Waylivra (volanesorsen) is a new type of selective P2X3 receptor antagonist, specifically indicated for the treatment of adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) who are at high risk of pancreatitis.
What are the Precautions for Waylivra (Volanesorsen) Administration?
Contraindication Confirmation
Waylivra is explicitly contraindicated in patients with hypersensitivity to the active pharmaceutical ingredient or any excipients.
Notably, this medication contains a sulfonamide moiety, which may cause cross-hypersensitivity reactions. A detailed allergy history must be obtained from the patient before administration.
Platelet Count Requirements
A platelet count test must be performed before treatment initiation. If the platelet count is below 140×10⁹/L, re-evaluation is required approximately one week later.
If the second measurement still falls below this value, initiation of Waylivra treatment is prohibited.
Standard Dosage Regimen
The recommended starting dose is 285 mg (1.5 mL), administered subcutaneously once weekly for 3 months.
After 3 months, the dosage frequency should be reduced to 285 mg every two weeks.
However, treatment should be discontinued if the patient's serum triglycerides decrease by <25% or fail to drop below 22.6 mmol/L after 3 months of treatment with 285 mg of Waylivra weekly.
Key Points for Administration Technique
Pre-injection Preparation: Before use, the pre-filled syringe should be removed from refrigerated storage (2°C to 8°C) and allowed to stand at room temperature for at least 30 minutes. Other heating methods must not be used.
Injection Site Selection: Include the abdomen, upper thigh area, or lateral upper arm area. If injecting into the upper arm, the injection must be administered by another person. Avoid injections in the waist and other areas that may be subjected to pressure or friction from clothing.
Waylivra (Volanesorsen) Administration Monitoring
Platelet Monitoring Requirements
Before Treatment Initiation: Platelet count must be measured. Re-evaluation is required if the count is below 140×10⁹/L.
During Treatment: Patients should have their platelet levels monitored at least every two weeks, depending on the platelet count.
Guidelines for Adjusting Monitoring Frequency
Platelet count ≥140×10⁹/L: Monitor every two weeks.
Platelet count 100-139×10⁹/L: Monitor weekly.
Platelet count 75-99×10⁹/L: Monitor weekly, and suspend treatment for at least 4 weeks. Resume treatment only when the platelet level returns to ≥100×10⁹/L.
Platelet count 50-74×10⁹/L: Monitor every 2-3 days.
Platelet count <50×10⁹/L: Monitor daily, and discontinue treatment.
Renal Function Monitoring
It is recommended to monitor for evidence of nephrotoxicity using routine urine dipsticks every quarter.
If the assessment result is positive, a more comprehensive renal function evaluation should be conducted.
