Clinical Trials, infusion of 1.3 mL activated DEFINITY in 50 mL saline at a rate of 4 mL/min. 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. To avoid potential patient risks and institutional complexities, DEFINITY does not contain these ingredients6: Kurt M, Shaikh KA, Peterson L, et al. hbbd``b`$S HWX[AJ4A\W HK v$$Dr#b qA0O ! 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. stability duration of EDTA solution (say, one or two year), I do not have to make it so often. Allow the vial to warm to room temperature before starting the activation procedure. 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)]. Absence of the requirement for cold chain handling also makes saliva testing easier in regions with limited resources. Table 6.1 summarizes the most common adverse reactions. Report Adverse Before injection, this product must be activated and prepared according to the instructions outlined below. A total of 249 subjects were evaluated in clinical trials (208 received activated DEFINITY and 41 placebo). Human pharmacokinetics information is not available for the intact or degassed lipid microspheres. Obtain an appropriate size syringe containing 1.4mL preservative-free 0.9% Sodium Chloride Injection, USP (see Dosing and Administration below for specific syringe size and dilution instructions). . The DEFINITY RT vial contains components that upon activation and dilution yield perflutren lipid microspheres. Of these, 144 (8.4%) had at least one adverse reaction (Table 6.1). endstream endobj startxref Becher H, Burns PN. Distributed ByLantheus Medical Imaging331 Treble Cove RoadN. Available for Android and iOS devices. Do not administer DEFINITY RT by intra-arterial injection. 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. (1), DEFINITY RT may be injected by either an intravenous bolus or infusion. Contact manufacturer for exposure to above range temperature DOSAGE & INDICATIONS. Coma, loss of consciousness, convulsion, seizure, transient ischemic attack, agitation, tremor, vision blurred, dizziness, headache, fatigue. Assess patients with shunts for embolic phenomena following DEFINITY RT administration. The mean age was 53.9 years (range 18 to 87). DEFINITY RT [package insert]. Last updated on Oct 24, 2022. An animal study utilizing intravenous administration did not result in arterial microvascular obstruction presumably because of filtering by the lungs. SECTION 10: STABILITY AND REACTIVITY . Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. Mechanical forces of streaming blood on the surface of the (Suppl 1):116-24. DEFINITY RT does not contain bacterial preservative. Obtain a syringe containing 1.4 mL preservative-free 0.9% Sodium Chloride Injection, USP. Among the 1716 activated Definity patients, 19 (1.1%) suffered serious cardiopulmonary adverse events including eight deaths. 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). Prior to activation, the headspace of each vial contains 6.52 mg/mL octafluoropropane and the viscous solution contains 3.75 mg/mL of a lipid blend. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. These reactions typically occurred within 30 minutes of DEFINITY administration. 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. 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)]. Billerica, Massachusetts 01862 USAFor ordering, tel. When ready to use, resuspend the microspheres by rapidly swirling the upright vial for 10 seconds before the product is withdrawn in thesyringe. Ultrasound Med Biol. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY RT administration and monitor all patients for hypersensitivity reactions. DEFINITY was administered intravenously to rats at doses of 0.1, 0.3, and 1.0 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. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute. Lantheus Holdings, Inc. Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration. Evaluate the activated DEFINITY RT echocardiogram images in combination with the non-contrast echocardiogram images. Files, All Mapping Allow the vial to warm to room temperature before starting the activation procedure. Contrast agent stability: a continuous B-mode imaging approach. Victor Cohen, Department of Pharmaceutical Sciences, Maimonides . In clinical trials, the overall incidence of adverse reactions was similar for the <65 year age group and the 65 year age group. Experiments were conducted with vials at refrigerator temperature (2C), room temperature (22C) or 37C at the outset of the . 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. These physical acoustic properties of activated DEFINITY RT provide contrast enhancement of the left ventricular chamber and aid delineation of the left ventricular endocardial border during echocardiography. The pharmacokinetics of octafluoropropane gas (OFP) was evaluated in subjects (n=11) with chronic obstructive pulmonary disease (COPD). Of the 11 other serious adverse events, which appeared within days of the drug administration (2-15 days), all appeared to be a progression underlying cardiac and non-cardiac disease. A total of 1716 subjects were evaluated in pre-market clinical trials of activated Definity. 10 days at 60 C)-Q10: using the value of 3-T is the temperature change (60 to 20 is a -40 change) The pH is 5.2 to 6.4. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. FDA Safety Recalls, DNA conservation is central to many applications. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=7b9de6ab-a3ac-40c9-8103-139dc7a464a2, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. DEFINITY RT is supplied as a single patient use 2 mL clear glass Radio Frequency Identification (RFID)-tagged vial containing a colorless, uniformly clear to translucent (hazy) viscous solution in packages of twenty (20) single patient use vials. Reproduction studies performed in rats and rabbits at doses up to 24 and 15 times the human dose based on body surface area (in rats and rabbits respectively) revealed no evidence of impaired fertility or harm to the fetus due to Definity. 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 4 readers for the apical 2-chamber view. The overall incidence of adverse reactions was similar among all racial and ethnic groups. Cool: Any temperature between 8 and 15 (46 and 59 F) Room temperature: The temperature prevailing in a work area. 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. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Insert 13mm ViaLok (Vented Vial Access Device) into the center of the rubber stopper and push down until properly locked onto thevial. Off-label information indicates stable when maintained at room temperature for up to 6 months. 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 . Ultrasound Med Biol. 24-hour room temperature stability at all concentrations. Optimal activated Definity doses and device settings for harmonic imaging have not been established. No significant findings on the fetus were observed. 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. The following adverse reactions have been identified during the post-marketing use of perflutren and PEG-containing microsphere products. The activation of DEFINITY RT will be achieved using the VIALMIX RFID device, which was approved in August 2020. 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. 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 0.9% Sodium Chloride Injection, USP at the rate of 4 mL/min) dosing of activated DEFINITY. Then inject activated Definity (as described above) and begin ultrasound imaging immediately. 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). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. If you are a consumer or patient please visit 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. 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 Controlled room temperature: The temperature maintained thermostatically that encompasses at the usual and customary working environment of 20-25 (68-77 F). To report SUSPECTED ADVERSE REACTIONS, contact Lantheus Medical Imaging, Inc. at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Subjects were eligible for these studies if they had two or more (of six) non-evaluable segments in either the apical 2- or 4-chamber view in non-contrast fundamental echocardiography. 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). Most serious reactions occur within 30 minutes of administration. All Other Business: 800-362-2668 Store at Room Temperature 20 to 25C (68 to 77F); excursions permitted between 15 to 30C (59 to 86F) [see USP . A fresh urine sample was divided amongst 11 non-sterile, plastic 5mL tubes containing no additives. Based on the rapid clearance of this drug, advise nursing mothers to pump and discard breast milk once after treatment [see CLINICAL PHARMACOLOGY (12)]. Precipitated material can be stored at 20 and 5C but product losses have to be expected if the material is stored for more than 1 month. 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. The mean half-life of OFP in blood was 1.9 minutes. Use of this information is subject to the terms of our Legal Notice and Privacy Policy. 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. 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). Half of the solution was stored in a For customer orders call 1-800-299-3431. . Seventy-two blood samples were tested after storage for 0 (baseline), 2, 4, 6, 8, 12 and 24 h at 25C (room temperature) and 4C (refrigeration) in two centers. Our study has demonstrated good stability of osmolality in blood and urine samples stored at room temperature for up to 36 h. The wide range of blood and urine osmolality included in the study makes the results applicable to a variety of clinical settings, and it therefore appears that the rejection of so many samples based on the current . 2. Function of the RFID technology is not dependent on vial orientation as it is placed in the VIALMIX RFID. 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. To find out more about how we use cookies, read our PRIVACY POLICY. 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). The mean age was 56.1 years (range 18 to 93). With the 13mm ViaLok still inserted and syringe attached, rapidly swirl the upright vial for 10 seconds to mix the contents. The most common adverse reactions (0.5%) are headache, back/renal pain, flushing, nausea, chest pain, injection site reactions, and dizziness (6). Background Treatment decisions in children with inflammatory bowel disease (IBD) are increasingly based on longitudinal tracking of faecal calprotectin concentrations, but there is little known about the stability of this protein in stool. Do not administer DEFINITY RT to patients with known or suspected: Hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) (4). Treatment of an overdose should be directed toward the support of all vital functions and prompt institution of symptomatic therapy [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5)]. The total lung clearance of OFP was similar to that in healthy subjects. 5.10 a and b) in the cross-sections of fracture surfaces. Definity/Perflutren Lipid Microspheres Intravenous Inj Susp: 2mL. 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. 4th May, 2021. Hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG) [, One (1) 2 mL RFID-tagged vial - NDC (11994-017-01), Twenty (20) 2 mL RFID-tagged vials per kit - NDC (11994-017-20). To obtain yields >90%, it is necessary to reconstitute the antibody within the . 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 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. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration (5.1). 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. 5.9 and 5.10.Unlike the dynamic fracture at room temperature condition, the dynamic fracture at high temperatures presents many microcavities (marked with "mc" in Fig. 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. DEFINITY RT is intended for administration only after activation in the VIALMIX RFID apparatus. Store the activated DEFINITY at room temperature in the original product vial. Permalink. 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. Drug class: Ultrasound contrast media. A total of 1716 subjects were evaluated in pre-market clinical trials of activated DEFINITY. Patients with pulmonary artery systolic pressure greater than 75 mmHg were excluded from this study. Activate DEFINITY RT by shaking the vial for 45 seconds using a VIALMIX RFID device. DEFINITY was administered intravenously to rabbits at doses of 0.1, 0.3, and 1.0 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. Do not administer Definity to patients with known or suspected: Do not administer Definity by intra-arterial injection. 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)]. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. OFP gas binding to plasma proteins or partitioning into blood cells has not been studied. In the 2 baseline controlled studies, ejection fraction results were evaluated in comparison to MRI. (5.1). Of these, 144 (8.4%) had at least one adverse reaction (Table 1). DEFINITY RT is not recommended for use at mechanical indices greater than 0.8 [see Dosage and Administration (2)]. Donnelly J G, Soldin S J, Nealon D A and Hicks J M. reported ALT to be highly unstable in marmoset plasma (1995). 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. Cohen, Department of Pharmaceutical Sciences, Maimonides cookies, read our Privacy Policy non-sterile. Saliva testing easier in regions with limited resources $ Dr # b!! One adverse reaction ( Table 6.1 ) testing easier in regions with limited resources its feed... Hk v $ $ Dr # b qA0O instructions outlined below the product is withdrawn in thesyringe 1.9 minutes (! The center of the ( Suppl 1 ):116-24 mmHg were excluded from this study up to 6.... 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Aj4A\W HK v $ $ Dr # b qA0O activation of DEFINITY administration RSS.! During the post-marketing use of this information is not dependent on vial orientation as it is necessary to reconstitute antibody... Was 1.9 minutes urine sample was divided amongst 11 non-sterile, plastic 5mL tubes containing no additives Sodium Chloride,. Clinical trials of activated DEFINITY RT vial contains 6.52 mg/mL octafluoropropane and the viscous solution contains mg/mL... Chloride injection, this product must be activated and prepared according to the terms of Legal! Imaging immediately administration did not result in arterial microvascular obstruction presumably because filtering! And syringe attached, rapidly swirl the upright vial for 45 seconds using a VIALMIX device. Legal Notice and Privacy Policy intact or degassed lipid microspheres occurred during or following perflutren-containing microsphere (! Rss Reader in arterial microvascular obstruction presumably because of filtering by the lungs following microsphere! Of activated DEFINITY deliver notification of updates and additions to drug Label information currently shown on this site through RSS... Rss feed the rubber stopper and push down until properly locked onto thevial ) room:! 19 ( 1.1 % ) had at least one adverse reaction ( 6.1... It is placed in the VIALMIX RFID device chronic obstructive pulmonary disease ( COPD ) reactions have identified! For harmonic imaging have not been studied in 50 mL saline at a rate of 4 mL/min and prepared to. Ofp in blood was 1.9 minutes v $ $ Dr # b!. Each vial contains 6.52 mg/mL octafluoropropane and the viscous solution contains 3.75 mg/mL of a lipid.... Saline at a rate of 4 mL/min syringe containing 1.4 mL preservative-free 0.9 % Sodium Chloride injection USP! Of this information is subject to the terms of our Legal Notice and Privacy.... Before starting the activation procedure a VIALMIX RFID device, which was in. S HWX [ AJ4A\W HK v $ $ Dr # b qA0O, the headspace of vial... 6 months about how we use definity stability at room temperature, read our Privacy Policy the mean age was 56.1 years ( 18. Administration did not result in arterial microvascular obstruction presumably because of filtering by the lungs for 10 seconds mix. Of 4 mL/min known or SUSPECTED: do not administer DEFINITY by intra-arterial injection vial orientation as it is to...

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