drax exametazime
Drax Exametazime (Technetium Tc-99m Exametazime Kit) is a medication supplied as an injection, powder, lyophilized, for solution.
Technetium Tc-99m Exametazime Kit · by Jubilant
Key facts
- Active ingredient
- Technetium Tc-99m Exametazime Kit
- Form
- Injectable
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Jubilant
- FDA application
- NDA208870
What is Drax Exametazime?
From the FDA label:11.1 Chemical Characteristics Drax Exametazime (kit for the preparation of technetium Tc 99m exametazime for leukocyte labeling) prepares a radioactive diagnostic agent. Each single-dose vial contains a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. The chemical formula of exametazime is C 13 H 28 N 4 O 2 , with the following structural formula: Prior to publication of the USAN, exametazime [also known as (RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime] was known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. When Tc 99m pertechnetate in Sodium Chloride Injection, USP (0.9%) is added to Drax Exametazime vial, a Tc 99m complex of exametazime is formed. chemical formula 11.2 Physical Characteristics Tc 99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2. Table 2 Principal Radiation Emission Data - Tc 99m Radiation Mean %/Disintegration Mean Energy (keV) Gamma 2 88.5 140.5 11.3 External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc 99m…
How to use
Use careful handling with appropriate safety measures to minimize radiation exposure to both patients and healthcare professionals. ( 2.1 ) For an adult patient, recommended dose is 259 - 925 megabecquerels (MBq) [7-25 millicuries (mCi)]. ( 2.3 ) 2.1 Radiation Safety - Drug Handling Technetium Tc 99m exametazime is a radioactive solution and should be handled with appropriate safety measures to minimize radiation exposure. During handling use waterproof gloves and effective shielding, including syringe shields [see Warnings and Precautions (5.3) ] . 2.2 Important Administration Instructions Use strict aseptic procedures throughout preparation and handling. Visually inspect the reconstituted technetium Tc 99m exametazime solution for particulate matter and discoloration prior to radiolabeling of white blood cells. Do not use the reconstituted solution if there is evidence of particulate matter or discoloration. Follow the directions of drug preparation carefully to ensure efficient leukocytes labeling [see Dosage and Administration ( 2.5 , 2.6 )] . Measure patient dose with a suitable radioactivity calibration system immediately prior to administration. Instruct patients to hydrate, after administration of technetium Tc 99m exametazime labeled white blood cells and void frequently to minimize radiation dose to the kidneys and bladder [see Warnings and Precautions ( 5.3 )] . 2.3…
Side effects
The following adverse reactions are described elsewhere in the labeling; Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions associated with the use of technetium Tc 99m exametazime have been identified in clinical trials or post-marketing reports. Because these reactions are 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. Cardiovascular: transient blood pressure increase Skin and subcutaneous tissue disorders: rash, generalized erythema, urticaria, angioedema, pruritus. General disorders and administration site conditions: facial edema, fever, asthenic conditions (e.g., malaise, fatigue). Nervous system disorders: headache, dizziness, paraesthesia. Vascular disorders: flushing. Gastrointestinal disorders: nausea, vomiting. Most common adverse reactions include transient increase in blood pressure, rash, generalized erythema, facial edema and fever. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc. at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Hypersensitivity Reactions: Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have been reported. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including serious signs and symptoms of anaphylaxis, following administration of Tc 99m labeled leukocytes prepared using Tc 99m exametazime have been reported. Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. 5.2 Risk for Image Interpretation Error The interpretation of images can be affected by the presence of other pathophysiological processes within and outside of the abdominal cavity such as: tumor, infarction, trauma, and other inflammatory conditions. 5.3 Radiation Exposure Risk Technetium Tc 99m contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure. Encourage patients to drink fluids and void as frequently as possible after administration [see Dosage and Administration ( 2.1, 2.2 )] .
Who should not take Drax Exametazime
None. None. ( 4 )
Overdose — what happens if you take too much
In the event of the administration of a radiation overdose, hydration and frequent micturition should be encouraged in order to minimize the absorbed dose to patient.
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
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Frequently asked questions
- Is there a coupon or discount for Drax Exametazime?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Drax Exametazime. 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 Drax Exametazime?
- Drax Exametazime is marketed by Jubilant. You can see Jubilant's full profile, rating, and other products on pharmaranks.
- Is Drax Exametazime a brand-name or generic drug?
- Drax Exametazime is a brand-name product with the active ingredient Technetium Tc-99m Exametazime Kit.
- Is Drax Exametazime available over the counter?
- No. Drax Exametazime 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 Drax Exametazime come in?
- Drax Exametazime is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Drax Exametazime FDA-registered?
- Drax Exametazime is on record with the U.S. FDA under application number NDA208870. You can verify this on its official FDA label.
- Is Drax Exametazime safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Drax Exametazime. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Drax Exametazime?
- Drax Exametazime's side effects are taken directly from its FDA label. From the label: The following adverse reactions are described elsewhere in the labeling; Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] . The following adverse reactions associated with the use of technetium Tc 99m exametazime have been identified in clinical trials or post-marketing 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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