Iobenguane i-123

FDA label, Medi-Physics Inc., intravenous, effective 2024-01-10. Full label on DailyMed

Patient handout

Looking up MedlinePlus…

From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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 may cause serious adverse reactions in premature or low birth-weight infants [see Warnings and Precautions and Use in Specific Populations ] . [See table below.] 2.6 Radiation Dosimetry The estimated absorbed radiation doses to adults and children from intravenous administration of AdreView are as shown in Table 2: [See table below.] 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.

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
EFFECTIVE DOSE	mSv/mCi	0.507		0.670		0.988		1.39		2.52		6

Preparation and administration

Prepare this dose

Your numbers for iobenguane i-123. Take vial strength, diluent, and limits from the label below.

Dose

Basis

Vial or stock concentrationmg/mLAmount per vialmgFinal bag volumemLInfuse overminDrip set

Enter a dose to see draw volume, final concentration, and rates.

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 ]. 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.

Preparation and Administration Assess pregnancy status before administering AdreView to a female of reproductive potential. 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.

Drug interactions

Check iobenguane i-123 against a medication list

Label text (3 paragraphs)

The following drugs have the potential to decrease the uptake of norepinephrine and cause false negative imaging results: antihypertensives that deplete norepinephrine stores or inhibit reuptake (e.g., reserpine, labetalol), antidepressants that inhibit norepinephrine transporter function (e.g., amitriptyline and derivatives, imipramine and derivatives, selective serotonin reuptake inhibitors), sympathomimetic amines (e.g., phenylephrine, phenylpropanolamine, pseudoephedrine and ephedrine), and cocaine.

Clinical studies have not determined which specific drugs may cause false negative imaging results nor whether all drugs in any specific pharmacologic class have the same potential to produce the negative imaging results. Increasing the dose of AdreView will not overcome any potential uptake limiting effect of these drugs. Before AdreView administration, discontinue (for at least 5 biological half-lives) drugs known or expected to reduce norepinephrine uptake, as clinically tolerated.

Amitryptiline and derivatives, imipramine and derivatives, other antidepressants that inhibit norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines and cocaine: Discontinue for 5 biological half-lives prior to AdreView administration ( 7 )

Contraindications

AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. Known hypersensitivity to iobenguane or iobenguane sulfate. ( 4 )

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Administration of an appropriate thyroid blocking agent is recommended before use of AdreView in a pregnant woman to protect the woman and fetus from accumulation of I 123 [see Dosage and Administration (2.2) ]. There are no available data on AdreView use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with iobenguane I 123.

All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Advise pregnant women of the potential risks of fetal exposure to radiation doses with administration of AdreView. AdreView contains 10.3 mg/mL of benzyl alcohol. Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4) ].

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

Price ladder

Not the price at the counter

These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

VA Federal Supply ScheduleCMS NADACMedicare Part D plan filesMedicaid State Drug Utilization Data

Iobenguane i-123

Dosing in kidney impairment

Preparation and administration

Prepare this dose

Drug interactions

Contraindications

Pregnancy and lactation

Supply and cost

Drug shortage status

Recalls (last 24 months)

Therapeutic equivalence (Orange Book)

Price ladder

Products and NDCs

Calculators for iobenguane i-123