Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1136
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Myoview (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:dosage |
The recommended dose range for MYOVIEW is 5-33 mCi (185-1221 MBq). For stress and rest imaging, 2 separate doses of MYOVIEW are used. When rest and stress injections are administered on the same day, the first dose should be 5-12 mCi (185-444 MBq) and followed by the second dose of 15-33 mCi (555-1221 MBq) given approximately 1 to 4 hours later. Imaging may begin 15 minutes following administration of the agent. Dose adjustment has not been established in renally or liver impaired, pediatric or geriatric patients.
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| dailymed-instance:descripti... |
The MYOVIEW kit is supplied as a pack of five vials for use in the preparation of a technetium Tc99m tetrofosmin intravenous injection to be used for the scintigraphic delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium and for the evaluation of ventricular function. Each vial contains a predispensed, sterile, non-pyrogenic, lyophilized mixture of 0.23 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.03 mg stannous chloride dihydrate (minimum stannous tin 0.005 mg; maximum total stannous and stannic tin 0.0158 mg), 0.32 mg disodium sulphosalicylate and 1.0 mg sodiumD-gluconate, and 1.8 mg sodium hydrogen carbonate. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. The structural formula of tetrofosmin is: When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial, a Tc99m complex of tetrofosmin is formed. Administration is by intravenous injection for diagnostic use.<br/>Physical Characteristics: Technetium Tc99m decays by isomeric transition with a physical half-life of 6.03 hours. Photons that are useful for imaging studies are listed in Table 1.<br/>External Radiation: The specific gamma ray constant for technetium Tc99m is 206 microCoulomb. kg/37 MBq-hr (0.8 R/mCi-hr) at 1 cm. The first half-value thickness of lead (Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 2.7 mm thickness of Pb will decrease the external radiation exposure by a factor of 1000. To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3.
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General: When technetium Tc99m pertechnetate is added to tetrofosmin in the presence of stannous reductant, a lipophilic, cationic technetium Tc99m complex is formed, Tc99m tetrofosmin. This complex is the active ingredient in the reconstituted drug product, on whose biodistribution and pharmacokinetic properties the indications for use depend.<br/>Pharmacokinetics: Studies in normal volunteers have demonstrated rapid myocardial uptake of Tc99m tetrofosmin, and rapid blood, liver and lung clearances. Uptake in the myocardium reaches a maximum of about 1.2% of the injected dose (i.d.) at 5 minutes and approximately 1% of the i.d. at 2 hours, respectively. Background activities in the blood, liver and lung were less than 5% of the administered activity in whole blood at 10 minutes post-injection, less than 4.5% i.d., after 60 minutes, and less than 2% i.d. after 30minutes. Approximately 66% of the injected activity is excreted within 48 hours post-injection, with approximately 40% excreted in the urine and 26% in the feces. The kinetics, elimination and protein binding of Tc99m tetrofosmin have not been determined.<br/>Pharmacodynamics: The pharmacodynamic cellular uptake of tetrofosmin in humans has not been established. In humans the recommended imaging time is 15 minutes at stress and 30 minutes at rest.<br/>Metabolism: The metabolic profile of tetrofosmin has not been established.<br/>Drug-Drug Interactions: Specific drug-drug interactions have not been studied.
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None known.
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| dailymed-instance:supply |
The kit comprises five vials containing a sterile, non-pyrogenic, freeze dried mixture of tetrofosmin, stannous chloride dihydrate, disodium sulphosalicylate, sodium D-Gluconate and sodium hydrogen carbonate, together with appropriate number of radiation labels, and a package insert. NDC 17156-024-05
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| dailymed-instance:precautio... |
General: To minimize radiation dose to the bladder, the patient should be encouraged to void when the examination is completed and as often thereafter as possible. Adequate hydration should be encouraged to permit frequent voiding. The contents of the MYOVIEW vial are intended only for use in the preparation of MYOVIEW Injection and are NOT to be administered directly to the patient. As with all injectable drug products, allergic reactions and anaphylaxis may occur. Sometimes Tc99m labeled myocardial imaging agents may produce planar and SPECT images with different imaging information. In patients who have a MYOVIEW GSPECT LVEF value or wall motion assessment that is not consistent with the clinical status, additional evaluations with other modalities should be considered as appropriate. MYOVIEW Injection, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. 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 radionuclides.<br/>Drug Interactions: Drug interactions were not noted and were not studied in clinical studies in which MYOVIEW was administered to subjects receiving concomitant medication. Drugs such as beta blockers, calcium blockers and nitrates may influence myocardial function and blood flow. The effects of such drugs on imaging results are not known.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been conducted to evaluate carcinogenic potential or effects on fertility. Tetrofosmin sulphosalicylate was not mutagenic in vitro in the Ames test, mouse lymphoma, or human lymphocyte tests, nor was it clastogenic in vivo in the mouse micronucleus test.<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with MYOVIEW. It is not known whether MYOVIEW can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Therefore, MYOVIEW should not be administered to a pregnant woman unless the potential benefit justifies the potential risk to the fetus.<br/>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.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been established.<br/>Geriatric Use: Of 2300 patients in clinical studies of MYOVIEW���(Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection), 1053 (46%) patients were 65 or older and 270 (12%) were 75 or older. No overall differences in safety were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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Tetrofosmin
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Myoview (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:adverseRe... |
Adverse events were evaluated in clinical studies (using an exercise/rest protocol) of 764 adults (511 men and 253 women) with a mean age of 58.7 years (range 29-94 years). The subjects received a mean dose of 7.67 mCi on the first injection and 22.4 mCi on the second injection of MYOVIEW. Deaths did not occur during the clinical study period of 2 days. Six cardiac deaths occurred 3 days to 6 months after injection and were thought to be related to the underlying disease or cardiac surgery. After MYOVIEW injection, serious episodes of angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject. The respiratory arrest occurred within minutes of MYOVIEW and pharmacologic stress dosing in a subject with underlying pulmonary disease. The patient was treated and fully recovered. Whether this event was caused by underlying disease or concurrent use of MYOVIEW injection and a pharmacologic stress agent cannot be determined. Overall cardiac adverse events occurred in less than 1% of subjects after MYOVIEW injection. The following events were noted in less than 1% of subjects: Cardiovascular: angina, hypertension, Torsades de Pointes. Gastrointestinal: vomiting, abdominal discomfort. Hypersensitivity: cutaneous allergy, hypotension, dyspnea. Special Senses: metallic taste, burning of the mouth, smell alteration. There was a low incidence (less than 4%) of a transient and clinically insignificant rise in white blood cell counts following administration of the agent. Adverse events were also evaluated in clinical studies using pharmacologic stress. In four studies of 438 adults (232 men and 205 women; gender was not recorded for one subject) with a mean age of 65.4 years (range 27-97 years; age was not recorded for two subjects) received a single pharmacologic stress agent. The subjects received a mean dose of 7.46-7.79 mCi on the rest/first injection and 22.12 - 33.79 mCi on the stress/second injection. Among the 438 subjects, 319 experienced an adverse event (73%). Events occurring in���1% of the subjects included angina (39%), flushing (36%), dyspnea (28%), headache (14%), abdominal pain (11%), dizziness (7%), palpitations (2%), nausea (2%), hypotension (1%) and pain (1%). Events occurring in<1% include cough, arrhythmia, bronchospasm, ECG abnormalities, hypertension, vomiting and asthenia. Attribution of the above events to MYOVIEW and/or the pharmacologic stress agent cannot be determined due to study design. In additional ventricular function studies with 1 and 2 day dosing protocols, the overall adverse event profile was similar to previous reports and included one subject who was withdrawn for syncope.<br/>Post-marketing experience: The following are spontaneously reported adverse reactions from post-marketing experience. Because the reports cite reactions reported spontaneously from worldwide post-marketing experience, frequency of reactions and the role of MYOVIEW in their causation cannot be reliably determined. The most common adverse reactions reported included the following: rash, urticaria, abnormal vision, allergic reactions, and fever.
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| dailymed-instance:warning |
In studying patients with known or suspected coronary artery disease, care should be taken to ensure continuous cardiac monitoring and the availability of emergency cardiac treatment. Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent's labeling.
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| dailymed-instance:indicatio... |
MYOVIEW is indicated for scintigraphic imaging of the myocardium following separate administrations under exercise and/or resting conditions. It is useful in the delineation of regions of reversible myocardial ischemia in the presence or absence of infarcted myocardium. MYOVIEW is also indicated for scintigraphic imaging of the myocardium to identify changes in perfusion induced by pharmacologic stress in patients with known or suspected coronary artery disease. MYOVIEW is also indicated for the assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients being evaluated for heart disease.
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Myoview
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