Optison

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Optison

Classes

Ultrasound Agents

Administration

 
NOTE: Hypersensitivity reactions, including serious cardiopulmonary reactions, may occur. Prior to administration, assess all patients for previous reactions to any of the active or inactive ingredients. Trained personnel and therapies used to treat hypersensitivity reactions (e.g., epinephrine, antihistamines, and corticosteroids) should be readily available. Observe patient for signs and symptoms of hypersensitivity reactions during and after administration. Most serious reactions occur within 30 minutes of drug administration.

Injectable Administration

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever suspension and container permit. Do not use if the suspension is not opaque, milky-white, and absent of particulate matter.
For intravenous administration only into a peripheral vein. Do not inject into the arterial circulation.

Intravenous Administration

Intravenous injection preparation:
Use a single vial for each individual patient; do not share vials among patients.
Do not use if container has been damaged or protective seal broken. The product contains no preservatives. Discard all unused product.
Do not use the vial if the upper white layer is absent. This would indicate that the microspheres have been damaged and would give poor or no contrast.
Do not inject air into the vial. (The headspace of the vial is filled with perflutren gas.)
Invert the vial and gently rotate to resuspend the microspheres. This will also bring the vial to room temperature (20 to 25 degrees C or 68 to 77 degrees F) before use.
Inspect the content of vial for complete resuspension. Failure to resuspend all particles will result in poor contrast. If the product is clear rather than appearing opaque and milky white, do not use.
Using a sterile vent spike or a sterile 18-gauge needle, vent the vial before withdrawing the suspension into an injection syringe.
The time between injection preparation/resuspension and administration must not exceed 1 minute. If 1 minute is exceeded resuspend the microspheres in syringe by rotating and inverting the syringe gently.
Intravenous injection procedure for use in echocardiography:
Before injection, provide IV access in a peripheral vein with a 20-gauge or larger angiocatheter. Suggested methods of administration include a short extension tubing, heparin lock, or intravenous line, all with a 3-way stopcock.
For short extension tubing or hep-lock, fill one syringe with 0.9% Sodium Chloride Injection, and flush the line for patency before and after the injection of perflutren protein-type A microspheres.
For a continuous intravenous line, open an intravenous line with 0.9% Sodium Chloride Injection or 5% Dextrose Injection at a slow infusion rate to maintain vascular patency. The line should be flushed immediately after injection of perflutren protein-type A microspheres.
DO NOT ASPIRATE blood back in the syringe prior to drug injection as this may cause the formation of a blood clot within the syringe.
The injection rate should not exceed 1 mL per second.
Follow the injection with a flush of 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

Adverse Reactions
Severe

seizures / Delayed / Incidence not known
coma / Early / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
bradycardia / Rapid / Incidence not known
cardiopulmonary reaction / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
respiratory arrest / Rapid / Incidence not known
atrial fibrillation / Early / Incidence not known
cardiac arrest / Early / Incidence not known
angioedema / Rapid / Incidence not known

Moderate

dyspnea / Early / 1.1-1.1
chest pain (unspecified) / Early / 1.1-1.1
erythema / Early / 0.7-0.7
palpitations / Early / 0-0.5
eosinophilia / Delayed / 0-0.5
wheezing / Rapid / 0-0.5
sinus tachycardia / Rapid / Incidence not known
edema / Delayed / Incidence not known
hypoxia / Early / Incidence not known
hypotension / Rapid / Incidence not known
peripheral edema / Delayed / Incidence not known
photophobia / Early / Incidence not known
blurred vision / Early / Incidence not known

Mild

headache / Early / 5.4-5.4
vomiting / Early / 4.3-4.3
nausea / Early / 4.3-4.3
flushing / Rapid / 3.6-3.6
dizziness / Early / 2.5-2.5
dysgeusia / Early / 1.8-1.8
fever / Early / 1.4-1.4
chills / Rapid / 1.4-1.4
fatigue / Early / 1.1-1.1
malaise / Early / 1.1-1.1
weakness / Early / 1.1-1.1
injection site reaction / Rapid / 1.1-1.1
tremor / Early / 0-0.5
paresthesias / Delayed / 0-0.5
irritability / Delayed / 0-0.5
xerostomia / Early / 0-0.5
rash / Early / 0-0.5
cough / Delayed / 0-0.5
pruritus / Rapid / 0-0.5
urticaria / Rapid / 0-0.5
back pain / Delayed / 0-0.5
myalgia / Early / 0-0.5
arthralgia / Delayed / 0-0.5
syncope / Early / Incidence not known
tinnitus / Delayed / Incidence not known
ocular irritation / Rapid / Incidence not known

Boxed Warning
Acute myocardial infarction, cardiopulmonary reaction, coronary artery disease, heart failure, ventricular arrhythmias

Although uncommon, a serious cardiopulmonary reaction, including some fatalities, has occurred during or immediately following the administration of perflutren protein-type A microspheres. These reactions (e.g., fatal cardiac or respiratory arrest, shock, syncope, cardiac arrhythmias, hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, convulsions) typically develop within 30 minutes of drug administration. Patients at increased risk include those with unstable cardiopulmonary conditions such as acute myocardial infarction, acute coronary artery disease, worsening or unstable heart failure, or serious ventricular arrhythmias. Ensure resuscitation equipment and trained personnel are readily available prior to perflutren protein-type A microspheres administration, and monitor all patients for acute reactions. Additionally, before contrast administration, adjust the ultrasound mechanical index value to 0.8 or lower. Failure to adjust the mechanical index value may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Further, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias.

Common Brand Names

Optison

Dea Class

Rx

Description

IV diagnostic radiopaque contrast agent of fluorocarbon gas formulated with albumin microspheres for targeted delivery
Used in patients with suboptimal echocardiograms to enhance visualization of left ventricular endocardial borders
Associated with risk for serious cardiopulmonary reactions

Dosage And Indications
For use during echocardiography to enhance ultrasound imaging by opacifying the left ventricle and improving the delineation of the left ventricular endocardial borders.
NOTE: Diagnostic echocardiography procedures that involve the use of this product should be carried out under the direction of a licensed practitioner having a thorough knowledge of the procedure and the safe use of the product.
Intravenous dosage Adults

0.5 mL IV at a rate not exceeding 1 mL per second. If contrast enhancement is inadequate, may repeat dose in increments of 0.5 mL, up to 5 mL IV in a 10-minute period. Maximum total dose of 8.7 mL per patient study.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Perflutren Protein-Type A Microspheres products.

How Supplied

Optison Intravenous Inj Susp

Maximum Dosage
Adults

Do not exceed 5 mL IV in any 10 minute period, or a maximum total dose of 8.7 mL IV per any one patient echocardiography study.

Geriatric

Do not exceed 5 mL IV in any 10 minute period, or a maximum total dose of 8.7 mL IV per any one patient echocardiography study.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mechanism Of Action

Perflutren protein-type A microspheres enhances visualization of ultrasound imaging. When the gas-filled perflutren protein-type A microspheres injected into the body are exposed to ultrasound waves, the microspheres resonate and echo strong signals back to the ultrasound machine. The difference in density between the gas-filled bubbles and the blood around them creates an increased level of contrast visible in the resulting ultrasound image. Because the flow pattern of the microspheres represent actual blood flow patterns, the agent can be useful in gauging circulation patterns and perfusion during ultrasound.
 
In an anesthetized dog model, the acoustic properties of perflutren protein-type A microspheres were established at 0.6 mechanical index and 2.5 MHz frequency. Frequencies used in human adult echocardiography are typically 2 to 5 MHz; the median assessed duration of contrast enhancement is as follows for the following dosages: 0.2 mL dose- 1 minute; 0.5 mL dose- 2 minutes; 3 mL dose- 4 minutes; 5 mL dose- 5 minutes.

Pharmacokinetics

Perflutren protein-type A microspheres is administered intravenously. Human pharmacokinetic studies of the intact microspheres have not been performed. The low partition coefficient of the perflutren (octafluoropropane) gas in blood contributes to the persistence of the microspheres in the circulation, and limits diffusion of the gas out of the microspheres. The low partition coefficient of the gas in blood also indicates that perflutren is not likely to bind to plasma proteins or partition into blood cells. Perflutren (octafluoropropane) gas is not metabolized. Pharmacokinetic studies of the human albumin component have not been done; however, the albumin component of the product is expected to be metabolized according to the normal metabolic pathway of albumin in humans.
 
Affected cytochrome P450 isoenzymes and drug transporters: none

Intravenous Route

Following a single 20 mL IV dosage in 10 healthy adults (5 males and 5 females), most (mean 96%) of the perflutren protein-type A microspheres injection was eliminated via the lungs within 10 minutes; the peak perflutren concentration in expired air occurred at roughly 30 to 40 seconds post dose administration. The pulmonary half-life was 1.3 +/- 0.69 minutes.

Pregnancy And Lactation
Pregnancy

Perflutren protein-type A microspheres is classified as FDA pregnancy category C. Animal studies have indicated a potential for embryo, fetal, or maternal risks. Adequate or well-controlled investigations have not been performed during human gestation. Perflutren protein-type A microspheres should be used during pregnancy only when the potential benefit justifies the potential fetal risk.

It is not known whether perflutren protein-type A microspheres is excreted in human breast milk. Use caution when administering perflutren protein-type A microspheres to a breast-feeding woman.