Optiray

OPTIRAY is indicated for:

Injection: clear, colorless to pale yellow solutions containing no undissolved solids, available in the following strengths and multiple-dose containers:

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Risks Associated with Inadvertent Intrathecal Administration
  [see Warnings and Precautions (

  5.1 Risks Associated with Inadvertent Intrathecal Administration

  OPTIRAY is indicated for intravascular use only

  [see Dosage and Administration ]

  . Inadvertent intrathecal administration can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

  )]
• Hypersensitivity Reactions
  [see Warnings and Precautions (

  5.2 Hypersensitivity Reactions

  OPTIRAY can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis and anaphylactic shock. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock. Most severe reactions develop shortly after the start of the injection (e.g. within 1 to 3 minutes), but delayed reactions may occur. There is an increased risk in patients with a history of a previous reaction to contrast agent, and known allergies (i.e., bronchial asthma, drug, or food allergies), and other hypersensitivities. Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

  Obtain a history of allergy, hypersensitivity, or prior hypersensitivity reactions to iodinated contrast agents. Always have emergency resuscitation equipment and trained personnel available and monitor all patients for hypersensitivity reactions.

  )]
• Contrast Induced Acute Kidney Injury
  [see Warnings and Precautions (

  5.3 Contrast Induced Acute Kidney Injury

  Acute kidney injury, including renal failure, may occur after OPTIRAY administration. Risk factors include: pre-existing renal impairment, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma / paraproteinaceous diseases, repetitive and/or large doses of an iodinated contrast agent.

  Use the lowest necessary dose of OPTIRAY in patients with renal impairment. Adequately hydrate patients prior to and following OPTIRAY administration. Do not use laxatives, diuretics, or preparatory dehydration prior to OPTIRAY administration.

  )]
• Cardiovascular Adverse Reactions
  [see Warnings and Precautions (

  5.4 Cardiovascular Adverse Reactions

  OPTIRAY increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, particularly when repetitive or large doses are administered.

  Life-threatening or fatal cardiovascular reactions have occurred with the use of OPTIRAY, including cardiac arrest, hypotensive collapse, and shock. Most deaths occur within 10 minutes of injection; with cardiovascular disease as the main underlying factor. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.

  Based upon literature reports, deaths from the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Use the lowest necessary dose of OPTIRAY in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.

  )]
• Thromboembolic Events
  [see Warnings and Precautions (

  5.5 Thromboembolic Events

  Angiocardiography

  
  
  Serious, fatal, thromboembolic events causing myocardial infarction and stroke can occur during angiographic procedures with OPTIRAY. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for thromboembolic events include: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications.

  To minimize thromboembolic events use meticulous angiographic technique. Avoid blood remaining in contact with syringes containing OPTIRAY, which increases the risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism

  [see Clinical Pharmacology ]

  .

  )]
• Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age
  [see Warnings and Precautions (5.8)]
• Severe Cutaneous Adverse Reactions
  [see Warnings and Precautions (

  5.11 Severe Cutaneous Adverse Reactions

  Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of a contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering OPTIRAY to patients with a history of a severe cutaneous adverse reaction to OPTIRAY.

  )

OPTIRAY is a clear, colorless to pale yellow, sterile, pyrogen-free, aqueous solution available in two strengths. The products are supplied in containers from which the air has been displaced by nitrogen. OPTIRAY is supplied in the following configurations:

6x500 mL Pharmacy Bulk Packages              0019-1333-61

6x500 mL Pharmacy Bulk Packages              0019-1323-61