rufinamide (Rx)

Brand and Other Names:Banzel
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
  • 400mg

oral suspension

  • 40mg/mL
more...

Lennox-Gastaut Syndrome

Indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome

Initial: 400-800 mg/day PO divided q12hr

Target dose: Increase daily dose by 400-800 mg every other day until a maximum of 3200 mg/day divided q12hr is reached

Unknown whether dose lower than the target dose is effective

Dosage Modifications

Hemodialysis: Systemic exposure may be reduced to a limited (~30%); consider adjusting dose during the dialysis process

Hepatic impairment: Not studied; therefore, not recommended with severe hepatic impairment

Coadministration with valproate: Initiate at a dose lower dose (ie, <400 mg/day)

Dosage Forms & Strengths

tablet

  • 200mg
  • 400mg

oral suspension

  • 40mg/mL
more...

Lennox-Gastaut Syndrome

Indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome

<1 year: Safety and efficacy not established

≥1 year

  • Initial: 10 mg/kg/day PO divided q12hr  
  • Target dose: Increase by ~10 mg/kg every other day until maximum of 45 mg/kg/day divided q12hr reached; not to exceed 3200 mg/day
  • Unknown whether dose lower than target dose is effective

Dosage Modifications

Hemodialysis: Systemic exposure may be reduced to a limited (~30%); consider adjusting dose during the dialysis process

Hepatic impairment: Not studied; therefore, not recommended with severe hepatic impairment

Coadministration with valproate: Initiate at a dose lower dose (ie, <10 mg/kg/day)

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Interactions

Interaction Checker

and rufinamide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Diplopia

            Dizziness

            Fatigue

            Headache

            Somnolence

            Nausea

            Vomiting

            Postmarketing reports

            Steven's-Johnson syndrome

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            Warnings

            Contraindications

            Documented hypersensitivity

            Familial Short QT syndrome

            Cautions

            Shortens QT interval

            Not recommended in severe hepatic impairment

            Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported in patients taking antiepileptic drugs, including rufinamide; DRESS may be fatal or life-threatening; if DRESS suspected, evaluate patient immediately; discontinue therapy and initiate alternative treatment

            Withdraw gradually

            May impair ability to drive or perform hazardous tasks

            May render hormonal contraceptives ineffective

            Monitor for suicidal behavior

            • (See FDA Warning on potential suicidal behavior)
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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk; do not nurse

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Modulates activity of sodium channels, prolonging their inactive state, which in turn limits repetitive firing of sodium-dependent action potentials and causing anticonvulsant effects

            Pharmacokinetics

            Bioavailability: 85%; increases by food

            Half-Life: 6-10 hr

            Vd: 50 L

            Peak Plasma Time: 4-6 hr

            Protein Bound: 34%

            Enzymes induced: weak: CYP3A4

            Enzymes Inhibited: weak: CYP2E1

            Metabolism: hydrolysis of carboxamide group to inactive derivative

            Excretion: Urine

            Dialyzable: Yes (hemodialysis)

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            Administration

            Instructions

            Take with food

            May crush tablet or cut in half

            Measure and administer the oral suspension with the provided adapter and calibrated oral dosing syringe

            Discontinuing drug

            • Do not abruptly discontinue
            • Reduce dose by 25% every 2 days to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus
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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.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • 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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