Version May 2024
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes perflutren administration. Always have resuscitation equipment and trained personnel readily available.
Cardiovascular imaging: Dose should be given following baseline noncontrast echocardiography. Imaging should begin immediately following dose and compared to noncontrast image. Mechanical index for the ultrasound device should be set at ≤0.8.
IV bolus: 10 microliters (mcL)/kg of activated product, followed by 10 mL saline flush; may repeat in 30 minutes (followed by 10 mL saline flush) if needed (maximum dose per imaging study: 2 bolus doses).
IV infusion: Initial: 4 mL/minute (or 240 mL/hour) of prepared infusion; titrate to achieve optimal image up to a maximum of 10 mL/minute (or 600 mL/hour) (maximum dose per imaging study: 1 IV infusion).
Focal liver lesion evaluation (off-label use): IV bolus: 0.1 to 0.6 mL per injection followed by a 5 mL saline flush; may be repeated at a minimum of every 5 minutes (ie, when most microbubbles have vanished) up to a maximum total dose of 10 microliters (mcL)/kg (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
1% to 10%:
Cardiovascular: Flushing (1%)
Gastrointestinal: Nausea (1%)
Nervous system: Headache (2%)
Neuromuscular & skeletal: Back pain (≤1%)
Renal: Renal pain (≤1%)
<1%:
Cardiovascular: Bradycardia, chest pain, ECG abnormality, hypertension, hypotension, palpitations, syncope, tachycardia
Dermatologic: Diaphoresis, erythematous rash, pruritus, skin rash, urticaria, xeroderma
Endocrine & metabolic: Albuminuria, hot flash
Gastrointestinal: Abdominal pain, diarrhea, dysgeusia, dyspepsia, tongue disease, vomiting, xerostomia
Hematologic & oncologic: Eosinophilia, granulocytosis, hematoma, leukocytosis, leukopenia
Local: Injection-site reaction
Nervous system: Dizziness, fatigue, hypertonia, pain, paresthesia, rigors, vertigo
Neuromuscular & skeletal: Arthralgia, lower limb cramp
Ophthalmic: Conjunctivitis, visual disturbance
Otic: Auditory impairment
Respiratory: Cough, dyspnea, hypoxia, pharyngitis, rhinitis
Miscellaneous: Fever
Postmarketing:
Cardiovascular: Atrial fibrillation, shock, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reaction
Nervous system: Agitation, coma, loss of consciousness, seizure, transient ischemic attacks, tremor
Ophthalmic: Blurred vision
Respiratory: Respiratory distress, stridor, wheezing
Hypersensitivity to perflutren or to any component of the formulation, including polyethylene glycol.
Canadian labeling: Additional contraindications (not in US labeling): Patients with known right-to-left, bi-directional, or transient right-to-left cardiac shunts; direct intra-arterial injection; within 24 hours prior to extracorporeal shock wave lithotripsy.
Concerns related to adverse effects:
• Hypersensitivity reactions: Postmarketing reports of serious anaphylactoid reactions (eg, death, shock, bronchospasm, throat tightness, angioedema, edema [oropharyngeal, palatal, peripheral, and localized], swelling [face, eye, lip, tongue, upper airway], facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema) have been reported in patients with no prior exposure. Assess patients for prior hypersensitivity reactions to products containing polyethylene glycol (eg, certain colonoscopy bowel preparations and laxatives); increased risk of serious reactions may occur. Monitor for signs and symptoms of hypersensitivity reactions. Equipment for resuscitation and trained personnel should be readily available.
• Serious cardiopulmonary reactions: [US Boxed Warning]: Serious cardiopulmonary reactions (including fatalities) have occurred during or following administration; most serious reactions occur within 30 minutes of administration. Assess all patients for the presence of any condition that precludes administration. Equipment for resuscitation and trained personnel experienced in handling medical emergencies should always be immediately available. Risk may be increased in patients with unstable cardiopulmonary conditions (eg, acute MI, acute coronary artery syndromes, worsening or unstable HF, serious ventricular arrhythmias). However, multiple retrospective and prospective studies involving the use of perflutren-based ultrasound contrast agents have suggested they may be safely used in patients with significant cardiopulmonary disease (ie, acute coronary syndromes, heart failure, COPD, pulmonary hypertension) or critical illness (Dolan 2009; Kurt 2009; Kusnetzky 2008; Main 2008; Main 2014; Nucifora 2008; Wei 2008; Wei 2012; Weiss 2012; Wever-Pinzon 2012).
• Ventricular arrhythmias: High ultrasound mechanical indices with or without end-systolic triggering may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Safety of activated perflutren lipid microspheres with mechanical indices >0.8 or use of end-systolic triggering has not been established.
Disease-related concerns:
• Cardiac shunts: Assess patients with cardiac shunts for embolic phenomena following administration; perflutren lipid microspheres can bypass filtering by the lung and enter the arterial circulation. Patients with small degrees of right-to-left shunting through patent foramen ovales (those that result in transient appearance of saline contrast in the left atrium or ventricle and do not fill the left atrial or LV cavity) are not considered at an increased risk for microvascular occlusion with perflutren-based ultrasound contrast agents (ASE [Porter 2014]); Kalra 2014; Muskula 2017; Parker 2013).
• Sickle cell disease: Acute pain episodes, including moderate to severe back pain and vaso-occlusive crisis, have occurred in persons with sickle cell disease shortly after administration. Discontinue use if new or worsening pain occurs.
Other warnings/precautions:
• Appropriate use: Product must be activated prior to use. For IV administration only; do not administer by intra-arterial injection.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]:
Definity: OFP 6.52 mg/mL and lipid blend 0.75 mg/mL (2 mL) [following activation, forms a suspension containing perflutren lipid microspheres 1.2 x 1010/mL and OFP 1.1 mg/mL]
Definity RT: OFP 6.52 mg/mL and lipid bleng 3.75 mg/mL (2 mL) [following activation, forms a suspension containing a maximum of perflutren lipid microspheres 1.2 x 1010/mL and OFP 0.65 mg/mL]
No
Suspension (Definity Intravenous)
6.52 mg/mL (per mL): $201.21
Suspension (Definity RT Intravenous)
6.52 mg/mL (per mL): $192.85
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Note: There are 2 different formulations of this product; one is a refrigerated product and one is a room temperature product. Make sure to follow correct procedures for the correct product.
Refrigerated formulation (Definity):
IV bolus (undiluted):
Cardiovascular imaging: Administer only after activation in the Vialmix or Vialmix RFID apparatus. Administer within 30 to 60 seconds of activation; follow each injection with a 10 mL saline flush.
Focal liver lesion evaluation (off-label use): Administer only after activation in the Vialmix apparatus. Follow each injection with a 5 mL saline flush (Ref).
IV bolus (diluted): Administer only after activation in the Vialmix or Vialmix RFID apparatus. Administer slowly up to 3 mL of solution; subsequent boluses of 1 to 2 mL may be used as needed.
IV infusion rate: Initially, 4 mL/minute (or 240 mL/hour) up to 10 mL/minute (or 600 mL/hour); adjust flow rate for optimal image enhancement.
Room temperature formulation (Definity RT):
IV bolus (undiluted):
Cardiovascular imaging: Administer only after activation in the Vialmix RFID apparatus. Administer within 5 minutes of activation; follow each injection with a 10 mL saline flush.
Focal liver lesion evaluation (off-label use): Administer only after activation in the Vialmix RFID apparatus. Follow each injection with a 5 mL saline flush (Ref).
IV infusion rate: Initially, 4 mL/minute (or 240 mL/hour) up to 10 mL/minute (or 600 mL/hour); adjust flow rate for optimal image enhancement.
Cardiovascular imaging: Opacification of the left ventricular chamber and improvement of delineation of the left ventricular endocardial border in patients with suboptimal echocardiograms
Focal liver lesion evaluation
Perflutren lipid microspheres may be confused with influenza virus vaccine
None known.
There are no known significant interactions.
Due to the very short half-life, administration during pregnancy is not expected to result in clinically relevant fetal exposure.
It is not known if perflutren lipid microspheres is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. The very short half-life should limit exposure to breast milk.
Cardiopulmonary reactions (rare); signs and symptoms of anaphylactoid reactions (rare). Monitor patient as appropriate based upon patient clinical disposition; specific monitoring parameters based upon perflutren lipid microspheres administration are not necessary (Muskula 2017).
Activated perflutren lipid microspheres provide contrast enhancement of the endocardial borders during echocardiography.
Onset of action: Immediate
Duration: IV bolus: 3.4 minutes; IV infusion: 7.1 minutes
Metabolism: Octafluoropropane gas (OFP): Not metabolized; Phospholipid component: Metabolized to free fatty acids
Half-life elimination: OFP: 1.3 minutes (healthy patients); 1.9 minutes (patients with COPD)
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