2.4 DEFINITY Activation, Preparation and Handling Instructions 1. LEAVE, Sign up for DEFINITY updates andannouncements, DEFINITY Vial for (Perflutren Lipid Microsphere) InjectableSuspension, DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension, Please see full Prescribing Information, including boxed. Package insert / product label 2009;53(9):802-810. 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. Data on file, Lantheus Medical Imaging, Inc. Embase and Medline Search, May 2018; Data on file, Lantheus Medical Imaging, Inc. 2021 Millennium Research Group, Inc. All rights reserved. In the 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 results were evaluated by 3 blinded, independent radiologists. Cool: Any temperature between 8 and 15 (46 and 59 F) Room temperature: The temperature prevailing in a work area. The stability of urine osmolality was assessed in a similar manner. Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions. Your decisions have real-life consequences. The pharmacokinetics of octafluoropropane gas (OFP) was evaluated in subjects (n=11) with chronic obstructive pulmonary disease (COPD). No clinically important pulmonary hemodynamic, systemic hemodynamic, or ECG changes were observed. The mean age was 56.1 years (range 18 to 93). Activated Definity (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. If you are a consumer or patient please visit In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. DEFINITY RT may be administered as a simple, straight bolus injection followed by a 0.9% Sodium Chloride Injection, USP flush to offer an easy, rapid image enhancement in small doses. Assess all patients for the presence of any condition that precludes DEFINITY administration . Obtain a syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP. A sterile syringe or cap should be attached to the Luer . Updated Follow all manufacturers' guidelines and do not operate any part of the VIALMIX RFID with DEFINITY RT RFID-tagged vials within 6 inches (15 cm) of a pacemaker and/or defibrillator. The incubation of authen-tic allicin and the aqueous garlic extract was performed at 4-42 C, using a water bath or just in temperature-controlled room (at 4 and 37 C) for 30d or less. The maximum dose is either two bolus doses or one single intravenous infusion. The pH is 5.2 to 6.4. Activate DEFINITY RT by shaking the vial for 45 seconds using a VIALMIX RFID device. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying conditions. The mean age was 53.9 years (range 18 to 87). The pH is 6.2-6.8. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. Activated Definity was 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. Based on the rapid clearance of this drug, advise nursing mothers to pump and discard breast milk once after treatment [see CLINICAL PHARMACOLOGY (12)]. 448 0 obj <>stream It is not known whether Definity is excreted in human milk. See Full Prescribing Information for instructions on preparation and administration. These adverse reactions appeared within minutes (1 15 min) of the drug administration and were of moderate intensity resolving usually without treatment within minutes or hours after onset. Most serious reactions occur within 30 minutes of administration. LEARN MORE . Store at Room Temperature (6877F; 2025C) . %%EOF If not used immediately, the activated, diluted DEFINITY RT can be stored at room temperature 20 to 25C (68 to 77F) in the original product vial with the 13mm ViaLok still attached for up to 4 hours. Follow with a 10 mL 0.9% Sodium Chloride Injection, USP flush. In animal models the acoustic properties of activated DEFINITY were established at or below a mechanical index of 0.7 (1.8 MHz frequency). However, a role for Definity in the initiation or course of these adverse events cannot be ruled out. Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration. J Am Coll Cardiol. Of these, 144 (8.4%) had at least one adverse reaction (Table 1). In postmarketing use, uncommon but serious anaphylactoid reactions were observed during or shortly following perflutren-containing microsphere administration including: Shock, hypersensitivity, 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 have occurred in patients with no prior exposure to perflutren-containing microsphere products [see ADVERSE REACTIONS (6)]. Systemic hemodynamic parameters and ECGs were also evaluated. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Of the total number of subjects in clinical trials of Definity, 144 (33%) were 65 and over. Lantheus Medical Imaging Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length. 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. There were 26 serious adverse events and 15 (0.9%) subjects discontinued because of an adverse event. Drug-drug interactions for activated Definity have not been studied. Immediately after activation in the VIALMIX, activated Definity appears as a milky white suspension and may be used immediately after activation. If DTT is kept at room temperature it will degrade/oxidize. 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 (6)]. To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Medical Imaging, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or, Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration, Assess all patients for the presence of any condition that precludes DEFINITY RT administration, Table 1 New-Onset Adverse Reactions Occurring in 0.5% of All DEFINITY-Treated Subjects, Table 3 MEAN (SD) ENDOCARDIAL BORDER LENGTH (CM) BY BOTH APICAL 2- AND 4-CHAMBER VIEWS AT END-SYSTOLE AND END-DIASTOLE BY STUDY, EVALUABLE SUBJECTS, All Drug Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue. To obtain yields >90%, it is necessary to reconstitute the antibody within the . N. Billerica, Massachusetts 01862 USA Illumina. However, the size distributions of Definity at 25 C and 37 C were similar. 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. Store at Room Temperature (6877F; 2025C), Attach ViaLok Add 1.4mL preservative-free Sodium Chloride Injection,USP, VIALMIX RFID delivers precise activation, providing predictable, quality images from study to study1-3. Amgen 800-772-6436 Formoterol (Foradil) Prior to dispensing, refrigerate at 36 to 46 F (2 to 8C). DNA-targeted nanocarriers for encapsulating an active agent and delivering it to extracellular DNA are provided. In patients with right-to-left, bi-directional, or transient right-to-left cardiac shunts phospholipid-encapsulated microspheres can bypass the pulmonary particle-filtering mechanisms and directly enter the arterial circulation resulting in microvascular occlusion and ischemia. No significant findings on the fetus were observed. Events, 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. Store at Room Temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP . Do not administer DEFINITY RT to patients with known or suspected: Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration. In a prospective, multicenter, open-label registry of 1053 patients receiving Definity in routine clinical practice, heart rate, respiratory rate, and pulse oximetry were monitored for 30 minutes after Definity administration. 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. Table 6.1 summarizes the most common adverse reactions. 331 Treble Cove Road In these studies, although there was a statistically significant increase in ventricular chamber enhancement, activated Definity did not significantly improve the assessment of ejection fraction compared to the baseline images. For customer orders call 1-800-299-3431. The rate of infusion should be initiated at 4 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute. In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren and PEG-containing microsphere administration [see Adverse Reactions (6)]. (2.2). Attenuation and size distribution was measured over time to assess the effect of temperature on the temporal stability of Definity . The objective of this work was to examine the effects of preactivation vial temperature on the size distribution, frequency dependent attenuation (1.5-27 MHz) and nonlinear imaging performance of Definity. Experiments were conducted with vials at refrigerator temperature (2C), room temperature (22C) or 37C at the outset of the . Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY RT administration and monitor all patients for acute reactions (5.1, 5.2). Ultrasound Med Biol. 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