Key facts
- Active ingredient
- Albumin Human
- Drug class
- Human Serum Albumin
- Form
- Injectable
- Strength
- Albumin Human 10MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ge Healthcare
- FDA application
- NDA020899
- FDA boxed warning
- Yes — see the boxed warning
What is Optison?
From the FDA label:OPTISON (perflutren protein-type A microspheres) injectable suspension is an ultrasound contrast agent for intravenous use. Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-perflutren with a molecular weight of 188, an empirical formula of C 3 F 8 , and the following structural formula: Each mL contains 5-8×10 8 protein-type A microspheres, 10 mg albumin human, 0.22 ± 0.11 mg perflutren, and the following inactive ingredients: 0.2 mg N-acetyltryptophan and 0.12 mg caprylic acid in 0.9% aqueous sodium chloride. The headspace of the vial is filled with perflutren gas. The pH is adjusted to 6.4 to 7.4. The protein in the microsphere shell makes up approximately 5% to 7% (w/w) of the total protein in the suspension. The microsphere particle size parameters are listed in Table 3. OPTISON is supplied as a clear liquid lower layer, a white liquid upper layer, and a headspace filled with perflutren gas, and after resuspension, OPTISION is a sterile, homogeneous, opaque, and milky-white suspension. Table 3. Microsphere Size Distribution Parameter Mean diameter (range) 3 to 4.5 µm Percent less than 10 µm 95% Maximum diameter 32 µm Chemical Structure
How to use
Adults 0.5 mL intravenously at a rate not exceeding 1 mL/s. If contrast enhancement is inadequate after the dose of 0.5 mL, additional doses of 0.5 mL may be repeated up to a total of 5 mL in a 10-minute period with a maximum total dose of 8.7 mL in any one patient study ( 2.1 ). Pediatric Patients 28 kg or less: 0.2 mL diluted with 0.2 mL of 0.9% Sodium Chloride Injection. 29 kg to 40 kg: 0.3 mL diluted with 0.3 mL of 0.9% Sodium Chloride Injection. 41 kg or more: 0.4 mL diluted with 0.4 mL of 0.9% Sodium Chloride Injection. Administer intravenously at a rate not exceeding 0.05 mL/s. If contrast enhancement is inadequate after the initial dose, up to four additional doses of the same diluted volume may be repeated for further contrast enhancement as needed ( 2.1 ). Follow the OPTISON injection with a flush of 0.9% Sodium Chloride Injection or 5% Dextrose Injection ( 2.3 ). See full prescribing information for preparation instructions ( 2.2 ). 2.1 Recommended Dosage Adults The recommended dose in adults is 0.5 mL administered intravenously at a rate not exceeding 1 mL/s [see Dosage and Administration (2.3) ] . If the contrast enhancement is inadequate after the dose of 0.5 mL, additional doses of 0.5 mL may be repeated for further contrast enhancement as needed. The maximum total dose is 5 mL in any 10-minute period. The maximum total dose is 8.7 mL in any one patient study.…
Side effects
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 2. Table 2. Adverse Reactions Reported in ≥ 0.5% of the Adult Patients who Received OPTISON in Controlled Clinical Studies…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions (5.1) ]. Assess all patients for the presence of any condition that precludes OPTISON administration [see Contraindications (4) ]. Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions (5.1) ] . WARNING: SERIOUS CARDIOPULMONARY REACTIONS See full prescribing information for complete boxed warning. Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration ( 5.1 ). Assess all patients for the presence of any condition that precludes OPTISON administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
Warnings
Important safety information
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) ] . Always have cardiopulmonary resuscitation personnel and equipment readily available prior to OPTISON administration and monitor all patients for acute reactions. 5.2 Hypersensitivity Reactions Serious anaphylactic reactions have been observed during or shortly following perflutren-containing microsphere administration including: shock, hypersensitivity, bronchospasm, throat tightness, angioedema, edema (pharyngeal, palatal, mouth, peripheral, localized), swelling (face, eye, lip, tongue upper airway), facial hypoesthesia, rash, urticaria, pruritus, flushing, and erythema have occurred in patients with no prior exposure to perflutren-containing microsphere products. Always have cardiopulmonary resuscitation personnel and equipment readily available prior to OPTISON administration and monitor all patients for hypersensitivity reactions [see Adverse Reactions (6.2) ] . 5.3 Systemic Embolization When administering OPTISON to patients with a cardiac shunt, microspheres can bypass filtering of the lung and enter the arterial circulation. Assess patients with shunts for embolic phenomena following OPTISON administration. OPTISON is only for intravenous administration; do not administer OPTISON by intra-arterial injection. 5.4 Ventricular Arrhythmia Related to High Mechanical Index High ultrasound mechanical index values may cause microsphere rupture and lead to ventricular arrhythmias. Additionally, end-systolic triggering with high mechanical indices has been reported to cause ventricular arrhythmias. OPTISON is not recommended for use at mechanical indices greater than 0.8.
Who should not take Optison
OPTISON is contraindicated in patients with known or suspected hypersensitivity to perflutren or albumin [see Warnings and Precautions (5.2) ] . Known or suspected hypersensitivity to perflutren or albumin ( 4 )
Drug class
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- Is there a coupon or discount for Optison?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Optison. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Optison?
- Optison is marketed by Ge Healthcare. You can see Ge Healthcare's full profile, rating, and other products on pharmaranks.
- Is Optison a brand-name or generic drug?
- Optison is a brand-name product with the active ingredient Albumin Human.
- Is Optison available over the counter?
- No. Optison is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Optison come in?
- Optison is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Optison?
- Optison is classified as human serum albumin, per the FDA's Established Pharmacologic Class.
- Is Optison FDA-registered?
- Optison is on record with the U.S. FDA under application number NDA020899. You can verify this on its official FDA label.
- Is Optison safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Optison. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Optison?
- Optison's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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