Human albumin microspheres and perflutren
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: SERIOUS CARDIOPULMONARY REACTIONS 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 ).
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Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation Instructions General Visually inspect the OPTISON vial. Do not use if the container has been damaged, the protective seal and/or rubber cap have been entered, or the upper white layer is absent (may indicate the microspheres have been damaged and may result in poor or no echo contrast). Invert the vial and gently rotate to resuspend the microspheres.
This process will allow the product to come to room temperature (20°C to 25°C or 68°F to 77°F) before use. Inspect the vial for complete resuspension. Do not use if the suspension appears to be clear rather than opaque and milky-white. Vent the OPTISON vial with a sterile vent spike or with a sterile 18-gauge needle before withdrawing the OPTISON suspension into the injection syringe.
Do not inject air into the vial. Use the product within one minute of suspension. If one minute is exceeded, resuspend by inverting and gently rotating the syringe for no less than 10 seconds. Failure to adequately resuspend OPTISON may cause inadequate delivery of the microspheres and may result in inadequate contrast.
Dilution for Pediatric Administration Invert the OPTISON vial and gently rotate to resuspend the microspheres. Draw equal volumes of OPTISON and 0.9% Sodium Chloride Injection into the same syringe to form a 1:1 dilution. Mix gently by holding the syringe horizontally between the palms and rolling it gently back and forth for at least 10 seconds.
If not used within 10 minutes after dilution, discard the diluted product.
Administration Instructions OPTISON is for intravenous use only and must not be administered by intra-arterial injection [see Warnings and Precautions ] . Inspect visually for foreign particulate matter and discoloration prior to administration, whenever suspension and container permit. Do not inject if the suspension is not opaque and milky-white, or foreign particulate matter is present.
For adults, inject through a 20-gauge or larger angiocatheter into a peripheral vein at a rate not exceeding 1 mL/s as a faster rate may reduce performance of the OPTISON microspheres . For pediatric patients, inject through a 24-gauge or larger angiocatheter into a peripheral vein at a rate not exceeding 0.05 mL/s as a faster rate may reduce performance of the OPTISON microspheres .
Suggested methods of administration include: a short extension tubing, heparin lock, or intravenous line, all with a 3-way stopcock. Do not aspirate blood back into the OPTISON-containing syringe before administration; this may promote the formation of a blood clot within the syringe. For short extension tubing or heparin lock, fill one syringe with 10 mL of 0.9% Sodium Chloride Injection for adults or 5 mL of 0.9% Sodium Chloride Injection for pediatric patients 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 or 5% Dextrose Injection to maintain vascular patency. Flush the line in its entirety immediately after injection of OPTISON. Each vial is for single-patient use. Discard unused portion.
Contraindications
4 CONTRAINDICATIONS 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 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no data with OPTISON use in pregnant women to inform any drug-associated risks. No adverse developmental outcomes were observed in animal reproduction studies with intravenous administration of OPTISON to pregnant rats and rabbits during organogenesis at doses up to at least 5 and 10 times the recommended human dose based on body surface area ( see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data OPTISON was administered intravenously to rats at doses of 0.25, 5 and 10 mL/kg/day (approximately 0.2, 5, and 10 times the recommended maximum human dose of 8.7 mL, respectively, based on body surface area) and to rabbits at 0.25, 2.5, and 5 mL/kg/day (approximately 0.5, 5, and 10 times the recommended maximum human dose, respectively, based on body surface area) during organogenesis. No significant findings attributable solely to a direct effect on the fetus were detected in the studies.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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