product-product-categories-contrast-media-omniscan-omniscan-logo.jpg

Omniscan


IMPORTANT SAFETY INFORMATION


WARNING — NOT FOR INTRATHECAL USE: Inadvertent intrathecal use of Omniscan has caused convulsions, coma, sensory, and motor neurologic deficits.


WARNING — NEPHROGENIC SYSTEMIC FIBROSIS (NSF): Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not administer Omniscan to patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/min/1.73m2) or acute kidney injury (AKI). Screen patients for AKI and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension, or diabetes), estimate GFR via laboratory testing. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration



See Indications and additional Important Safety Information about Omniscan at the bottom of this page.
Dear Healthcare Professional Letter– Gadolinium Retention Important Drug Warning for All Gadolinium-Based Contrast Agents.

Please also read the Full Prescribing Information and patient Medication Guide.

OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to:

  • Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues
  • Facilitate the visualization of lesions with abnormal vascularity within the thoracic, abdominal, pelvic cavities, and the retroperitoneal space

MRI contrasts, such as Omniscan may be an appropriate choice for eligible patients and procedures based on its clinical profile and a long tradition of patient and clinician experience. Benefits of Omniscan include:

  • It has been used in a clinical setting for more than 15 years in more than 40 million contrast-enhanced MRI scans.1
  • Available in +PLUSPAKTM polymer bottle packaging.

1. Data on file. GE Healthcare. 2011.

Indications

See Indications and additional Important Safety Information about Omniscan at the bottom of this page.

Please also read the Full Prescribing Information and patient Medication Guide.

Omniscan is approved for multiple contrast media indications.1,2

Indication

Dose
CNS
(central nervous system)
adult pediatric
(2-16 years)

brain x x 0.1 mmol/kg IV bolus
spine x x 0.1 mmol/kg IV bolus
Body adult pediatric
(2-16 years)

kidney
 x x 0.05 mmol/kg IV bolus
 intrathoracic  x 0.1 mmol/kg IV bolus 
intra-abdominal   x 0.1 mmol/kg IV bolus 
 pelvic  x 0.1 mmol/kg IV bolus 

1. Please refer to the Dosage and Administration section of the Omniscan Prescribing Information for recommended dosing details.
2. Omniscan Prescribing Information.

How Supplied

See Indications and additional Important Safety Information about Omniscan at the bottom of this page.

Please also read the Full Prescribing Information and patient Medication Guide.

Omniscan is available in a variety of packaging options:

  • Glass vials
    Glass

    Product Product Code NDC
    5 mL in 10 mL VIAL J068
    0407-0690-05
     10 mL VIAL J100  0407-0690-10
     15 mL in 20 mL VIAL J120 0407-0690-15 
     20 mL VIAL J140  0407-0690-20
  • Prefilled Syringes
    Prefilled Syringes

    Product Product Code NDC
     10 mL in 20 mL PREFILLED SYRINGE  J160 0407-0690-12 
    15 mL in 20 mL PREFILLED SYRINGE  J170  0407-0690-17
     20 mL PREFILLED SYRINGE  J180 0407-0690-22 
    15 mL in 20mL Prefill Plus™ EASY DELIVERY SYSTEM   J640   0407-0691-62
     20 mL Prefill Plus™ EASY DELIVERY SYSTEM  J650 0407-0691-63 
  • +PLUSPAK (polymer bottle)
    • 100 mL +PLUSPAK (polymer bottle) Pharmacy Bulk Packaging provides convenience when drawing multiple single doses
    • +PLUSPAK (polymer bottle) packaging has been approved as an ecomagination product within GE
    • +PLUSPAK container meets both OSHA and JC safety standards for packaging
    • +PLUSPAK container label provides peel-off tracking labels
+PLUSPAK

Product Product Code NDC
100 mL +PLUSPAK Pharmacy Bulk Pack J800
0407-0690-70

Please also read the Pharmacy Bulk Package Full Prescribing Information and patient Medication Guide.

    Please see Important Safety Information About Omniscan (gadodiamide) Injection Pharmacy Bulk Packaging below.

    Omniscan MRI contrast is a sterile, clear, colorless to slightly yellow, aqueous solution containing 287 mg/mL of Gadodiamide in +PLUSPAK polymer bottles, rubber stoppered vials and prefilled syringes.

    Product should be protected from strong daylight and direct exposure to sunlight. Do not freeze. Freezing can cause small crack in the vials, which would compromise the sterility of the product. Do not use if the product is inadvertently frozen. Store at a controlled room temperature 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP].

    A. Use only in a suitable work area, such as a laminar flow hood, to transfer contrast media from the Pharmacy Bulk Package.

    B. Penetrate the container closure only once using a suitable transfer device and aseptic technique.

    C. Once the closure is penetrated, withdraw the container contents without delay. If delay is unavoidable, complete the fluid transfer as soon as possible within a maximum time of 8 hours. 

    D. Once the closure is penetrated, keep the container is the aseptic area and at room temperature (do not exceed 30°C).

    E. Use each individual dose of Omniscan Injection immediately following withdrawal from the Pharmacy Bulk Package; discard any unused portion of the Omniscan Injection not used immediately. 

    F. Discard any remaining MRI Contrast in the Pharmacy Bulk Package 8 hours after the penetration of the container closure.

Reimbursement

See Indications and additional Important Safety Information about Omniscan at the bottom of this page.

Please also read the Full Prescribing Information and patient Medication Guide.

GE Healthcare Life Sciences Reimbursement

GE Healthcare advocates for timely patient access to medically appropriate, high quality contrast media services, provided by knowledgeable and skilled providers of care. We recognize the significant impact that reimbursement policies can have on you and your practice and strive to provide accurate and reliable information to help you navigate the reimbursement process.

Reimbursement Information for Contrast Agents:  Medicare Coding and Payment for Contrast Used in Magnetic Resonance Imaging Procedures

CodeMap Medicare Reimbursement Calculator

Coding and Payment Information

Under HOPPS, Medicare will continue “packaging” payment for contrast imaging agents into the payment for the associated procedure.

Contrast media is separately payable in physician offices and freestanding imaging centers. Payment is based on the average sales price (ASP) + 6%. ASP rates are adjusted quarterly and are based on the prior quarter’s ASP data. The rates can be viewed on the  Centers for Medicare & Medicaid Services (CMS) web site at:

https://www.cms.gov/McrPartBDrugAvgSalesPrice

Physicians performing diagnostic imaging procedures using contrast media should report the appropriate HCPCS code for the product along with the appropriate CPT® code(s) for the procedure(s). Physicians should select codes based on the iodine concentration used in the procedure. The mL of contrast volume reported should be consistent with the mL of contrast given to complete the imaging study. Listed above are applicable codes for Omniscan.

2016 Medicare Average Sales Price  
HCPCS Short Description Dosage Q1 Payment Q2 Payment Q3 Payment Q4 Payment
A9579
Gold-base MR Constrast
NOS
1 mL 1.890 - - -

Important Safety Information

Important Safety Information About OmniscanTM (gadodiamide) Injection

PRODUCT INDICATIONS: Omniscan is indicated for intravenous use in MRI to visualize lesions with abnormal vascularity in the brain, spine, and associated tissues; and within the thoracic (noncardiac), abdominal, pelvic cavities, and the retroperitoneal space.

Boxed Warning and Important Safety Information About Omniscan


WARNING — NOT FOR INTRATHECAL USE: Inadvertent intrathecal use of Omniscan has caused convulsions, coma, sensory, and motor neurologic deficits.


WARNING — NEPHROGENIC SYSTEMIC FIBROSIS (NSF): Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted magnetic resonance imaging (MRI) or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not administer Omniscan to patients with chronic, severe kidney disease (glomerular filtration rate [GFR] <30 mL/min/1.73m2) or acute kidney injury (AKI). Screen patients for AKI and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension, or diabetes), estimate GFR via laboratory testing. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs. Do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to any readministration



CONTRAINDICATIONS: Omniscan is contraindicated in patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m2), AKI, or prior hypersensitivity reaction to Omniscan.

WARNINGS AND PRECAUTIONS - Hypersensitivity: Anaphylactoid and anaphylactic reactions, with cardiovascular, respiratory, and/or cutaneous manifestations, resulting in death have occurred. Acute Renal Failure: In patients with renal insufficiency, acute renal failure requiring dialysis or worsening renal function have occurred, mostly within 48 hours of dosing. The risk of renal failure may increase with increasing dose. Impaired Visualization: GBCAs such as Omniscan might impair the visualization of lesions that are seen on the noncontrast MRI.

ADVERSE REACTIONS: In adult clinical trials, the most frequent adverse reactions were nausea, headache, and dizziness. In pediatric clinical trials, the adverse reactions were similar to those reported in adults. Postmarketing Experience - Nervous System: Inadvertent intrathecal use causes convulsions, coma, paresthesia, and paresis. General: Nephrogenic systemic fibrosis. Renal and Urinary System Disorders: In patients with preexisting renal insufficiency: Acute renal failure, renal impairment, and increased blood creatinine.

SPECIFIC POPULATIONS - Pregnancy: Adequate and well-controlled studies in pregnant women have not been conducted. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when administering Omniscan to a nursing woman. Pediatric Use: The safety and efficacy of a single dose of 0.05 to 0.1 mmol/kg have been established in pediatric patients two years of age and older, based on adequate and well-controlled studies of Omniscan in adults, a pediatric CNS imaging study, and safety data in the scientific literature. The optimal dosing regimen and imaging times in patients younger than two years of age have not been established. Geriatric Use: Clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity in the elderly cannot be ruled out. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The risk of toxic reactions to Omniscan is greater in patients with impaired renal function. Renal/Hepatic Impairment: Dose adjustments in renal or hepatic impairment have not been studied. Caution should be exercised in patients with impaired renal insufficiency.

Please also read the Full Prescribing Information and Medication Guide.