Clinical Trials Experience

OPTISON was administered in clinical studies in 279 patients. Of these patients there were 192 (68.8%) men and 87 (31.2%) women. The racial demographics were 199 (71.3%) Caucasian, 52 (18.6%) Black, 24 (8.6%) Hispanic, and 4 (1.4%) other racial or ethnic groups.

In these patients, 47 (16.8%) reported at least one adverse event. Of these one event was serious and required treatment with antihistamines for hypersensitivity manifestations of dizziness, nausea, flushing and temperature elevation. Deaths were not reported during the clinical studies.

Of the reported adverse reactions following the use of OPTISON the most frequently reported were headache (5.4%), nausea and/or vomiting (4.3%), warm sensation or flushing (3.6%), and dizziness (2.5%). The most common adverse events observed in clinical studies of OPTISON are given in Table 4.

Table 4: SELECTED ADVERSE EVENTS REPORTED IN ≥ 0.5% OF THE SUBJECTS WHO RECEIVED OPTISON™ IN CONTROLLED CLINICAL STUDIES ⁽¹⁾⁽²⁾

Adverse events reported in < 0.5% of subjects who received OPTISON included: arthralgia, back pain, body or muscle aches, induration, urticaria, dry mouth, eosinophilia, palpitations, paresthesia, photophobia, premature ventricular contraction, pruritus, rash, irritableness, hypersensitivity, tinnitus, tremor, visual blurring, wheezing, oxygen saturation decline due to coughing, discoloration at the Heplock site, and burning sensation in the eyes.

Overall the reported adverse events with OPTISON were similar in type and frequency to those reported in the 199 patients who received ALBUNEX®.

In the clinical dose ranging studies of 40 normal volunteers, doses higher than those recommended in the DOSAGE AND ADMINISTRATION section tended to be associated with an increased frequency of reported adverse events.

Postmarketing Experience

The following adverse reactions have been identified during the postmarketing use of perflutren­containing microsphere products. 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.

Fatal cardiac arrests and other serious but non-fatal adverse reactions were uncommonly reported. Most of these uncommon reactions included cardiopulmonary symptoms and signs such as cardiac or respiratory arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory distress or decreased oxygenation. Reports also identified neurologic reactions (loss of consciousness or convulsions) as well as anaphylactoid reactions (see WARNINGS).

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