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REDEMPLO plozasiran 25 mg/.5mL Injection, Solution, 1 syringe — NDC 84141-0025-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

REDEMPLO plozasiran 25 mg/.5mL Injection, Solution, 1 syringe — NDC 84141-025-01 (Billing 84141-0025-01)

by Arrowhead Pharmaceuticals, Inc. · 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS

This is a package of 1 syringe of REDEMPLO plozasiran 25 mg/.5mL Injection, Solution from Arrowhead Pharmaceuticals, Inc., marketed since Nov 2025 and currently FDA-listed. It is this product's only package size.

NDC 84141-0025-01
🏷️ FDA NDC (as labeled) 84141-025-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 84141-025-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
84141 labeler · 025 product · 01 package
Package marketed since
Nov 19, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8414102501 7
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84141-025-01
Product NDC 84141-025
11-digit billing NDC 84141002501
NCPDP billing unit ML — per mL (volume)
RxCUI 2728183, 2728184
UNII XG9ARL6P25
Application # NDA219947
SPL Set ID 7fd37993-f85a-4af1-8bbe-133299f226ed
Established class (EPC) APOC-III-directed RNA Interaction; Small Interfering RNA
Physiologic effect Increased RNA Degradation
Chemical class RNA, Small Interfering
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-19
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance PLOZASIRAN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 088421
GCN 58549
HICL code 051006
Ingredient (HICL) Plozasiran Sodium
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M4
Therapeutic class — intermediate (HIC2) Affect Blood Lipids/Sugar/Amino Acids
HIC3 code M4R
Therapeutic class — specific (HIC3) Antihyperlipidemic - Apolipoprotein Inhibitor
AHFS code 24:06.92.00
AHFS class Antilipemic Agents, Miscellaneous
FDB label name REDEMPLO 25 MG/0.5 ML SYRINGE
FDB brand name Redemplo
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 088421
  • GCN: 58549
  • HICL (First Databank): 051006
  • AHFS class code: 24:06.92.00
  • RxCUI (RxNorm): 2728183
Why two NDCs? The FDA registers this code as 84141-025-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84141-0025-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Small Interfering RNA class.

Pharmacologic class Small Interfering RNA, APOC-III-directed RNA Interaction
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name REDEMPLO 25 MG/0.5 ML SYRINGE Ingredient Plozasiran Sodium
📖 What it is MedlinePlus · NLM

Plozasiran injection is used to reduce triglycerides (a type of fat that your body uses for energy but can cause heart disease, strokes or problems with your pancreas if levels get too high) in patients with familial chylomicronemia syndrome(FCS; a rare genetic disorder where the body does not break down fats which leads to increased triglyceride levels). Plozasiran injection is in a class of medications called apolipoprotein C-III inhibitors. It works by decreasing the production of apoC-III, which increases the breakdown and removal of triglycerides from the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It lowers triglycerides in adults with familial chylomicronemia syndrome, an inherited condition that causes very high triglycerides. You use it along with a low-fat diet, not inst...
  • Just once every 3 months, under the skin of your thigh or abdomen. Someone else can use the outer upper arm. We'll make sure you or a caregiver are trained before the first dose.
  • Take it as soon as you remember. Then count 3 months from that date for your next dose.
  • The most common are high blood sugar, headache, nausea, and injection site reactions. Because blood sugar can rise, tell your doctor about symptoms of high blood sugar or if you ha...
📖 Read our full Plozasiran guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $21,494.37 $21,494.37 / 1 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84141-0025-01 You're viewing this Main listing 1 SYRINGE, GLASS in 1 CARTON / 1 mL in 1 SYRINGE, GLASS 2025-11-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Redemplo 25 mg/.5mLthis 84141-0025-01 Arrowhead 1 syringe — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
First FDA approval
Nov 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2038
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Sep 2038. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 18, 2025 RLD RS ⏳ ~11.9 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 12365899 — drug substance (U-4360)
US 11214801 — drug substance (U-4360)
US 10597657 — drug substance (U-4360)
US 10294474 — drug substance (U-4360)
US 11174481 — drug substance
Exclusivity ODE-541
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (5)
PatentTypeUse codeExpires
US 12365899 ↗ Drug substance U-4360 Sep 10, 2038
US 11214801 ↗ Drug substance U-4360 Sep 10, 2038
US 10597657 ↗ Drug substance U-4360 Sep 10, 2038
US 10294474 ↗ Drug substance U-4360 Mar 7, 2037
US 11174481 ↗ Drug substance — Mar 7, 2037
FDA exclusivity
CodeWhat it grantsExpires
ODE-541Orphan Drug Exclusivity (7-year)Nov 18, 2032
Common questions
Is there a generic version of REDEMPLO 25 MG/0.5 ML SYRINGE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for REDEMPLO 25 MG/0.5 ML SYRINGE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Sep 2038 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Plozasiran inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerArrowhead Pharmaceuticals, Inc.
Application holderARROWHEAD PHARMACEUTICALS INC
FDA applicationNDA219947 (NDA)
Labeler code84141
First marketedNov 2025
Product typeHuman Prescription Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

1 INDICATIONS AND USAGE REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). REDEMPLO is an apolipoprotein C-III ( apoC-III )-directed small interfering ribonucleic acid (siRNA) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). ( 1 )

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months. ( 2.1 ) Inject REDEMPLO subcutaneously into the front of the thigh or abdomen. The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection. ( 2.2 )

2.1Recommended Dosage The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months.

2.2Important Administration Instructions Prior to initiation, train patients and/or caregivers on proper preparation and administration of REDEMPLO [see Instructions for Use ] . Adhere to a low-fat diet (less than or equal to 20 grams fat per day) in conjunction with REDEMPLO. Visually inspect the REDEMPLO pre-filled syringe prior to administration.

The solution should be clear and colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration. Inject REDEMPLO subcutaneously into the front of the thigh or abdomen.

The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection. Do not inject REDEMPLO in an area where the skin is damaged (tender, bruised, red, hard, or cut). Do not inject into areas with scars or stretch marks.

If a dose is missed, administer REDEMPLO as soon as possible. Resume dosing every 3 months from the date of the most recently administered dose.

💊 Dosage Forms and Strengths 37 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 25 mg/0.5 mL of plozasiran as a clear and colorless to yellow solution in a single-dose pre-filled syringe. Injection: 25 mg/0.5 mL solution in a single-dose pre-filled syringe. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Arrowhead Pharmaceuticals Inc. at 1-844-REDEMPLO (1-844-733-3675), or https://arrowheadpharma.com/safetyreporting, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of REDEMPLO cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of REDEMPLO was evaluated in 75 patients with FCS enrolled in Trial 1 (NCT05089084) [see Clinical Studies ( 14 )] . In this trial, patients received at least one dose of REDEMPLO 25 mg (N=26) or 50 mg of plozasiran (N=24) and 25 patients received placebo.

Plozasiran 50 mg is not an approved dosage regimen for FCS [see Dosage and Administration ( 2.1 )] . Across treatment groups, the mean age was 46 years and 49% of patients were male. Seventy-three percent (73%) of patients were White, 21% were Asian, and 5% were reported as other races; 3% identified as Hispanic or Latino ethnicity.

Fifty (50) patients were exposed to REDEMPLO for a median of 11.6 months; 26 patients were treated with REDEMPLO 25 mg every 3 months for a median of 11.8 months. Adverse reactions led to discontinuation of treatment in 3 (6.0%) of REDEMPLO-treated patients and 0% of placebo-treated patients. The reasons for REDEMPLO treatment discontinuation were hyperglycemia and urticaria.

Adverse reactions occurring in greater than or equal to 10% of REDEMPLO-treated patients and greater than 5% more frequently than in placebo-treated patients are listed below in Table 1 . Table 1. Adverse Reactions Occurring in Greater than or Equal to 10% of REDEMPLO-treated Patients and Greater than 5% More Frequently than with Placebo in Trial 1 1 Grouped terms composed of several similar terms Adverse Reactions Placebo (N=25) (%) REDEMPLO (N=50) (%) Hyperglycemia 1 2 (8%) 10 (20%) Headache 2 (8%) 8 (16%) Nausea 2 (8%) 7 (14%) Injection site reaction 1 1 (4%) 5 (10%) Laboratory Tests Increase in Glucose: Mean increases from baseline in HbA1c (up to 0.36%) and fasting glucose (up to 9 mg/dL) were observed over time in the 25 mg REDEMPLO group.

The incidence of hyperglycemia (defined as adverse events consistent with diabetes mellitus or hyperglycemia, new antidiabetic medication, or laboratory values) was higher in 25 mg REDEMPLO-treated patients without a medical history of diabetes at baseline (40%) compared to placebo-treated patients (20%). Increase in Liver Enzymes: Increases from baseline liver enzymes within the normal range were observed with plozasiran treatment in the FCS population. These increases occurred within the first 3 months of treatment and stabilized.

Increase in LDL-cholesterol: Increases in low-density lipoprotein cholesterol (LDL-C) and total apolipoprotein B (apoB) were observed in the FCS population treated with REDEMPLO compared to those treated with placebo [see Clinical Studies ( 14 )] . Despite increases in the LDL-C, the average LDL-C value at Month 12 was less than 50 mg/dL in the 25 mg REDEMPLO group.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are insufficient data on REDEMPLO use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS are at risk for pancreatitis during pregnancy because of defects in lipid metabolism and increased triglyceride levels (see Clinical Considerations ) . In animal reproduction studies, no adverse drug-related developmental effects were observed in pregnant rats or rabbits with subcutaneous administration of plozasiran during organogenesis up to 23 and 140 times, respectively, the maximum recommended human dose (MRHD) (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Triglyceride levels increase during the third trimester of pregnancy.

In patients with underlying defects in lipid metabolism, such as FCS, severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy. Data Animal Data In an embryo-fetal development study, pregnant rats were administered plozasiran by subcutaneous injection at 0, 5, 15, or 60 mg/kg, or 60 mg/kg rat specific surrogate, once daily during the period of organogenesis (gestational days 6 to 17). There was no evidence of drug-related embryo-fetal toxicity or fetal malformations up to 60 mg/kg plozasiran [23 times the MRHD based on body surface area (BSA)].

At maternally toxic doses there were embryo-fetal toxicities including increases in post-implantation loss and mean number of late resorptions at 60 mg/kg (23 times the MRHD based on BSA), early deliveries, reduced fetal body weight, and fetal skeletal developmental variations at ≥15 mg/kg (6 times the MRHD based on BSA). No adverse embryo-fetal developmental effects were observed from a single subcutaneous administration of 50 mg/kg plozasiran (19 times the MRHD based on BSA) or the rat specific surrogate to pregnant rats on gestation day 10.

In an embryo-fetal development study in pregnant rabbits, plozasiran was administered by subcutaneous injection at 0, 30, 60, or 180 mg/kg/day once daily during the period of organogenesis (gestational days 7 to 19). No evidence (of embryo-fetal toxicity or developmental abnormalities) was observed up to 180 mg/kg (140 times the MRHD based on BSA). In a rat pre- and post-natal development study, plozasiran was administered at 0, 8, 24, or 80 mg/kg by subcutaneous injection once a week from gestation day 6 through lactation day 17.

Plozasiran increased the number of females with stillborn offspring and the increase in stillborn offspring per litter resulted in reductions in live birth index at 80 mg/kg (31 times the MRHD based on BSA). There were decreases in offspring body weight and offspring survival at ≥24 mg/kg (9 times the MRHD based on BSA). No adverse effects were noted on offspring development up to 80 mg/kg (31 times the MRHD based on BSA).

8.2Lactation Risk Summary There is no information regarding the presence of plozasiran in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Oligonucleotide-based products typically have poor oral bioavailability. Therefore, it is considered that if plozasiran is present in breastmilk, it is unlikely to lead to clinically relevant levels in breastfed infants.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for REDEMPLO and any potential adverse effects on the breastfed infant from REDEMPLO or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of REDEMPLO in pediatric patients with FCS have not been established.

8.5Geriatric… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are insufficient data on REDEMPLO use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS are at risk for pancreatitis during pregnancy because of defects in lipid metabolism and increased triglyceride levels (see Clinical Considerations ) . In animal reproduction studies, no adverse drug-related developmental effects were observed in pregnant rats or rabbits with subcutaneous administration of plozasiran during organogenesis up to 23 and 140 times, respectively, the maximum recommended human dose (MRHD) (see Data ) .

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20% respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Triglyceride levels increase during the third trimester of pregnancy.

In patients with underlying defects in lipid metabolism, such as FCS, severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy. Data Animal Data In an embryo-fetal development study, pregnant rats were administered plozasiran by subcutaneous injection at 0, 5, 15, or 60 mg/kg, or 60 mg/kg rat specific surrogate, once daily during the period of organogenesis (gestational days 6 to 17). There was no evidence of drug-related embryo-fetal toxicity or fetal malformations up to 60 mg/kg plozasiran [23 times the MRHD based on body surface area (BSA)].

At maternally toxic doses there were embryo-fetal toxicities including increases in post-implantation loss and mean number of late resorptions at 60 mg/kg (23 times the MRHD based on BSA), early deliveries, reduced fetal body weight, and fetal skeletal developmental variations at ≥15 mg/kg (6 times the MRHD based on BSA). No adverse embryo-fetal developmental effects were observed from a single subcutaneous administration of 50 mg/kg plozasiran (19 times the MRHD based on BSA) or the rat specific surrogate to pregnant rats on gestation day 10.

In an embryo-fetal development study in pregnant rabbits, plozasiran was administered by subcutaneous injection at 0, 30, 60, or 180 mg/kg/day once daily during the period of organogenesis (gestational days 7 to 19). No evidence (of embryo-fetal toxicity or developmental abnormalities) was observed up to 180 mg/kg (140 times the MRHD based on BSA). In a rat pre- and post-natal development study, plozasiran was administered at 0, 8, 24, or 80 mg/kg by subcutaneous injection once a week from gestation day 6 through lactation day 17.

Plozasiran increased the number of females with stillborn offspring and the increase in stillborn offspring per litter resulted in reductions in live birth index at 80 mg/kg (31 times the MRHD based on BSA). There were decreases in offspring body weight and offspring survival at ≥24 mg/kg (9 times the MRHD based on BSA). No adverse effects were noted on offspring development up to 80 mg/kg (31 times the MRHD based on BSA).

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use The safety and effectiveness of REDEMPLO in pediatric patients with FCS have not been established.

🧓 Geriatric Use 58 words ▾

8.5Geriatric Use Of the 75 patients with FCS randomized in Trial 1, 9 (12%) were 65 years of age or older, including 2 (3%) patients who were 75 years of age or older. No overall differences in safety or effectiveness of REDEMPLO have been observed between patients 65 years of age and older and younger adult patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Plozasiran is a siRNA conjugated with GalNAc that degrades the apoC-III mRNA through the RNA interference mechanism resulting in reduced levels of hepatic and serum apoC-III protein. Reduction of apoC- III protein leads to increased clearance of serum triglycerides.

12.2Pharmacodynamics In Trial 1 [see Clinical Studies ( 14 )] , following the recommended dose of 25 mg administered every 3 months in patients with FCS, REDEMPLO reduced median fasting serum apoC-III protein. The placebo-corrected median percent change in fasting serum apoC-III protein from baseline was -90% at 1 month, -93% at 3 months, -82% at 6 months, -91% at 10 months, and -87% at 12 months. Cardiac Electrophysiology At a dose 4 times the recommended dose of 25 mg administered every 3 months, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics REDEMPLO exhibited linear and time-invariant pharmacokinetics following subcutaneous injections within the dose range of 10 mg to 100 mg. The following pharmacokinetic parameters were observed in healthy adults after receiving a 25 mg dose of REDEMPLO. Absorption Plozasiran peak plasma concentration (C max ) is 68.5 ng/mL.

The median time to reach C max (T max ) is 6 hours. Distribution Plozasiran is 78% protein bound in vitro at the clinically relevant plasma concentrations. Following subcutaneous multiple administration of 25 mg plozasiran, the apparent volume of distribution is approximately 146 L.

Plozasiran is distributed in plasma and extracellular body water before its uptake by hepatocytes to decrease apoC-III mRNA expression and reduce serum triglycerides. Elimination The terminal elimination half-life of plozasiran in plasma is approximately 3 to 4 hours. The mean apparent systemic clearance is

33.8L/hour. Metabolism Plozasiran is primarily metabolized by nucleases to shorter oligonucleotides of varying lengths. Excretion Approximately 16 to 19% of REDEMPLO dose is excreted in urine.

Specific Populations No clinically significant differences in plozasiran pharmacokinetics based on age, sex, race, mild and moderate renal impairment (eGFR ≥30 to <90 mL/min), or mild hepatic impairment (total bilirubin ≤1 times ULN and AST >1 times ULN, or total bilirubin >1.0 to 1.5 times ULN and any AST) were found in the population pharmacokinetic analysis. The impact of severe renal impairment, end-stage renal impairment, or moderate to severe hepatic impairment is not known. Drug Interaction Studies In Vitro Assessment of Drug Interactions CYP450 Enzymes Plozasiran is not a substrate, inhibitor, or inducer of CYP450 enzymes at clinically relevant concentrations.

Transporter Systems Plozasiran is not a substrate or an inhibitor of P-gp, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2-K.

12.6Immunogenicity The observed incidence of anti-drug antibodies (ADAs) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADAs in the trial described below with the incidence of anti-drug antibodies in other studies, including those of plozasiran. In Trial 1, none of the 50 FCS-patients treated with REDEMPLO over a period of 12 months developed treatment-induced or treatment-boosted ADAs.

Because ADAs were not observed in the limited number of REDEMPLO-treated patients, the effect of ADAs on the pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of REDEMPLO products is unknown.

🧬 Mechanism of Action 43 words ▾

12.1Mechanism of Action Plozasiran is a siRNA conjugated with GalNAc that degrades the apoC-III mRNA through the RNA interference mechanism resulting in reduced levels of hepatic and serum apoC-III protein. Reduction of apoC- III protein leads to increased clearance of serum triglycerides.

📦 How Supplied / Storage and Handling 112 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING REDEMPLO injection is a clear and colorless to yellow solution supplied in a single-dose prefilled syringe. Each prefilled syringe of REDEMPLO is filled to deliver 0.5 mL of solution containing 25 mg of plozasiran. REDEMPLO is available in cartons containing one 25 mg single-dose prefilled syringe each (NDC 84141-025-01).

Storage Store REDEMPLO refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton, until ready for use. REDEMPLO prefilled syringe can also be kept at room temperature at 20°C to 25°C (68°F to 77°F) in the original carton for up to 30 days. If not used within the 30 days stored at room temperature, discard REDEMPLO.

📋 Description 206 words ▾

11 DESCRIPTION REDEMPLO contains plozasiran (present as plozasiran sodium), a small interfering RNA (siRNA) that degrades apolipoprotein C-III ( apoC-III ) mRNA by RNA interference. Plozasiran contains a covalently linked ligand containing three N-acetylgalactosamine (GalNAc) residues to facilitate delivery to hepatocytes. The 2´ positions of the ribose subunits in plozasiran are modified with either fluorine (2´F) or methoxy (2´O-Me) groups.

Each strand of plozasiran also includes multiple phosphorothioates. The molecular formula of plozasiran sodium is C 493 H 611 F 11 N 164 Na 43 O 311 P 43 S 7 and its molecular weight is 16,563.98 Da. Plozasiran sodium is freely soluble in water.

Plozasiran has the following structural formula: Abbreviations: A = 2’-O-methyladenosine; A = 2’-fluoro(2’-deoxy-2’-fluoro)adenosine; C = 2’-O-methylcytidine; C = 2’-fluorocytidine; G = 2’-O-methylguanosine; G = 2’-fluoroguanosine; I = 2’-O-methylinosine; U = 2’-O-methyluridine; U = 2’-fluorouridine; - (single line) = phosphodiester linkage; = (double line) = phosphorothioate linkage; · (middle dot) depicts base pairing between the two strands REDEMPLO is a sterile, preservative-free, clear, colorless to yellow solution for subcutaneous use in a prefilled syringe.

Each syringe contains 0.5 mL of solution containing 25 mg plozasiran (present as 27 mg plozasiran sodium), sodium chloride to adjust tonicity, and water for injection. Chemical Structure

💬 Information for Patients 132 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Adherence to Diet Advise patients with FCS that use of lipid-regulating agents does not reduce the importance of adhering to a low-fat diet (less than or equal to 20 grams fat per day) [see Dosage and Administration ( 2.2 )] . Missed Dose Instruct patients to take REDEMPLO as prescribed.

If a dose is missed, instruct patients to take as soon as they remember. Resume dosing every 3 months from the date of the most recently administered dose [see Dosage and Administration ( 2.2 )] . Distributed by: Arrowhead Pharmaceuticals, Inc.

Pasadena, CA 91105 © 2025, Arrowhead Pharmaceuticals, Inc. All rights reserved. REDEMPLO is a registered trademark of Arrowhead Pharmaceuticals, Inc.

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics REDEMPLO exhibited linear and time-invariant pharmacokinetics following subcutaneous injections within the dose range of 10 mg to 100 mg. The following pharmacokinetic parameters were observed in healthy adults after receiving a 25 mg dose of REDEMPLO. Absorption Plozasiran peak plasma concentration (C max ) is 68.5 ng/mL.

The median time to reach C max (T max ) is 6 hours. Distribution Plozasiran is 78% protein bound in vitro at the clinically relevant plasma concentrations. Following subcutaneous multiple administration of 25 mg plozasiran, the apparent volume of distribution is approximately 146 L.

Plozasiran is distributed in plasma and extracellular body water before its uptake by hepatocytes to decrease apoC-III mRNA expression and reduce serum triglycerides. Elimination The terminal elimination half-life of plozasiran in plasma is approximately 3 to 4 hours. The mean apparent systemic clearance is

33.8L/hour. Metabolism Plozasiran is primarily metabolized by nucleases to shorter oligonucleotides of varying lengths. Excretion Approximately 16 to 19% of REDEMPLO dose is excreted in urine.

Specific Populations No clinically significant differences in plozasiran pharmacokinetics based on age, sex, race, mild and moderate renal impairment (eGFR ≥30 to <90 mL/min), or mild hepatic impairment (total bilirubin ≤1 times ULN and AST >1 times ULN, or total bilirubin >1.0 to 1.5 times ULN and any AST) were found in the population pharmacokinetic analysis. The impact of severe renal impairment, end-stage renal impairment, or moderate to severe hepatic impairment is not known. Drug Interaction Studies In Vitro Assessment of Drug Interactions CYP450 Enzymes Plozasiran is not a substrate, inhibitor, or inducer of CYP450 enzymes at clinically relevant concentrations.

Transporter Systems Plozasiran is not a substrate or an inhibitor of P-gp, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, or MATE2-K.

🧬 Pharmacodynamics 93 words ▾

12.2Pharmacodynamics In Trial 1 [see Clinical Studies ( 14 )] , following the recommended dose of 25 mg administered every 3 months in patients with FCS, REDEMPLO reduced median fasting serum apoC-III protein. The placebo-corrected median percent change in fasting serum apoC-III protein from baseline was -90% at 1 month, -93% at 3 months, -82% at 6 months, -91% at 10 months, and -87% at 12 months. Cardiac Electrophysiology At a dose 4 times the recommended dose of 25 mg administered every 3 months, clinically significant QTc interval prolongation was not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of REDEMPLO was demonstrated in a randomized, placebo-controlled, double-blind trial in adult patients with genetically confirmed or clinically diagnosed FCS maintained on a low-fat diet(≤20 grams fat per day) (Trial 1; NCT05089084). Patients were randomized to receive four total doses of REDEMPLO 25 mg (n=26) or matching placebo (n=25), injected subcutaneously once every 3 months over a 12-month treatment period The diagnosis of FCS was based on adults with a screening fasting TG ≥880 mg/dL refractory to lipid-lowering therapy, with a history of elevated triglycerides (in excess of 1,000 mg/dL at least three times), and evidence of FCS by known genotypes, evidence of low lipoprotein lipase activity, or a clinical diagnosis.

In this trial, for patients with clinically diagnosed FCS, the inclusion criteria specified at least one of the following: recurrent episodes of acute pancreatitis not caused by alcohol or cholelithiasis; recurrent hospitalizations for severe abdominal pain without other explainable cause; childhood pancreatitis; or family history of hypertriglyceridemia-induced pancreatitis. Patient demographics were generally similar across the treatment groups [see Adverse Reactions ( 6.1 )] . At enrollment, the percentage of patients with genetic confirmation of FCS was 46% in the REDEMPLO 25 mg group compared with 56% in the placebo group; diabetes was 15% in the REDEMPLO 25 mg group compared with 32% in the placebo group; and a history of documented acute pancreatitis in the prior 5 years was 54% in the REDEMPLO 25 mg group compared with 68% in the placebo group.

Patients in the REDEMPLO 25 mg and placebo groups were treated with statins (43%), omega-3 fatty acids (29%), fibrates (69%), or no background TG lowering therapies (25%) at study entry. Mean (SD) and median fasting TG levels at baseline were 2,311 (1,258) mg/dL and 2,030 mg/dL, respectively (range of 747 to 5,596 mg/dL). The primary efficacy endpoint was percent change in fasting triglycerides from baseline at Month 10 (average of 2 assessments, 2 to 7 days apart).

The median difference between REDEMPLO 25 mg and the placebo group in percent change in fasting triglyceride levels from baseline to Month 10 was -58.7% (95% CI: -89.6, -27.9; p< 0.0001). For additional results see Table 2 . Table 2: Baseline and Percent Changes from Baseline in Lipid/Lipoprotein Parameters in Patients with FCS at Month 10 in Trial 1 Abbreviations: ApoB = apolipoprotein B; CI= confidence interval; BL = baseline; FCS=familial chylomicronemia syndrome; non-HDL-C = non-high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol. a Reached statistical significance (p value ˂ 0.0001). b Median; Hodges-Lehmann method was used to estimate the median difference (location shift) and its corresponding 95% confidence interval for percent changes.

Missing data were imputed using washout imputation. c Mean; Analysis of covariance (ANCOVA) model was used to estimate the mean difference and its corresponding 95% confidence interval for percent changes. Missing data were imputed using washout imputation. REDEMPLO 25 mg N=26 Placebo (pooled) N=25 REDEMPLO 25 mg vs.

Placebo Parameter (mg/dL) BL % change at Month 10 BL % change at Month 10 Treatment Difference % change (95% CI) at Month 10 Triglyceridesb b 2008 -80 2053 -17 -59 a (-90, -28) Non-HDL-C c 279 -39 268 4 -42 (-67, -18) LDL-C c 24 112 28 20 92 (4, 180) Total ApoB c 72 27 79 12 15 (-16, 46) ApoB-48 c 10 -61 11 45 -106 (-180, -33) Median percent change in TG from baseline ( Figure 1 ) and median absolute TG values ( Figure 2 ) over time demonstrated a consistent lowering effect during the 12-month treatment period. Figure 1: Median Percent Change from Baseline in Fasting Triglycerides Over Time in Trial 1 Figure 2: Median Absolute Fasting Triglyceride Levels (mg/dL) in Trial 1 Over the 12-month treatment period, the numerical incidence of acute pancreatitis in patients treated with RED… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 173 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 26-week study in RasH2Tg mice, plozasiran was administered subcutaneously once every 8 weeks at dose levels of 30, 60, and 120 mg/kg. Plozasiran was not carcinogenic up to the highest tested dose of 120 mg/kg (23-times MRHD based on BSA). Mutagenesis Plozasiran was not mutagenic or clastogenic in a standard battery of genetic toxicity assays, including a bacterial mutation (Ames) assay, and in vitro and in vivo mouse micronucleus assays.

Impairment of Fertility In a fertility and early embryonic-development study, male and female rats were administered subcutaneously with vehicle or plozasiran at the doses of 12.5, 25 or 50 mg/kg or rat specific surrogate at 25 mg/kg. Males were treated once weekly before and throughout cohabitation, while females received treatment either once every 3 days or once weekly before and through mating until gestation day 6. There were no adverse effects on mating and fertility in males or females up to 50 mg/kg corresponding to 19-times the MRHD, based on BSA.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 170 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis In a 26-week study in RasH2Tg mice, plozasiran was administered subcutaneously once every 8 weeks at dose levels of 30, 60, and 120 mg/kg. Plozasiran was not carcinogenic up to the highest tested dose of 120 mg/kg (23-times MRHD based on BSA). Mutagenesis Plozasiran was not mutagenic or clastogenic in a standard battery of genetic toxicity assays, including a bacterial mutation (Ames) assay, and in vitro and in vivo mouse micronucleus assays.

Impairment of Fertility In a fertility and early embryonic-development study, male and female rats were administered subcutaneously with vehicle or plozasiran at the doses of 12.5, 25 or 50 mg/kg or rat specific surrogate at 25 mg/kg. Males were treated once weekly before and throughout cohabitation, while females received treatment either once every 3 days or once weekly before and through mating until gestation day 6. There were no adverse effects on mating and fertility in males or females up to 50 mg/kg corresponding to 19-times the MRHD, based on BSA.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: 11/2025 PATIENT INFORMATION REDEMPLO ® [ree-DEM-plo] (plozasiran) injection, for subcutaneous use Read this Patient Information carefully before you start taking REDEMPLO.

If you have any questions about REDEMPLO, ask your healthcare provider. What is REDEMPLO? REDEMPLO is an injectable prescription medicine used together with a low-fat diet to reduce triglycerides (fat in the blood) in adults with a condition that keeps the body from breaking down fats called familial chylomicronemia syndrome (FCS).

It is not known if REDEMPLO is safe and effective in children. Before using REDEMPLO, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if REDEMPLO can harm your unborn baby.

Tell your healthcare provider if you become pregnant while using REDEMPLO. are breastfeeding or plan to breastfeed. It is not known if REDEMPLO passes into your breast milk and if it can harm your baby. Talk with your healthcare provider about the best way to feed your baby while using REDEMPLO.

Tell your healthcare provider about all of the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use REDEMPLO? Read the Instructions for Use that comes with your REDEMPLO pre-filled syringe. Your healthcare provider will show you and/or your caregiver(s) how to inject REDEMPLO the first time.

REDEMPLO is injected under the skin (subcutaneous use) in the front of your upper legs (thighs) or in your stomach area (abdomen). Only your healthcare provider or caregiver(s) may give you an injection in the outer area of your upper arm. REDEMPLO should be injected 1 time every 3 months.

If you miss a dose, take the missing dose as soon as possible. Then inject REDEMPLO 3 months from the date of your last dose to get back on the every-3-month dosing schedule. Stay on a low-fat diet (less than or equal to 20 grams of fat each day) while using REDEMPLO.

What are the possible side effects of REDEMPLO? The most common side effects of REDEMPLO include: high blood sugar (hyperglycemia) headache nausea injection site reaction (pain, redness, or swelling) These are not all of the possible side effects of REDEMPLO. Tell your healthcare provider if you have any of the above side effects.

Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by calling 1-844-REDEMPLO (1-844-733-3675) or via https://arrowheadpharma.com/safetyreporting. How should I store REDEMPLO?

Store REDEMPLO prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton, until you are ready to use. REDEMPLO can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the original carton for up to 30 days. Throw away the REDEMPLO prefilled syringe if kept at room temperature longer than 30 days.

General information about the safe and effective use of REDEMPLO. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use REDEMPLO for a condition for which it was not prescribed.

Do not give REDEMPLO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about REDEMPLO that is written for health professions.

What are the ingredients in REDEMPLO? Active ingredients: plozasiran sodium Inactive ingredients: sodium chloride, water for injection Distributed by: Arrowhead Pharmaceuticals, Inc. Pasadena, CA 91105 ©2025, Arrowhead Pharmaceuticals, Inc.

All rights reserved.

📖 Instructions for Use ~3 min read ▾

This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 11/2025 INSTRUCTIONS FOR USE REDEMPLO ® [ree-DEM-plo] (plozasiran) injection, for subcutaneous use single-dose prefilled syringe 25 mg/0.5 mL This Instructions for Use contains information on how to inject REDEMPLO (plozasiran).

Read this Instructions for Use before you start using your REDEMPLO prefilled syringe and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider should show you or your caregiver how to use your REDEMPLO prefilled syringe the right way. Call your healthcare provider or pharmacist if you have any questions. Guide to Parts Each carton contains a single-dose REDEMPLO (plozasiran) Injection prefilled syringe for single use under the skin (subcutaneous) injection.

Important Information You Need to Know Before Injecting REDEMPLO REDEMPLO is for subcutaneous injection only Each carton contains a 1-time (single-dose) REDEMPLO (plozasiran) prefilled syringe. Do not use your REDEMPLO single-dose prefilled syringe if the carton appears damaged or the tamper evident seal on the carton is broken. Do not remove the gray needle cap until you are ready to inject ( Step 6 ).

Do not use if the single-dose prefilled syringe appears damaged. Throw away (dispose of) your REDEMPLO prefilled syringe in a sharps disposal container right away after use (Step 10: Disposing of REDEMPLO ). Storing REDEMPLO Keep the REDEMPLO prefilled syringe in the original carton until ready to use.

Store the REDEMPLO prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton. REDEMPLO prefilled syringe can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the original carton for up to 30 days . Do not let REDEMPLO reach temperatures above 77°F (25°C).

Throw away the REDEMPLO prefilled syringe if kept at room temperature and not used within 30 days. If the product is not stored in any of the above conditions, throw away the prefilled syringe in a sharps disposal container and use a new prefilled syringe. Keep REDEMPLO prefilled syringe and all medicine out of reach of children.

Preparing to Inject REDEMPLO Step 1: Gather all materials needed for your REDEMPLO injection Figure A On a clean, well-lit, flat work surface, place: Provided in the carton (see Figure A ): 1 REDEMPLO prefilled syringe Other materials not provided (see Figure A ): Alcohol wipes Cotton ball or gauze pad Adhesive bandage Sharps disposal container Step 2: Prepare to use REDEMPLO prefilled syringe Figure B Figure C Figure D If refrigerated, remove the carton from the refrigerator. Open the carton lid and remove the syringe by the syringe barrel and place on a flat surface (see Figure B ).

Do not use the prefilled syringe if tamper evident seal on the carton is broken. Do not pick up or pull the prefilled syringe by the plunger rod or gray needle cap. Check the expiration date on the REDEMPLO prefilled syringe.

(see Figure C ). Do not use if the expiration date has passed. Wait 30 minutes for the prefilled syringe to reach room temperature before injecting (see Figure D ).

Do not try to warm the prefilled syringe by using a heat source such as hot water or a microwave. Do not remove the gray needle cap from the prefilled syringe until you are ready to inject. Step 3: Check the medicine and syringe Figure E Figure F Check the the REDEMPLO medicine in the prefilled syringe (see Figure E ).

The medicine should be clear and colorless to yellow. Do not use the prefilled syringe if the medicine is cloudy, discolored or contains particles. It is normal to see air bubbles in the medicine.

Inspect the prefilled syringe (see Figure F ). Do not use the prefilled syringe if any part appears cracked or broken. Do not use the prefilled syringe if the gray needle cap is missing or not… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 30 words ▾

PRINCIPAL DISPLAY PANEL - NDC: 84141-025-01 - Carton Label - 25mg/0.5mL Carton Label - 25mg/0.5mL

PRINCIPAL DISPLAY PANEL - NDC: 84141-025-01 - Container Label - 25mg/0.5mL Container Label - 25mg/0.5mL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Redemplo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Redemplo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$411.8K
Claims incl. refills
27
Beneficiaries
27
Spend / beneficiary
$15,251.80
Spend / claim
$15,251.80
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for REDEMPLO (this brand).

Top reported reactions

Headache14
Nausea13
Blood Glucose Increased8
Injection Site Pain4
Dizziness3
Injection Site Bruising3
Pancreatitis Acute3

Age at onset

Adult1

Reporter sex

56 reports
Male · 43%
Female · 57%
Reports over time (by year) — tap or hover for the count & year
2025 2026 56 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Arrowhead Pharmaceuticals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Arrowhead Pharmaceuticals, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 84138-0003-05 · Thrive 84142-0001-01 · SNJ →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.