Optison perflutren Protein - Type A Microspheres - Human Albumin Microspheres And Perflutren injection, Solution

• Assess all patients for the presence of any condition that precludes OPTISON administration

  [see

  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

  ].
• Always have resuscitation equipment and trained personnel readily available

  [see

  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.

  ]

  .

• 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 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.

    Pediatric Patients

    • The recommended dose by body weight in pediatric patients is shown in Table 1.
    • Administer by intravenous injection at a rate not exceeding 0.05 mL/s

      [see Dosage and Administration (2.3)]

      .
    • If the 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.
    • OPTISON must be diluted with 0.9% Sodium Chloride Injection to form a 1:1 dilution for pediatric administration

      [see Dosage and Administration (2.2)].

      Table 1. Recommended Dose of OPTISON by Body Weight in Pediatric Patients

      Body Weight	Dose
      28 kg or less	0.2 mL of OPTISON diluted with 0.2 mL of 0.9% Sodium Chloride Injection
      29 kg to 40 kg	0.3 mL of OPTISON diluted with 0.3 mL of 0.9% Sodium Chloride Injection
      41 kg or more	0.4 mL of OPTISON diluted with 0.4 mL of 0.9% Sodium Chloride Injection
    ).
• 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 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.

    Pediatric Patients

    • The recommended dose by body weight in pediatric patients is shown in Table 1.
    • Administer by intravenous injection at a rate not exceeding 0.05 mL/s

      [see Dosage and Administration (2.3)]

      .
    • If the 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.
    • OPTISON must be diluted with 0.9% Sodium Chloride Injection to form a 1:1 dilution for pediatric administration

      [see Dosage and Administration (2.2)].

      Table 1. Recommended Dose of OPTISON by Body Weight in Pediatric Patients

      Body Weight	Dose
      28 kg or less	0.2 mL of OPTISON diluted with 0.2 mL of 0.9% Sodium Chloride Injection
      29 kg to 40 kg	0.3 mL of OPTISON diluted with 0.3 mL of 0.9% Sodium Chloride Injection
      41 kg or more	0.4 mL of OPTISON diluted with 0.4 mL of 0.9% Sodium Chloride Injection
    ).
• Follow the OPTISON injection with a flush of 0.9% Sodium Chloride Injection or 5% Dextrose Injection (
  2.3 Administration Instructions

  • OPTISON is for intravenous use only and must not be administered by intra-arterial injection
    [see Warnings and Precautions (5.3)]
    .
  • 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.
  ).
• See full prescribing information for preparation instructions (
  2.2 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.
  ).

Injectable suspension: 5-8×10⁸/mL protein-type A microspheres, 10 mg/mL albumin human, and 0.22 ± 0.11 mg/mL perflutren as a clear liquid lower layer, a white liquid upper layer, and a headspace filled with perflutren gas in 3 mL single-patient use vial; after resuspension, OPTISON is a sterile, homogeneous, opaque, and milky-white injectable suspension.

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 (

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.