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Optimark

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OptiMARK

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%)
Headache 123 (9.4%)
Pain Abdomen 24 (1.8%)
Asthenia 20 (1.5%)
Pain Back 16 (1.2%)
Pain 13 (1.0%)
Cardiovascular 103 (7.9%)
Vasodilatation 84 (6.4%)
Digestive 99 (7.6%)
Nausea 42 (3.2%)
Diarrhea 25 (1.9%)
Dyspepsia 16 (1.2%)
Injection Site 35 (2.7%)
Injection Site Reaction 20 (1.5%)
Musculoskeletal 18 (1.4%)
Nervous System 109 (8.3%)
Dizziness 49 (3.7%)
Paresthesia 29 (2.2%)
Respiratory 46 (3.5%)
Rhinitis 20 (1.5%)
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:

Body as a Whole: allergic reaction, edema face, fever, flu-like syndrome, malaise, mucous membrane discharge, neck rigidity, neck pain, pelvic pain, increased sweating

Cardiovascular: arrhythmia, chest pain, hypertension, hypotension, pallor, palpitation, syncope, tachycardia, vasospasm

Digestive: anorexia, increased appetite, constipation, dry mouth, dysphagia, eructation, flatulence, increased salivation, thirst, vomiting

Hemic and Lymphatic: thrombocytopenia

Metabolic and Nutritional: increased creatinine, edema, hypercalcemia, hyperglycemia, hypoglycemia, hyponatremia

Musculoskeletal: arthralgia, leg cramps, myalgia, myasthenia, spasm

Nervous System: agitation, anxiety, confusion, depersonalization, diplopia, dystonia, hallucinations, hypertonia, hypesthesia, nervousness, somnolence, tremor, vertigo

Respiratory System: asthma, cough, dyspnea, epistaxis, hemoptysis, laryngismus, pharyngitis, sinusitis, voice alteration

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

Special Senses: amblyopia, conjunctivitis, hyperacusis, parosmia, tinnitus

Urogenital: dysuria, oliguria, urine frequency

Post-Marketing Experience

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) (see WARNINGS); hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema; and seizure.

Read the OptiMARK (gadoversetamide injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drug interactions with other contrast agents and other drugs have not been studied.

Laboratory Test interactions

Interference by OptiMARK™ Injection in the measurement of serum iron, copper and zinc has been observed. OptiMARK™ Injection causes interference in the measurement of serum calcium using the ortho-cresophthalin complexone (OCP) colorimetric method. In the presence of OptiMARK™ Injection, OCP produces an erroneous, low value for serum calcium. The magnitude of this artifact is proportional to the concentration of OptiMARK™ Injection in the blood, and accurate values can be obtained approximately 90 minutes following injection. In patients with renal insufficiency, clearance of OptiMARK™ Injection is slowed and the interference with calcium determination by OCP is prolonged. Neither the arsenazo III dye system nor the inductively coupled plasma mass spectroscopy methods for calcium assay are affected by OptiMARK™ Injection.

Last reviewed on RxList: 9/9/2013
This monograph has been modified to include the generic and brand name in many instances.

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