Initial treatment1
To start a new patient on Versacloz:
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Order Baseline Labs:
- Prior to initiating treatment, obtain a baseline absolute neutrophil count (ANC)
- For patients with documented Benign Ethnic Neutropenia (BEN), obtain at least two baseline ANC levels
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Verify Lab Results:
- General Population: VERSACLOZ initiation is not recommended in patients with a baseline ANC less than 1500/µL
- Patients with BEN: VERSACLOZ initiation is not recommended in patients with BEN with a baseline ANC less than 1000/µL
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Starting Dose
- The recommended starting oral dosage is 12.5 mg once or twice daily.
- This low starting dose is necessary to reduce the risk of orthostatic hypotension, bradycardia, and syncope
Initial Titration
- If well-tolerated, increase the total daily dose in increments of 25 mg to 50 mg per day.
- Achieve a target dosage of 150 mg to 225 mg twice per day (300-450 mg/day total) by the end of two weeks.
Subsequent Titration
- After the initial two weeks, the dosage may be increased in increments of up to 100 mg once weekly or twice weekly.
Maximum Dose
- The maximum recommended oral dosage is 450 mg twice daily (900 mg/day total).
Important Safety Information
DRUG INTERACTIONS
- CYP1A2 Inhibitors: Reduce VERSACLOZ dose to one-third when coadministered with strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, enoxacin). Dose reduction may be necessary with concomitant use of moderate or weak CYP1A2 inhibitors (e.g., oral contraceptives or caffeine).
- CYP2D6 or CYP3A4 Inhibitors. Dose reduction may be necessary with concomitant use of CYP2D6 or CYP3A4 inhibitors (e.g., cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline).
- CYP1A2 or CYP3A4 Inducers. Concomitant use with strong CYP3A4 inducers (carbamazepine, phenytoin, St. John's wort, rifampin) is not recommended. Dose increase may be necessary with concomitant use of moderate CYP1A2 (e.g., tobacco smoke) or CYP3A4 inducers. Consider reducing VERSACLOZ dose when CYP1A2 (e.g., tobacco smoke) or CYP3A4 (e.g., carbamazepine) inducers are discontinued.
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Reference: 1. Versacloz® Prescribing Information, Douglas Pharmaceuticals America Ltd. 2025
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