Lumason Prescribing Information
fatalities, have occurred uncommonly during or following the injection
of ultrasound contrast agents, including sulfur hexafluoride lipid
microspheres
Reactions
Serious cardiopulmonary reactions, including fatalities have occurred
uncommonly during or shortly following administration of ultrasound
contrast agents, including Lumason. These reactions typically occurred
within 30 minutes of administration. The risk for these reactions
may be increased among patients with unstable cardiopulmonary conditions
(acute myocardial infarction, acute coronary artery syndromes, worsening
or unstable congestive heart failure, or serious ventricular arrhythmias).
Always have cardiopulmonary resuscitation personnel and equipment
readily available prior to Lumason administration and monitor all
patients for acute reactions.
The reported reactions that may follow the
administration of ultrasound contrast agents include: fatal cardiac
or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial
fibrillation, tachycardia, bradycardia, supraventricular tachycardia,
ventricular fibrillation, and ventricular tachycardia), hypertension,
hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor,
wheezing, loss of consciousness, and convulsions.
within 30 minutes of administration
(
Reactions
Serious cardiopulmonary reactions, including fatalities have occurred
uncommonly during or shortly following administration of ultrasound
contrast agents, including Lumason. These reactions typically occurred
within 30 minutes of administration. The risk for these reactions
may be increased among patients with unstable cardiopulmonary conditions
(acute myocardial infarction, acute coronary artery syndromes, worsening
or unstable congestive heart failure, or serious ventricular arrhythmias).
Always have cardiopulmonary resuscitation personnel and equipment
readily available prior to Lumason administration and monitor all
patients for acute reactions.
The reported reactions that may follow the
administration of ultrasound contrast agents include: fatal cardiac
or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial
fibrillation, tachycardia, bradycardia, supraventricular tachycardia,
ventricular fibrillation, and ventricular tachycardia), hypertension,
hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor,
wheezing, loss of consciousness, and convulsions.
- Assess all patients for the presence of any condition
that precludes administration[see Contraindications (.)]4 CONTRAINDICATIONSLumason is contraindicated in patients with
known or suspected:- Hypersensitivity to sulfur hexafluoride lipid microsphere
or its components, such as polyethylene glycol (PEG)[see.
Warnings and Precautions and
Description ]
- Hypersensitivity to sulfur hexafluoride lipid microspheres
or its components, such as polyethylene glycol (PEG)
- Hypersensitivity to sulfur hexafluoride lipid microsphere
- Always have resuscitation equipment and trained personnel
readily available[see Warnings and Precautions (.)]5.1 Serious Cardiopulmonary
ReactionsSerious cardiopulmonary reactions, including fatalities have occurred
uncommonly during or shortly following administration of ultrasound
contrast agents, including Lumason. These reactions typically occurred
within 30 minutes of administration. The risk for these reactions
may be increased among patients with unstable cardiopulmonary conditions
(acute myocardial infarction, acute coronary artery syndromes, worsening
or unstable congestive heart failure, or serious ventricular arrhythmias).
Always have cardiopulmonary resuscitation personnel and equipment
readily available prior to Lumason administration and monitor all
patients for acute reactions.The reported reactions that may follow the
administration of ultrasound contrast agents include: fatal cardiac
or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial
fibrillation, tachycardia, bradycardia, supraventricular tachycardia,
ventricular fibrillation, and ventricular tachycardia), hypertension,
hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor,
wheezing, loss of consciousness, and convulsions.
Contraindications (Lumason is contraindicated in patients with
| 4/2021 |
Warnings and Precautions, Hypersensitivity Reactions (Reactions In postmarketing use, serious hypersensitivity reactions were observed Anaphylaxis, with manifestations that may These reactions may occur in patients with [see Adverse Reactions ] . Clinically assess patientsfor prior hypersensitivity reactions to products containing PEG, such as certain colonoscopy bowel preparations and laxatives. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to Lumason administration and monitor all patients for hypersensitivity reactions. | 4/2021 |
Lumason is indicated
for use in adult and pediatric patients with suboptimal echocardiograms
to opacify the left ventricular chamber and to improve the delineation
of the left ventricular endocardial border.
Lumason is indicated
for use with ultrasound of the liver in adult and pediatric patients
to characterize focal liver lesions.
Tract
Lumason
is indicated for use in ultrasonography of the urinary tract in pediatric
patients for the evaluation of suspected or known vesicoureteral reflux.
Avoid intra-arterial injection (
Instructions
Do not administer Lumason by intra-arterial injection
Warnings and Precautions ]
When administering Lumason to
patients with cardiac shunt, microspheres can bypass filtering by
the lung and enter the arterial circulation. Assess patients with
shunts for embolic phenomena following Lumason administration. Lumason
is only for intravenous and/or intravesical administration; do not
administer Lumason by intra-arterial injection
and Administration ].
See Full Prescribing Information for reconstitution instructions (
Instructions
- Refer to Section 2.3.1 for instructions for using the single
patient use kit with diluent provided - Refer to Section 2.3.2 for instructions for using the 20-vial
pack without diluent provided
patient use kit)
- Inspect the Lumason kit and its components for signs of
damage. Do not use the kit if the protective caps on the Lumason
vial and prefilled syringe with 5 mL 0.9% Sodium Chloride Injection,
USP are not intact or if the kit shows other signs of damage. - Under aseptic conditions, reconstitute the Lumason vial
using the following illustrated steps:
1. Connect the plunger rod
to the prefilled 0.9% Sodium Chloride Injection, USP syringe barrel
by screwing it clockwise into the syringe (see Figure 1).
2. Open the Mini-Spike blister and remove the syringe tip cap (see
Figure 2).
3. Remove the Mini-Spike green cap and connect
the syringe to the Mini-Spike by screwing it in clockwise (see Figure
3).
4. Remove the Mini-Spike spike protection and position the spike
in the center of the rubber stopper of the vial. Press firmly inward
until the spike is fully inserted in the stopper (see Figure 4).
5. Empty the content of the syringe into the vial by pushing on the
plunger rod (see Figure 5).
6. Shake vigorously for 20 seconds, mixing
all the contents in the vial (see Figure 6). A homogeneous white milky
liquid indicates formation of sulfur hexafluoride lipid microspheres.
7. For preparation of doses greater than or equal to 1 mL, invert
the system and slowly withdraw the intended volume of suspension into
the syringe (see Figure 7). For preparation of doses less than 1 mL,
withdraw 2 mL of the reconstituted suspension into the 5 mL syringe
and measure the volume of Lumason to inject by using the 0.2 mL graduations
between the 1 mL and 2 mL marks.
8. Unscrew the syringe from the Mini-Spike (see Figure 8). Peel and
remove the diluent label to display the reconstituted product label.
For intravenous administration, immediately connect the syringe to
a dose administration line (20 G) and administer as directed under
the Administration Instructions below. For intravesical administration,
immediately connect the syringe to a sterile urinary catheter (6 French
to 8 French) and administer as directed under the Administration Instructions
below.
- Following reconstitution, Lumason suspension contains 1.5
to 5.6 x108microspheres/mL with 45 mcg/mL
of sulfur hexafluoride. - Use immediately after reconstitution. If the suspension
is not used immediately after reconstitution, resuspend the microspheres
for a few seconds by hand agitation before the suspension is drawn
into the syringe. Reconstituted suspension within a vial may be used
for up to 3 hours from the time of its reconstitution. Maintain the
vial containing the reconstituted suspension at room temperature 25°C
(77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Pack (20-vial pack)
*Please note: This presentation
does not include pre-filled syringes of 0.9% Sodium Chloride Injection,
USP (Diluent).
Lumason
vials are to be used with the supplied Mini-Spike only.
0.9% Sodium Chloride Injection, USP for the reconstitution of Lumason.
- Inspect the Lumason components for signs of damage. Do not
use the Lumason vial if the protective cap on the vial is not intact
or other components in the pack show signs of damage. - Use aseptic conditions for the preparation and administration
of Lumason.
1. Obtain a 5 mL syringe,
with luer lock tip, and fill with 5 mL of additive-free 0.9% Sodium
Chloride Injection, USP (diluent) (see Figure 1).
- Two healthcare professionals (HCPs) should verify that the
solution selected for reconstitution of Lumason is additive-free 0.9%
Sodium Chloride Injection, USP.- Ensure that any air in the syringe is expelled.
[Note: A prefilled syringe containing additive-free 0.9% Sodium Chloride
Injection, USP may be used. Ensure that any air in the syringe is
expelled.]
2. Remove
the Mini-Spike green cap and connect the syringe to the Mini-Spike
by screwing it in clockwise (see Figure 2).
3. Remove the Mini-Spike spike protection and position the spike
in the center of the rubber stopper of the vial. Press firmly inward
until the spike is fully inserted in the stopper (see Figure 3).
4. Empty the entire 5 mL content of the syringe into the vial by
pushing on the plunger rod (see Figure 4).
5. Shake vigorously for 20 seconds, mixing all the contents in the
vial (see Figure 5). A homogeneous white milky liquid indicates formation
of sulfur hexafluoride lipid microspheres.
6. To obtain required dose, invert the system and slowly withdraw
the intended volume of suspension into the syringe (see Figure 6).
7. Unscrew the syringe from the Mini-Spike (see Figure 7).
8. Label the syringe using the peel-off sticker provided.
9. For intravenous administration,
immediately connect the syringe to a dose administration line (20G)
and administer as directed under the Administration Instructions below.
For intravesical administration, immediately connect the syringe
to a sterile urinary catheter (6 French to 8 French) and administer
as directed under the Administration Instructions below.
- Following reconstitution, Lumason suspension contains 1.5
to 5.6 x108microspheres/mL with 45 mcg/mL
of sulfur hexafluoride. - Use immediately after reconstitution. If the suspension
is not used immediately after reconstitution, resuspend the microspheres
for a few seconds by hand agitation before the suspension is drawn
into the syringe. Reconstituted suspension within a vial may
be used for up to 3 hours from the time of its reconstitution. Maintain
the vial containing the reconstituted suspension at room temperature
25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).
- Echocardiography in adults: After reconstitution, administer 2 mL as an intravenous injection (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- Echocardiography in pediatric patients: After reconstitution, administer 0.03 mL per kg as an intravenous injection up to a maximum of 2 mL per injection (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- Ultrasonography of the liver in adults: After reconstitution, administer 2.4 mL as an intravenous injection (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- Ultrasonography of the liver in pediatric patients: After reconstitution, administer 0.03 mL per kg as an intravenous injection, up to a maximum of 2.4 mL per injection (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- May repeat dose one time during a single examination (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- Follow each injection with an intravenous flush of 0.9% Sodium Chloride Injection, USP (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- Ultrasonography of the urinary tract: After reconstitution, administer 1 mL via sterile 6 to 8F urinary catheter. Bladder should be first emptied and then partially filled with 0.9% Sodium Chloride Injection, USP before injection of Lumason (,
2.2 Recommended DosageEchocardiographyAdultsThe recommended dose
of Lumason after reconstitution is 2 mL administered as an intravenous
bolus injection during echocardiography. During a single examination,
a second injection of 2 mL may be administered to prolong contrast
enhancement. Follow each Lumason injection with an intravenous flush
using 5 mL of 0.9% Sodium Chloride Injection, USP.Pediatric PatientsThe recommended dose of Lumason
after reconstitution in pediatric patients is 0.03 mL per kg administered
as an intravenous injection during echocardiography. During a single
examination, a second injection of 0.03 mL per kg may be administered,
if needed. Do not exceed 2 mL per injection. Follow Lumason injection
with an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Ultrasonography
of the LiverAdultsThe recommended dose of Lumason after reconstitution in adult patients
is 2.4 mL administered as an intravenous injection during ultrasonography
of the liver. During a single examination, a second injection of
2.4 mL may be administered, if needed. Follow Lumason injection with
an intravenous flush using 5 mL of 0.9% Sodium Chloride Injection,
USP.Pediatric
PatientsThe
recommended dose of Lumason after reconstitution in pediatric patients
is 0.03 mL per kg administered as an intravenous injection during
ultrasonography of the liver. During a single examination, a second
injection of 0.03 mL per kg may be administered, if needed. Do not
exceed 2.4 mL per injection. Follow Lumason injection with an intravenous
flush of 0.9% Sodium Chloride Injection, USP.Ultrasonography of the Urinary
TractPediatric PatientsThe recommended dose of Lumason after
reconstitution is 1 mL. The bladder may be refilled with 0.9% Sodium
Chloride Injection, USP for a second cycle of voiding and imaging,
without the need of a second Lumason administration.)2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
- After Lumason administration, continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion ()
2.4 Administration InstructionsInspect visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted suspension is milky-white, and does not contain visible particulate matter. Do not use the single-patient use vial for more than one patient.
Intravenous AdministrationAdminister Lumason as an intravenous bolus injection.
Intravesical Administration in Pediatric Patients- Insert a sterile 6 French to 8 French urinary catheter into the bladder under sterile conditions;
- Empty the bladder of urine, and then fill the bladder with sterile 0.9% Sodium Chloride Injection, USP to approximately one third or half of its predicted total volume. The total bladder volume in children is calculated as [(age in years + 2) x 30] mL;
- Administer Lumason as an intravesical bolus injection through the urinary catheter;
- Continue filling the bladder with 0.9% Sodium Chloride Injection, USP until the patient has the urge to micturate or at the first sign of back pressure to the infusion.
- Immediately following the first voiding, the bladder may be refilled with 0.9% Sodium Chloride Injection, USP for a second cycle of voiding and imaging, without the need of a second Lumason administration.
For injectable suspension: Lumason
is supplied in two presentations (single patient use kit or 20-vial
pack):
3-part single
patient use kit comprised of:
- one Lumason clear vial containing 25 mg of lipid-type A
sterile white lyophilized powder with headspace filled with 60.7 mg
of sulfur hexafluoride gas - one prefilled syringe containing 5 mL of 0.9% Sodium Chloride
Injection, USP (Diluent) - one Mini-Spike
20-vial pack comprised
of:
- twenty Lumason clear vials, each containing 25 mg of lipid-type
A sterile white lyophilized powder with headspace filled with 60.7
mg of sulfur hexafluoride gas - twenty Mini-Spikes
- twenty peel-off syringe labels
Following reconstitution,
Lumason is a homogeneous, milky white suspension containing 1.5 to
5.6 x 108 microspheres/mL with 45 mcg/mL
of sulfur hexafluoride.
There are no data with Lumason use in pregnant
women to inform any drug-associated risks. No adverse developmental
outcomes were observed in animal reproduction studies with administration
of sulfur hexafluoride lipid-type A microspheres in pregnant rats
and rabbits during organogenesis at doses up to at least 10 and 20
times, respectively, the maximum human dose of 4.8 mL based on body
surface area (
In the U.S. general population,
the estimated background risk of major birth defects and miscarriage
in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Lumason was administered intravenously
to rats at doses of 0.2, 1, and 5 mL/kg (approximately 0.4, 2, and
10 times the recommended maximum human dose of 4.8 mL, respectively,
based on body surface area); Lumason doses were administered daily
for about 30 consecutive days, from two weeks before pairing until
the end of organogenesis. Lumason was administered intravenously to
rabbits at doses of 0.2, 1, and 5 mL/kg (approximately 0.8, 4, and
20 times the recommended maximum human dose, respectively, based on
body surface area); Lumason doses were administered daily from gestation
day 6 to day 19 inclusive. No significant findings on the fetus were
observed.