"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
- Clinician Information:
Optimark Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
OptiMARK 0.5 mmol/mL (gadoversetamide) Injection is a paramagnetic agent used with magnetic resonance imaging (MRI) in patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues, and 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. Common side effects include headache, widening of blood vessels, changes in taste, dizziness, nausea, and tingling sensation.
OptiMARK Injection is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual or by power injection. OptiMARK may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, OptiMARK should be used only if prescribed. OptiMARK passes into breast milk. Women should discontinue nursing and discard breast milk up to 72 hours after receiving OptiMARK Injection. Consult your doctor before breastfeeding.
Our OptiMARK 0.5 mmol/mL (gadoversetamide) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Optimark FDA Prescribing Information: Side Effects
A total of 1309 subjects (24 healthy volunteers and 1285 patients) received OptiMARK™ Injection and 46 subjects received placebo (saline). Of the 1309 subjects who received OptiMARK™ Injection, 680 (52%) were men and 629 (48%) were women with a mean age of 50 years (range 12 to 85 years). In this population there were 1102 (84%) white, 116 (9%) black, 33 (3%) Asian, and 58 (4%) subjects and patients of other racial groups.
In the clinical trials there were 8 serious adverse events and 1 death. The one death occurred in a patient with advanced multisystem disease and appeared to be related to the underlying disease. Six of the eight serious events appeared to be related to underlying disease. Two patients had either persistent paresthesia or numbness of unknown etiology that required hospitalization for diagnostic evaluations or treatment.
Of the 1309 subjects, 460 (35%) reported at least one adverse event out of a total of 997 adverse events; and 22 (47.8%) of the 46 subjects who received placebo reported at least one adverse event out of a total of 81 adverse events.
The most commonly noted adverse events were headache (9.4%), vasodilatation (6.4%), taste perversion (6.2%), dizziness (3.7%), nausea (3.2%), and paresthesia (2.2%). All adverse events reported in 1% or greater of all patients are listed in Table 5. Of the subjects and patients who experienced adverse events, 95.8% of the adverse events were of mild or moderate intensity after dosing with OptiMARK™ Injection.
Table 5: Summary Adverse Events Experiencedby
≥ 1% of the Patients
|Body System or Event Type||OptiMARK™
(N = 1309)
|Number of patients with one or more adverse events||460 (35.1%)|
|Total Number of Adverse Events||997|
|Patients with any injectionassociated discomfort||345 (26.4%)|
|Body as a Whole||193 (14.7%)|
|Pain Abdomen||24 (1.8%)|
|Pain Back||16 (1.2%)|
|Injection Site||35 (2.7%)|
|Injection Site Reaction||20 (1.5%)|
|Nervous System||109 (8.3%)|
|Skin and Appendages||37 (2.8%)|
|Special Senses||96 (7.3%)|
|Taste Perversion||81 (6.2%)|
The following adverse reactions occurred in less than 1% of the patients:
Hemic and Lymphatic: thrombocytopenia
Skin and Appendages: application site reaction, edema injection site, erythema multiforme, pruritus, rash macular-papular and vesicullous bullous, skin dry, thrombophlebitis, inflammation injection site, urticaria
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™ .
Read the entire FDA prescribing information for Optimark (Gadoversetamide Injection) »
Additional OptiMARK Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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