Technetium Tc 99M Pyrophosphate

FDA Drug Information • Also known as: Technescan Pyp

Brand Names
Technescan Pyp
Route
INTRAVENOUS
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Type
HUMAN PRESCRIPTION DRUG

Description

DESCRIPTION Drug Characteristics Technescan™ PYP™ (kit for the preparation of technetium Tc 99m pyrophosphate injection) is a radioactive diagnostic drug for intravenous use after radiolabeling with sodium pertechnetate Tc 99m injection or after reconstitution with 0.9% sodium chloride injection in conjunction with sodium pertechnetate Tc 99m injection. Each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl 2

  • 2H 2 O), and 4.4 mg (maximum) total tin expressed as stannous chloride (SnCl 2
  • 2H 2 O). 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 vial contains a sterile, non-pyrogenic, lyophilized powder packaged under nitrogen. The precise structures of the stannous-pyrophosphate and technetium Tc 99m pyrophosphate complexes are not known.

  • What Is Technetium Tc 99M Pyrophosphate Used For?

    INDICATIONS AND USAGE Technescan PYP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for:

  • Skeletal imaging to demonstrate areas of altered osteogenesis in adults
  • Cardiac imaging as an adjunct in the diagnosis of acute myocardial infarction in adults (See WARNINGS ) Technescan PYP, in conjunction with sodium pertechnetate Tc 99m injection for red blood cell (RBC) labeling, is indicated for gated cardiac blood pool imaging and for the detection of gastrointestinal bleeding sites in adults.

  • Dosage and Administration

    DOSAGE AND ADMINISTRATION Radiation Safety – Drug Handling After radiolabeling of Technescan PYP, the reaction vial contains Technetium Tc 99m Pyrophosphate Injection. Handle Technetium Tc 99m Pyrophosphate 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 Pyrophosphate 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, Administration, and Imaging Instructions for Skeletal and Cardiac Imaging Dosing and Administration Instructions The recommended activity of Technetium Tc 99m Pyrophosphate Injection for each type of imaging is presented in Table 4. Administer Technetium Tc 99m Pyrophosphate Injection intravenously over 10 seconds to 20 seconds. Measure the patient dose with a dose calibrator immediately before administration. If not contraindicated by patient’s condition, encourage patients to drink fluids before and after administration and void as often as possible to reduce unnecessary radiation exposure. For radiolabeling instructions, see Directions for Drug Preparation , Procedure for the Preparation of Technetium Tc 99m Pyrophosphate Injection. Table 4. Recommended Administered Activity of Technetium Tc 99m Pyrophosphate Injection for Skeletal and Cardiac Imaging in Adults Indication Activity of Technetium Tc 99m Pyrophosphate Fraction of Vial Contents Required for Pyrophosphate Skeletal Imaging 185 MBq to 555 MBq (5 mCi to 15 mCi) 0.07 to 0.91 Cardiac Imaging 370 MBq to 555 MBq (10 mCi to 15 mCi) 0.26 to 0.45 Skeletal Imaging Begin imaging 1 hour to 6 hours following administration. Cardiac Imaging The patient's cardiac condition should be stable before beginning the cardiac imaging procedure. Begin imaging 60 minutes to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to 9 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 include anterior, left anterior oblique, and left lateral projections. Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three recommended projections. Recommended Dosage, Administration, and Imaging Instructions for Gated Cardiac Blood Pool and Gastrointestinal Bleed Imaging Dose The recommended dose of Technescan PYP reconstituted in 0.9% sodium chloride injection for gated cardiac blood pool and gastrointestinal bleed imaging in adults is 1 mL, followed by 555 MBq to 740 MBq (15 mCi to 20...

    Side Effects (Adverse Reactions)

    ADVERSE REACTIONS The following adverse reactions associated with the use of Technescan PYP have been reported: flushing, hypotension, fever, chills, nausea, vomiting, and dizziness, as well as hypersensitivity reactions such as itching and various skin rashes.

    Warnings and Precautions

    WARNINGS Image interpretation errors can occur. As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the estimate of false negative image interpretations was 6%. False negative image interpretations can occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. In a study involving 22 patients in whom ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the estimates of false negative and false positive image interpretations were 23% and 9%, respectively. False positive image interpretations have been reported following coronary artery bypass graft surgery and in unstable angina pectoris, old myocardial infarcts, and cardiac contusions. Technetium Tc 99m pyrophosphate may impair brain imaging with sodium pertechnetate Tc 99m and result in false positive or false negative image interpretation. It is recommended, where feasible, that brain imaging precede skeletal imaging procedures. Gated cardiac blood pool and gastrointestinal bleed imaging may be impaired 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. Avoid heparinized catheter systems for administration of Technescan PYP. 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 are observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)

    Drug Interactions

    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 .)

    Contraindications

    CONTRAINDICATIONS None known.

    Pregnancy and Breastfeeding

    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. All radiopharmaceuticals, including Technescan PYP, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technescan PYP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m pyrophosphate 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 feeding.

    Overdosage

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

    How Supplied

    HOW SUPPLIED Technescan PYP (kit for the preparation of technetium Tc 99m pyrophosphate injection) contains 11.9 mg sodium pyrophosphate as a white lyophilized powder in a multiple-dose vial. Technescan PYP is available in cartons of 5 vials (NDC 69945-094-20). Before preparation, store the Technescan PYP reaction vial refrigerated at 2°C to 8°C (36°F to 46°F). After preparation, store the vial at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. If radiolabeled, store the vial in appropriate shielding to protect from radiation. Use within 6 hours of preparation. Dispose of unused Technetium Tc 99m Pyrophosphate Injection in accordance with appropriate regulations. This reagent kit is for distribution to persons licensed by the U.S. Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State. Manufactured by: Curium US LLC 2703 Wagner Place Maryland Heights, MO 63043 Made in USA ©2025 Curium US LLC. Technescan TM PYP TM , Curium TM , and the Curium logo are trademarks of a Curium company. A094I0 Revised: 11/2025 CURIUM™

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.