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AdreView (iobenguane i 123 injection for intravenous use) is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
DOSAGE AND ADMINISTRATION
AdreView (iobenguane i 123 injection for intravenous use) 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 (iobenguane i 123 injection for intravenous use) 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 (iobenguane i 123 injection for intravenous use) administration, encourage hydration to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following AdreView administration [see CLINICAL PHARMACOLOGY].
Before administration of AdreView (iobenguane i 123 injection for intravenous use) , 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].
Preparation and Administration
Inspect the AdreView (iobenguane i 123 injection for intravenous use) 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].
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].
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]. The benzyl alcohol in AdreView (iobenguane i 123 injection for intravenous use) may cause serious adverse reactions in premature or low birth-weight infants [see WARNINGS AND PRECAUTIONS].
Table 1: AdreView (iobenguane i 123 injection for intravenous use) 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.|
The estimated absorbed radiation doses to adults and children from intravenous administration of AdreView (iobenguane i 123 injection for intravenous use) are as shown in Table 2:
Table 2: Estimated Absorbed Radiation Dose from AdreView (iobenguane i 123 injection for intravenous use)
|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|
|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|
|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|
|Urinary Bladder Wall||66||0.244||84||0.311||110||0.407||110||0.407||200||0.740||478.0||1.769|
|*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]|
The effective dose resulting from an administered activity amount of 10 mCi is 5.07 mSv in an adult.
Begin whole body planar scintigraphy imaging 24 ± 6 hours following administration of AdreView (iobenguane i 123 injection for intravenous use) . Single photon emission computed tomography (SPECT) may be performed following planar scintigraphy, as appropriate [see Clinical studies].
Dosage Forms And Strengths
Single use vials containing 5 mL solution for intravenous injection (2 mCi/mL at calibration time).
AdreView (iobenguane i 123 injection for intravenous use) is supplied in 10 mL glass vials containing a total volume of 5.0 mL of solution with a total radioactivity of 370 MBq (10 mCi) at calibration time. Each vial is enclosed in a lead container of appropriate thickness.
Store AdreView (iobenguane i 123 injection for intravenous use) at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP]. This product does not contain a preservative. Store within the original lead container or equivalent radiation shielding.
In accordance with USP recommendations Iobenguane I 123 Injection preparations should not be used after the expiration date and time stated on the label.
This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 Ill. Adm. Code Section 330.260(a) and 355.4010 or equivalent licenses of the Nuclear Regulatory Commission or an Agreement State.
Manufactured and Distributed by GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL 60004 U.S.A.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/2/2009
Additional AdreView Information
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