AdreView

Name: AdreView

Iobenguane I-123 Dosage

Iobenguane I-123 is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. It is usually given about 24 hours before your radiologic test.

At least 1 hour before you are treated with iobenguane I-123, you will be given a liquid drink that contains medicine to protect your thyroid from harmful radioactive effects of iobenguane I-123.

Drink extra fluids before you receive iobenguane I-123, and for at least 48 hours afterward. Follow your doctor's instructions about the types and amount of liquids you should drink before and after your test. Iobenguane I-123 is radioactive and it can cause dangerous effects on your bladder if it is not properly eliminated from your body through urination.

Expect to urinate often during the first 48 hours after your test. You will know you are getting enough extra fluid if you are urinating more than usual during this time. Urinating often will help rid your body of the radioactive iodine.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Since iobenguane I-123 is used only given once before your radiologic test, you will not be on a daily dosing schedule. Call your doctor if for some reason you will not be able to complete your radiologic test within 24 hours after you receive your injection.

What should I discuss with my healthcare provider before receiving iobenguane I-123?

You should not be treated with iobenguane I-123 if you are allergic to it.

To make sure iobenguane I-123 is safe for you, tell your doctor if you have:

  • kidney disease;

  • a thyroid disorder;

  • Parkinson's disease or other neurologic disorder;

  • high blood pressure;

  • if you are dehydrated or unable to urinate; or

  • if you are allergic to iodine.

Older adults may need kidney function tests before receiving iobenguane I-123. Your kidney function may also need to be watched closely after you have received this medication.

It is not known whether Iobenguane I-123 will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether iobenguane I-123 passes into breast milk or if it could harm a nursing baby. You should not breast-feed within 6 days after receiving iobenguane I-123. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Commonly used brand name(s)

In the U.S.

  • AdreView

Available Dosage Forms:

  • Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses of AdreView

  • It is used to see if there is a tumor in the adrenal glands or nervous system.
  • It is used with a test for the heart.

How is this medicine (AdreView) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into a vein.
  • Drink lots of noncaffeine liquids before the test and for at least 48 hours after the test as your doctor has told you.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

AdreView Dosage and Administration

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].

Overdosage

The major manifestations of overdose relate predominantly to increased radiation exposure, with the long term risks for neoplasia.

AdreView Description

AdreView (Iobenguane I 123 Injection) is a sterile, pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 – 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzlyguanidine sulfate and has the following structural formula:

Physical Characteristics

Iodine 123 is a cyclotron-produced radionuclide that decays to Te 123 by electron capture and has a physical half-life of 13.2 hours.

Table 3 Principal Radiation Emission Data – Iodine 123
Radiation Energy Level (keV) Abundance (%)
Gamma 159 83

External Radiation

The specific gamma ray constant for iodine 123 is 1.6 R/mCi-hr at 1 cm. The first half value thickness of lead (Pb) for I 123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000).

Table 4 Reduction in In-air Collision Kerma Caused by Lead Shielding*
Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma
* Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Report NISTIR 5632.
0.04 0.5
0.13 10-1
0.77 10-2
2.16 10-3
3.67 10-4

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Side effects

Clinical Study Experience

Serious adverse reactions were not observed in the AdreView (iobenguane i 123 injection for intravenous use) clinical study. The data described below reflect AdreView (iobenguane i 123 injection for intravenous use) exposure to 251 patients with known or suspected pheochromocytoma or neuroblastoma. The average ages were 49 years (range 17 - 88 years) for adults and, for pediatric patients, 4 years (range 1 month - 16 years). Slightly less than half the patients were male. All patients were monitored for adverse reactions over a 24 hour period following AdreView (iobenguane i 123 injection for intravenous use) administration.

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.

Adverse reactions were all mild to moderate in severity and were predominantly isolated occurrences ( ≤ 2 patients) of one of the following reactions: dizziness, rash, pruritus, flushing or injection site hemorrhage.

Postmarketing Experience

Because postmarketing 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.

Hypersensitivity reactions have uncommonly been reported during the postmarketing use of AdreView [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for AdreView (Iobenguane I 123 Injection for Intravenous Use)

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