Medical Editor: John P. Cunha, DO, FACOEP
Myoview (Kit for the preparation of technetium Tc99m tetrofosmin injection) for intravenous use is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for 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; and assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease. Common side effects of Myoview include:
- chest pain (angina),
- high blood pressure (hypertension),
- torsades de pointes,
- abdominal discomfort,
- skin allergy,
- low blood pressure (hypotension),
- shortness of breath,
- metallic taste,
- burning of the mouth, and
- changes in smell.
The recommended dose range for Myoview for rest or stress imaging is 185-1221 megabecquerels (MBq) [5-33 millicuries (mCi)] by intravenous administration. Myoview may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Myoview; all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. Myoview passes into breast milk. A lactating woman should pump and discard breast milk for 60 hours after technetium Tc 99m tetrofosmin administration. Consult your doctor before breastfeeding.
Our Myoview (Kit for the preparation of technetium Tc99m tetrofosmin injection) for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
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 29-94 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.
The following reactions were noted in less than 1% of subjects:
Cardiovascular: angina, hypertension, torsades de pointes.
Gastrointestinal: vomiting, abdominal discomfort.
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 27-97 years) received a single pharmacologic stress agent. The subjects received a mean dose of 7 - 8 mCi on the rest/first injection and 22 - 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.
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.
Read the entire FDA prescribing information for Myoview (Technetium Tc99m Tetrofosmin Kit)
© Myoview Patient Information is supplied by Cerner Multum, Inc. and Myoview Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.