Trade Name: Technetium Tc 99m Sestamibi

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Curium US LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 1 mg/mL

Storage and handling

TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Technetium Tc 99m Sestamibi (Technetium Tc 99m Sestamibi) which is also known as Technetium Tc 99m Sestamibi and Manufactured by Curium US LLC. It is available in strength of 1 mg/mL.

Technetium Tc 99m Sestamibi (Technetium Tc 99m Sestamibi) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

  • No data
  • Myocardial Imaging: Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent's labeling).n
  • It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia.n
  • Breast Imaging: Technetium Tc 99m Sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass.n
  • Technetium Tc 99m Sestamibi is not indicated for breast cancer screening, to confirm the presence or absence of malignancy, and it is not an alternative to biopsy.n
  • Technetium Tc 99m Sestamibi, is a myocardial perfusion agent indicated for:n
  • detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) ()n
  • evaluating myocardial function and developing information for use in patient management decisions ()n
  • For Myocardial Imaging:
  • For Breast Imaging:
  • For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc 99m Sestamibi in a single dose to be employed in the average patient (70 Kg) is 370-1110 MBq (10-30 mCi) ().n
  • For Breast Imaging: The recommended dose range for I.V. administration of Technetium Tc 99m Sestamibi is a single dose of 740-1110 MBq (20-30 mCi) ().n
  • Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is supplied as a 10 mL vial in a kit of five (5) (NDC # 69945-092-20) or a carton of thirty (30)u00a0(NDC # 69945-092-40), sterile and non-pyrogenic.
  • Prior to lyophilization the pH is between 5.6-5.7.u00a0 The contents of the vial are lyophilized and stored under nitrogen. Protect from light prior to reconstitution.u00a0 Technetium Tc 99m Sestamibi contains no preservatives.
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F) before and after reconstitution.u00a0
  • Included in each five (5) vial kit is one (1) package insert and five (5) radioassay information labels. Included in each thirty (30) vial carton is one (1) package insert and thirty (30) radioassay information labels.
  • This reagent kit is approved by the U.S. Nuclear Regulatory Commission for distribution to persons licensed to use by-product material identified in u00a735.200 tou00a010 CFR Part 35, to persons who have a similar authorization issued by an Agreement State, and, outside the United States, to persons authorized by the appropriate authority.
  • Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is supplied as a 10 mL vial in a kit of five (5) (NDC # 69945-092-20) or a carton of thirty (30) (NDC # 69945-092-40), sterile and non-pyrogenic (). n
  • Prior to lyophilization the pH is between 5.6-5.7.u00a0 The contents of the vial are lyophilized and stored under nitrogen. Protect from light prior to reconstitution. Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F) before and after reconstitution ().
  • None known.n
  • None known.n
  • No data
  • Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events ().n
  • Technetium Tc 99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Technetium Tc 99m Sestamibi imaging ().n
  • Caution should be exercised and emergency equipment should be available when administering Technetium Tc 99m Sestamibi ().n
  • Before administering Technetium Tc 99m Sestamibi patients should be asked about the possibility of allergic reactions to either drug ().n
  • The contents of the vial are intended only for use in the preparation of Technetium Tc 99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure ().n
  • Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patients' genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred []. Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc 99m Sestamibi administration are shown in the following table:
  • In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.
  • The following adverse reactions have been reported in u2264 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc 99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent.
  • The following adverse reactions have been reported in > 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc 99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent ().To report SUSPECTED ADVERSE REACTIONS, contact Curium US LLC at 1-866-789-2211 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.n
  • Specific drug-drug interactions have not been studied.n
  • Specific drug-drug interactions have not been studied ().n
  • No data
  • tIn one study of 46 subjects who received Technetium Tc 99m Sestamibi, the radioactivity in both children and adolescents exhibited blood PK profiles similar to those previously reported in adults ().n
  • No data
  • The clinical consequences of overdosing with Technetium Tc 99m Sestamibi are not known.n
  • Each 10 mL vial contains a sterile, non-pyrogenic, lyophilized mixture of:
  • Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate - 1 mg
  • Sodium Citrate Dihydrate - 2.6 mg
  • L-Cysteine Hydrochloride Monohydrate - 1 mg
  • Mannitol - 20 mg
  • Stannous Chloride, Dihydrate, minimum (SnClu20222HO) - 0.025 mg
  • Stannous Chloride, Dihydrate (SnClu20222HO) - 0.075 mg
  • Tin Chloride (stannous and stannic) Dihydrate, maximum (as SnClu20222HO) - 0.086 mg
  • Prior to lyophilization the pH is 5.6 to 5.7, and sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment. The contents of the vial are lyophilized and stored under nitrogen.
  • This drug is administered by intravenous injection for diagnostic use after reconstitution with sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection. The pH of the reconstituted product is 5.5 (5.0u20136.0). No bacteriostatic preservative is present.
  • The precise structure of the technetium complex is Tc99m[MIBI]n where MIBI is 2-methoxy isobutyl isonitrile.
  • Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetrafluoroborate has the following structural formula:
  • The molecular formula is CHNOBFCu, and the molecular weight is 602.98.
  • No data
  • In comparison with most other diagnostic technetium labeled radiopharmaceuticals, the radiation dose to the ovaries (1.5 rads/30 mCi at rest, 1.2 rads/30 mCi at exercise) is high. Minimal exposure (ALARA) is necessary in women of childbearing capability [n n ].
  • The active intermediate, Cu(MIBI)BF, was evaluated for genotoxic potential in a battery of five tests. No genotoxic activity was observed in the Ames, CHO/HPRT and sister chromatid exchange tests (all ). At cytotoxic concentrations (>20 u03bcg/mL), an increase in cells with chromosome aberrations was observed in the human lymphocyte assay. Cu(MIBI)BF did not show genotoxic effects in the mouse micronucleus test at a dose which caused systemic and bone marrow toxicity (9 mg/kg, > 600 X maximal human dose).
  • Clinical Trials:
  • Myocardial Imaging:n- Table 7
  • Although patients with normal images had a lower cardiac event rate than those with abnormal images, in all patients with abnormal images it was not possible to predict which patient would be likely to have further cardiac events; i.e., such individuals were not distinguishable from other patients with abnormal images.
  • The findings were not evaluated for defect location, disease duration, specific vessel involvement or intervening management.
  • In earlier trials, using a template consisting of the anterior wall, inferior-posterior wall and isolated apex, localization in the anterior or inferior-posterior wall in patients with suspected angina or coronary artery disease was shown. Disease localization isolated to the apex has not been established. In adults, Tc 99m Sestamibi has not been studied or evaluated in cardiac disorders other than coronary artery disease.
  • Breast Imaging:
  • Both clinical studies evaluated women who were referred for further evaluation for either: 1) a mammographically detected (with varying degrees of malignant likelihood) but not palpable breast lesion (study A, n=387, mean age = 54 years), or 2) a palpable breast lesion (study B, n=286, mean age = 50 years). In both studies all patients were scheduled for biopsy.
  • Technetium Tc 99m Sestamibi (20u201330 mCi) was injected intravenously in a vein that was contralateral to the breast lesion in question. Planar imaging was completed with a high resolution collimator with a 10% window centered at 140 KeV, and 128 x 128 matrix. An initial marker image, that was not used in the data analysis, was obtained using a cobalt Co57 point source as a marker of a palpable mass. Images were obtained 5 minutes after injection as follows: lateral image of the affected breast for 10 minutes, lateral image of the contralateral breast for 10 minutes, and an anterior image of both breasts for 10 minutes. For the lateral image the patients were positioned in a prone position. For the anterior image, the patients were supine. The Technetium Tc 99m Sestamibi scintigraphic images were read in a randomized method by two groups of three blinded readers. Technetium Tc 99m Sestamibi uptake was scored as: normal (no uptake), equivocal, low, moderate, or high uptake. The results of Technetium Tc 99m Sestamibi images and mammography were analyzed in comparison to histopathologic findings of malignant or non-malignant disease.
  • As shown in for the 483 evaluable patients, the sensitivity and specificity of any degree of Technetium Tc 99m Sestamibi uptake appear to vary with the presence or absence of palpable mass.
  • In separate retrospective subset analyses of 259 patients with dense (heterogeneously/extremely dense) and 275 patients with fatty (almost entirely fat/numerous vague densities) breast tissue, the Technetium Tc 99m Sestamibi results were similar. Overall, the studies were not designed to compare the performance of Technetium Tc 99m Sestamibi with the performance of mammography in patients with breast densities or other coexistent breast tissue disorders.
  • In general the histology seems to correlate with the degree of Technetium Tc 99m Sestamibi uptake. As shown in and , the majority of the normal Technetium Tc 99m Sestamibi images are associated with non-malignant tissue (78u201381%) and the majority of low, moderate or high uptake Technetium Tc 99m Sestamibi images are associated with malignant disease (79u201383%). In an individual patient, however, the intensity of Technetium Tc 99m Sestamibi uptake can not be used to confirm the presence or absence of malignancy. Equivocal results do not have a correlation with histology.
  • An estimate of the likelihood of malignancy based on the Technetium Tc 99m Sestamibi uptake score in combination with the mammographic score has not been studied.
  • In these two studies approximately 150 additional, non-biopsied lesions were found to be positive after Technetium Tc 99m Sestamibi imaging. These lesions were identified in sites that did not physically correlate with identified entry criteria mammographic lesions and these lesions were not palpable. These lesions were not biopsied. Whether these lesions were benign or malignant is not known. Technetium Tc 99m Sestamibi uptake can occur in both benign and malignant disease. THE CLINICAL USEFULNESS OF A POSITIVE Technetium Tc 99m Sestamibi IMAGE IN THE ABSENCE OF AN ABNORMAL MAMMOGRAM OR A PALPABLE LESION IS NOT KNOWN.
  • Not applicable.n
  • The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Radiochemical purity should be checked prior to patient administration.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
  • Store at 15u00b0 to 25u00b0C (59u00b0 to 77u00b0F) before and after reconstitution.u00a0 Protect from light prior to reconstitution.
  • CARDIOLITE and MIRALUMA are different names for the same drug (Kit for the Preparation of Technetium Tc 99m Sestamibi Injection). Patients should be advised to inform their health care provider if they had an allergic reaction to either drug or if they had an imaging study with either drug.
  • Curium and the Curium logo are trademarks of a Curium company.u00a92018 Curium US LLC. All Rights Reserved.n
  • CARDIOLITE, MIRALUMA and Recon-o-Stat are trademarks of Lantheus Medical Imaging, Inc.
  • A092I3
  • Manufactured by:Curium USu00a0LLC2703 Wagner PlaceMaryland Heights, MO 63043
  • Made in USA
  • Issued R12/2018
  • CURIUMu2122
  • Kit for the Preparation of Technetium Tc 99m Sestamibi Injectionn- FOR INTRAVENOUS USE AFTER LABELING WITH ADDITIVE-FREE TECHNETIUM Tc 99mn- Rx only
  • Made in USA
  • CURIUMu2122
  • R12/2018

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