Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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.
5 WARNINGS AND PRECAUTIONS Risk with exercise or pharmacologic stress: Continuous cardiac monitoring should be performed in studying patients with known or suspected coronary artery disease ( 5.1 ) When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information ( 5.1 ) Appropriate safety measures should be used to minimize radiation exposure to clinical personnel and to the patient consistent with proper patient management ( 2.1 , 5.2 ) 5.1 Risks Associated with Exercise or Pharmacologic Stress Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular reactions such as headache, paraesthesias, convulsions, somnolence and cerebrovascular accident, including hemorrhage.
Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available.
When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information.
5.2 Radiation Risks Technetium Tc99m contributes to a patient's overall long-term cumulative radiation exposure.
Long-term cumulative radiation exposure is associated with an increased risk of cancer.
Like all medications, Myoview can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: