gadoversetamide (Rx)

Brand and Other Names:OptiMARK
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 330.9 mg/mL (0.5mmol/mL)
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CNS or Liver MRI

Indicated for use with MRI in abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues; also indicated to enhance visualization of lesions with abnormal vascularity in the liver

0.2 mL/kg (0.1 mmol/kg) IV; infuse peripherally at rate of 1-2 mL/sec

Safety and efficacy not established

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Interactions

Interaction Checker

and gadoversetamide

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Headache (9.4%)

            Vasodilation (6.4%)

            Dizziness (3.7%)

            Nausea (3.2%)

            Paresthesia (2.2%)

            Diarrhea (1.9%)

            Abdominal pain (1.8%)

            Rhinitis (2%)

            Injection site reaction (2%)

            Back pain (1%)

            Dyspepsia (1%)

            <1%

            Seizures

            Amblyopia

            Anorexia

            Cough

            Diplopia

            Dry skin

            Dystonia

            Flatulence

            Hyponatremia

            Neck pain

            Pallor

            Parosmia

            Rash

            Seizure

            Postmarketing Reports

            Seizures

            Nephrogenic systemic fibrosis

            Hypersensitivity reactions including bronchospasm and laryngeal/pharyngeal edema

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            Warnings

            Black Box Warnings

            Nephrogenic systemic fibrosis

            • Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs
            • Avoid use of GBCAs in these patients unless diagnostic information is essential and not available with noncontrasted MRI or other modalities
            • NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs
            • Highest risk for NSF is among patients with chronic, severe kidney disease (GFR <30 mL/min/1.73²) OR acute kidney injury
            • Screen patients for acute kidney injury and other conditions that may reduce renal function
            • For patients at risk for chronically reduced renal function (eg, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing
            • For patients at highest risk for NSF, do not exceed recommended dose and allow a sufficient period of time for elimination of the drug from the body prior to readministration

            Contraindications

            Severe hypersensitivity reactions including anaphylaxis reported

            Acute kidney disease or chronic, severe kidney disease (ie, GFR<30 mL/min/1.73m²); use associated with increased risk for nephrogenic systemic fibrosis (NSF)

            Cautions

            Screen all patients for renal dysfunction

            Acute renal failure has occurred in patients with pre-existing renal insufficiency; use the lowest necessary dose and evaluate renal function

            Nephrogenic systemic fibrosis (NSF) reported in patients with impaired elimination; higher than recommended dosing or repeat dosing appears to increase the risk

            Anaphylactoid and other serious hypersensitivity reactions including fatal reactions reported, particularly in patients with history of allergy or drug reactions; monitor patients closely for need of emergency cardiorespiratory support

            Thrombotic syndromes, anemia, hepatic/renal impairment, hemoglobinopathies (sickle cell anemia)

            Risk of hypotension

            Caution with hepatic impairment

            History of grand mal seizure

            Gadolinium retention

            • Gadolinium is retained for months or years in several organs
            • Highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (eg, brain, skin, kidney, liver, and spleen)
            • Duration of retention also varies by tissue and is longest in bone
            • Patients requiring multiple lifetime doses, pregnant and pediatric patients, and patients with inflammatory conditions are at higher risk of gadolinium retention
            • Brain deposits
              • FDA investigated the risk of brain deposits following repeated use of GBCAs for MRI in 2015
              • Publications in the medical literature have reported that deposits of GBCAs remain in the brains of some patients who undergo ≥4 contrast MRI scans, long after the last administration
              • As of 2017, the FDA review had not identified adverse health effects from gadolinium retained in the brain after the use of GBCAs MRI; all GBCAs may be associated with some gadolinium retention in the brain and other body tissues
              • Early data in rat studies show that linear GBCAs are more prone to dissociation into free gadolinium and demonstrate greater brain deposition than macrocyclic GBCAs, which are less prone to dissociation
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            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

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Nonionic gadolinium contrast agent; paramagnetic ion that develops a magnetic moment when placed in magnetic field that can disrupt water protons in the vicinity leading to an increase in signal intensity (brightness) of tissues

            Pharmacokinetics

            Half-Life: 103.6 minutes (elimination)

            Vd: 162 mL/kg

            Excretion: Urine (96%)  

            Hemodialysis: 98% removed by hemodialysis over 3 sessions within 120 hr

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.