Tetrofosmin
FDA Drug Information • Also known as: Myoview
- Brand Names
- Myoview
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION 11.1 Chemical Characteristics MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin injection for intravenous use. Technetium Tc99m tetrofosmin is a radioactive diagnostic agent. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, lyophilized powder 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 0.015 mg; total stannous and stannic tin 0.0522 mg) 0.32 mg disodium sulphosalicylate, 1 mg sodium D-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 chemical formula of tetrofosmin is C 18 H 40 O 4 P 2 with the following structural formula: C 18 H 40 O 4 P 2 When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial, a Tc99m complex of tetrofosmin is formed. The radiolabeled product is a clear solution and the pH is in the range of 7.5 to 9.0. Chemical Structure 11.2 Physical Characteristics Technetium Tc99m 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 - technetium Tc99m 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 Tc99m is 5.23 m 2 ∙pGy∙(MBq) −1 ∙s −1 [0.795 cm 2 ∙R∙(mCi) −1 ∙h −1 ]. A range of values for the relative radiation attenuation by various thicknesses of Pb shielding is shown in Table 3. For example, the use of 3 mm thick Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 3 Radiation attenuation by lead shielding Shield thickness (Pb) mm Factor of attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 5 10 -5 To correct for physical decay of this radionuclide, the fractions...
What Is Tetrofosmin Used For?
1 INDICATIONS AND USAGE MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease ( 1.1 ) Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease ( 1.2 ) 1.1 Myocardial Perfusion Imaging Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. 1.2 Ventricular Function Imaging MYOVIEW is indicated for assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Use appropriate radiation safety measures and aseptic technique during preparation and handling ( 2.1 , 2.3 ) The recommended dose range for MYOVIEW for rest or stress imaging is 185 to 1,221 megabecquerels (MBq) [5 to 33 millicuries (mCi)] by intravenous administration ( 2.2 ) When rest and stress injections are administered on the same day, the first dose should be 185 to 444 MBq (5 to 12 mCi) followed by the second dose of 555 to 1,221 MBq (15 to 33 mCi) given approximately 1 to 4 hours later ( 2.2 ) The recommended dose range for MYOVIEW for ventricular function assessment is 185 to 1,221 MBq (5 to 33 mCi) as an intravenous injection ( 2.2 ) See Full Prescribing Information for instructions for preparation and determination of radiochemical purity ( 2.4 , 2.5 ) Imaging may begin 15 minutes following administration of the agent ( 2.6 ) 2.1 Radiation Safety – Drug Handling Technetium Tc99m tetrofosmin is a radioactive drug and should be handled with appropriate safety measures to minimize radiation exposure during administration [see Warnings and Precautions (5.2) ] . Use waterproof gloves and effective shielding, including syringe shields, when preparing and administering technetium Tc99m tetrofosmin injection. 2.2 Recommended Dosage The recommended dose range for MYOVIEW is 185 to 1,221 megabecquerels (MBq) (5 to 33 millicuries (mCi) by intravenous administration for rest and stress imaging. When rest and stress intravenous injections are administered on the same day, the first dose should be 185 to 444 MBq (5 to 12 mCi) and followed by the second dose of 555 to 1,221 MBq (15 to 33 mCi) given approximately 1 to 4 hours later. The recommended dose range for MYOVIEW is 185 to 1,221 MBq (5 to 33 millicuries (mCi) by intravenous administration as an intravenous injection for ventricular function assessment. 2.3 Administration Instructions Use aseptic technique for all drug preparation and handling. Measure the dose in a suitable radioactivity calibration system immediately prior to intravenous administration. Visually inspect the drug for particulate matter and discoloration prior to administration. Do not use or administer the drug if there is evidence of particulate matter or discoloration. Instruct patients to remain hydrated and void frequently following administration to decrease radiation exposure [see Warnings and Precautions (5.2) ]. 2.4 Instructions for Preparation The following steps as detailed are critical and should be followed to ensure adequate preparation of the product. The technetium Tc99m labeling reaction involved in the preparation of MYOVIEW Injection depends on maintaining tin in the divalent (reduced) state. Any oxidant present in the sodium pertechnetate Tc99m used may adversely affect the quality of the preparation. Sodium pertechnetate Tc99m containing oxidants should not be used for the preparation of the labeled product. Elute the technetium generator with sodium chloride injection, USP....
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence < 1%) after MYOVIEW injection: 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of MYOVIEW cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions 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 to 94 years). The subjects received a mean dose of 285 MBq (7.7 mCi) on the first injection and 829 MBq (22.4 mCi) on the second injection of MYOVIEW. After MYOVIEW injection, angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject. The following reactions 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. In four studies, 438 adults (232 men and 205 women: gender was not recorded for one subject) with a mean age of 65 years (range 27 to 97 years) received a single pharmacologic stress agent. The subjects received a mean dose of 7 to 8 mCi on the rest/first injection and 22 to 34 mCi on the stress/second injection. Among the 438 subjects, 319 subjects (73%) experienced an adverse reaction. Reactions 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. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of MYOVIEW. 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. The most common adverse reactions reported included: rash, urticaria, abnormal vision, hypersensitivity reactions, and fever.
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary There are no data with technetium Tc99m tetrofosmin use in pregnant women to inform any drug associated risks. Animal reproduction studies with technetium Tc99m tetrofosmin have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering technetium Tc99m tetrofosmin administration to a pregnant woman advise the pregnant woman of risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How supplied Five (5) multiple-dose kits, each containing a 10 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, 1.8 mg sodium hydrogen carbonate. NDC 17156-024-05 The radionuclide is not part of the kit. Before radiolabeling with Tc99m, the contents of the kit are not radioactive. 16.2 Storage and Handling Store the kit at 2° to 8°C (36° to 46°F), protected from light. Store the radiolabeled vial at 2° to 25°C (36° to 77°F), using appropriate radiation shielding. Use within 12 hours of preparation. This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State; store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations. 16.1 How supplied Five (5) multiple-dose kits, each containing a 10 mL glass vial with a sterile, non-pyrogenic, lyophilized powder containing 0.23 mg tetrofosmin, 0.03 mg stannous chloride dihydrate, 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, 1.8 mg sodium hydrogen carbonate. NDC 17156-024-05 The radionuclide is not part of the kit. Before radiolabeling with Tc99m, the contents of the kit are not radioactive.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.