neurolite
Neurolite (Technetium Tc-99m Bicisate Kit) is a medication supplied as a kit.
Technetium Tc-99m Bicisate Kit · by Shine
Key facts
- Active ingredient
- Technetium Tc-99m Bicisate Kit
- Form
- Kit
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Shine
- FDA application
- NDA020256
What is Neurolite?
From the FDA label: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 Tc99m Injection. The precise structure of the Technetium complex is [ N , N '-ethylenedi- L -cysteinato(3-)]oxo[ 99m Tc] technetium (V), diethyl ester.
How to use
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.
Side effects
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.
Warnings
Important safety information
None known.
Who should not take Neurolite
None known.
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Neurolite?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neurolite. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Neurolite?
- Neurolite is marketed by Shine. You can see Shine's full profile, rating, and other products on pharmaranks.
- Is Neurolite a brand-name or generic drug?
- Neurolite is a brand-name product with the active ingredient Technetium Tc-99m Bicisate Kit.
- Is Neurolite available over the counter?
- No. Neurolite is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Neurolite come in?
- Neurolite is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Neurolite FDA-registered?
- Neurolite is on record with the U.S. FDA under application number NDA020256. You can verify this on its official FDA label.
- Is Neurolite safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Neurolite. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Neurolite?
- Neurolite's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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