Volanesorsen (Waylivra) is a medication indicated for the treatment of specific hereditary hypertriglyceridemia. By inhibiting the synthesis of apolipoprotein C-III, it effectively reduces blood triglyceride levels, thereby lowering the risk of pancreatitis.
What are the Indications for Volanesorsen (Waylivra)?
Main Indications
Volanesorsen is indicated as adjunctive therapy in adult patients with familial chylomicronemia syndrome (FCS).
FCS is a rare hereditary disorder characterized by significantly elevated levels of chylomicrons and triglycerides in the blood due to genetic mutations. Patients are highly susceptible to acute pancreatitis, which poses a serious threat to life and health.
Target Population
Diagnosis of FCS confirmed by genetic testing.
At high risk of pancreatitis.
Triglyceride levels remain inadequately controlled despite adherence to dietary management and other lipid-lowering medications.
Specifications and Properties of Volanesorsen (Waylivra)
Active Ingredient Composition
Each milliliter of solution contains 200 mg of volanesorsen sodium salt, equivalent to 190 mg of volanesorsen active ingredient.
Each single-dose prefilled syringe contains 285 mg of volanesorsen in a 1.5 mL volume.
Formulation Characteristics
Dosage form: Solution for injection (prefilled syringe).
Appearance: Clear, colorless to pale yellow liquid.
pH value: Approximately 8.0.
Osmolality: 363–485 mOsm/kg.
Excipient composition: Water for injection, sodium hydroxide, and hydrochloric acid (for pH adjustment).
Packaging Specifications
Single packaging: 1 prefilled syringe.
Multiple packaging: Combination of 4 individually packaged prefilled syringes.
Storage Conditions for Volanesorsen (Waylivra)
Routine Storage Requirements
Primary storage condition: Refrigerate at 2°C to 8°C.
Must be stored in the original carton to protect from light.
Freezing is strictly prohibited.
Special Usage Conditions
After removal from refrigeration, the medication can be stored at room temperature (not exceeding 30°C) for a maximum of 6 weeks. During this period, it may be moved between refrigerated and room temperature environments as needed.
The date of first removal from the refrigerator must be recorded in the designated area on the outer carton.
If not used within 6 weeks, the medication must be discarded immediately.
The original packaging must be retained during room temperature storage.
Pre-Use Inspection Standards
Visually inspect the solution before injection: It must remain clear, colorless to pale yellow.
If turbidity, precipitation, or visible particles are present, do not use the medication and return it to the pharmacy.
Disposal Precautions
Each prefilled syringe is for single use only.
After use, it must be placed in a dedicated sharps container and disposed of professionally in accordance with local medical waste disposal regulations.
