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  2.1 Radiation Safety

  AdreView emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides. AdreView dosing is based upon the radioactivity determined using a suitable calibration system immediately prior to administration.

  To minimize radiation dose to the bladder, prior to and following AdreView administration, encourage hydration to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following AdreView administration [see Clinical Pharmacology (12.2)].

  2.2 Thyroid Blockade

  Before administration of AdreView to patients at risk for thyroid accumulation of the drug, administer Potassium Iodide Oral Solution or Lugol's Solution (equivalent to 100 mg iodide for adults, body-weight adjusted for children) or potassium perchlorate (400 mg for adults, body-weight adjusted for children) to block uptake of iodine 123 by the patient's thyroid. Administer the blocking agent at least one hour before the dose of AdreView [see Warnings and Precautions (5.6)]. Individualize thyroid blockade; for example, the blockade may not be necessary for patients who have undergone thyroidectomy or those with a very limited life expectancy.

  2.3 Preparation and Administration

  Inspect the AdreView vial for particulate matter and discoloration prior to administration. Use aseptic procedures and a radiation shielding syringe during administration. Administer the dose as an intravenous injection over 1 to 2 minutes. A subsequent injection of 0.9% sodium chloride may be used to ensure full delivery of the dose.

  2.4 Recommended Dose for Adults

  For adults (≥ 16 years of age), the recommended dose is 10 mCi (370 MBq) [see Clinical Studies (14.1, 14.2)].

  2.5 Recommended Dose for Pediatric Patients

  For pediatric patients < 16 years of age weighing ≥ 70 kg, the recommended dose is 10 mCi (370 MBq) [see Clinical Studies (14.1)].

  For pediatric patients < 16 years of age weighing < 70 kg, the recommended dose should be calculated according to patient body weight as shown in Table 1 [see Clinical Studies (14.1)]. The benzyl alcohol in AdreView may cause serious adverse reactions in premature or low birth-weight infants [see Warnings and Precautions (5.3)].

  Table 1. AdreView Dose Preparation for Pediatric Patients* Weight (kg) Fraction of adult activity AdreView (mCi) pediatric dose AdreView (MBq) pediatric dose * Based on a reference activity for an adult scaled to body weight according to the schedule proposed by the European Association of Nuclear Medicine Paediatric Task Group. 3 0.1 1 37 4 0.14 1.4 52 6 0.19 1.9 70 8 0.23 2.3 85.1 10 0.27 2.7 99.9 12 0.32 3.2 118.4 14 0.36 3.6 133.2 16 0.4 4 148 18 0.44 4.4 162.8 20 0.46 4.6 170.2 22 0.5 5 185 24 0.53 5.3 196.1 26 0.56 5.6 207.2 28 0.58 5.8 214.6 30 0.62 6.2 229.4 32 0.65 6.5 240.5 34 0.68 6.8 251.6 36 0.71 7.1 262.7 38 0.73 7.3 270.1 40 0.76 7.6 281.2 42 0.78 7.8 288.6 44 0.8 8 296 46 0.82 8.2 303.4 48 0.85 8.5 314.5 50 0.88 8.8 325.6 52 0.9 9 333 54 0.9 9 333 56 0.92 9.2 340.4 58 0.92 9.2 340.4 60 0.96 9.6 355.2 62 0.96 9.6 355.2 64 0.98 9.8 362.6 66 0.98 9.8 362.6 68 0.99 9.9 366.3 2.6 Radiation Dosimetry

  The estimated absorbed radiation doses to adults and children from intravenous administration of AdreView are as shown in Table 2:

  Table 2. Estimated Absorbed Radiation Dose from AdreView ORGAN / TISSUE ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY ADULT 15-YEAR OLD 10-YEAR OLD 5-YEAR OLD 1-YEAR OLD NEONATES μGy/
  MBq rad/mCi μGy/
  MBq rad/mCi μGy/
  MBq rad/mCi μGy/
  MBq rad/mCi μGy/
  MBq rad/mCi μGy/
  MBq rad/mCi *OLINDA/EXM calculation based on biodistribution data from Swanson et al. and Publication 53 of the ICRP (International Commission on Radiological Protection) [Annals of the ICRP 1987; 18 (1-4): 329-331] Adrenals 16 0.059 21 0.078 31 0.115 42 0.155 67 0.248 111 0.411 Brain 3.9 0.014 4.9 0.018 8.1 0.030 13 0.048 24 0.089 55.9 0.207 Breast 4.7 0.017 5.9 0.022 9.4 0.035 15 0.056 28 0.104 65.3 0.242 Gallbladder 20 0.074 24 0.089 34 0.126 51 0.189 95 0.352 200 0.740 GI Tract Stomach Wall 7.6 0.028 10 0.037 17 0.063 27 0.100 51 0.189 114 0.422 Small Intestine Wall 7.7 0.028 9.8 0.036 16 0.059 25 0.093 46 0.170 104 0.385 Colon Wall 8.1 0.030 10 0.037 16 0.059 26 0.096 46 0.170 104.3 0.386 Upper Large Intestine Wall 8.4 0.031 11 0.041 18 0.067 30 0.111 53 0.196 119 0.440 Lower Large Intestine Wall 7.7 0.028 9.6 0.036 15 0.056 21 0.078 38 0.141 84.9 0.314 Heart Wall 18 0.067 23 0.085 35 0.130 53 0.196 94 0.348 182 0.673 Kidneys 13 0.048 16 0.059 24 0.089 35 0.130 59 0.218 132 0.488 Liver 67 0.248 87 0.322 130 0.481 180 0.666 330 1.221 720 2.664 Lungs 16 0.059 23 0.085 32 0.118 48 0.178 89 0.329 215 0.796 Muscles 6 0.022 7.6 0.028 12 0.044 17 0.063 33 0.122 75.1 0.278 Esophagus 6 0.022 7.6 0.028 11 0.041 18 0.067 32 0.118 72.2 0.267 Osteogenic Cells 16 0.059 21 0.078 31 0.115 47 0.174 100 0.370 254 0.940 Ovaries 7.9 0.029 10 0.037 15 0.056 22 0.081 41 0.152 92.3 0.342 Pancreas 12 0.044 15 0.056 25 0.093 39 0.144 68 0.252 143 0.529 Red marrow 5.6 0.021 6.8 0.025 10 0.037 15 0.056 30 0.111 89.5 0.331 Skin 3.7 0.014 4.4 0.016 7.1 0.026 11 0.041 21 0.078 53.1 0.196 Spleen 20 0.074 27 0.100 42 0.155 64 0.237 110 0.407 282 1.043 Testes 5.4 0.020 7.1 0.026 11 0.041 16 0.059 30 0.111 69.9 0.259 Thymus 6 0.022 7.6 0.028 11 0.041 18 0.067 32 0.118 72.2 0.267 Thyroid 4.7 0.017 6.1 0.023 9.9 0.037 16 0.059 30 0.111 69.4 0.257 Urinary Bladder Wall 66 0.244 84 0.311 110 0.407 110 0.407 200 0.740 478.0 1.769 Uterus 11 0.041 14 0.052 21 0.078 28 0.104 51 0.189 110.0 0.407 Whole Body 8.1 0.030 10 0.037 16 0.059 24 0.089 44 0.163 104.0 0.385 EFFECTIVE DOSE µSv/MBq 13.7 18.1 26.7 37.6 68 162 mSv/mCi 0.507 0.670 0.988 1.39 2.52 6

  The effective dose resulting from an administered activity amount of 10 mCi is 5.07 mSv in an adult.

  2.7 Imaging Guidelines

  Pheochromocytoma and Neuroblastoma

  Begin whole body planar scintigraphy imaging 24 ± 6 hours following administration of AdreView. Single photon emission computed tomography (SPECT) may be performed following planar scintigraphy, as appropriate [see Clinical Studies (14.1)].

  Congestive Heart Failure

  Begin anterior planar imaging of the chest at 4 hours (± 10 minutes) following administration of AdreView. Single photon emission computed tomography (SPECT) can then be performed. The recommended collimator for all imaging is a low-energy high-resolution. The recommended matrix for planar images is 128×128. The camera should be positioned to include the entire heart and as much of the upper chest as possible within the field of view [see Clinical Studies (14.2)].

  2.8 Estimation of the H/M Ratio among Patients with Congestive Heart Failure

  Initial evaluation of cardiac AdreView images involves visual examination of the location, pattern and intensity of cardiac radioactivity uptake to guide quantitative assessment (see Step 1 below). Perform quantitative assessment of radioactivity uptake in terms of the heart/mediastinum ratio (H/M) on anterior planar images of the chest (see Step 2 below).

  Step 1. Visual Guidelines for AdreView Cardiac Uptake on Anterior Planar Chest Images

    a. Normal:
  Distinct visualization of the left ventricular myocardium in the left lower chest, with greater uptake in the heart than in the adjacent lungs and mediastinum (Figure 1).   Figure 1. Normal anterior planar AdreView image of the chest
  

   

    b. Abnormal:
  Homogeneously or heterogeneously decreased cardiac uptake, with indistinct or absent visualization of the left ventricular myocardium. Cardiac activity is usually less than or equal to that of the adjacent left lung (Figure 2a). In extreme cases, little or no AdreView uptake is seen in the left lower chest (Figure 2b).   Figure 2. Abnormal anterior planar AdreView images of the chest: a) Heterogeneously reduced cardiac uptake; b) Absent cardiac uptake
  Figure 2a
  

   

  Figure 2b
  

   

  Step 2. Quantitate AdreView Cardiac Uptake

  The AdreView H/M ratio is determined from the activity in heart (H) and mediastinum (M) regions of interest (ROIs) drawn on the anterior planar chest image (Figure 3) using the following procedure:

  (1) Draw an irregular ROI defining the epicardial border of the heart. If the epicardial border cannot be defined because all or the majority of the myocardium is not visualized, draw the ROI based upon the presumed location of the heart, using the medial aspects of the left and right lower lung for anatomical guidance. (2) Draw a horizontal line to mark the estimated location of the lung apices. If the most superior aspect of the image does not include the lung apices (because of limited field of view for a small gamma camera), draw this line at the top of the image display. (3) Draw a vertical line approximately equidistant from the medial aspects of the right and left lung. (4) Examine the counts for the 12 pixels along the vertical line starting 4 pixels below the intersection point with the horizontal line determined in step 2, and identify the pixel with the lowest counts. If more than one pixel has this same number of counts, choose the most superiorly located pixel. (5) Using the pixel defined in step 4 as the center, draw a square ROI of 7×7 dimensions. (6) Calculate the H/M ratio by dividing the counts/pixel in the total myocardium ROI determined in step 1 by the counts/pixel in the 7×7 pixel mediastinal ROI determined in step 5.

  Figure 3. Illustration of creation of regions of interest for determination of the H/M ratio

   

  Step 3. Interpretation of AdreView H/M Ratio

  The expected range for AdreView H/M ratio is 1.0 to 2.4 [see Clinical Studies (14.2)].

  Figure 4. Examples of AdreView Images in Subjects with Lower One and Two Year Mortality Risk

   

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