LUMASON
Clinical safety rating: caution
Comprehensive clinical and safety monograph for LUMASON (LUMASON).
LUMASON (sulfur hexafluoride lipid-type A microspheres) is an ultrasound contrast agent that consists of gas-filled microspheres. After intravenous injection, the microspheres enhance the ultrasound signal by increasing the backscatter of ultrasound waves, thereby improving the visualization of cardiac chambers, endocardial borders, and vascular structures.
| Metabolism | Sulfur hexafluoride is eliminated unchanged via the lungs. The lipid shell components are metabolized via normal lipid pathways. |
| Excretion | Primarily renal; >90% excreted unchanged in urine within 24 hours. Fecal elimination is negligible (<1%). |
| Half-life | Terminal elimination half-life is approximately 2 hours (range 1.5–2.5 hours) after intravenous administration, reflecting rapid clearance and supporting use as a diagnostic agent without significant accumulation. |
| Protein binding | Protein binding is negligible (<5%); predominantly bound to albumin if any, but essentially free in plasma. |
| Volume of Distribution | Volume of distribution is approximately 0.3 L/kg (range 0.2–0.4 L/kg), consistent with distribution primarily in the extracellular fluid and minimal tissue binding. |
| Bioavailability | Bioavailability is 100% via intravenous route, as it is administered as an IV injection. Oral bioavailability is not applicable. |
| Onset of Action | Onset occurs within 1–2 minutes after intravenous injection, corresponding to peak contrast enhancement in the liver during ultrasound imaging. |
| Duration of Action | Duration of diagnostic enhancement lasts approximately 30–60 minutes post-injection, sufficient for liver lesion characterization. No sustained clinical effect is observed beyond imaging. |
0.5 mL intravenous bolus injection, followed by 5 mL saline flush. May repeat once if needed.
| Dosage form | FOR SUSPENSION |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific dose adjustment required; use with caution due to potential comorbidity. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for LUMASON (LUMASON).
| Breastfeeding | It is unknown if sulfur hexafluoride is excreted in human milk. No M/P ratio available. Caution should be exercised when administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for LUMASON and any potential adverse effects on the breastfed infant. |
| Teratogenic Risk | LUMASON (sulfur hexafluoride lipid microspheres) is an ultrasound contrast agent. No adequate and well-controlled studies in pregnant women. Animal studies show no evidence of fetal harm. Risk cannot be ruled out; use only if clearly needed. First trimester: avoid unless essential. Second and third trimesters: consider risk-benefit. |
■ FDA Black Box Warning
WARNING: SERIOUS CARDIOPULMONARY REACTIONS. Serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes following administration of LUMASON. These reactions include fatal cardiac arrest, shock, anaphylaxis, respiratory arrest, and hypoxia. Always have resuscitation equipment and trained personnel readily available.
| Serious Effects |
["Known or suspected hypersensitivity to sulfur hexafluoride or any component of LUMASON","Intracardiac shunts (right-to-left, bidirectional, or transient right-to-left shunts)"]
| Precautions | ["Serious cardiopulmonary reactions: Monitor patients during and for at least 30 minutes after administration","Hypersensitivity reactions: May include anaphylaxis, angioedema, and bronchospasm","Risk of embolism in patients with unstable cardiopulmonary conditions","Extravasation and injection site reactions","Limited clinical data in patients with severe heart failure or pulmonary hypertension"] |
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| Fetal Monitoring | Monitor for signs of hypersensitivity reactions (e.g., urticaria, hypotension, bronchospasm) during and after administration. For pregnant patients, assess fetal heart rate and uterine activity if clinically indicated. Post-dose observation for at least 30 minutes. |
| Fertility Effects | No human data on fertility effects. Animal studies have not shown impaired fertility at clinically relevant doses. Theoretical risk from microvascular occlusion, but no evidence of reproductive toxicity. |