pharmacopeia

Oxidronate

Radiopharmaceutical ActivityUS-FDASourced from openFDA
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Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Radiopharmaceutical Activity.

Indications

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  • Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.

Contraindications

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  • None known.contraindicated

Dosage & administration

Sourced from openFDA

Radiation Safety – Drug Handling After radiolabeling of Technescan HDP, the reaction vial contains Technetium Tc 99m Oxidronate Injection. Handle Technetium Tc 99m Oxidronate 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 Oxidronate 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 Adults The recommended amount of radioactivity of Technetium Tc 99m Oxidronate Injection in adults is 555 MBq (15 mCi) with a range of 370 MBq to 740 MBq (10 mCi to 20 mCi). The maximum dose of oxidronate sodium in adults is 2 mg. Pediatric Patients The recommended amount of radioactivity of Technetium Tc 99m Oxidronate Injection in pediatric patients is 7.4 MBq/kg to 13 MBq/kg (0.20 mCi/kg to 0.35 mCi/kg). The recommended minimum and maximum activity in pediatric patients are 37 MBq (1 mCi) and 740 MBq (20 mCi), respectively. The maximum dose of oxidronate sodium in pediatric patients is 2 mg. Administration Instructions Measure the patient dose with a dose calibrator just prior to administration. Administer the dose intravenously by slow injection 1 hour to 4 hours before imaging.

Warnings & precautions

Sourced from openFDA

Technetium Tc 99m oxidronate may cause life-threatening hypersensitivity reactions. Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. (See ADVERSE REACTION S .) Technetium Tc 99m oxidronate is known to complex cations such as calcium. Particular caution should be used with patients who have or who may be predisposed to hypocalcemia. 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. 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 .)

Adverse reactions

Sourced from openFDA

The following adverse reactions associated with the use of Technescan HDP have been reported: hypersensitivity reactions, including life-threatening reactions, as well as nausea, vomiting, and injection site reactions.

Use in specific populations

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

In the event of the administration of an overdose of Technetium Tc 99m Oxidronate Injection, encourage patients to drink fluids and void frequently to reduce the radiation dose to the patient.

Approval history

Sourced from openFDA
  • Feb 18, 1981NDANDA018321Curium

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
134 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea1612%
  2. 2Bone Scan Abnormal1410%
  3. 3Injection Site Pain107.5%
  4. 4Drug Ineffective96.7%
  5. 5Headache96.7%
  6. 6Injection Site Swelling86.0%
  7. 7Injection Site Erythema75.2%
  8. 8Injection Site Extravasation75.2%
  9. 9Dizziness64.5%
  10. 10Product Administration Error64.5%
  11. 11Product Preparation Issue64.5%
  12. 12Radioisotope Scan Abnormal64.5%
  13. 13Vomiting64.5%
  14. 14Chest Pain53.7%
  15. 15Dysgeusia53.7%

Frequently asked questions

How does Oxidronate work?
Mechanism-of-action class: Radiopharmaceutical Activity.
What is Oxidronate used for?
According to FDA labeling, Oxidronate carries indications including: Technescan HDP, after radiolabeling with sodium pertechnetate Tc 99m, is indicated for skeletal imaging to demonstrate areas of altered osteogenesis in adult and pediatric patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Oxidronate?
Oxidronate is classified as Radiopharmaceutical Activity.
What are the contraindications for Oxidronate?
Oxidronate labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for oxidronate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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