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Myoview Side Effects

Please note - some side effects for Myoview may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Myoview Side Effects - for the Professional

Myoview

Applies to: intravenous injection, powder, lyophilized, for solution

Adverse events 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 7.67 mCi on the first injection and 22.4 mCi on the second injection of Myoview.

Deaths did not occur during the clinical study period of 2 days. Six cardiac deaths occurred 3 days to 6 months after injection and were thought to be related to the underlying disease or cardiac surgery. After Myoview injection, serious episodes of angina occurred in 4 subjects, ventricular tachycardia in 1 subject, and respiratory arrest in 1 subject. The respiratory arrest occurred within minutes of Myoview and pharmacologic stress dosing in a subject with underlying pulmonary disease. The patient was treated and fully recovered. Whether this event was caused by underlying disease or concurrent use of Myoview injection and a pharmacologic stress agent cannot be determined.

Overall cardiac adverse events occurred in less than 1% of subjects after Myoview injection.

The following events 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.

There was a low incidence (less than 4%) of a transient and clinically insignificant rise in white blood cell counts following administration of the agent.

Adverse events were also evaluated in clinical studies using pharmacologic stress. In four studies of 438 adults (232 men and 205 women; gender was not recorded for one subject) with a mean age of 65.4 years (range 27-97 years; age was not recorded for two subjects) received a single pharmacologic stress agent. The subjects received a mean dose of 7.46-7.79 mCi on the rest/first injection and 22.12 - 33.79 mCi on the stress/second injection.

Among the 438 subjects, 319 experienced an adverse event (73%). Events 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. Attribution of the above events to Myoview and/or the pharmacologic stress agent cannot be determined due to study design.

In additional ventricular function studies with 1 and 2 day dosing protocols, the overall adverse event profile was similar to previous reports and included one subject who was withdrawn for syncope.

Post-marketing experience

The following are spontaneously reported adverse reactions from post-marketing experience. Because the reports cite reactions reported spontaneously from worldwide post-marketing experience, frequency of reactions and the role of Myoview in their causation cannot be reliably determined. The most common adverse reactions reported included the following: rash, urticaria, abnormal vision, allergic reactions, and fever.

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