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GADOVERSETAMIDE
Overview
What is OPTIMARK?
Optimark (gadoversetamide) injection is a nonionic gadolinium chelate of diethylenetriamine pentaacetic acid bismethoxyethylamide (gadoversetamide), for intravenous injection.
Optimark injection is provided as a sterile, preservative-free, nonpyrogenic, clear, and colorless to pale yellow, aqueous solution of gadoversetamide. Each mL of Optimark contains 330.9 mg of gadoversetamide (0.5 millimole), 28.4 mg of calcium versetamide sodium (0.05 millimole), 0.7 mg calcium chloride dihydrate (0.005 millimole), and water for injection. Sodium hydroxide and/or hydrochloric acid may have been added for pH adjustment.
Gadoversetamide is designated chemically as [8, 11-bis(carboxymethyl)-14-[2-[(2-methoxyethyl)amino]-2-oxoethyl]-6-oxo-2-oxa-5,8,11,14-tetraazahexadecan-16-oato(3-)] gadolinium with a formula weight of 661.77 g/mol and empirical formula of CHNOGd. The structural formula of gadoversetamide in aqueous solution is:
Optimark has a pH of 5.5 to 7.5. Pertinent physiochemical data are provided below (Table 4).
Optimark has an osmolality of approximately 3.9 times that of plasma (285 mOsm/kg water) and is hypertonic under conditions of use.
What does OPTIMARK look like?
What are the available doses of OPTIMARK?
Optimark is supplied as a clear, colorless to slightly yellow solution for injection in a 50 mL Pharmacy Bulk Package. Each mL contains 330.9 mg of gadoversetamide (equivalent to 0.5 mmol/mL) for injection.
What should I talk to my health care provider before I take OPTIMARK?
How should I use OPTIMARK?
Optimark is indicated for use with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues.
The 50 mL Pharmacy Bulk Package is used as a multiple dose container with an appropriate transfer device to fill empty sterile syringes. Use the following procedure when transferring Optimark from the pharmacy bulk package to individual syringes:
What interacts with OPTIMARK?
Sorry No Records found
What are the warnings of OPTIMARK?
Sorry No Records found
What are the precautions of OPTIMARK?
Sorry No Records found
What are the side effects of OPTIMARK?
Sorry No records found
What should I look out for while using OPTIMARK?
Optimark is contraindicated in patients with:
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.
What might happen if I take too much OPTIMARK?
Clinical consequences of overdosage with Optimark have not been reported. Treatment of overdose is directed toward supporting vital functions and prompt institution of symptomatic therapy. Optimark has been shown to be dialyzable .
How should I store and handle OPTIMARK?
Optimark should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. Optimark may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).How SuppliedOptimark is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. Optimark is supplied in 50 mL Pharmacy Bulk Packages containing 50 mL of solution. Each glass bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configuration: 50 mL in glass bottles in cartons of 5 bottles (NDC Code 0019-1177-50)StorageOptimark should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. Optimark may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).How SuppliedOptimark is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. Optimark is supplied in 50 mL Pharmacy Bulk Packages containing 50 mL of solution. Each glass bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configuration: 50 mL in glass bottles in cartons of 5 bottles (NDC Code 0019-1177-50)StorageOptimark should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. Optimark may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).How SuppliedOptimark is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. Optimark is supplied in 50 mL Pharmacy Bulk Packages containing 50 mL of solution. Each glass bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configuration: 50 mL in glass bottles in cartons of 5 bottles (NDC Code 0019-1177-50)StorageOptimark should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. Optimark may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).How SuppliedOptimark is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. Optimark is supplied in 50 mL Pharmacy Bulk Packages containing 50 mL of solution. Each glass bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configuration: 50 mL in glass bottles in cartons of 5 bottles (NDC Code 0019-1177-50)StorageOptimark should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. Optimark may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).How SuppliedOptimark is a clear, colorless to slightly yellow solution containing 330.9 mg/mL, (equivalent to 0.5 mmol/mL) of gadoversetamide for injection. Optimark is supplied in 50 mL Pharmacy Bulk Packages containing 50 mL of solution. Each glass bottle is rubber stoppered with an aluminum seal and the contents are sterile. Bottles are contained in shipping cartons with the following configuration: 50 mL in glass bottles in cartons of 5 bottles (NDC Code 0019-1177-50)StorageOptimark should be stored at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature] and protected from light and freezing. Optimark may be stored at 37°C for up to one month in a contrast media warmer utilizing circulating warm air. For periods longer than one month, store at 20°C to 25°C (68°F to 77°F).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Gadoversetamide is a paramagnetic agent that develops a magnetic moment when placed in a magnetic field. The relatively large magnetic moment can enhance the relaxation rates of water protons in its vicinity, leading to an increase in signal intensity (brightness) of tissues.
Non-Clinical Toxicology
Optimark is contraindicated in patients with: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.
The results of a study of coadministration of ethambutol hydrochloride (50mg/kg) with an aluminum hydroxide containing antacid to 13 patients with tuberculosis showed a reduction of mean serum concentrations and urinary excretion of ethambutol of approximately 20% and 13%, respectively, suggesting that the oral absorption of ethambutol may be reduced by these antacid products. It is recommended to avoid concurrent administration of ethambutol with aluminum hydroxide containing antacids for at least 4 hours following ethambutol administration.
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR <30 mL/min/1.73m) as well as patients with acute kidney injury. Do not administer Optimark to these patients. The risk appears lower for patients with chronic, moderate kidney disease (GFR 30 to 59 mL/min/1.73m) and little, if any, for patients with chronic, mild kidney disease (GFR 60 to 89 mL/min/1.73m). NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Report any diagnosis of NSF following Optimark administration to Liebel-Flarsheim Company LLC (1-855-266-5037) or FDA (1-800-FDA-1088 or www.fda.gov/medwatch).
Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury, or drug-induced kidney toxicity. 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.
Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. 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 .
The following adverse reactions are discussed in greater detail in other sections of the prescribing information:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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