Product Description

AdreView (Iobenguane I 123 injection) is a sterile pyrogen-free radiopharmaceutical for intravenous injection. Each mL contains 0.08 mg iobenguane sulfate, 74 MBq (2 mCi) of I 123 (as iobenguane sulfate I 123) at calibration date and time on the label, 23 mg sodium dihydrogen phosphate dihydrate, 2.8 mg disodium hydrogen phosphate dihydrate and 10.3 mg (1% v/v) benzyl alcohol with a pH of 5.0 - 6.5. Iobenguane sulfate I 123 is also known as I 123 meta-iodobenzylguanidine sulfate.

AdreView contains benzyl alcohol (10.3 mg/mL), which may cause serious reactions in premature or low birth-weight infants. Benzyl alcohol has been associated with a fatal "Gasping Syndrome" in premature infants and infants of low birth weight. Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration. AdreView 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. AdreView is contraindicated in patients with known hypersensitivity to iobenguane or iobenguane sulfate. In clinical trials the most common adverse reactions seen were dizziness, rash, pruritis, flushing, or injection site hemorrhage reported in less than 1% of patients.