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WARNING
SERIOUS CARDIOPULMONARY REACTIONS
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see WARNINGS AND PRECAUTIONS]. Most serious reactions occur within 30 minutes of administration.
DEFINITY (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent. The DEFINITY vial contains components that upon activation yield perflutren lipid microspheres. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic liquid, which upon activation with the aid of a VIALMIX, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres. The suspension of activated DEFINITY is administered by intravenous injection.
The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) - hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)-∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]-ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt (abbreviated MPEG5000 DPPE).
Octafluoropropane is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula:
 |
DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula:
 |
DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula:
 |
MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, and the following structural formula:
 |
Prior to VIALMIX activation, the DEFINITY vial contains 6.52 mg/mL octafluoropropane in the headspace. Each mL of the clear liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE), 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in Water for Injection. The pH is 6.2-6.8.
After activating the contents of the vial in a VIALMIX, each mL of the milky white suspension contains a maximum of 1.2 X 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) octafluoropropane. The microsphere particle size parameters are listed in Table 2 below:
Table 2 : Microsphere Size Distribution
| Microsphere particle size parameters | |
| Mean diameter range | 1.1 μm – 3.3 μm |
| Percent less than 10 | 98% |
| Maximum diameter | 20 μm |
DEFINITY is indicated, after activation, 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.
The recommended bolus dose in adult patients is 10 microL/kg of activated DEFINITY administered intravenously over 30 seconds to 60 seconds followed by a 10 mL flush of 0.9% Sodium Chloride Injection, USP. If necessary, administer a second 10 microL/kg dose followed by a second 10 mL flush of 0.9% Sodium Chloride Injection, USP 30 minutes after the first injection to prolong contrast enhancement.
The recommended infusion dose in adult patients is 1.3 mL of activated DEFINITY added to 50 mL of preservative-free 0.9% Sodium Chloride Injection, USP administered intravenously. Initiate infusion at 4 mL/minute, titrating the infusion rate as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute.
The recommended bolus dose in pediatric patients is 3 microL/kg of activated DEFINITY administered intravenously over 30 seconds to 60 seconds followed by a 5 mL flush of 0.9% Sodium Chloride Injection, USP. If necessary, administer a second bolus at a dose of 3 microL/kg to 5 microL/kg, followed by a second 5 mL flush of 0.9% Sodium Chloride Injection, USP 30 minutes after the first injection to prolong contrast enhancement.
After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound device at 0.8 or below [see WARNINGS AND PRECAUTIONS]. Then inject activated DEFINITY (as described above) and begin ultrasound imaging immediately [see CLINICAL PHARMACOLOGY]. Evaluate the DEFINITY echocardiogram images in combination with the non-contrast echocardiogram images.
After baseline non-contrast echocardiography is completed, set the mechanical index for the ultrasound transducer at 0.3 or below [see WARNINGS AND PRECAUTIONS]. Then inject activated DEFINITY (as described above) and begin ultrasound imaging immediately [see CLINICAL PHARMACOLOGY]. Evaluate the DEFINITY echocardiogram images in combination with the non-contrast echocardiogram images.
The radio frequency identification (RFID) tag integrated on the back of the vial label when used with VIALMIX RFID allows for the exchange of product information such as activation time and activation rate. If the RFID tag is damaged or otherwise non-functional, the vial with the non-functional RFID tag cannot be activated with VIALMIX RFID. Discard the non-functional RFID-tagged vial. Do not activate RFID-tagged DEFINITY vials in the VIALMIX RFID within 6 inches (15 cm) of a pacemaker and/or defibrillator (see the VIALMIX RFID User’s Guide).
DEFINITY is supplied in a single-patient use vial containing 6.52 mg/mL perflutren in the headspace and 0.75 mg/mL of a lipid blend as a clear colorless liquid with 1.5 mL volume. After activation, each mL contains a maximum of 1.2 X 1010 perflutren lipid microspheres as a homogeneous milky white injectable suspension, and about 150 microL/mL (1.1 mg/mL) perflutren.
DEFINITY (perflutren lipid microsphere) injectable suspension is supplied in a single-patient use clear glass vial or a single patient use clear glass Radio Frequency Identification (RFID)Âtagged vial containing 6.52 mg/mL perflutren in the headspace of the vial and 0.75 mg/mL of a lipid blend in a clear, colorless liquid phase with 1.5 mL volume. DEFINITY is available in the following packages:
One (1) vial or RFID-tagged vial per carton -NDC (11994-011-01)
Four (4) vials or RFID-tagged vials per carton -NDC (11994-011-04)
Sixteen (16) vials or RFID-tagged vials per carton -NDC (11994-011-16)
Order VIALMIX or VIALMIX RFID from Lantheus Medical Imaging.
Before activation, store between 2° to 8°C (36° to 46°F).
Regarding interference with medical devices, the RFID tag and VIALMIX RFID unit meets the IEC 60601-1-2 requirements for emission and immunity standards for medical devices.
Distributed By Lantheus Medical Imaging 331 Treble Cove Road, N. Billerica, Massachusetts 01862 USA. Revised: Mar 2024
The following serious adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Safety of DEFINITY was evaluated in a total of 1,716 adult subjects in pre-market clinical trials. In this group, 1,063 (62%) were male and 653 (38%) were female, 1,328 (77%) were White, 258 (15%) were Black or African American, 74 (4%) were Hispanic, and 56 (3%) were classified as other racial or ethnic groups. The mean age was 56 years (range 18 to 93).
Among the 1,716 subjects, 19 (1.1%) suffered serious cardiopulmonary adverse reactions.
Adverse reactions that led to discontinuation in a total of 15 (0.9%) subjects receiving DEFINITY in the clinical trials included urticaria, pruritus, dizziness, chest pain, dyspnea, and back pain.
Table 1 summarizes the most common adverse reactions occurring at ≥0.5%.
Table 1 : Adverse Reactions Occurring in ≥0.5% of All DEFINITY-Treated Adult Subjects
| DEFINITY (N=1,716) |
||
| Total Number of Adverse Reactions | 269 | |
| Total Number of Subjects with an Adverse Reaction | 144 | (8.4%) |
| Body system | ||
| Preferred term | n | (%) |
| Application Site Disorders | 11 | (0.6) |
| Injection Site Reactions | 11 | (0.6) |
| Body as a Whole | 41 | (2.4) |
| Back/renal pain | 20 | (1.2) |
| Chest pain | 13 | (0.8) |
| Central and peripheral nervous system disorder | 54 | (3.1) |
| Headache | 40 | (2.3) |
| Dizziness | 11 | (0.6) |
| Gastrointestinal system | 31 | (1.8) |
| Nausea | 17 | (1.0) |
| Vascular (extracardiac) disorders | 19 | (1.1) |
| Flushing | 19 | (1.1) |
| N=Sample size 1,716 subjects who received activated DEFINITY n=Number of subjects reporting at least one Adverse Reaction |
||
Other adverse reactions that occurred in <0.5% of the activated DEFINITY-dosed adult subjects were:
Body as a Whole: Fatigue, fever, hot flushes, pain, rigors, and syncope
Cardiovascular: Abnormal ECGs, bradycardia, tachycardia, palpitation, hypertension, and hypotension
Digestive: Dyspepsia, dry mouth, tongue disorder, toothache, abdominal pain, diarrhea, and vomiting
Hematology: Granulocytosis, leukocytosis, leukopenia, and eosinophilia
Musculoskeletal: Arthralgia
Nervous System: Leg cramps, hypertonia, vertigo, and paresthesia
Platelet, Bleeding, and Clotting: Hematoma
Respiratory: Coughing, hypoxia, pharyngitis, rhinitis, and dyspnea
Special Senses: Decreased hearing, conjunctivitis, abnormal vision, and taste perversion
Skin: Pruritus, rash, erythematous rash, urticaria, increased sweating, and dry skin
Urinary: Albuminuria
In a study of DEFINITY in 40 pediatric patients 1 month of age and older, no new safety signals were observed [see Use In Specific Populations and CLINICAL PHARMACOLOGY].
In published studies of DEFINITY in 149 patients 5 years to 24 years of age (mean age 16.8 years; 56% male) clinically indicated for echocardiography, no additional safety signals were observed.
In a prospective, multicenter, open-label registry of 1,053 patients receiving DEFINITY in routine clinical practice, heart rate, respiratory rate, and pulse oximetry were monitored for 30 minutes after DEFINITY administration. No deaths or serious adverse reactions were reported.
The following adverse reactions have been identified during the post-marketing use of perflutren and PEG-containing microsphere products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiopulmonary
Fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing.
Immune System
Anaphylaxis, with manifestations that may include death, shock, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, erythema.
Neurologic
Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue.
Blood And Lymphatic System
Acute pain episodes including vaso-occlusive crisis in patients with sickle cell disease.
No Information provided
Included as part of the PRECAUTIONS section.
Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically 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 DEFINITY administration and monitor all patients for acute reactions.
The reported reactions include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness, and convulsions [see ADVERSE REACTIONS].
In postmarketing use, serious hypersensitivity reactions were observed during or shortly following perflutren-containing microsphere administration including:
Anaphylaxis, with manifestations that may include death, shock, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue, upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema.
These reactions have occurred in patients with no prior exposure to perflutren-containing microsphere products. DEFINITY contains PEG. There may be increased risk of serious reactions including death in patients with prior hypersensitivity reaction(s) to PEG [see ADVERSE REACTIONS Â and DESCRIPTION]. Clinically assess patients for prior hypersensitivity reactions to products containing PEG, such as certain colonoscopy bowel preparations and laxatives. DEFINITY is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components such as PEG [see CONTRAINDICATIONS]. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY administration and monitor all patients for hypersensitivity reactions.
When administering DEFINITY to patients with a cardiac shunt, the microspheres can bypass filtering by the lung and enter the arterial circulation. Assess patients with shunts for embolic phenomena following DEFINITY administration. DEFINITY is only for intravenous administration and must not be administered by intra-arterial injection [see DOSAGE AND ADMINISTRATION].
High ultrasound mechanical index values may cause microsphere cavitation or rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. The maximum recommended mechanical index for use with DEFINITY is 0.8 in adult patients and 0.3 in pediatric patients [see DOSAGE AND ADMINISTRATION].
In postmarketing reports, acute pain episodes shortly following DEFINITY administration have been reported in patients with sickle cell disease (SCD). The pain episodes included moderate to severe back pain and vaso-occlusive crisis [see ADVERSE REACTIONS]. If a patient with sickle cell disease experiences new or worsening pain, discontinue DEFINITY.
Studies with activated DEFINITY have not been performed to evaluate carcinogenic potential. Evidence of genotoxicity was not found in the following studies with activated DEFINITY: 1) bacterial mutagenesis assay (Ames assay), 2) in vitro mammalian mutagenesis assay, 3) in vitro human lymphocyte chromosome aberration assay, and 4) in vivo rat micronucleus assay.
Impairment of male or female fertility was not observed in rats and rabbits treated with activated DEFINITY at doses up to 24 and 15 times the human dose based on body surface area (in rats and rabbits respectively).
Available data from case reports with DEFINITY use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. DEFINITY has a very short half-life; therefore, administration of DEFINITY to a pregnant woman is not expected to result in clinically relevant fetal exposure. No adverse developmental outcomes were observed in animal reproduction studies with administration of activated DEFINITY, in pregnant rats and rabbits during organogenesis at doses up to 8 and 16 times, respectively, the maximum human dose based on body surface area (see Data).
All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Animal Data
DEFINITY was administered intravenously to rats at doses of 0.1 mL/kg, 0.3 mL/kg, and 1 mL/kg (approximately 0.8, 2.4, and 8 times the recommended maximum human dose based on body surface area); DEFINITY doses were administered daily from day 6 to day 17 of gestation. DEFINITY was administered intravenously to rabbits at doses of 0.1 mL/kg, 0.3 mL/kg, and 1 mL/kg (approximately, 1.6, 4.8, and 16 times the recommended maximum human dose based on body surface area); DEFINITY doses were administered daily from day 7 to day 19 of gestation. No significant findings on the fetus were observed.
There are no data on the presence of perflutren lipid microspheres in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEFINITY and any potential adverse effects on the breastfed infant from DEFINITY or from the underlying maternal condition.
The safety and effectiveness of DEFINITY have been established for use in pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left endocardial border. Use of DEFINITY for this indication is supported by evidence from adequate and well-controlled studies in adults [see Clinical Studies], a pharmacodynamic and safety study in 40 pediatric patients 1 month of age and older [see ADVERSE REACTIONS Â and CLINICAL PHARMACOLOGY], and published studies in 149 patients 5 years to 24 years of age [see ADVERSE REACTIONS].
Of the total number of subjects in clinical trials of DEFINITY, 144 (33%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences between the elderly and younger patients.
No Information provided
DEFINITY is contraindicated in patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) [see WARNINGS AND PRECAUTIONS and DESCRIPTION].
Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. These physical acoustic properties of activated DEFINITY provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography.
In animal models the acoustic properties of activated DEFINITY were established at or below a mechanical index of 0.7 (1.8 MHz frequency). In clinical trials, the majority of the patients were imaged at or below a mechanical index of 0.8.
In a crossover trial of 64 adult subjects randomized to both bolus and infusion, the duration of clinically useful contrast enhancement for fundamental imaging was approximately 3.4 minutes after a 10 microL/kg bolus and was approximately 7.1 minutes during the continuous infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of 4 mL/min.
In a pharmacodynamic and safety study, DEFINITY was administered to 40 pediatric patients 1 month of age and older clinically indicated for echocardiography (60% male; 10 patients were 1 month to younger than 1 year of age; 9 patients were 1 to 5 years of age; 10 patients were 6 to 10 years of age; 10 patients were 11 to 16 years of age; and 1 patient was 17 years of age). Patients underwent echocardiography with a mechanical index of ≤ 0.3 and received DEFINITY as a series of sequential bolus injections (3 microL/kg and 5 microL/kg) with each injection separated by approximately 7 minutes. Patients had acceptable cardiac imaging at baseline. Left ventricular opacification with DEFINITY was graded as adequate or full in 80% to 95% of patients (depending on view) at the 3 microL/kg dose and 85% to 88% of patients at the 5 microL/kg dose [see DOSAGE AND ADMINISTRATION]. The mean duration of clinically useful contrast enhancement was approximately 2.7 minutes after a bolus dose of 3 microL/kg and 3.9 minutes after a bolus dose of 5 microL/kg.
The impact of DEFINITY on pulmonary hemodynamics was explored in a prospective, open-label study of patients with normal (≤ 35 mmHg, 16 patients) and elevated (> 35 mmHg, < 75 mmHg, 16 patients) pulmonary artery systolic pressure undergoing right heart catheterization. Patients with pulmonary artery systolic pressure greater than 75 mmHg were excluded from this study. Systemic hemodynamic parameters and ECGs were also evaluated. No clinically important pulmonary hemodynamic, systemic hemodynamic, or ECG changes were observed.
Human pharmacokinetics information is not available for the intact or degassed lipid microspheres. The pharmacokinetics of perflutren gas was evaluated in healthy subjects (n=8) after the intravenous administration of activated DEFINITY at 50 microL/kg (5 times the recommended dose).
Perflutren gas binding to plasma proteins or partitioning into blood cells has not been studied. However, perflutren protein binding is expected to be minimal due to its low partition coefficient into whole blood.
Metabolism
Perflutren is a stable gas that is not metabolized. The phospholipid components of the microspheres are thought to be metabolized to free fatty acids.
Excretion
Perflutren was not detectable after 10 minutes in most subjects either in the blood or in expired air. Perflutren concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects.
The pharmacokinetics of perflutren gas was evaluated in subjects (n=11) with chronic obstructive pulmonary disease (COPD). The mean half-life of perflutren in blood was 1.9 minutes. The total lung clearance of perflutren was similar to that in healthy subjects.
Effectiveness and safety of DEFINITY were evaluated in four controlled clinical trials (two open-label baseline controlled, unpaired blinded image evaluation studies and two identical placebo-controlled, unpaired blinded image evaluation studies) in 249 subjects who had two or more (of six) non-evaluable segments in either the apical 2-or 4-chamber view in non-contrast fundamental echocardiography.
In this group, 154 (62%) were male and 95 (38%) were female; 183 (74%) were White, 38 (15%) were Black or African American, 21 (8%) were Hispanic, and 7 (3%) were classified as other racial or ethnic groups. The mean age was 54 years (range 18 to 87).
In the two open-label baseline controlled studies, a total of 126 (67 in study A and 59 in study B) subjects received a bolus dose of 10 microL/kg activated DEFINITY. The outcome measures in these studies included the blinded assessment of ejection fraction (EF), endocardial border length (EBL) obtained by direct measurement, and qualitative assessment of wall motion.
In the two placebo-controlled studies a total of 123 subjects were randomized in 1:2 ratio to receive two intravenous bolus doses of either 0.9% Sodium Chloride Injection (placebo) or activated DEFINITY 10 microL/kg (17 placebo vs. 33 DEFINITY subjects and 24 placebo vs. 49 DEFINITY subjects, respectively). The outcome measure for assessing the effectiveness of DEFINITY was the blinded assessment of improvement in ventricular chamber enhancement (measured by videodensitometry at end-diastole and end-systole).
As shown in Table 3, compared to baseline, a single bolus dose of 10 microL/kg of activated DEFINITY increased the length of endocardial border that could be measured at both end-systole and end-diastole. The mean change in border length from baseline at end-diastole was statistically significant for all readers in the apical 4-chamber view and for 3 out of 4 readers for the apical 2-chamber view. The mean change in border length from baseline at end-systole was statistically significant for 3 out of 4 readers for the apical 4-chamber view and for 2 out of 4 readers for the apical 2-chamber view.
Left ventricular chamber enhancement after an activated DEFINITY dose of 10 microL/kg was significantly increased from baseline compared to placebo in both views at the mid-ventricular and apical levels at end-diastole. Similar results were noted at end-systole, with the exception of the 4-chamber view.
In a retrospective analysis, in a subset of subjects (n=12 to 47, depending on reader) having at least 2 adjacent segments non-evaluable on non-contrast imaging, DEFINITY converted a baseline non-evaluable image to an evaluable image in 58 to 91% of the subjects, depending on the reader. In the converted images, the accuracy of wall motion (i.e., normal versus abnormal) improved in 42 to 71% of the subjects, depending on the reader, however, improvement in the specific diagnostic accuracy (e.g., hypokinetic, akinetic etc.) was not established. Also, in 13 to 37% of the subjects, depending on the reader, DEFINITY was found to obscure the wall motion rendering the image non-evaluable.
In the 2 baseline controlled studies, ejection fraction results were evaluated in comparison to MRI. The results were evaluated by 3 blinded, independent radiologists. In these studies, although there was a statistically significant increase in ventricular chamber enhancement, DEFINITY did not significantly improve the assessment of ejection fraction compared to the baseline images.
Table 3 : MEAN (SD) ENDOCARDIAL BORDER LENGTH (CM) BY BOTH APICAL 2-AND 4-CHAMBER VIEWS AT END-SYSTOLE AND ENDÂDIASTOLE BY STUDY, EVALUABLE SUBJECTS
| Study/View | Endocardial Border Length - Blinded Read | |||
| Mean(SD) at End-Diastole | Mean(SD) at End-Systole | |||
| Reader 1 | Reader 2 | Reader 1 | Reader 2 | |
| Studv A: (N = 67) | ||||
| Apical 2-chamber | ||||
| Baseline | 8.0 (3.4) | 4.7 (2.8) | 7.1 (33) | 4.3 (2.6) |
| Post-DEFINITY | 12.8 (5.2)* | 5.8 (2.6)* | 10.6 (5.0)* | 4.4 (2.3) |
| Apical 4-chamber | ||||
| Baseline | 8.1 (3.3) | 4.5 (2.6) | 7.6 (3.2) | 4.5 (2.7) |
| Post-DEFINITY | 13.5 (5.2)* | 6.8 (3.3)* | 11.5 (4.4)* | 53 (3.1) |
| Study B: (N = 59) | ||||
| Apical 2-chamber | ||||
| Baseline | 4.3 (2.6) | 7.8 (5.3) | 4.1 (2.4) | 6.5 (5.1) |
| Post-DEFINITY | 5.7 (4.7)* | 8.2 (6.5) | 5.5 (4.4)* | 6.9 (6.3) |
| Apical 4-chamber | ||||
| Baseline | 4.0 (2.7) | 9.2 (5.9) | 3.8 (2.6) | 7.3 (5.6) |
| Post-DEFINITY | 7.1 (5.5)* | 11.5 (7.5)* | 5.9 (5.3)* | 8.7 (6.3)* |
| Activated DEFINITY Bolus Dose = 10 microL/kg * Significant change from baseline (paired t-test, p<0.05) |
||||
Advise patients to inform their healthcare provider if they develop any symptoms of hypersensitivity after DEFINITY administration, including rash, wheezing, or shortness of breath [see WARNINGS AND PRECAUTIONS].
