Technegas FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 3, 2023.
FDA Approved: Yes (First approved September 29, 2023)
Brand name: Technegas
Generic name: technetium Tc 99m carbon
Dosage form: Inhalation Aerosol
Company: Cyclopharm Limited
Treatment for: Diagnosis and Investigation
Technegas (technetium Tc 99m carbon) is a radioactive diagnostic agent for the evaluation of pulmonary embolism.
- Technegas, when used with sodium pertechnetate Tc 99m in the Technegas Plus System, provides technetium Tc 99m-labeled carbon inhalation aerosol (Technegas Aerosol) for use in adults and pediatric patients aged 6 years and older for:
- visualization of pulmonary ventilation
- evaluation of pulmonary embolism when paired with perfusion imaging. - Technegas is a carbon-based nanoparticle developed in Australia in 1984 and has been in widespread clinical use, including SPECT imaging, since 1986.
- The Technegas technology is a structured ultra-fine dispersion of radioactive labelled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced for a few seconds at around 2,700°C. The resultant gas like substance is inhaled by the patient (lung ventilation) via a breathing apparatus, which then allows multiple views and tomography imaging under a gamma or single photon emission computed tomography (SPECT) camera for evaluating functional ventilation imaging.
- Technegas is administered by oral inhalation using an FDA-cleared radionuclide rebreathing system for Technegas Aerosol.
- Warnings and precautions associated with Technegas include decreased oxygen saturation and radiation exposure risk.
- The most common adverse reaction is hypoxia.
Development timeline for Technegas
| Date | Article |
|---|---|
| Oct 2, 2023 | Approval FDA Approves Technegas (Technetium Tc 99-m Labeled Carbon) Radioactive Diagnostic Agent |
Further information
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