Gadoversetamide

Indications

Gadoversetamide is used for: Injection 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. It 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.

Adult Dose

Kilograms (kg) 40 Pounds (lb)88 Volume (mL)8.0 Kilograms (kg) 50 Pounds (lb)110 Volume (mL)10.0 Kilograms (kg) 60 Pounds (lb)132 Volume (mL)12.0 Kilograms (kg) 70 Pounds (lb)154 Volume (mL)14.0 Kilograms (kg) 80 Pounds (lb)176 Volume (mL)16.0 Kilograms (kg) 90 Pounds (lb)198 Volume (mL)18.0 Kilograms (kg)100 Pounds (lb)220 Volume (mL)20.0 Kilograms (kg) 110 Pounds (lb)242 Volume (mL)22.0 Kilograms (kg) 120 Pounds (lb)264 Volume (mL)24.0 Kilograms (kg) 130 Pounds (lb)286 Volume (mL)26.0 Kilograms (kg) 140 Pounds (lb) 308 Volume (mL) 28.0 Kilograms (kg) 150 Pounds (lb)330 Volume (mL)30.0

Child Dose

Renal Dose

Administration

Contra Indications

- chronic, severe kidney disease (glomerular filtration rate, GFR <30 mL/min/1.73m2), or - acute kidney injury, or - known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.

Precautions

Diagnostic procedures that involve the use of contrast agents should be carried out under direction of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed. Personnel trained in resuscitation techniques and resuscitation equipment should be available. The possibility of a reaction, including serious, life threatening, fatal, anaphylactoid or cardiovascular reactions or other idiosyncratic reactions should always be considered especially in those patients with a known clinical hypersensitivity, a history of asthma, or other respiratory disorders . Some paramagnetic contrast agents may impair the visualization of existing lesions, which are seen on the unenhanced, non-contrast MRI. This may be due to effects of the paramagnetic contrast agent, imaging parameters, misregistration, etc. CAUTION SHOULD BE EXERCISED WHEN A CONTRAST ENHANCED INTERPRETATION IS MADE IN THE ABSENCE OF A COMPANION UNENHANCED MRI.

Pregnancy-Lactation

Pregnancy GBCAs cross the placenta and result in fetal exposure and gadolinium retention Human data on the association between GBCAs and adverse fetal outcomes are limited and inconclusive Estimated background risk of major birth defects and miscarriage for the indicated population is unknown All pregnancies have a background risk of birth defect, loss, or other adverse outcomes Lactation Estimated infant exposure is 0.001%-0.04% of the maternal dose Unknown whether the effects of the drug on the breastfed infant or the effects of the drug on milk production Developmental and health benefits of breastfeeding should be considered together with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant or from underlying maternal condition

Interactions

Adverse Effects

Side effects of Gadoversetamide : 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

Mechanism of Action