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Xenon Xe-129 hyperpolarized: Pediatric drug information

Xenon Xe-129 hyperpolarized: Pediatric drug information
(For additional information see "Xenon Xe-129 hyperpolarized: Drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Therapeutic Category
  • Radiopharmaceutical
Dosing: Pediatric
Diagnostic imaging

Diagnostic imaging:

Children ≥12 years and Adolescents: Oral inhalation: 75 to 100 mL Dose Equivalent (DE) via the entire contents of one dose delivery bag. Do not use dose delivery bag if the DE is <75 mL; DE of >100 mL is acceptable.

Note: DE is the total volume (mL) of 100% hyperpolarized, 100% isotopically enriched xenon Xe 129 that would provide the equivalent total Xe 129 magnetization (MRI) signal. DE is measured by the HPX Polarization Measurement Station and is defined by the following formula:

DE = (total volume xenon gas) × (fraction of xenon Xe 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization)

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Xenon Xe-129 hyperpolarized: Drug information")

Diagnostic imaging

Diagnostic imaging: Inhalation: Target dose: 75 to 100 mL dose equivalent (DE) (entire contents of one dose delivery bag); minimum dose: 75 mL DE; >100 mL DE is acceptable.

DE is the volume (mL) of 100% hyperpolarized, 100% isotopically enriched xenon XE 129 that provides the equivalent total X2 129 magnetization (MRI signal) and is defined by the following formula:

DE = (total volume xenon gas) × (fraction of xenon XE 129 isotopic enrichment in the xenon gas) × (fraction of hyperpolarization)

where volume of xenon gas is 250 to 750 mL, the fraction of xenon Xe 129 isotropic enrichment is >80% and the mean fraction of hyperpolarization is ≥38% to 54% at the completion of polarization of 250 mL of xenon gas.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

1% to 10%:

Nervous system: Dizziness, headache

Respiratory: Oropharyngeal pain

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Warnings/Precautions

Concerns related to adverse effects:

• Hypoxia: Transient hypoxemia may occur; treat as clinically indicated.

Other warnings/precautions:

• Appropriate use: Has not been evaluated for use with lung perfusion imaging. Concomitant supplemental oxygen may decrease image quality due to depolarization; withhold oxygen inhalation for 2 breaths prior to xenon Xe 129 hyperpolarized inhalation and resume immediately following imaging breath hold.

Warnings: Additional Pediatric Considerations

Transient heart rate elevation, numbness, and tingling have been reported with use in pediatric patients 6 to 18 years of age.

Product Availability

Xenoview: FDA approved December 2022; anticipated availability currently unknown.

Administration: Pediatric

Oral inhalation: Administer within 5 minutes of dose equivalent measurement; refer to the HPX Hyperpolarization System Operator's Manual and/or manufacturer labeling for detailed administration instructions.

Administration: Adult

Inhalation: Administer by inhalation within 5 minutes of dose equivalent measurement; refer to the HPX Hyperpolarization System Operator’s Manual and manufacturer labeling for detailed administration instructions.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F) for ≤5 minutes after final dose equivalent measurement; discard 60 minutes after filling dose delivery bag. Store xenon Xe 129 gas blend at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Use

Contrast agent for use with MRI for evaluation of lung ventilation (FDA approved in ages ≥12 years and adults). Note: Use in patients <12 years of age is not approved because the dose cannot be accurately administered.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Due to minimal absorption following inhalation, maternal use is not expected to result in fetal exposure.

Monitoring Parameters

Oxygen saturation; heart rate; signs or symptoms of hypoxemia.

Mechanism of Action

Contrast agent that when inhaled is distributed throughout the ventilated lung and can be used for imaging with a multi-nuclear capable MRI scanner; hyperpolarized xenon Xe 129 nuclei are directly detected by a Xe 129 MRI coil.

Pharmacokinetics (Adult Data Unless Noted)

Duration: Ventilated areas of the lungs; small amount into pulmonary vessels leading to distal organ distribution. Solubility is greater in fatty tissue than aqueous tissue or body compartments (eg, plasma).

Half-life elimination: 14.5 seconds (75% Xe/25% N2 gas mixture); 14.3 seconds (25% Xe/75% N2 gas mixture).

  1. Xenoview (xenon Xe 129 hyperpolarized) [prescribing information]. Durham, NC: Polarean, Inc; December 2022
Topic 140395 Version 6.0

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