Oxidronate

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

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

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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The recommended maximum activity of sodium pertechnetate Tc 99m injection to be added to the vial is 11,100 MBq (300 mCi). Shake the vial gently, for approximately 30 seconds, to ensure complete dissolution. Using proper shielding, visually inspect the reaction vial. The resulting solution should be clear and free of particulate matter.

Add 3 mL to 6 mL of 0.9% sodium chloride injection. Shake the vial gently for approximately 30 seconds to assure complete dissolution. c. Withdraw and discard all but approximately 1 mL of the solution. d. Place the vial in a lead vial shield. Add an appropriate amount of sodium pertechnetate Tc 99m injection for a single adult dose or for one or more pediatric doses and shake gently.

Drug interactions

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Label text (4 paragraphs)

Drug Interactions The biodistribution of technetium Tc 99m oxidronate 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 oxidronate 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 technetium Tc 99m oxidronate affects fertility in males and females. Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m oxidronate. It is also not known whether technetium Tc 99m oxidronate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. All radiopharmaceuticals, including Tehnescan HDP, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

If considering Technescan HDP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m oxidronate 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 feedings. Pediatric Use Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in pediatric patients.

The relatively higher effective dose and radiation exposure of the epiphyses in growing bone should be considered in pediatric patients. (See DOSAGE AND ADMINISTRATION , Radiation Dosimetry ). Geriatric Use This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Contraindications

None known.

Pregnancy and lactation

Pregnancy

Pregnancy Animal reproduction studies have not been conducted with technetium Tc 99m oxidronate. It is also not known whether technetium Tc 99m oxidronate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. All radiopharmaceuticals, including Tehnescan HDP, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering Technescan HDP administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium Tc 99m oxidronate 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 feedings.

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

Supply and cost

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