Myoview .23 mg/1
Tetrofosmin · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Medi-Physics Inc. dba GE Healthcare
Myoview is a injection, powder, lyophilized, for solution containing tetrofosmin at .23 mg/1, taken intravenous. Manufactured by Medi-Physics Inc. dba GE Healthcare.
Key Facts
- Brand Name
- Myoview
- Generic Name
- Tetrofosmin
- NDC Code (Product)
17156-024- Manufacturer
- Medi-Physics Inc. dba GE Healthcare
- Strength
- .23 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA020372
- Marketing Start
- 02/09/1996
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & 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 prepar…
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
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…
Frequently Asked Questions
What is Myoview used for?
Myoview contains Tetrofosmin. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Myoview a controlled substance?
Myoview is not classified as a controlled substance by the DEA.
What is the generic name for Myoview?
The generic name for Myoview is Tetrofosmin. There are no other listed brand versions of Tetrofosmin.
What is the NDC code for Myoview .23 mg/1?
The NDC (National Drug Code) for Myoview .23 mg/1 is 17156-024, listed by Medi-Physics Inc. dba GE Healthcare.
Other Myoview Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)