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.

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 toNEUROLITE ® . A total of 60 subjects experienced adverse reactions; the adverse reaction rates were comparable in 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.

DESCRIPTION This kit formulation consists of two nonradioactive vials: Vial A contains bicisate dihydrochloride (N, N'-1,2-ethylenediylbis-L-cysteine diethyl ester dihydrochloride) and a reducing agent as a lyophilized solid and vial B contains a buffer solution. Both vials are sterile and non-pyrogenic. Vial A – Bicisate dihydrochloride (ECD•2HCl) 0.9 mg Edetate disodium, dihydrate 0.36 mg Mannitol 24 mg Stannous chloride, dihydrate, theoretical (SnCl 2 •2H 2 O) 72 μg Stannous chloride, dihydrate, minimum (SnCl 2 •2H 2 O) 12 μg Total Tin, (stannous and stannic), dihydrate (as SnCl 2 •2H 2 O) 83 μg The contents of vial A are lyophilized and stored under nitrogen. The pH of the solution before lyophilization is 2.7 ± 0.25. This vial is stored at 15-25°C. Protect from light. Vial B – Sodium phosphate dibasic heptahydrate 4.1 mg Sodium phosphate monobasic monohydrate 0.46 mg Water for Injection qs 1 mL The contents of vial B are stored under air. The pH of the solution is 7.6 ± 0.4. This vial is stored at 15-25°C. This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc-99m Injection. The precise structure of the Technetium complex is [ N , N '-ethylenedi- L -cysteinato(3-)]oxo[ 99m Tc] technetium (V), diethyl ester.

HOW SUPPLIED Lantheus Medical Imaging, Inc. Neurolite® Kit for the Preparation of Technetium Tc99m Bicisate for Injection, is supplied in kits of two (2) vials of A and two (2) vials of B (NDC # 11994-006-02); and five (5) vials of A and five (5) vials of B (NDC 11994-006-05). Included in each kit are one (1) package insert and twelve (12) radiation labels. Prior to reconstitution, vial A and vial B are stored 15-25°C. Protect vial A from light. Store at controlled room temperature after preparation. Use within 6 hours of preparation. This reagent kit is approved for distribution to persons licensed pursuant to the Code of Massachusetts Regulations 105 CMR 120.500 for the uses listed in 105 CMR 120.547 or 120.552 or under equivalent regulations of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States.