Myoview
Generic: TETROFOSMIN
Basic Information
Manufacturer
Medi-Physics Inc. dba GE Healthcare
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
98c85037-a907-4a3a-8864-c3a5298b4759
Indications & Usage
1 INDICATIONS AND USAGE MYOVIEW 30 mL 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.
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.
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) 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.
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) 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.