Sovateltide Dosing for 50 kg Patient
For a 50 kg patient with acute cerebral ischemic stroke, administer sovateltide 0.3 µg/kg intravenously as a bolus over 1 minute, which equals 15 µg per dose.
Dosing Regimen
The complete treatment protocol consists of three doses per treatment day (0.9 µg/kg total daily dose), administered at 3 ± 1 hour intervals, on Days 1,3, and 6 following stroke onset. 1, 2
Specific Calculation for 50 kg Patient:
- Single dose: 0.3 µg/kg × 50 kg = 15 µg per injection 1, 2
- Daily total: 0.9 µg/kg × 50 kg = 45 µg (given as three 15 µg doses) 1, 2
- Treatment days: Day 1, Day 3, and Day 6 1, 2
Administration Details
- Route: Intravenous bolus 1, 2
- Duration of injection: Over 1 minute 1
- Timing between doses: 3 ± 1 hour intervals on each treatment day 1, 2
- Window for initiation: Within 24 hours of stroke onset 2, 3
Clinical Context
This dosing was established in Phase III trials where patients received the investigational drug at approximately 18 hours after stroke onset, with a median baseline NIHSS of 9-10. 2 The regimen demonstrated significant efficacy with 22.67% more patients achieving mRS 0-2 at 90 days compared to control (OR 2.75,95% CI 1.37-5.57). 2
Sovateltide was well-tolerated with no drug-related adverse events and no effect on hemodynamic, biochemical, or hematological parameters at this dosing. 1 The safety profile showed similar rates of intracranial hemorrhage between sovateltide (8.75%) and control groups (8.97%), indicating no increased bleeding risk. 2
Important Caveats
- This dosing applies specifically to acute cerebral ischemic stroke patients aged 18-78 years with NIHSS ≥6 and radiologic confirmation of stroke. 2
- Patients receiving endovascular therapy, those with intracranial hemorrhage, or recurrent stroke were excluded from trials and should not receive this regimen. 2
- No dose adjustment based on weight was used in clinical trials; the same 0.3 µg/kg dose was administered regardless of patient size. 1, 2