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dofetilide (Rx)Brand and Other Names:Tikosyn

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 125mcg
  • 250mcg
  • 500mcg
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Conversion of Atrial Fibrillation/Flutter to Normal Sinus Rhythm

QTc must be <440 msec (or <500 msec with ventricular conduction abnormalities) before initiating first dose; contraindicated if >440 msec (or >500 msec with ventricular conduction abnormalities)

Initial dose

  • CrCl >60 mL/min: 500 mcg PO q12hr
  • CrCl 40-60 mL/min: 250 mcg PO q12hr
  • CrCl 20-40 mL/min: 125 mcg PO q12hr
  • CrCl <20 mL/min: Contraindicated

Sinus Rhythm Maintenance After Conversion

  • Post initial dose adjustment based on QTc (2-3 hours after initial dose)
  • If QTc increases <15% of baseline, continue current dose
  • If QTc increases >15% or >500 msec (550 msec with ventricular conduction abnormalities) decrease dose as follows:
  • If initial dose 500 mcg q12hr, decrease to 250 mcg q12hr
  • If initial dose 250 mcg q12hr, decrease to 125 mcg q12hr
  • If initial dose 125 mcg q12hr, decrease to 125 mcg qDay

Monitoring

Must be hospitalized to initiate

Measure QTc 2-3 hours after first 5 doses during inpatient stay

Discontinue dofetilide if at any time after second dose, QTC >500 msec (550 msec with ventricular conduction abnormalities)

Not recommended

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Interactions

Interaction Checker

dofetilide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (11%)

            1-10%

            Chest pain (10%)

            Dizziness (8%)

            Insomnia (4%)

            Respiratory tract infection (7%)

            Dyspnea (6%)

            Rash (3%)

            Flu-like syndrome (4%)

            Back pain (3%)

            Ventricular tachycardia (3-4%)

            Torsade de pointes (3% in HF patients and 0.9% in patients with recent MI)

            Nausea (5%)

            Diarrhea (3%)

            Frequency Not Defined

            AV block, QTc interval prolongation, torsades de pointes, ventricular arrhythmias

            Difficulty sleeping

            Liver damage

            Cough

            Paresthesia

            Angioedema

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            Warnings

            Black Box Warnings

            Hospitalize minimum of 3 days during initiation or reinitiation to minimize risk of induced arrhythmia

            Facility must provide CrCl calculations, continuous ECG monitoring, and resuscitation for at least 3 days when initiating or restarting therapy

            Experienced personnel who manage serious arrhythmias & setting required

            Monitoring

            • Baseline & continuous ECG during therapy
            • Do not initiate if baseline QTc >440 msec (500 msec in patients w/ ventricular conduction problems)
            • Do not initiate if heart rate <60 bpm
            • Baseline CrCl determines initial dosage; dosage adjustments determined by QTc changes
            • Reevaluate renal function and QTc q3mth or more often if medically required

            Contraindications

            Hypersensitivity

            Congenital or acquired long QT syndromes; do not use with baseline QTc >440 msec (500 msec with ventricular conduction abnormalities)

            Concomitant use of cation transport system inhibitors (eg, verapamil, cimetidine, trimethoprim, ketoconazole, prochlorperazine, dolutegravir and megestrol); each of these drugs cause a substantial increase in dofetilide plasma concentrations

            Severe renal impairment: CrCl <20 mL/min

            Cautions

            Atrioventricular block, bradycardia, electrolyte imbalance, patients taking potassium-depleting diuretics, moderate QT interval prolongation prior to treatment, proarrhythmic events, liver disease, renal impairment

            Coadministration of drugs that prolong QT interval and other antiarrhythmic agents: phenothiazines, cisapride, bepridil, TCAs, oral macrolides, class I or class III antiarrhythmics & amiodarone

            Grapefruit juice may increase levels; avoid concurrent use

            Magnesium and potassium serum levels should be maintained within normal range to avoid QTc prolongation

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: excretion in milk unknown/not recommended

            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

            Blocks channels carrying delayed rectifier potassium currents, IKr

            Markedly prolongs action potential as a result of delayed repolarization

            Absorption

            Bioavailability: >90%

            Peak Plasma Time: 2-3 hr

            Onset: 2 hr

            Duration: 4 hr

            Distribution

            Protein Bound: 60-70%

            Vd: 3-4 L/kg

            Metabolism

            50% of absorbed dose metabolized in liver by CYP3A4 to inactive metabolites

            Metabolites: No quantifiable metabolites found in plasma, 5 metabolites identified in urine

            Elimination

            Half-Life: 10 hr

            Excretion: 80% urine; <10% feces

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            Images

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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.
            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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