iobenguane I 123 (Rx)

Brand and Other Names:AdreView
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 2mCi/mL at calibration time (0.08mg/mL iobenguane sulfate 74 MBq/mL of I 123)
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Gamma Scintigraphy

Diagnostic radiopharmaceutical agent for gamma-scintigraphy

Pheochromocytoma or neuroblastoma

  • Indicated for detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests
  • 10 mCi (5 mL; 370 MBq) IV
  • Begin whole body planar scintigraphy imaging 24 ± 6 hours following administration

Congestive heart failure

  • Indicated for assessment of myocardial sympathetic innervation in patients with NYHA class 2-3 heart failure with an LVEF <35%; among these patients, may help identify those with lower 1 and 2 year mortality risks as indicated by an H/M ratio ≥1.6
  • 10 mCi (5 mL; 370 MBq) IV (2 mCi/mL at calibration time)
  • Begin anterior planar imaging of the chest at 4 hours (± 10 minutes) following administration

Administration

Administer IV over 1-2 minutes, then flush with 0.9% NaCl to ensure full dose delivery

Radiation safety

  • Emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients
  • Minimize bladder exposure by encourage hydration before and after to permit frequent voiding, particularly for the first 48 hr after administration

Thyroid blockade

  • 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
  • Individualize according to patient; blockade may not be needed for patients who have undergone thyroidectomy or those with limited life expectancy

Dosage Forms & Strengths

IV solution

  • 2mCi/mL at calibration time (0.08mg/mL iobenguane sulfate 74 MBq/mL of I 123)
more...

Gamma Scintigraphy

Indicated for detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests, and also for assessment of myocardial sympathetic innervation in patients with NYHA class 2-3 heart failure with an LVEF <35%

Pheochromocytoma or neuroblastoma: Begin whole body planar scintigraphy imaging 24 (± 6 hours) following administration

CHF: Begin anterior planar imaging of the chest at 4 hours (± 10 minutes) following administration

Neonates <1 month: Safety and efficacy not established

<16 yr and ≥70 kg: 10 mCi (5 mL; 370 MBq)

<16 yr (3-18 kg)

  • 3 kg: 1 mCi (37 MBq)
  • 4 kg: 1.4 mCi (52 MBq)
  • 6 kg: 1.9 mCi (70 MBq)
  • 8 kg: 2.3 mCi (85.1 MBq)
  • 10 kg: 2.7 mCi (99.9 MBq)
  • 12 kg: 3.2 mCi (118.4 MBq)
  • 14 kg: 3.6 mCi (133.2 MBq)
  • 16 kg: 4 mCi (148 MBq)
  • 18 kg: 4.4 mCi (162.8 MBq)

<16 yr (20-40 kg)

  • 20 kg: 4.6 mCi (170.2 MBq)
  • 22 kg: 5 mCi (185 MBq)
  • 24 kg: 5.3 mCi (196.1 MBq)
  • 26 kg: 5.6 mCi (207.2 MBq)
  • 28 kg: 5.8 mCi (214.6 MBq)
  • 30 kg: 6.2 mCi (229.4 MBq)
  • 32 kg: 6.5 mCi (240.5 MBq)
  • 34 kg: 6.8 mCi (251.6 MBq)
  • 36 kg: 7.1 mCi (262.7 MBq)
  • 38 kg: 7.3 mCi (270.1 MBq)
  • 40 kg: 7.6 mCi (281.2 MBq)

<16 yr (42-50 kg)

  • 42 kg: 7.8 mCi (288.6 MBq)
  • 44 kg: 8 mCi (296 MBq)
  • 46 kg: 8.2 mCi (303.4 MBq)
  • 48 kg: 8.5 mCi (314.5 MBq)
  • 50 kg: 8.8 mCi (325.6 MBq)

<16 yr (52 kg to <70 kg)

  • 52-54 kg: 9 mCi (333 MBq)
  • 56-58 kg: 9.2 mCi (340.4 MBq)
  • 60-62 kg: 9.6 mCi (355.2 MBq)
  • 64-66 kg: 9.8 mCi (362.6 MBq)
  • 68 kg: 9.9 mCi (366.3 MBq)

Administration

Administer IV over 1-2 minutes, then flush with 0.9% NaCl to ensure full dose delivery

Radiation safety

  • Emits radiation and must be handled with appropriate safety measures to minimize radiation exposure to clinical personnel and patients
  • Minimize bladder exposure by encourage hydration before and after to permit frequent voiding, particularly for the first 48 hr after administration

Thyroid blockade

  • 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
  • Individualize according to patient; blockade may not be needed for patients who have undergone thyroidectomy or those with limited life expectancy
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Interactions

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            Adverse Effects

            Frequency Not Defined

            Dizziness

            Rash

            Pruritus

            Flushing

            Injection site hemorrhage

            Postmarketing Reports

            Hypersensitivity

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Emits radiation and must be handled with appropriate safety measures for radiopharmaceuticals

            Fully investigate history of allergic response to previous contrast agents or iodine

            Contains benzyl alcohol (10.3 mg/mL); associated with fatal gasping syndrome in premature infants and infants of low birth weight; excessive amounts associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and increased incidence of kernicterus in small preterm infants

            Increased radiation exposure in patients with severe renal impairment; cleared by glomerular filtration and is not dialyzable

            Failure to block thyroid uptake of iodine 123 may result in increased long-term risk for thyroid neoplasia; administer thyroid blocking medications (see Administration)

            Drugs that interfere with norepinephrine uptake or retention may cause false negative imaging results; if clinically feasible, discontinue these drugs before administering iobenguane I 123

            Individuals with conditions that affect the sympathetic nervous system (eg, Parkinson disease, multiple system atrophy) may show decreased cardiac uptake of iobenguane I 123 independent of heart disease

            Assess pulse and blood pressure before and intermittently for 30 minutes following administration

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            Pregnancy & Lactation

            Pregnancy Category: C; any radiopharmaceutical may cause fetal harm

            Lactation: Unknown whether iobenguane is excreted in human breast milk; however, iodine 123 is excreted into human milk

            Decide whether to interrupt nursing after administration not to administer iobenguane I 123, taking into account the importance of the drug to the mother; based on the half-life of iodine 123 (13.2 hr) nursing women may consider interrupting nursing for 6 days after use

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Iobenguane is similar in structure to guanethidine and the neurotransmitter norepinephrine (NE), and is therefore subject to the same uptake and accumulation pathways as NE

            Diagnostic radiopharmaceutical contains only a small quantity of iobenguane that is not expected to produce a pharmacodynamic effect

            Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles; accumulates in adrenergically innervated tissues (eg, adrenal medulla, salivary glands, heart, liver, spleen, lungs) as well as tumors derived from the neural crest

            Metabolism

            Metabolic process not well characterized and pharmacologic activity of metabolites has not been studied

            Metabolites: Radioiodinated metabolite m-iodohippuric acid (MIHA); free radioiodide

            Elimination

            Half-life: 13.2 hr (I 123)

            Dialyzable: No

            Excretion: 70-90% (unchanged iobenguane) in urine within 4 days

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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