Xenon

Xenon is an FDA-registered drug product whose active ingredient is XENON XE-133. It is labelled by Shine Spect USA, LLC taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 87333-127, application NDA017284, label effective 20260910. It is one of 2 FDA drug label records sharing the active ingredient XENON XE-133. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing XENON XE-133 are most often described in connection with: usage inhalation, xenon gas, proved valuable, evaluation pulmonary, applied assessment, cerebral flow. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE: Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.

DOSAGE AND ADMINISTRATION: Xenon Xe 133 Gas is administered by inhalation from closed respirator systems or spirometers. The suggested activity range employed for inhalation by the average adult patient (70 kg) is: Pulmonary function including imaging: 74-1110 MBq (2-30 mCi) in 3 liters of air. Cerebral blood flow: 370-1110 MBq (10-30 mCi) in 3 liters of air. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. RADIATION DOSIMETRY The estimated absorbed radiation doses 2 to an average patient (70 kg) for pulmonary perfusion and cerebral blood flow studies from a maximum dose of 1110 MBq (30 mCi) of Xenon Xe 133 in 3 liters of air are shown in Table 4. Table 4. Radiation Doses Effective Whole Half-Time Lungs* Brain Body *99% of activity is in lungs. 2 Method of Calculation: A Schema for Absorbed-Dose Calculation for Biologically Distributed Radionuclides, Supplement No. 1, MIRD pamphlet No. 1, J. Nucl. Med., p.7 (1968). mGy/1110 MBq (rads/30 mCi) Pulmonary Perfusion 2 min. 2.5(0.25) 0.014(0.0014) 0.027(0.0027) Cerebral Blood Flow 5 min. 6.3(0.63) 0.035(0.0035) 0.068(0.0068)

CONTRAINDICATIONS: None known.

WARNINGS: Xenon Xe 133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leakproof to avoid loss of radioactivity into the environs not specifically protected by exhaust systems. Xenon Xe 133 adheres to some plastics and rubber and should not be allowed to stand in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic. The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

ADVERSE REACTIONS: Adverse reactions related to the use of this agent have not been reported to date.

FDA lists 2 drug label records with XENON XE-133 as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Xenon used for?
INDICATIONS AND USAGE: Inhalation of Xenon Xe 133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.

Who makes Xenon?
Shine Spect USA, LLC is the labeler of record for Xenon. 2 FDA label records share the active ingredient XENON XE-133, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Xenon come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Xenon prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing XENON XE-133?
Yes. 2 FDA drug label records list XENON XE-133 as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Xenon been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.