Iobenguane I 123

What is Iobenguane I 123?

• Iobenguane I 123 (AdreView) is a radiopharmaceutical agent used to find certain types of tumors, including pheochromocytomas and neuroblastomas.
• Radiation from I 123 may help show where cancer cells are in the body.
• Iobenguane I 123 is a type of radioconjugate.
• Also called 123I-MIBG, AdreView, and iodine I 123-metaiodobenzylguanidine.

What are the uses of this medicine?

• AdreView is a radiopharmaceutical indicated for use in the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.
• AdreView is indicated for scintigraphic assessment of sympathetic innervation of the myocardium by measurement of the heart to mediastinum (H/M) ratio of radioactivity uptake in patients with New York Heart Association (NYHA) class II or class III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%.
• Among these patients, AdreView may be used to help identify patients with lower one and two year mortality risks, as indicated by an H/M ratio ≥ 1.6.

How does this medicine work?

• Iobenguane is similar in structure to the antihypertensive drug guanethedine and to the neurotransmitter norepinephrine (NE).
• Iobenguane is, therefore, largely subject to the same uptake and accumulation pathways as NE.
• Iobenguane is taken up by the NE transporter in adrenergic nerve terminals and stored in the presynaptic storage vesicles.
• Iobenguane accumulates in adrenergically innervated tissues such as the adrenal medulla, salivary glands, heart, liver, spleen and lungs as well as tumors derived from the neural crest.
• By labeling iobenguane with the isotope iodine 123, it is possible to obtain scintigraphic images of the organs and tissues in which the radiopharmaceutical accumulates.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity to iobenguane or iobenguane sulfate.

What drug interactions can this medicine cause?

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)
• cocaine

• Before AdreView administration, discontinue (for at least 5 biological half-lives) drugs known or expected to reduce norepinephrine uptake, as clinically tolerated.

Is this medicine FDA approved?

• Initial U.S. Approval: 2008

How should this medicine be used?

Recommended dosage:

• For patients ≥ 16 years of age or < 16 years of age and ≥ 70 kg: administer 10 mCi (370 MBq).
• For patients < 16 years of age and < 70 kg: amount scaled to the adult reference activity based on weight.

Administration:

• AdreView emits radiation and must be handled with appropriate safety measures.
• Administer thyroid blockade medications to patients at risk for thyroid accumulation of AdreView.
• Measure patient dose by a suitable radioactivity calibration system immediately prior to 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 5 mL of sterile solution for intravenous injection in a single use vial (2 mCi/mL at calibration time).

This medicine is available in fallowing brand namesː

• AdreView

What side effects can this medication cause?

The most common side effects of this medicine include:

• dizziness
• rash
• pruritis
• flushing
• headache
• injection site hemorrhage

What special precautions should I follow?

• Hypersensitivity reactions have followed AdreView administration. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration.
• Drugs which block norepinephrine uptake or deplete norepinephrine stores may decrease AdreView uptake. When medically feasible, stop these drugs before AdreView administration and monitor patients for withdrawal signs and symptoms.
• AdreView contains benzyl alcohol (10.3 mg/mL) which may cause serious reactions in premature or low birth-weight infants.
• Patients with severe renal impairment may have increased radiation exposure and decreased quality of AdreView images. AdreView safety and efficacy have not been established in these patients.
• Individuals with conditions that affect the sympathetic nervous system, e.g., Parkinsonian syndromes such as Parkinson's disease or multiple system atrophy, may show decreased cardiac uptake of AdreView independent of heart disease.
• Failure to block thyroid uptake of iodine 123 may result in an increased long term risk for thyroid neoplasia.
• Assess the patient's pulse and blood pressure before and intermittently for 30 minutes after AdreView administration. Prior to AdreView administration, ensure emergency cardiac and anti-hypertensive treatments are readily available.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• increased radiation exposure, with the long term risks for neoplasia.

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• 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.
• 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.

Can this medicine be used in children?

• The safety and effectiveness of AdreView have been established in the age groups 1 month to 16 years in patients with known or suspected neuroblastoma.
• Safety and effectiveness in pediatric patients below the age of 1 month or in any pediatric patient with congestive heart failure have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Iobenguane I-123

Inactive ingredients:

• Sodium phosphate, monobasic, dihydrate
• Sodium phosphate, dibasic, dihydrate
• Benzyl alcohol

Who manufactures and distributes this medicine?

• Manufactured and Distributed by GE Healthcare, Medi-Physics, Inc., Arlington Heights, IL U.S.A.
• AdreView is a trademark of GE Healthcare or one of its subsidiaries.

What should I know about storage and disposal of this medication?

Storage:

• Store AdreView at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F).
• 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.

Handling:

• This preparation is approved for use by persons licensed by the Illinois Emergency Management Agency pursuant to 32 IL. Adm. Code Section 330.260(a) and 335.4010 or equivalent licenses of the Nuclear Regulatory Commission or an Agreement State.

• Dailymed label info on Iobenguane I 123
• FDA Iobenguane I 123

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