AdreView Dosage

Generic name: Iobenguane I 123
Dosage form: injection

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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)].

Thyroid Blockade

Before administration of AdreView, 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 (5.4)].

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.

Recommended Dose for Adults

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

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 (5.2)].

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

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
ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY
ORGAN / TISSUE 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.

Imaging Guidelines

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].

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