Dosing & Uses
Dosage Forms & Strengths
- 5-8 x10^8/mL (Optison); 2 and 3 mL vials
- 1.2 x10^10/mL (Definity); concentration after mixing
Indicated for suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border
- Do not use without activating product! (see IV preparation)
- IV Bolus: 10 mcL/kg over 30-60 sec, THEN 10 mL saline flush, if necessary repeat a second time (dose and flush) after 30 min
- IV Infusion: 1.3 mL in 50 mL NS0.9% NaCl (preservative-free); initiate IV at 4 mL/min, titrate PRN, not to exceed infusion rate of 10 mL/min
- 0.5 mL IV bolus; slowly infuse IV into peripheral vein slowly at rate no more than 1 mL/sec, flush with 0.9% NaCl or D5W
- May give additional 0.5 mL doses to enhance imaging quality
- Not to exceed cumulative dose of 5 mL in a 10-min period
- Not to exceed cumulative dose/study of 8.7 mL per patient
Safety and efficacy not established
Flushing/warn sensation (1.1-3.6%)
Altered taste (1.8%)
Back/renal pain (1.2%)
Chest pain (0.8-1.1%)
Flu-like symptoms (1.1%)
Injection site discomfort (0.6-1.1%)
Fatal cardiac arrests and other serious but nonfatal adverse reactions were uncommonly reported
Most of these uncommon reactions included cardiopulmonary symptoms and signs (eg, cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation)
Neurologic reactions: loss of consciousness or convulsions
Black Box Warnings
Serious cardiopulmonary reactions, including death, can occur during or after use
Most serious reactions occur within 30 minutes of administration
Evaluate patients closely for contraindications
Resuscitation equipment and personnel should be readily available
Hypersensitivity to perflutren; Optison brand also warns for hypersensitivity to blood, blood products, or albumin
For IV use only; do not administer by intra-arterial injection
Chronic pulmonary vascular disorder
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or shortly following administration (see Black Box Warnings)
Acute anaphylactoid reactions including shock, bronchospasm, upper airway swelling, and loss of consciousness, urticaria, and pruritus reported
In patients with cardiac shunts, perflutren-containing microspheres can bypass the pulmonary particle-filtering mechanisms and directly enter the arterial circulation resulting in microvascular embolization that may cause occlusion and ischemia; assess patients with shunts for embolic phenomena following administration
QT prolongation reported
Assess patients for presence of conditions that preclude therapy administration; always have cardiopulmonary resuscitation personnel and equipment readily available prior to administration and monitor all patients for acute reactions
Pregnancy & Lactation
Pregnancy Category: B (Definity); C (Optison)
Lactation: use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Definity: Suspension of microspheres of human serum albumin with perflutren for contrast enhancement of the endocardial borders during echocardiography
Optison: A stable gas that creates an echogenic contrast effect in the blood and allows improved delineation of the left ventricular endocardial border
- Warm vial to room temperature before activation process
- Activate by shaking vial 45 sec using a Vialmix
- May use immediately after activation; if not used within 5 min, resuspend by 10 sec hand agitation (inversion)
- May use for up to 12 hr after Vialmix activation, but only after resuspension
- Invert the vial and withdraw the activated milky white suspension using the Intellipin (Dispensing Pin) or 18- or 20-gauge syringe needle
- Withdraw the material from the middle of the liquid in the inverted vial
- Do not inject air into the vial
- Use immediately after withdrawal into syringe; do not let stand in syringe
- The vial contains a clear liquid lower layer and a white upper layer that, after resuspension by gentle mixing, provides a homogeneous, opaque, milky-white suspension for IV injection
- Do not use the product if the upper white layer is absent; this indicates that the microspheres may have been damaged and may result in poor or no echo contrast
- Invert the vial and gently rotate to resuspend the microspheres; this process will allow the product to come to room temperature before use
- Inspect the vial for complete resuspension; failure to adequately resuspend product may cause an under delivery of the microspheres, and may result in inadequate contrast
- Do not use product if after resuspension the solution appears to be clear rather than opaque milky-white
- Vent the vial with a sterile vent spike or with a sterile 18-gauge needle before withdrawing the suspension into the injection syringe
- Do not inject air into the vial
- Invert syringe to resuspend
- Inject within 1 min; if 1 min is exceeded invert syringe to remix
Unopened vials are stable until date indicated on package when stored refrigerated temperature (2-8 degrees C [36-46 degrees F]) in carton and protected from light
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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