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AdreView

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AdreView

AdreView

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions have been reported following AdreView (iobenguane i 123 injection for intravenous use) administration. Prior to administration, question the patient for a history of prior reactions to iodine, an iodine-containing contrast agent or other products containing iodine. If the patient is known or strongly suspected to have hypersensitivity to iodine, an iodine-containing contrast agent or other products containing iodine, the decision to administer AdreView (iobenguane i 123 injection for intravenous use) should be based upon an assessment of the expected benefits compared to the potential hypersensitivity risks. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration [see ADVERSE REACTIONS].

Risks for Benzyl Alcohol Toxicity in Infants

AdreView (iobenguane i 123 injection for intravenous use) contains benzyl alcohol at a concentration of 10.3 mg/mL. Benzyl alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight. Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol. [see DESCRIPTION].

Observe infants for signs or symptoms of benzyl alcohol toxicity following AdreView (iobenguane i 123 injection for intravenous use) administration. AdreView (iobenguane i 123 injection for intravenous use) safety and effectiveness have not been established in neonates (pediatric patients below the age of 1 month).

Increased Radiation Exposure in Patients with Severe Renal Impairment

AdreView (iobenguane i 123 injection for intravenous use) is cleared by glomerular filtration and is not dialyzable. The radiation dose to patients with severe renal impairment may be increased due to the delayed elimination of the drug. Delayed AdreView (iobenguane i 123 injection for intravenous use) clearance may also reduce the target to background ratios and decrease the quality of scintigraphic images. These risks importantly may limit the role of AdreView (iobenguane i 123 injection for intravenous use) in the diagnostic evaluation of patients with severe renal impairment. AdreView (iobenguane i 123 injection for intravenous use) safety and efficacy have not been established in these patients [see CLINICAL PHARMACOLOGY].

Thyroid Accumulation

Failure to block thyroid uptake of iodine 123 may result in an increased long term risk for thyroid neoplasia. Administer thyroid blocking medications before AdreView administration [see DOSAGE AND ADMINISTRATION].

Risks with Concomitant Medication Withdrawal

Drugs which interfere with norepinephrine uptake or retention may decrease the uptake of AdreView (iobenguane i 123 injection for intravenous use) in neuroendocrine tumors and lead to false negative imaging results. When medically feasible, stop these drugs before AdreView (iobenguane i 123 injection for intravenous use) administration and monitor patients for the occurrence of clinically significant withdrawal symptoms, especially patients with elevated levels of circulating catecholamines and their metabolites [see DRUG INTERACTIONS].

Hypertension

Assess the patient's pulse and blood pressure before and intermittently for 30 minutes after AdreView (iobenguane i 123 injection for intravenous use) administration. AdreView (iobenguane i 123 injection for intravenous use) may increase release of norepinephrine from chromaffin granules and produce a transient episode of hypertension, although this was not observed in the clinical study. Prior to AdreView (iobenguane i 123 injection for intravenous use) administration, ensure emergency cardiac and anti-hypertensive treatments are readily available.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Iobenguane sulfate was not mutagenic in vitro in the Ames bacterial mutation assay and in the in vitro mouse lymphoma test, and was negative in the in vivo micronucleus test in rats.

Long-term animal studies have not been conducted to evaluate AdreView (iobenguane i 123 injection for intravenous use) 's carcinogenic potential or potential effects on fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Any radiopharmaceutical, including AdreView (iobenguane i 123 injection for intravenous use) , has a potential to cause fetal harm. It is not known whether AdreView (iobenguane i 123 injection for intravenous use) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Animal reproduction studies have not been conducted with AdreView (iobenguane i 123 injection for intravenous use) . AdreView (iobenguane i 123 injection for intravenous use) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether AdreView (iobenguane i 123 injection for intravenous use) is excreted into human milk. However, iodine 123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of AdreView (iobenguane i 123 injection for intravenous use) or not to administer AdreView (iobenguane i 123 injection for intravenous use) , taking into account the importance of the drug to the mother. Based on the physical half-life of iodine 123 (13.2 hours) nursing women may consider interrupting nursing for 6 days after AdreView (iobenguane i 123 injection for intravenous use) administration in order to minimize risks to nursing infants.

Pediatric Use

The safety and effectiveness of AdreView (iobenguane i 123 injection for intravenous use) have been established in the age groups 1 month to 16 years [see Clinical Studies]. Safety and effectiveness in pediatric patients below the age of 1 month have not been established [see WARNINGS AND PRECAUTIONS].

Geriatric Use

The AdreView (iobenguane i 123 injection for intravenous use) clinical study did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly population should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

AdreView (iobenguane i 123 injection for intravenous use) is excreted by the kidneys, and the risks of adverse reactions, increased radiation dose, and occurrence of falsely negative imaging results, may be greater in patients with severely impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and image interpretation. Consider assessment of renal function in elderly patients prior to AdreView (iobenguane i 123 injection for intravenous use) administration..

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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