Volanesorsen (Waylivra) is an antisense oligonucleotide drug that selectively inhibits apolipoprotein C-III (apoC-III). It is specifically indicated for adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) who are at high risk of pancreatitis. The drug exerts its effects by regulating triglyceride metabolism, and its use must strictly adhere to the principle of individualized medication.

Dosage and Administration of Volanesorsen (Waylivra)

Standard Dosing Regimen

The recommended starting dose of volanesorsen is 285 mg (1.5 mL solution) administered subcutaneously once weekly for 3 months.

After completing 3 months of treatment, the dosing frequency should be adjusted to once every two weeks.

Each injection should be administered on the same day of the scheduled date determined by the healthcare professional to maintain stable blood drug concentrations.

Evaluation of Treatment Response

After 3 months of treatment with 285 mg volanesorsen weekly, if the patient’s serum triglyceride level reduction does not reach 25% or fails to decrease to below 22.6 mmol/L, treatment should be discontinued.

For patients with suboptimal serum triglyceride reduction after 6 months of treatment, if the platelet count is within the normal range, the dosing frequency may be re-adjusted to once weekly.

Administration Operating Specifications

Volanesorsen is for subcutaneous injection only; intramuscular or intravenous injection is strictly prohibited.

Each prefilled syringe is for single use only and must not be reused.

Before injection, the drug should be removed from the refrigerator and allowed to reach room temperature in its original packaging for at least 30 minutes. Other heating methods must not be used.

Dosage Adjustments for Volanesorsen (Waylivra)

Platelet Monitoring Requirements

Platelet count must be measured before initiating treatment.

If the initial platelet count is below 140 x 10⁹/L, it should be rechecked after approximately one week. If the second measurement is still below this value, treatment should not be initiated.

After starting treatment, patients should have their platelet count monitored at least every two weeks based on platelet levels.

The treatment and monitoring plan should be adjusted according to laboratory test results in accordance with the monitoring and treatment recommendation table in the product insert.

Missed Dose Handling

If a missed dose is discovered within 48 hours, the missed dose should be administered as soon as possible.

If more than 48 hours have passed since the missed dose, the dose should be skipped, and the next injection should be given as scheduled.

Use in Special Populations

Patients with Renal Impairment

No starting dose adjustment is required for patients with mild to moderate renal impairment.

The safety and efficacy of volanesorsen in patients with severe renal impairment have not been established, and these patients require close monitoring.

Patients with Hepatic Impairment

The drug has not been studied in patients with hepatic impairment.

Since volanesorsen is not metabolized by the hepatic cytochrome P450 enzyme system, dose adjustment may not be necessary for patients with hepatic impairment.

Pregnant and Lactating Women

Data on the use of volanesorsen in pregnant women are limited. Animal studies have not shown direct or indirect harmful effects.

As a precautionary measure, use during pregnancy is not recommended.

Lactating women should consider discontinuing breastfeeding or stopping treatment, weighing the benefits of breastfeeding for the infant against the benefits of treatment for the woman.