Optison

Name: Optison

Optison Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with perflutren, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Patient information

Advise patients to inform their healthcare provider if they develop any symptoms of hypersensitivity after Optison administration including rash, wheezing, or shortness of breath.

Side effects

The following serious adverse reactions are described elsewhere in the labeling:

  • Serious Cardiopulmonary Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

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.

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 reaction. Of these one reaction 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 reactions observed in clinical studies of Optison are given in Table 1.

Table 1 :�SELECTED ADVERSE REACTIONS REPORTED IN ≥ 0.5% OF THE SUBJECTS WHO RECEIVED OPTISON™ IN CONTROLLED CLINICAL STUDIES)

No. of Patients Exposed to Optison 279
No. of Patients Reporting on Adverse Reactions 47 (16.8%)
Body as a Whole 38 (13.6%)
Headache 15 (5.4%)
Warm Sensation/Flushing 10 (3.6%)
Chills/fever 4 (1.4%)
Flu-like Symptoms 3 (1.1%)
Malaise/Weakness/Fatigue 3 (1.1%)
Cardiovascular System 12 (4.3%)
Dizziness 7 (2.5%)
Chest Pain 3 (1.1%)
Digestive System 12 (4.3%)
Nausea and/or Vomiting 12 (4.3%)
Nervous System 3 (1.1%)
Respiratory System 5 (1.8%)
Dyspnea 3 (1.1%)
Skin & Appendages 11 (3.9%)
Injection Site Discomfort 3 (1.1%)
Erythema 2 (0.7%)
Special Senses 9 (3.2%)
Altered Taste 5 (1.8%)
(1) Patients are counted separately within each body system.
(2) The body system is reported if the aggregate is ≥ 0.5%. Details are not shown if the subsystem is not ≥ 0.5%.

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

Postmarketing Experience

In a prospective, post-marketing safety surveillance study of Optison used in routine clinical practice, a total of 1039 subjects received Optison. Of these patients, 648 (62.4%) were male and 391 (37.6%) were female with average age of 59.9 years (min, max: 20, 97). The racial distributions were 864 (83.2%) White, 141 (13.6%) Black, 18 (1.7%) Asian, and 16 (1.5%) other racial or ethnic groups. Overall, 175 patients (16.8%) reported at least one adverse event. No serious adverse reactions, including deaths, were reported in this study.

The following adverse reactions have been identified during the postmarketing use of Optison. 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.

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

Read the entire FDA prescribing information for Optison (Perflutren Protein-Type A Microspheres)

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  • Ventricular Septal Defect

What should I avoid after receiving Optison (perflutren)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Commonly used brand name(s)

In the U.S.

  • Optison

Available Dosage Forms:

  • Suspension

Therapeutic Class: Diagnostic Agent, Cardiac Function

Before Using Optison

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of perflutren protein type A microsphere injection in the pediatric population. Safety and efficacy have not been established. .

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of perflutren protein type A microsphere injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to albumin or
  • Allergy to blood or blood products—Should not be given to patients with these conditions.
  • Congenital heart defects or
  • Liver problems—Use is not recommended because its effect when these conditions are present is not known.
  • Congestive heart failure or
  • Heart attack or
  • Heart disease (eg, coronary artery syndrome) or
  • Heart rhythm problems (eg, ventricular arrhythmia) or
  • Heart shunt or
  • Lung disease—May increase risk for more serious side effects.

Uses of Optison

  • It is used before a heart imaging test.

What are some things I need to know or do while I take Optison?

  • Tell all of your health care providers that you take Optison. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Optison - Clinical Pharmacology

General

The Optison microspheres create an echogenic contrast effect in the blood.

Pharmacokinetics

Studies in humans have evaluated the pharmacokinetics of the perflutren component of the Optison microspheres. After injection of Optison, diffusion of the perflutren gas out of the microspheres is limited by the low partition coefficient of the gas in blood that contributes to the persistence of the microspheres. The diffusion rate has not been studied.

In an anesthetized dog model, the acoustic properties of Optison were established at 0.6 mechanical index and 2.5 MHz frequency.

Neither the pharmacokinetics of the intact microspheres or of the human albumin component have been evaluated in humans.

Metabolism

Perflutren is a stable gas that is not metabolized. The human albumin component of the microsphere is expected to be handled by the normal metabolic routes for human albumin.

Perflutren Elimination

Following a single intravenous dose of 20 mL Optison to 10 healthy volunteers (5 men and 5 women), most of the perflutren was eliminated through the lungs within 10 minutes. The recovery was 96% ± 23% (mean ± SD), and the pulmonary elimination half-life was 1.3 ± 0.69 minutes (mean ± SD). The perflutren concentration in expired air peaked approximately 30-40 seconds after administration.

Perflutren Protein Binding

The binding of perflutren to plasma proteins or its partitioning into blood cells have not been studied. However, perflutren protein binding is expected to be minimal due to the low partition coefficient of the gas in blood.

Special Populations

The pharmacokinetics of Optison have not been studied in patients with hepatic or respiratory diseases.

Gender, Age, Race

The effects of gender, age, or race on the pharmacokinetics of Optison have not been studied.

Drug-Drug Interactions

Drug-drug interactions for Optison have not been studied.

Pediatrics

The pharmacokinetics of Optison in pediatric patients have not been studied.

Pharmocodynamics

The general acoustic properties of Optison are similar to those of ALBUNEX®. The acoustic impedance of the Optison microspheres is much lower than that of the blood. Therefore, impinging ultrasound waves are scattered and reflected at the microsphere-blood interface and ultimately may be visualized in the ultrasound image. At the frequencies used in adult echocardiography (2-5 MHz), the microspheres resonate which further increases the extent of ultrasound scattering and reflection.

As assessed by the unblinded investigators in clinical studies, the median duration of Optison contrast enhancement for each of the four doses of Optison (0.2, 0.5, 3.0, and 5.0 mL) were approximately one, two, four, and five minutes, respectively (see CLINICAL TRIALS section).

Injection procedure

The time from resuspension of the Optison to injection must not exceed one minute. If one minute is exceeded, resuspend the microspheres in the syringe by gently rotating and inverting the syringe.

Before injection, provide intravenous access in a peripheral vein with a 20-gauge or larger angiocatheter. Suggested methods of administration include: a short extension tubing, heparin lock, or intravenous line, all with a 3-way stopcock.

For short extension tubing or heparin lock: fill one syringe with 0.9% Sodium Chloride Injection, USP, and flush the line for patency before and after the injection of Optison.

For a continuous intravenous line: open an intravenous line with 0.9% Sodium Chloride Injection, USP (or 5% Dextrose Injection, USP) at a slow infusion rate to maintain vascular patency. The line should be flushed immediately after injection of Optison.

DO NOT ASPIRATE blood back into the Optison containing syringe before administration; this may promote the formation of a blood clot within the syringe.

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