gadoversetamide (Rx)

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Brand and Other Names:OptiMARK

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

No Results

     activity indicator 
    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

            Risk for nephrogenic systemic fibrosis (NSF) with acute or chronic renal insufficiency (GFR <30 mL/min/1.73m²), hepatorenal syndrome, or acute renal insufficiency resulting from perioperative liver transplant

            NSF affects internal organs, skin, and muscle and can be fatal

            Only use if essential and MRI cannot not provide appropriate diagnostic image

            Screen for renal dysfunction, do not exceed recommended dosage, and allow for drug elimination before giving subsequent doses

            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

            Brain deposits

            • 7/28/2015: FDA is investigating the risk of brain deposits following repeated use of gadolinium-based contrast agents (GBCAs) for MRI
            • Recent 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
            • It is unknown whether these gadolinium deposits are harmful or can lead to adverse health effects
            • 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 Category: C

            Lactation: Excreted in milk of lactating rats; official prescribing information advises women to discontinue breastfeeding and discard milk for 72 hr after receiving gadoversetamide

            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

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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