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 serious adverse reactions are described elsewhere in the labeling: Serious Cardiopulmonary Reactions [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Common adverse reactions (incidence ≥ 0.5%) were: headache, nausea and/or vomiting, warm sensation or flushing, dizziness, dysgeusia, chills or fever, flu-like symptoms, malaise/weakness/fatigue, chest pain, dyspnea, injection site discomfort, and erythema ( 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 a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Adults The safety of OPTISON was evaluated in 279 adult patients in clinical studies.
These patients were 69% male, 31% female, 71% White, 19% Black or African American, 9% Hispanic or Latino, and 1% other racial or ethnic groups.
Adverse reactions reported in ≥ 0.5% of patients who received OPTISON by intravenous injection are given in Table
Adverse Reactions Reported in ≥ 0.5% of the Adult Patients who Received OPTISON in Controlled Clinical Studies Adverse Reaction OPTISON n=279 % Body as a Whole Headache 5.4 Warm Sensation/Flushing 3.6 Chills/fever 1.4 Flu-like Symptoms 1.1 Malaise/Weakness/Fatigue 1.1 Cardiovascular System Dizziness 2.5 Chest Pain 1.1 Digestive System Nausea and/or Vomiting 4.3 Respiratory System Dyspnea 1.1 Skin & Appendages Injection Site Discomfort 1.1 Erythema 0.7 Special Senses Dysgeusia 1.8 Adverse reactions reported in < 0.5% of patients who received OPTISON included: Body as a Whole: induration, discoloration at the injection site Cardiovascular system : premature ventricular contractions, palpitations Digestive system : dry mouth Immune system disorders : hypersensitivity Musculoskeletal and connective tissue disorders : back pain, arthralgia, body or muscle aches Nervous system : tremor, paresthesia, irritableness Respiratory system : oxygen saturation decline due to coughing, wheezing Skin and appendages : urticaria, rash, pruritus Special Senses : tinnitus, visual blurring, photophobia, burning sensation in the eyes Adverse Reactions in Pediatric Patients Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients [see Clinical Studies (14.2) ].
6.2 Postmarketing Experience Adverse Reactions from Observational Studies In a prospective, post-marketing safety surveillance study of OPTISON used in routine clinical practice, a total of 1,039 patients received OPTISON.
These patients had an average age of 59.9 years (min, max: 20, 97) and were 62% male, 38% female, 83% White, 14% Black or African American, 2% Asian, and 1.5% other racial or ethnic groups.
Overall, 17% of patients reported at least one adverse event.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious anaphylactic reactions have been observed.
Always have cardiopulmonary resuscitation personnel and equipment readily available prior to OPTISON administration and monitor all patients for hypersensitivity reactions ( 5.2 ).
5.1 Serious Cardiopulmonary Reactions Serious cardiopulmonary reactions including fatalities have occurred uncommonly during or shortly following perflutren-containing microsphere administration, typically within 30 minutes of administration.
The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias).
The reported reactions to perflutren-containing microspheres include: fatal cardiac or respiratory arrest, shock, syncope, symptomatic arrhythmias (atrial fibrillation, tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia), hypertension, hypotension, dyspnea, hypoxia, chest pain, respiratory distress, stridor, wheezing, loss of consciousness and convulsions [see Adverse Reactions (6.2) ] .
Like all medications, Optison Perflutren Protein-Type A Microspheres 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: