Safety and Tolerability

Adverse events were evaluated in clinical trials 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^TM.

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 3 patients. Overall cardiac adverse events occurred in 5/764 (less than 1%) of patients after Myoview injection.

The following events were noted in less than 1 % of patients: Cardiovascular: angina, hypertension, Torsades de Pointes Gastrointestinal: vomiting, abdominal discomfort
Hypersensitivity: cutaneous allergy, hypotension, dyspnea Special Senses: metallic taste, burning of the mouth, smelling something¹¹

A low incidence of white blood cell count elevations has also been noted between 6 and 24 hours after MYOVIEW injection, but the vast majority of increases typically remained within normallimits.^4,11 Increases in neutrophils and lymphocytes appear to contribute to most white blood cell elevations.⁷ The effect is considered transient and clinically insignificant. No clinically signifi- cant changes in other laboratory parameters have been noted.⁴

Radiation Dosimetry
Estimated absorbed radiation doses for an average adult patient (70kg) from intravenous injections of Tc-99m-tetrofosmin are listed in Table 3. The values are calculated assuming urinary bladder emptying at 3.5 hour intervals.

The effective dose equivalent (EDE) resulting from the administration of doses of reconstituted MYOVEW of 250MBq (6.8 mCi) after exercise and 750MBq (20.3 mCi) at rest is 2.15mSv after exercise and 8.38mSv at rest (per 70kg individual).

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