nephroscan
Nephroscan (Technetium Tc-99m Succimer) is a medication supplied as an injection, powder, lyophilized, for solution.
Technetium Tc-99m Succimer · by Theragnostics
Key facts
- Active ingredient
- Technetium Tc-99m Succimer
- Form
- Injectable
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Theragnostics
- FDA application
- NDA214993
What is Nephroscan?
From the FDA label:11.1 Chemical Characteristics NEPHROSCAN is a sterile, single-dose kit for the preparation of Technetium Tc 99m Succimer Injection a radioactive diagnostic agent, for intravenous use. The active ingredient, succimer is meso-2,3-dimercaptosuccinic acid with a molecular weight of 182.22 g/mol. The chemical structure of succimer is shown below. Subsequent to radiolabeling with sodium pertechnetate Tc 99m, the active moiety technetium Tc 99m succimer is obtained in situ. Each vial contains 1 mg succimer, 0.1 mg ascorbic acid, 0.42 mg stannous (tin) chloride dihydrate, 0.02 mg hydrochloric acid and 0.2 mg sodium hydroxide as a white-yellowish to off-white lyophilized powder. In addition, after radiolabeling with sodium pertechnetate Tc 99m injection, each vial contains up to 1,480 MBq (40 mCi) of technetium Tc 99m succimer in 0.9% sodium chloride injection as a sterile, clear, and colorless solution. pH of the final solution is between 3 and 3.5. FDA approved pH specifications differ from USP. Chemical Structure 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 3. Table 3 Principal Radiation Emission Data for Technetium Tc 99m Radiation/ Emission Mean % / Disintegration Mean Energy (keV) Gamma 2 89.07 140.5 To correct for…
How to use
Instruct patients to drink a sufficient amount of water before administration and to continue to drink and to void frequently following administration ( 2.2 ) The recommended amount of radioactivity by intravenous injection (bolus) is: For adults: 74 MBq to 222 MBq (2 mCi to 6 mCi) ( 2.3 ) For pediatric patients: 1.85 MBq/kg (0.05 mCi/kg) of body weight with a range of 19 MBq to 74 MBq (0.5 mCi to 2 mCi). ( 2.3 ) Begin image acquisition 1 hour to 4 hours after administration ( 2.7 ) Delay imaging up to 6 hours to 24 hours in patients with severely reduced eGFR ( 2.7 ) See Full Prescribing Information for radiation safety, drug preparation, administration, and radiation dosimetry information ( 2.1 , 2.4 , 2.5 , 2.6 , 2.8 ) 2.1 Radiation Safety – Drug Handling After radiolabeling, handle Technetium Tc 99m Succimer Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions (5.2) ] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Technetium Tc 99m Succimer Injection. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of…
Side effects
The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of NEPHROSCAN were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders : Hypersensitivity including urticaria, rash, pruritus, and erythema General Disorders : syncope, fever, and nausea. The following adverse reactions have been reported: urticaria, rash, pruritus, erythema, syncope, fever, and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Theragnostics, Inc., at 1-888-286-3848 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Hypersensitivity Reactions: Have appropriate instruments and medications necessary for immediate treatment of allergic reactions and monitor patients for hypersensitivity reactions during and after administration ( 5.1 ) Radiation risks: Ensure safe handling to minimize radiation exposure to patients and health care workers ( 5.2 ) Risk in Patients with Advanced Renal Failure: Image interpretation may be affected as the kidneys may not absorb technetium Tc 99m succimer. ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium Tc 99m succimer injection in adults and pediatric patients. The time of onset of the reactions varied within 2 hours to several hours after the injection. Have appropriate instruments and medications necessary for immediate treatment of hypersensitivity reactions and monitor patients for reactions during and after administration [see Adverse Reactions (6) ] . 5.2 Radiation Risks Technetium Tc 99m succimer injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.2) ] . 5.3 Risk in Patients with Advanced Renal Failure The use of technetium Tc 99m succimer injection in patients with severely reduced estimated glomerular filtration (eGFR) may have an effect on image interpretation as the kidneys may not absorb the technetium Tc 99m succimer and thus the Tc 99m succimer may distribute to organs or parts of the body other than the kidneys. It has been reported that satisfactory images may be obtained in some of these patients by delaying imaging between 6 hours to 24 hours [see Dosage and Administration (2.7) ] .
Who should not take Nephroscan
None None ( 4 )
Overdose — what happens if you take too much
In the event of an overdose of technetium Tc 99m succimer, reduce the radiation absorbed dose to the patient where possible by increasing the elimination of the drug from the body using hydration and frequent bladder voiding. A diuretic might also be considered. If possible, an estimate of the radiation effective dose given to the patient should be made.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Injectable
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
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Frequently asked questions
- Is there a coupon or discount for Nephroscan?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nephroscan. 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 Nephroscan?
- Nephroscan is marketed by Theragnostics. You can see Theragnostics's full profile, rating, and other products on pharmaranks.
- Is Nephroscan a brand-name or generic drug?
- Nephroscan is a brand-name product with the active ingredient Technetium Tc-99m Succimer.
- Is Nephroscan available over the counter?
- No. Nephroscan 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 Nephroscan come in?
- Nephroscan is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Nephroscan FDA-registered?
- Nephroscan is on record with the U.S. FDA under application number NDA214993. You can verify this on its official FDA label.
- Is Nephroscan safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Nephroscan. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Nephroscan?
- Nephroscan's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of NEPHROSCAN were identified in clinical studies or postmarketing reports.… 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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