"The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.
GCTB generally occurs in a"...
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
The following adverse reactions are discussed in greater detail in other sections of the prescribing information:
- Nephrogenic systemic fibrosis [see CONTRAINDICATIONS, BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The adverse reactions described in this section were observed in a total of 1,309 subjects (24 healthy volunteers and 1,285 patients in clinical trials). Patients ranged in age from 12 to 85 years (mean age of 50 years) and 680 subjects (52%) were men. The ethnic distribution was 84% White, 9% Black, 3% Asian, and 4% other.
Overall, 460 subjects (35%) reported at least one adverse reaction. Most adverse reactions were mild or moderate in severity. The most commonly noted adverse reactions were: injection associated discomfort (26%), headache (9.4%), vasodilatation (6.4%), taste perversion (6.2%), dizziness (3.7%), nausea (3.2%), and paresthesia (2.2%). Table 2 lists adverse reactions reported in 1% or greater of patients.
Table 2 : Adverse Reactions Experienced by ≥ 1%
|Body System or Event||OptiMARK
(N = 1309)
|Injection associated discomfort||26.4%|
|Injection Site Reaction||1.5%|
The following adverse reactions occurred in less than 1% of the patients:
Metabolic and Nutritional: increased creatinine, edema, hypercalcemia
Special Senses: parosmia, tinnitus
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 (NSF)
- Hypersensitivity reactions
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.
Find out what women really need.