Sodium pyrophosphate and stannous chloride

FDA label, Curium US LLC, intravenous, effective 2025-12-05. Full label on DailyMed

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Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Basis

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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 mCi) of sodium pertechnetate Tc 99m injection.

Administration Instructions for In Vivo RBC Labeling Method a. Reconstitute Technescan PYP with 0.9% sodium chloride injection. (See Directions for Drug Preparation , Procedure for the Reconstitution of Technescan PYP.) b. Administer the patient dose of reconstituted Technescan PYP intravenously by direct venipuncture. Do not use heparinized catheters. (See WARNINGS .) c.

Wait 15 minutes to 30 minutes. d. Administer sodium pertechnetate Tc 99m injection intravenously. Administration Instructions for Modified In Vivo/In Vitro RBC Labeling Method Using ACD a. Reconstitute Technescan PYP with 0.9% sodium chloride injection. (See Directions for Drug Preparation , Procedure for the Reconstitution of Technescan PYP.) b.

Administer the patient dose of reconstituted Technescan PYP intravenously by direct venipuncture. Do not use heparinized catheters. (See WARNINGS .) c. Insert an intravenous line with a 3-way stopcock in a large peripheral vein and maintain the line with a continuous drip of 0.9% sodium chloride injection. d. 30 minutes post-injection: Clear the line by withdrawing and discarding approximately 5 mL of blood.

Inject the mixture via the 3-way stopcock. Administration Instructions for Modified In Vivo/In Vitro RBC Labeling Method Using Heparin a. Reconstitute Technescan PYP with 0.9% sodium chloride injection. (See Directions for Drug Preparation , Procedure for the Reconstitution of Technescan PYP.) b. Administer the patient dose of reconstituted Technescan PYP intravenously by direct venipuncture.

Do not use heparinized catheters. (See WARNINGS .) c. Insert an infusion set fitted with a 3-way stopcock in a large peripheral vein, and heparinize the intravenous line with 0.9% sodium chloride injection containing 5 units/mL to 10 units/mL of preservative-free heparin. d. Thirty minutes after Technescan PYP injection, draw 3 mL of blood into a syringe containing 555 MBq to 740 MBq (15 mCi to 20 mCi) of sodium pertechnetate Tc 99m 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 preservative-free 0.9% sodium chloride injection and injected intravenously prior to labeling of red blood cells with sodium pertechnetate Tc 99m injection using either the in vivo or modified in vivo/in vitro method.

With the reaction vial in the Dispensing Shield (with cap in place), shake sufficiently to bring the lyophilized material into solution. Allow to stand for 5 minutes at room temperature. 5. Using proper shielding, visually inspect the reaction vial. The resulting solution should be clear and free of particulate matter. If not, do not use the product. 6.

Use within 6 hours of radiolabeling. 9. Dispose of unused drug in a safe manner in accordance with applicable regulations. Procedure for the Reconstitution of Technescan PYP a. Remove a Technescan PYP reaction vial from the refrigerator and allow the vial contents to come to room temperature, 20°C to 25°C (68°F to 77°F), for approximately 5 minutes. b.

Add 3 mL of preservative-free 0.9% sodium chloride injection to the reaction vial. c. Shake the reaction vial sufficiently to bring the lyophilized material into solution. Allow to stand for 5 minutes at room temperature. d. Visually inspect the reaction vial. The resulting solution should be clear and free of particulate matter.

If not, do not use the product. e. Store the reconstituted reaction vial upright at 20°C to 25°C (68°F to 77°F). Use within 6 hours of reconstitution. Radiation Dosimetry Skeletal and Cardiac Imaging Estimated absorbed radiation doses from an intravenous injection of Technetium Tc 99m Pyrophosphate Injection in adults are shown in Table 5. [See table below.] Ovaries 2-hr. void 0.003 4.8-hr. void 0.004 Heart Normal 0.002 Impaired 0.004 *Dose at point of highest uptake may be a factor of 10 higher.

Drug interactions

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Label text (1 paragraph)

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

None known.

Pregnancy and lactation

Pregnancy

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.

Lactation

Nursing Mothers Technetium-99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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