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.
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.
Omniscan is approved for multiple contrast media indications.1,2
(central nervous system)
brain x x 0.1 mmol/kg IV bolus spine x x 0.1 mmol/kg IV bolus
Body adult pediatric
x x 0.05 mmol/kg IV bolus intrathoracic x x 0.1 mmol/kg IV bolus intra-abdominal x x 0.1 mmol/kg IV bolus pelvic x 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.
Omniscan is available in a variety of packaging options:
- Glass vials
Product Product Code NDC 5 mL in 10 mL VIAL J068
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
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
Product Product Code NDC 100 mL +PLUSPAK Pharmacy Bulk Pack J800
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.
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
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:
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|
||Gold-base MR Constrast
Professional Resources and Disclosures
Please see the following for more information: