NEUROLITE

INDICATIONS Neurolite single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite is not indicated for assessment of functional viability of brain tissue. Also, Neurolite is not indicated for distinguishing between stroke and other brain lesions.

DOSAGE AND ADMINISTRATION Before administration, a patient should be well hydrated. After administration, the patient should be encouraged to drink fluids liberally and to void frequently. The recommended dose range for intravenous administration for a 70 kg patient is 370-1110 MBq (10-30mCi). Dose adjustments for age, weight, gender or renal or hepatic impairment have not been studied. The dose for the patient should be measured by a suitable radioactivity calibration system immediately before administration to the patient. Radiochemical purity should be checked before administration to the patient. Neurolite, like other parenteral drug products, should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with all applicable regulations. Prior to reconstitution, vial A and vial B are stored at 15-25°C. Protect vial A from light. Store at controlled room temperature after preparation. Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.

CONTRAINDICATIONS None known.

WARNINGS None known.

ADVERSE REACTIONS In clinical trials, Neurolite has been administered to 1063 subjects (255 normals, 808 patients). Of these, 566 (53%) were men and 494 (47%) were women. The mean age was 58 years (range 17 to 92 years). In the 808 patients, who had experienced neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite. A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in the <65 year, and the >65 year age groups. The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis. In clinical trials of 197 patients, there were inconsistent changes in the serum calcium and phosphate levels. The cause of the changes has not been identified and their frequency and magnitude have not been clearly characterized. None of the changes required medical intervention.

Pregnancy: Teratogenic Effects Animal reproduction studies have not been conducted with Technetium Tc99m Bicisate. It is also not known whether Technetium Tc99m Bicisate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Technetium Tc99m Bicisate should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.