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Dronedarone Initiation and Titration Pathway

Document Purpose: Standardized recommendations for initiation of dronedarone and ongoing monitoring/patient management

Clinical Indication:

• Symptomatic AF in the absence of significant heart failure or liver abnormalities

Absolute Contraindications:

• Permanent AF

• Heart failure with recent decompensation requiring hospitalization

• Left ventricular systolic dysfunction (LVEF 440 msec (men) or >460 msec (women) in the absence of a pre-existing bundle branch block

• Severe hepatic impairment

Relative Contraindications (caution for use):

• Sinus bradycardia (25% increase from baseline QTc (>500ms) |

| |Every 6-12 months if stable |Heart rate 150ms |

| | |Heart rate 150ms |

| | |Heart rate 440 msec (men) or >460 msec (women) in the absence of a pre-existing bundle branch block

• Sinus bradycardia (75 years of age)

• Reactive airway disease

• Systolic heart failure (use cautiously if LVEF 1.4 cm on echocardiogram

• Hypokalemia or hypomagnesemia (correct imbalances prior to use and throughout therapy)

• Should be avoided in patients at high risk of Torsades de Pointes VT

o i.e. women aged >65 y taking diuretics or those with renal insufficiency

Baseline Investigations:

• Blood pressure

• ECG (within 1 week)

• Echocardiogram (or other assessment of LV function; within 1 year)

• Laboratory investigations (within 1 month) - Serum electrolytes, and Serum Creatinine/eGFR

Dosing:

• Starting Dose

o 40 mg BID (optional) or 80 mg BID (usual starting dose)

• Renal Dosing

o CrCl 40-60 ml/min: adjust dose to once daily

o CrCl < 40 ml/min: contraindicated

• Titration: See table below

|Current Dose |Increase Dose to |Decrease Dose to |

|40 mg BID |80 mg BID |----- |

|80 mg BID |120 mg BID |40 mg BID |

|120 mg BID |160 mg BID |80 mg BID |

|160 mg BID |-------- |120 mg BID |

If the patient’s dosing does not fall into one of the intervals, contact the EP/cardiologist or consult clinical pharmacist for closest equivalent dosing.

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Monitoring:

|Parameter |Frequency |Considerations |

|ECG |Within 7 days of a dose change |Notify prescriber if any of the following develop: |

| |Every 6-12 months if stable |>25% increase from baseline QTc (>500ms) |

| | |Heart rate 440 msec (men) or >460 msec (women) in the absence of a pre-existing bundle branch block

• Hypersensitivity to the drug components, including iodine

Relative Contraindications (caution for use):

• Sinus bradycardia (6 months) - Chest X-ray, PFT with DLCO

Dosing:

• Loading Dose

o 600 to 800 mg daily, in divided doses until 10 g total or

o 400 mg twice daily x 1 week then 400 mg once daily x 2 weeks or

o 400 mg daily x 1 month

• Maintenance Dose:

o 200 mg daily (lower maintenance doses can be considered)

Monitoring - Routine Surveillance for chronic amiodarone use

• ECG - every 6-12 months if stable

• Liver Panel & Thyroid Function Tests - every 6 months

• Chest-RAY – every 12 months

• Eye Exam – as needed for symptoms

• Pulmonary Function Test – as needed if symptoms arise

|Parameter |Frequency |Considerations |

|ECG |Within 7 days of a dose change,|QTc increases >25% of baseline or to ≥500 ms |

| |at the end of the loading |Notify MD/NP |

| |phase, and every 6-12 months |Given the risk of torsades is low for amiodarone it may be acceptable to continue despite QTc ≥550|

| | |ms |

| | |Look for reversible causes of QTc prolongation such as hypokalemia, hypomagnesemia, drug |

| | |interactions etc |

| | |Heart rate ................
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