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NEUROLITE
Overview
What is NEUROLITE?
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.
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.
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 Tc99m Injection. The precise structure of the Technetium complex is [, '-ethylenedi--cysteinato(3-)]oxo[Tc] technetium (V), diethyl ester.
What does NEUROLITE look like?
What are the available doses of NEUROLITE?
Sorry No records found.
What should I talk to my health care provider before I take NEUROLITE?
Sorry No records found
How should I use NEUROLITE?
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.
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.
What interacts with NEUROLITE?
None known.
What are the warnings of NEUROLITE?
Since benztropine mesylate contains structural features of atropine, it may produce anhidrosis. For this reason, it should be administered with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease, and those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred.
What are the precautions of NEUROLITE?
General
USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT. TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION. WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN. DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED.
Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs.
Contents of the vials are intended only for use in the preparation of Technetium Tc99m Bicisate and are not to be administered directly to the patient without first undergoing the preparation procedure.
The contents of each vial are sterile and non-pyrogenic. To maintain sterility, aseptic technique must be used during all operations in the manipulations and administration of Neurolite.
Technetium Tc99m Bicisate should be used within six hours of the time of preparation.
As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. When tested in vitro, Neurolite prepared with decayed generator eluate induced unscheduled DNA synthesis in rat hepatocytes and caused an increased frequency of sister chromatid exchanges in CHO cells; but, it did not induce chromosome aberrations in human lymphocytes or cause gene mutations in the Ames test or in a CHO/HGPRT test. Unreacted bicisate dihydrochloride increased the apparent rate of gene mutation of the TA 97a strain of in the Ames test; but, it did not demonstrate clastogenic activity in an in vivo micronucleus assay in mice.
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.
Nursing Mothers
Technetium Tc99m Pertechnetate can be excreted in human milk. Therefore, formula should be substituted for breast milk until the technetium has cleared from the body of the nursing woman.
Pediatric Use
Safety and effectiveness in the pediatric population has not been established.
Geriatric Use
Of 808 patients in clinical studies of NEUROLITE®, 421 patients were 65 or older and 190 were 75 or older. Based on the evaluation of the frequency of adverse events and review of vital signs and laboratory data, no overall differences in safety were observed between these subjects and younger subjects. Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
NEUROLITE® is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to assess renal function prior to administration.
What are the side effects of NEUROLITE?
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.
What should I look out for while using NEUROLITE?
None known.
None known.
What might happen if I take too much NEUROLITE?
Sorry No Records found
How should I store and handle NEUROLITE?
Store at 25 °C (77 °F); excursions permitted to 15-30 °C (59-86 °F). 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.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.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.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.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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Neurolite®, Kit for the Preparation of Technetium Tc99m Bicisate for Injection forms a stable, lipophilic complex which can cross the blood brain barrier. Technetium Tc99m Bicisate crosses intact cell membranes and the intact blood brain barrier by passive diffusion. Five percent of the injected dose remains in the blood at one hour. The amount of Technetium Tc99m Bicisate in the brain is stable until about 6 hours. After background clearance, images of the brain can be obtained from 10 minutes to 6 hours after injection. Optimal images occur 30-60 minutes after injection. Technetium Tc99m Bicisate is cleared primarily by the kidneys.
Non-Clinical Toxicology
None known.None known.
Antipsychotic drugs such as phenothiazines or haloperidol; tricyclic antidepressants .
USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT. TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION. WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN. DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED.
Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs.
Contents of the vials are intended only for use in the preparation of Technetium Tc99m Bicisate and are not to be administered directly to the patient without first undergoing the preparation procedure.
The contents of each vial are sterile and non-pyrogenic. To maintain sterility, aseptic technique must be used during all operations in the manipulations and administration of Neurolite.
Technetium Tc99m Bicisate should be used within six hours of the time of preparation.
As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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