Perflutren

The safety of perflutren for use during human pregnancy has not been established. In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed. The clinical relevance of this finding is unknown. Therefore, perflutren should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.

It is not known whether perflutren is excreted in human milk. Therefore, caution should be exercised when perflutren is administered to breast-feeding women.

No studies on the effects on the ability to drive and use machines have been performed.

Adverse reactions to perflutren are rare and usually of a non-serious nature. In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever. Anaphylactic reactions have been associated with the administration of human albumin products. The reported adverse events following the use of perflutren in Phase III human clinical studies have been mild to moderate with subsequent full recovery.

In clinical trials with perflutren, undesirable effects were reported as adverse events with the following frequencies given in the list below: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood and lymphatic system disorders

Uncommon: Eosinophilia

Nervous system disorders

Common: Dysgeusia (altered taste), headache

Rare: Tinnitus, dizziness, paraesthesia

Eye disorders

Not known*: Visual disturbances

Cardiac disorders

Rare: Ventricular tachycardia

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Vascular disorders

Common: Flushing

Gastrointestinal disorders

Common: Nausea

General disorders and administration site conditions

Common: Warm sensation

Uncommon: Chest pain

Immune system disorders

Not known*: Allergic type symptoms (e.g. anaphylactoid reaction or -shock, face oedema, urticaria)

* Reactions for which no frequency rate can be provided due to lack of clinical trial data have been classified as “Not known”.