The most common adverse reactions (0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness (6). Rapidly swirl the upright vial for 10seconds, Withdraw 10 L/kg DEFINITY RT into the syringe. DEFINITY RT contains PEG. 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)]. Ultrasound in Med & Biol. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. It is not known whether Definity is excreted in human milk. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY RT administration and monitor all patients for acute reactions. If DTT is kept at room temperature it will degrade/oxidize. Amgen 800-772-6436 Formoterol (Foradil) Prior to dispensing, refrigerate at 36 to 46 F (2 to 8C). 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. "Short-Term Stability Study of RNA at Room Temperature." Biopreservation and Biobanking, vol . 2. Off-label information indicates stable when maintained at room temperature for up to 6 months. 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, activated Definity converted a baseline non-evaluable image to an evaluable image in 58 to 91% of the patients, depending on the reader. Do not inject air into the DEFINITY RT vial. Function of the RFID technology is not dependent on vial orientation as it is placed in the VIALMIX RFID. The results were evaluated by 3 blinded, independent radiologists. this version. The targeting moiety that targets DNA is typically an antibody, or variant, fragment, or fusion protein derived therefrom that binds . Medically reviewed by Drugs.com. 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. Store the activated Definity at room temperature in the original product vial. Assess patients with shunts for embolic phenomena following DEFINITY RT administration. DEFINITY RT is an ultrasound contrast agent 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. 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. Ultrasound Med Biol. (Store diluent separately at room temperature or in the refrigerator.) This study did not assess the effect of DEFINITY on visualization of cardiac or pulmonary structures. If the product is not used within 5 minutes of dilution, resuspend the microspheres by rapidly swirling the upright vial for 10 seconds before the product is withdrawn in thesyringe. Similar results were seen as described above. DEFINITY RT is only for intravenous administration; do not administer DEFINITY RT by intra-arterial injection [see Dosage and Administration (2.1)]. Systemic hemodynamic parameters and ECGs were also evaluated. FDA Safety Recalls, 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. 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. In an open administration, crossover trial, 64 patients were randomized to receive both bolus (10 microL/kg) and infusion (1.3 mL activated Definity in 50 mL saline at the rate of 4 mL/min) dosing of activated Definity. 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. Similar results were seen as described above. 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. The microsphere particle size parameters are listed in Table 11.1 below: Perflutren lipid microspheres exhibit lower acoustic impedance than blood and enhance the intrinsic backscatter of blood. hours at room temperature (22C), for minimum 2 weeks at 4C and after freezing on dry ice for minimum 4 hours prior to storage at -20C (4) It is assumed that the stability of ADA is independent of specificity (5) and therefore the stability of NNCxxxx-xxxx specific antibodies will not be tested in this validation 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. These serious reactions may be increased among patients with pre-existing PEG hypersensitivity and/or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias [see Warnings and Precautions (5.1, 5.2)]. To obtain yields >90%, it is necessary to reconstitute the antibody within the . DEFINITY RT is a modified formulation of DEFINITY that allows both storage and shipment at room temperature (DEFINITY's previously approved formulation requires refrigerated storage). In this group, 154 (61.8%) were male and 95 (38.2%) were female; 183 (73.5%) were White, 38 (15.3%) were Black, 21 (8.4%) were Hispanic, and 7 (2.8%) were classified as other racial or ethnic groups. Octafluoropropane is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. A total of 1716 subjects were evaluated in pre-market clinical trials of activated Definity. Bacterial contamination with the risk of post-administration septicemia can occur following the puncture of the elastomeric septum. In a crossover trial of 64 patients 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. Do not expose VELETRI to direct sunlight. The mean age was 53.9 years (range 18 to 87). Also, in 13 to 37% of the patients, depending on the reader, activated Definity was found to obscure the wall motion rendering the image non-evaluable. The maximum dose is either two bolus doses or one single intravenous infusion. 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. 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. The au- In this group, 1063 (61.9%) were male and 653 (38.1%) were female, 1328 (77.4%) were White, 258 (15.0%) were Black, 74 (4.3%) were Hispanic, and 56 (3.3%) were classified as other racial or ethnic groups. endstream endobj startxref Citations, WARNING: SERIOUS CARDIOPULMONARY REACTIONS, 2.1 Important Administration Instructions, 2.4 DEFINITY RT Activation, Preparation and Handling Instructions, 5.4 Ventricular Arrhythmia Related to High Mechanical Index, 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility, PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton, Report Adverse OFP concentrations in blood were shown to decline in a mono-exponential fashion with a mean half-life of 1.3 minutes in healthy subjects. Optimal activated Definity doses and device settings for harmonic imaging have not been established. In the converted images, the accuracy of wall motion (i.e., normal versus abnormal) improved in 42 to 71% of the patients, depending on the reader, however, improvement in the specific diagnostic accuracy (e.g., hypokinetic, akinetic etc.) The maximum dose is either two bolus doses or one single intravenous infusion. In 1987, Sterchele5 described the frequency of drug information requests received concerning room-temperature storage of drug prod-ucts labeled for refrigeration. Table 1 summarizes the most common adverse reactions. Since the commercial EDTA solution was maintained at pH 8.0 for the obvious reason, I am wondering how EDTA could be stable that long at . Smaller, incremental dose amounts of 0.2mL to 0.3mL are better suited for current ultrasound system technology. 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, contains <100ppm Ca2+ and the following structural formula: Prior to activation, the DEFINITY RT vial contains 6.52 mg/mL octafluoropropane in the headspace which is confirmed by positive IR spectroscopic testing in every vial. Forty-six out of 64 subjects with QTc prolongations were further evaluated and 39% (18/46) showed associated cardiac rhythm changes. The mean age was 56.1 years (range 18 to 93). The overall incidence of adverse reactions was similar between males and females. 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. Insulin remains stable for 120 hours at room temperature on whole blood K + -EDTA plasma samples (mean 97 . This study did not assess the effect of Definity on visualization of cardiac or pulmonary structures. Store refrigerated, 28 C (3646 F) Structure of brin: impact on clot stability. The stability of platelet counts according to the 1 CV lower CVI, higher CVI, BV DES2014, EFLM 2019b, and IQMH methods was extended to 240 min when stored at room temperature and the stability of PDW and plateletcrit as determined by all tested methods were extended to 240 min when stored at 4C. When ready to use, resuspend the microspheres by rapidly swirling the upright vial for 10 seconds before the product is withdrawn in thesyringe. 448 0 obj <>stream Patients receiving activated Definity should be instructed to inform their healthcare provider if they: Distributed By High DEF(INITY), high-resolution echocardiograms help answer clinical questions and improve patient management.1, DEFINITY provides prolonged enhancement at a low dose so your patients get the accurate echoes and diagnoses theydeserve.1,2, contrast-enhanced echoes are performed with DEFINITY3, Our advanced microbubble technology helps you see in High DEF(INITY) with proven safety and consistent quality from echo to echo.3,6,7 DEFINITY (Perflutren Lipid Microsphere) is the most used, most studied, and most trusted diagnostic ultrasound enhancing agent in theUS.35, Trusted DEFINITY efficacy and safety with room temperature storage3,6,10, Demonstrated across gender, race, andage3, DEFINITY is a diagnostic ultrasound enhancing agent that opacifies the left ventricular chamber and improves the delineation of the left ventricular endocardial border in patients with suboptimal echocardiograms.6, Move the slider to see in HighDEF(INITY). 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)]. ), More about getting RSS News & Updates from DailyMed, N=Sample size 1716 subjects who received activated DEFINITY, n=Number of subjects reporting at least one Adverse Reaction, Total Number of Subjects with an Adverse Reaction, Central and peripheral nervous system disorder, 0.35 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, MANUFACTURE(11994-017) , ANALYSIS(11994-017), ANALYSIS(11994-017) , MANUFACTURE(11994-017) , PACK(11994-017) , LABEL(11994-017), 5 When administering DEFINITY RT to patients with a cardiac shunt, the microspheres can bypass filtering by the lung and enter the arterial circulation. The deaths occurred several days after activated Definity administration and appeared to be related to the course of underlying disease. told that it is stable for 2 years at room temperature. Report Adverse In the primary serum and K. 3. In 1975, Wolfert and Cox 3 recognized that pharmacists were often asked about the stability of refrigerated medications that are accidentally stored at room-temperature. As shown in Table 14.1, 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. 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. For all adverse reactions, the overall incidence of adverse experiences was similar for the <65 year age group and the > 65 year age group, similar in males and in females, similar among all racial or ethnic groups, and similar for bolus and infusion dosing. View Labeling Archives, 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. The outcome measure for assessing the effectiveness of activated DEFINITY was the blinded assessment of improvement in ventricular chamber enhancement (measured by videodensitometry at end-diastole and end-systole). The perflutren lipid microspheres are composed of octafluoropropane encapsulated in an outer lipid shell consisting of (R) hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-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]- -methoxypoly(ox-1,2-ethanediyl), monosodium salt (abbreviated MPEG5000 DPPE). If the product is not used within 5 minutes of VIALMIX activation, the microspheres should be resuspended by 10 seconds of hand agitation by inverting the vial before the product is withdrawn in a syringe. (5.1). Illumina. N. Billerica, MA: Lantheus Medical Imaging, Inc. VialMix RFID User's Guide. Outcome measures for this study included clinically useful ventricular cavity enhancement and endocardial border length. OFP is a stable gas that is not metabolized. The unactivated vial contains a colorless, uniformly clear to translucent (hazy), viscous, sterile, non-pyrogenic solution, which upon activation with the aid of a VIALMIX RFID and dilution with 0.9% Sodium Chloride Injection, USP, provides a homogeneous, hypertonic, milky white injectable suspension of perflutren lipid microspheres. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration (5.1). The mean half-life of OFP in blood was 1.9 minutes. Trademarks, registered or otherwise, are the property of their respective owner(s). Storage: Store the activated, diluted product at room temperature, 20 to 25 degrees C (68 to 77 degrees F), in the original vial with the 13 mm ViaLok still attached for up to 4 hours. tubes at room temperature. A sterile syringe or cap should be attached to the ViaLok until use. 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. Invert the vial and withdraw the activated milky white suspension through the 13mm ViaLok into the syringe. Generic name: perflutren 2003;16(11):1178-1185. Do not inject air into the Definity VIAL. A sterile syringe or cap should be attached to the Luer . OFP gas binding to plasma proteins or partitioning into blood cells has not been studied. Activated DEFINITYRT may be used for up to 4 hours from the time of dilution, stored at room temperature in the product vial with the ViaLok attached. In the two placebo-controlled studies a total of 123 subjects were randomized in 1:2 ratio to receive two IV bolus doses of either saline (placebo) or activated Definity 10 microL/kg (17 placebo vs. 33 activated Definity patients and 24 placebo vs. 49 activated Definity patients, respectively). For Single Use Only, Discard Unused Portion (1984), they 2. infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of 4 mL/min. Serious acute hypersensitivity reactions have occurred in patients with no prior exposure to perflutren-containing microsphere products, including patients with prior hypersensitivity reaction(s) to PEG (5.2, 6). Anaphylactic/anaphylactoid reaction, anaphylactic 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, erythema. Primary serum and K. 3 adverse reactions was similar between males and females rapidly swirl the upright vial 10seconds! Stable for 120 hours at room temperature on whole blood K + -EDTA plasma samples ( 97. Otherwise, are the property of their respective owner ( s ) 2003 ; 16 ( 11:1178-1185. 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And K. 3 when ready to use, resuspend the microspheres by swirling. Evaluated in pre-market clinical trials of activated Definity administration and appeared to be related to course... Effect of Definity on visualization of cardiac or pulmonary structures 10 L/kg Definity RT administration monitor...