venipuncture. Heparinized catheter systems should be avoided.

Bone and Cardiac Imaging

The recommended adult doses of Technetium TC 99M Pyrophosphate Injection are:

Technetium TC 99M Pyrophosphate Injection is injected intravenously over a 10- to 20-second period. For optimal results, bone imaging should be done one to six hours following administration. Cardiac imaging should be done 60 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to nine days following onset of symptoms, with maximum localization at 48 to 72 hours. Cardiac imaging should be done with a gamma scintillation camera. It is recommended that images be made of the anterior, left anterior oblique and left lateral projections.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. It is also recommended that the radiochemical purity be checked prior to administration.

Blood Pool Imaging

The recommended adult dose of TechneScan PYP is one-third (0.33) to the entire vial contents, followed by 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Cardiac imaging should be done 10 minutes following the administration of sodium pertechnetate Tc 99m (in vivo method) or Tc 99m labeled red blood cells (modified in vivo/in vitro method) utilizing a scintillation camera interfaced to an electrocardiographic gating device.

In Vivo Method: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives. The patient dose is administered intravenously 15 to 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. TechneScan PYP should be injected by direct venipuncture. Heparinized catheter systems should be avoided.

Modified In Vivo/In Vitro Method Using Acid-Citrate-Dextrose (ACD): TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An intravenous line containing a 3-way stopcock is inserted in a large peripheral vein and kept patent with a continuous drip of sterile, non-pyrogenic normal saline containing no preservatives. Thirty minutes after TechneScan PYP injection, the infusion line and stopcock are cleared by withdrawing and discarding approximately 5 milliliters of whole blood. Immediately following, approximately 5 milliliters of whole blood are withdrawn into a syringe containing 1 milliliter preservative-free acid-citrate-dextrose (ACD) and 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. The stopcock is then turned, residual blood is flushed from the intravenous line, and the normal saline flow is readjusted. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock.

Modified In Vivo/In Vitro Method Using Heparin: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An infusion set fitted with a 3-way stopcock is placed in a large peripheral vein, and the intravenous line is heparinized with a saline solution containing 5-10 units preservative-free heparin per milliliter. Thirty minutes after TechneScan PYP injection, 3 milliliters of blood are withdrawn into a syringe containing 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Anticoagulation of the blood is provided by residual heparin in the intravenous line. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if contents are turbid.

The TechneScan PYP Kit must be maintained in a refrigerator, 2-8°C (36-46°F) until use. The reconstituted vial should be stored at controlled room temperature, 20-25°C (68-77°F).