redemplo plozasiran sodium injection reduce triglyceride levels of fcs 0

Description

Indication & Scope

Redemplo® Plozasiran Sodium Injection serves as chronic subcutaneous injection therapy to persistently reduce elevated serum triglyceride levels in adult patients diagnosed with familial chylomicronemia syndrome (FCS).

Mechanism: Hepatic-targeted small interfering RNA therapeutic. It binds and degrades hepatic apolipoprotein C-III (APOC3) messenger RNA, silences liver APOC3 protein synthesis, reduces circulating triglyceride-rich chylomicron particles and drastically lowers baseline serum triglyceride concentrations in FCS patients.
Drug class: Liver-directed APOC3 siRNA nucleic acid therapeutic / Lipid-lowering biologic injectable drug.
Clinical use: Long-term monthly prophylaxis for severe hypertriglyceridemia in FCS adults; reduces recurrent acute pancreatitis risk triggered by extreme triglyceride elevation, complementary to low-fat dietary intervention.

Specification

Generic Name	Plozasiran Sodium Injection
Brand Name	Redemplo
Ingredient	Plozasiran Sodium
Dosage Form	Injection
Package	0.5ml: 25mg*1 syringe/box
Conditions Treated	Severe hypertriglyceridemia secondary to familial chylomicronemia syndrome (FCS) in adult patients
Taboos	Severe hypersensitivity to plozasiran sodium or lipid nanoparticle formulation excipients; patients with decompensated cirrhosis or acute hepatic failure; pregnant and breastfeeding women
Place of origin	11040 Roselle Street, San Diego, CA 92121, USA
Prescription type	Prescription-only
Storage Conditions	Sealed prefilled syringes refrigerated continuously at 2°C–8°C, strictly avoid freezing; protect syringes from direct ultraviolet light exposure
Manufacturer	PCI San Diego, Inc.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	HJ20260001
Approval Date	Jan 5, 2026
Shelf Life	24 months

How to use ?

Recommended Dose: Standard fixed subcutaneous injection dose of 180 mg, administered once every four weeks (monthly maintenance dosing).

Time: Monthly fixed-day subcutaneous injection, no meal timing restrictions for administration.

Instructions for use: Deliver single subcutaneous injection into abdominal or thigh adipose tissue; perform baseline liver function testing before initiation; monitor serum triglycerides and hepatic transaminases every 3 months during chronic therapy; maintain strict low-fat dietary compliance alongside injections.

Interaction: Concurrent fish oil or fibrate lipid-lowering agents generate additive triglyceride reduction effect with minimal increased adverse risk; hepatotoxic medications require monthly liver enzyme monitoring co-administration.

Side effects:

1. Common mild adverse reactions: injection site erythema, pruritus, headache, mild transient ALT elevation, fatigue.

2. Rare severe risks: drug-induced liver injury, persistent hyperbilirubinemia, systemic hypersensitivity reactions.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What hepatic gene messenger RNA does Plozasiran Sodium Injection silence to lower serum triglycerides in FCS patients?

It degrades apolipoprotein C-III (APOC3) mRNA to block liver production of triglyceride-elevating APOC3 protein.

What severe life-threatening complication of familial chylomicronemia syndrome is the primary clinical outcome target of Plozasiran Sodium Injection therapy?

Recurrent episodes of acute pancreatitis driven by extreme circulating triglyceride concentrations.

What two routine laboratory biomarkers require quarterly monitoring during chronic Plozasiran Sodium Injection treatment?

Fasting serum triglyceride levels and liver function panel (ALT/AST bilirubin) to track hepatic safety and therapeutic response.

Why are patients with decompensated liver cirrhosis strictly prohibited from receiving Plozasiran Sodium Injection?

The lipid nanoparticle delivery system accumulates in damaged hepatocytes, raising irreversible drug-induced liver failure risk in cirrhotic patients.