Optison

Perflutren is injected into a vein through an IV. A healthcare provider will give you this injection just before the start of your echocardiogram.

Your heart rate, breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 30 minutes after you receive perflutren. This is to make sure you do not have an allergic reaction to the medicine.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Since perflutren is given with an echocardiogram, you will not be on a regular dosing schedule.

Dosage Forms And Strengths

Injectable suspension: 3 mL single-patient use vial containing a clear liquid lower layer and a white liquid upper layer, and a headspace filled with perflutren gas. Each mL of Optison contains 5-8x108 protein-type A microspheres, 10 mg albumin human, and 0.22 ± 0.11 mg perflutren. The sterile suspension is homogeneous, opaque, and milky-white after resuspension.

Optison is supplied as 3 mL single-patient use vials containing a clear liquid lower layer, a white liquid upper layer, and a headspace filled with perflutren gas and is homogeneous, opaque, and milky-white after resupsension. Each mL contains 5-8 x108 protein-type A microspheres, 10 mg albumin human, and 0.22 ± 0.11 mg perflutren:

Five (5) - 3 mL vials per carton NDC 0407-2707-03
Eighteen (18) - 3mL vials per carton NDC 0407-2707-18

Storage And Handling

Store OPTISON refrigerated between 2°-8°C (36°-46°F).

Caution: Do not freeze.

Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A. Manufactured by GE Healthcare AS, Oslo, Norway. Revised: Sep 2016

You should not be treated with perflutren if you have a genetic heart condition called "cardiac shunt."

In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregiver right away if you feel dizzy, nauseated, light-headed or short of breath, or if you have a severe headache, pounding in your ears, chest pain, fast or slow heartbeats, wheezing, or shallow breathing.

You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder).

Get emergency medical help if you have any of these signs of an allergic reaction: hives, skin redness, itching; warmth, redness, numbness, or tingly feeling; wheezing, trouble breathing, tight feeling in your chest or throat; swelling of your face, lips, tongue, or throat.

In rare cases, serious or fatal reactions may occur during the injection or shortly afterward. Tell your caregivers right away if you have:

• a light-headed feeling, like you might pass out;

• severe dizziness, or a cold sweat;

• chest pain, wheezing, trouble breathing;

• fast or slow heartbeats;

• severe headache, blurred vision, pounding in your neck or ears, anxiety, confusion; or

• slow heart rate, weak pulse, fainting, weak or shallow breathing.

You may be more likely to have a serious reaction if you have severe or uncontrolled heart problems (congestive heart failure, a recent heart attack, serious heart rhythm disorder).

Common side effects may include:

• headache, dizziness;

• flushing (warmth, redness, or tingly feeling);

• nausea;

• chest pain;

• pain in your side or lower back; or

• pain, swelling, or irritation where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Perflutren protein type A microsphere injection is used during an echocardiogram to help diagnose or find problems in the heart.

Perflutren protein type A microsphere is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. Ultrasound is a special kind of diagnostic procedure. It uses high-frequency sound waves to create images or “pictures” of certain areas inside the body. The sound waves produced by the ultrasound equipment can be reflected (bounced off) by different parts of the body, such as, the heart. As the sound waves return they are electronically converted into images on a television screen. Unlike x-rays, ultrasound does not involve ionizing radiation. The albumin microspheres sonicated preparation contains very small gas-filled albumin microspheres that reflect the sound waves and help create a better picture.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in ultrasound procedures.

• If you have an allergy to perflutren protein type A, albumin, blood products, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a heart shunt.

This is not a list of all drugs or health problems that interact with Optison.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use Optison as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.
• This medicine must not be given into an artery. Talk with the doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Echocardiography

The efficacy of Optison was evaluated in two identical multicenter, dose escalation, randomized, cross-over studies of Optison and ALBUNEX®. The test drugs were administered single blind and the image analysis was double blind. Eligible patients were undergoing routine echocardiography and all patients were required to have at least two of six segments of the left ventricular endocardial border that were not well delineated in the apical 4-chamber view. In these studies, the 203 patients (Study A: n=101, Study B: n=102) received at least one dose of study drug had the following characteristics: 79% men, 21% women, 64% White, 25% Black, 10% Hispanic, and 1% other race or ethnic group. The patients had a mean age of 61 years (range: 21 to 83 years), a mean weight of 196 lbs (range: 117 to 342 lbs), a mean height of 68 inches (range: 47 to 78 inches), and a mean body surface area of 2.0m2 (range: 1.4 to 2.6m2). Approximately 23% of the patients had chronic pulmonary disease, and 17% had congestive and dilated cardiomyopathy with left ventricular ejection fractions (LVEFs) of between 20% and 40% (by previous echocardiography). Patients with a LVEF of less than 20% or with New York Heart Association Class IV heart failure were not included in the studies.

The study test drugs were four doses of Optison (0.2, 0.5, 3.0 and 5.0 mL) and two doses of ALBUNEX® (0.08 and 0.22 mL/kg). The two test drugs were administered to the patients in a random sequence, with two to ten days between each drug. After non-contrast imaging, the test doses were administered in ascending order with at least ten minutes between each dose. Ultrasound settings were optimized for the baseline (non-contrast) apical four-chamber view and remained unchanged for the contrast imaging. Static echocardiographic images and video-tape segments were interpreted by a reader who was blinded to the patient's clinical history and to the identity and dose of the test drug. The primary efficacy endpoint was left ventricular endocardial border delineation, assessed before and after Optison administration, by the measurement of visualized endocardial border length. The six segments of the left ventricular endocardial border were also assessed qualitatively (i.e., not well delineated, average delineation, good delineation, excellent delineation) before and after Optison administration.

In comparison to non-contrast ultrasound, Optison significantly increased the length of endocardial border that could be visualized both at end-systole and end-diastole (see Table 2). In these patients there was a trend towards less visualization in women. Similarly, in comparison to non-contrast ultrasound, Optison significantly improved the qualitative ability to delineate each of the left ventricular segments, though the effect was less for the septal segments. As assessed by videodensitometry, Optison increased left ventricular opacification (peak intensity) in the mid-chamber and apical views (see Table 3). In subset analysis, Optison tended to enhance the quality of the spectral Doppler signal of the pulmonary veins. The imaging effects of Optison on endocardial border delineation and left ventricular opacification tended to be qualitatively similar in patients with and without pulmonary disease or dilated cardiomyopathy.

In these studies, quantitative measures of left ventricular function (e.g., ejection fraction), quantitative measurements of anatomical structures (e.g., wall thickness), or the evaluation of myocardial perfusion were not performed.

Pulmonary Hemodynamic Effects

The effect of Optison on pulmonary hemodynamics was studied in a prospective, open-label study of 30 patients scheduled for pulmonary artery catheterization, including 19 with an elevated baseline pulmonary arterial systolic pressure (PASP) (>35 mmHg) and 11 with a normal PASP (≤35 mmHg).

Systemic hemodynamic parameters and ECGs were also evaluated. No clinically important pulmonary hemodynamic, systemic hemodynamic, or ECG changes were observed. This study did not assess the effect of Optison on visualization of cardiac or pulmonary structures.

Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders.