OPTIMARK® (gadoversetamide) Injection
For more information about OPTIMARK®, please see the Full Prescribing Information and Medication Guide.
Dear Health Care Provider Letter - Gadolinium Retention.
IMPORTANT SAFETY INFORMATION
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
- Do not administer Optimark to patients with:
- chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
- Acute kidney injury
- Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
Do not exceed the recommended Optimark dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.------------------------------------------------
Indications and Usage
Optimark® (gadoversetamide) injection is a prescription gadolinium-based paramagnetic contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues. It is also indicated for use with MRI to provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomography.
Optimark is also contraindicated in patients with:
- Known hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
Warnings and Precautions
- Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs (<30 mL/min/1.73m2) and patients with acute kidney injury. Do not administer Optimark to these patients.
- Screen patients for acute kidney injury and other conditions that may reduce renal function. Serum creatinine levels and estimated GFR may not reliably assess renal function in the setting of acute kidney injury. For patients at risk for chronic kidney disease (e.g., age > 60 years, diabetes mellitus or chronic hypertension), estimate the GFR through laboratory testing.
- When administering Optimark, do not exceed the recommended dose and allow a sufficient period of time for elimination of the drug prior to any re-administration. Record the specific GBCA and the dose administered to a patient.
- Gadolinium Retention: Gadolinium is retained for months or years in several organs. The highest concentrations have been identified in the bone, followed by brain, skin, kidney, liver and spleen. The duration of retention also varies by tissue, and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs.
- Consequences of gadolinium retention in the brain have not been established. Adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.
- Acute Kidney Injury: In patients with chronically reduced renal function, acute kidney injury requiring dialysis has occurred with the use of GBCAs. The risk of acute kidney injury may increase with increasing dose of the contrast agent; administer the lowest dose necessary for adequate imaging.
- Severe hypersensitivity reactions including anaphylaxis have been observed with administration of gadolinium products including Optimark. Patients with a history of allergy, drug reactions or other hypersensitivity-like disorders may be at greater risk and should be closely observed during the procedure and for several hours after drug administration.
- Interference by Optimark in the measurements of serum iron, copper and zinc has been observed.
- In the presence of Optimark, the Ortho-cresophthalin complexone (OCP) produces an erroneous, low value for serum calcium. The magnitude of this artifact is proportional to the concentration of Optimark in the blood, and accurate values can be obtained approximately 90 minutes following injection. In patients with renal insufficiency, clearance of Optimark is slowed and the interference with calcium determination by OCP is prolonged.
- The following adverse reactions have been identified during post-approval use of Optimark. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Optimark.
- Nephrogenic Systemic Fibrosis
- Hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema
- Common adverse reactions were injection associated discomfort, headache, vasodilatation, taste perversion, dizziness, nausea, and paresthesia.
Use in Specific Populations
- Pregnancy: GBCAs cross the placenta and result in fetal exposure and gadolinium retention. The human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive. Instruct patients to inform their physician if they are pregnant.
- Nursing Mothers: Women should discontinue nursing and discard breast milk up to 72 hours after Optimark injection. Instruct patients to inform their physician if they are breast feeding.
- Pediatric Use: The safety and effectiveness of Optimark injection in pediatric patients have not been established. Pediatric patients may be particularly vulnerable to adverse GBCA reactions due to renal immaturity and/or unrecognized renal insufficiency.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/metwatch or call 1-800-FDA-1088.