PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - A094V0

Technescan™ PYP™

(Stannous Pyrophosphate)
Vial contains 11.9 mg Sodium Pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl 2•2H 2O) and 4.4 mg (maximum) total tin as stannous chloride (SnCl 2•2H 2O). Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. The contents are sealed under nitrogen.
Sterile, non-pyrogentic. For Intravenous use after drug preparation. See package insert for directions for use.
Do not use Tc 99m solutions containing an oxidizing agent.
Rx only
Store refrigerated at 2° to 8°C (36° to 46°F).

Manufactured by:
Curium US LLC
Maryland Heights, MO 63043

Made in USA

**CURIUM™**A094V0

R12/2018

![Display Panel A094VO](/dailymed/image.cfm?name=technescan- pyp-69945-1.jpg&id=877335)

DESCRIPTION SECTION

DESCRIPTION

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 (SnCl 2•2H 2O) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (SnCl 2•2H 2O) 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.

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION

Bone and Cardiac Imaging

The recommended adult doses of Technetium Tc 99m Pyrophosphate Injection are:

Indication	Doses as Technetium Tc 99	Fraction of Vial Contents Required
Skeletal Imaging	185 to 555 megabecquerels (5 to 15 mCi)	0.07 to 0.91
Cardiac Imaging	370 to 555 megabecquerels (10 to 15 mCi)	0.26 to 0.45

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 to 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.

WARNINGS SECTION

WARNINGS

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.

The biodistribution of technetium Tc 99m pyrophosphate 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.)

PRECAUTIONS SECTION

PRECAUTIONS

General

Technescan PYP should not be used more than six hours after preparation.

The components of the kit are sterile and non-pyrogenic. It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation.

The contents of this kit are not radioactive. However, after sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained.

The imaging of gastrointestinal bleeding is dependent on such factors as the region of imaging, rate and volume of the bleed, efficacy of labeling of the red blood cells and timeliness of imaging. Due to these factors, images should be taken sequentially over a period of time until a positive image is obtained or clinical conditions warrant the discontinuance of the procedure. The period of time for collecting the images may range up to thirty-six hours.

Any sodium pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use in the preparation of Technetium Tc 99m Pyrophosphate Injection.

The contents of the Technescan PYP reaction vial may be used for the preparation of Technetium Tc 99m Pyrophosphate Injection. Technescan PYP may also be reconstituted with sterile, non-pyrogenic normal saline containing no preservatives and injected intravenously prior to labeling of red blood cells with sodium pertechnetate Tc 99m using either the in vivo or modified in vivo/in vitro method.

As in the use of any other radioactive material, care should be taken to ensure minimum radiation exposure to the patient, consistent with proper patient management, and to ensure minimum radiation exposure to occupational workers.

Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Overdosage

In case of overdose of Technetium Tc 99m Pyrophosphate, encourage patients to maintain hydration and to void frequently to minimize radiation exposure.

Bone Imaging

Both prior to and following administration of Technetium Tc 99m Pyrophosphate Injection, patients should be encouraged to drink fluids. Patients should void as often as possible after administration of Technetium Tc 99m Pyrophosphate Injection to minimize background interference from its accumulation in the bladder and to reduce unnecessary exposure to radiation.

Cardiac Imaging

The patient's cardiac condition should be stable before beginning the cardiac imaging procedure.

If not contraindicated by the cardiac status, patients should be encouraged to ingest fluids and to void frequently in order to reduce unnecessary radiation exposure.

Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three recommended projections.

Drug Interactions

The biodistribution of technetium Tc 99m pyrophosphate 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 pyrophosphate 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 this drug affects fertility in males or females.

Pregnancy

Animal reproduction studies have not been conducted with Technetium Tc 99m Pyrophosphate Injection. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m Pyrophosphate 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 Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

HOW SUPPLIED SECTION

HOW SUPPLIED

Catalog Number 094.

Technescan PYP is supplied as a lyophilized powder packaged in vials. Each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl 2•2H 2O) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (SnCl 2•2H 2O), sealed 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.

Kit containing 5 vials is available.

Storage

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

SPL UNCLASSIFIED SECTION

This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.

Manufactured by: Curium US LLC

Maryland Heights, MO 63043