What is the recommended weight‑based intravenous bolus dosing regimen of sovateltide for adult patients with acute ischemic stroke?

Sovateltide Dosing for Acute Ischemic Stroke

The recommended intravenous dosing regimen of sovateltide for adult patients with acute cerebral ischemic stroke is 0.3 µg/kg administered as an IV bolus over 1 minute, given in three doses at 3 ± 1 hour intervals on Days 1,3, and 6 (total daily dose of 0.9 µg/kg on each treatment day). 1, 2

Weight-Based Dosing Protocol

• Each individual dose is 0.3 µg/kg body weight administered as an intravenous bolus over exactly 1 minute 1, 2
• Three doses are given per treatment day at intervals of 3 ± 1 hours (meaning 2-4 hours between doses) 1, 2
• Treatment days are Day 1, Day 3, and Day 6 following stroke onset 1, 2
• Total daily dose on each treatment day is 0.9 µg/kg (0.3 µg/kg × 3 doses) 1, 2

Administration Timing and Patient Selection

• Sovateltide should be initiated within 24 hours of stroke onset in patients with radiologically confirmed acute cerebral ischemic stroke 1, 2
• Patients must have an NIHSS score ≥ 6 at presentation to qualify for treatment 2
• Age range for treatment is 18-78 years based on the phase III trial that led to regulatory approval 2
• The median time to first dose administration in clinical trials was approximately 18 hours after stroke onset 2

Key Exclusion Criteria

• Patients receiving endovascular therapy are excluded from sovateltide treatment 1, 2
• Intracranial hemorrhage is an absolute contraindication 1, 2
• Recurrent stroke patients should not receive sovateltide 2

Administration Technique

• Administer as a slow IV bolus push over 1 minute (not as an infusion) 1, 2
• Each dose is given separately with the specified 3 ± 1 hour interval between the three daily doses 1, 2
• Sovateltide is administered in addition to standard of care for acute ischemic stroke 1, 2

Safety Profile

• Sovateltide was well-tolerated with no drug-related adverse events in clinical trials 1
• Hemodynamic, biochemical, and hematological parameters were not affected by sovateltide administration 1
• The incidence of intracranial hemorrhage was similar between sovateltide (8.75%) and control groups (8.97%), indicating no increased bleeding risk 2

Clinical Context and Efficacy

• Sovateltide received regulatory approval in India in May 2023 for treatment of cerebral ischemic stroke within 24 hours of onset 3
• At 90 days post-treatment, 22.67% more patients achieved mRS 0-2 (odds ratio 2.75) with sovateltide compared to standard of care alone 2
• 17.05% more patients achieved NIHSS 0-5 at 90 days (odds ratio 2.67) with sovateltide treatment 2

Critical Dosing Distinction

• Do not confuse sovateltide dosing (0.3 µg/kg per dose) with thrombolytic dosing used for other stroke medications like alteplase (0.9 mg/kg) or tenecteplase 4, 5
• Sovateltide uses micrograms per kilogram (µg/kg), not milligrams, reflecting its potency as an endothelin-B receptor agonist 1, 2