Plozasiran
Plozasiran is a once-every-3-months injection that lowers triglycerides in adults with familial chylomicronemia syndrome (FCS), used alongside a low-fat diet.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Redemplo (plozasiran) is a specialist injection, new to the U.S. market in 2025, that lowers triglycerides (a blood fat) in adults with familial chylomicronemia syndrome, a rare inherited condition, by switching off the liver's instructions for a protein called apoC-III so the body clears them more easily. Given once every 3 months alongside a low-fat diet, it is generally well tolerated, and headache, nausea and soreness where you inject are what people most often notice. The real watch point is higher blood sugar, the most common reason people stopped treatment, so keep up with the blood sugar checks your prescriber orders and report new thirst or frequent urination.
Clinical pearls
- It adds to a low-fat diet rather than replacing it, so keep following your eating plan even as triglycerides fall.
- With only one dose every 3 months, set a calendar reminder so a dose does not slip by unnoticed.
- LDL (“bad”) cholesterol may rise and liver enzymes can drift up early, so expect your lab results to shift.
- Raise pregnancy plans early, since human data are limited and FCS itself makes pancreatitis (an inflamed pancreas) more likely in pregnancy.
Patient information guide A plain-language walkthrough of Plozasiran, written from its FDA label.
What Plozasiran is used for
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Plozasiran is used for one condition:
- Redemplo (plozasiran) is used with diet to lower triglycerides in adults with familial chylomicronemia syndrome (FCS).
How Plozasiran works
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Plozasiran is a small interfering RNA (siRNA) attached to a GalNAc tag, which helps it reach liver cells. Inside the liver, it breaks down the messenger RNA used to make apoC-III protein. Less apoC-III means the body clears triglycerides from the blood faster.
Plozasiran dosage
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Redemplo is injected under the skin once every 3 months. It comes in a pre-filled syringe, and you or a caregiver should be trained before the first dose. It should be used with a low-fat diet.
- Good injection sites are the front of the thigh or the abdomen.
- The outer upper arm can be used only if someone else gives the shot.
- If you miss a dose, take it as soon as you can. Then go back to every 3 months from that date.
Dosing details from the FDA-approved label
From the Plozasiran prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (indication not named in the provided text)
- 25 mg injected subcutaneously once every 3 months
- Adhere to a low-fat diet (less than or equal to 20 grams fat per day) in conjunction with REDEMPLO. If a dose is missed, administer as soon as possible and resume dosing every 3 months from the date of the most recently administered dose.
Read the label’s full dosing text
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 ) 2.1 Recommended Dosage The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months. 2.2 Important 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.
Read the full Dosage and Administration section on DailyMed →
Plozasiran side effects
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The most common side effects in the trial were:
Common side effects
- High blood sugar (hyperglycemia)
- Headache
- Nausea
- Injection site reactions
When to get medical help
- Call your doctor if you notice signs of high blood sugar or new diabetes, since high blood sugar was the most common reason people stopped treatment.
- Get medical help if you develop hives (urticaria) or other allergic-type skin reactions.
- Call your doctor if an injection site reaction is bothersome or does not go away.
A small number of people stopped treatment because of high blood sugar or hives. Let your doctor know if these happen.
Plozasiran warnings and precautions
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- Blood sugar: Redemplo can raise blood sugar and HbA1c, including in people with no history of diabetes.
- Liver enzymes: Levels rose within the normal range early on, then stabilized.
- LDL cholesterol: LDL and apoB rose compared with placebo.
- Diet: A low-fat diet is part of treatment.
Plozasiran interactions
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Lab studies suggest plozasiran is unlikely to interact with many other medicines.
- It is not processed by or changed by CYP450 liver enzymes.
- It does not affect the common drug transporters tested.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Plozasiran
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- There are no listed contraindications.
- Pregnancy: human data are insufficient. FCS raises the risk of pancreatitis during pregnancy, so talk with your doctor.
- Breastfeeding: no information on milk; weigh the benefits of breastfeeding against your need for the medicine.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences were seen.
- Mild to moderate kidney or mild liver impairment: the dose stays the same. The effect of severe kidney impairment or moderate to severe liver impairment is not known.
What Plozasiran does in the body
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In the trial, Redemplo lowered apoC-III protein in the blood by about 82% to 93% compared with placebo over 12 months. At four times the recommended dose, no clinically significant QTc prolongation (a heart rhythm effect) was seen.
How your body processes Plozasiran
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After a shot under the skin, plozasiran peaks in the blood in about 6 hours. It leaves the blood quickly, with a half-life of about 3 to 4 hours, as it is taken up by liver cells. It is broken down by enzymes called nucleases, and about 16 to 19% of the dose leaves in urine. Age, sex, race, and mild to moderate kidney problems did not significantly change how the body handles it.
How to store Plozasiran
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Store REDEMPLO refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton, until ready for use. stored at room temperature, discard REDEMPLO.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Plozasiran: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Plozasiran — the kind of thing our pharmacy team would talk through with you at the counter.
What is Redemplo for?
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How often do I inject it?
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What if I miss a dose?
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What side effects should I expect?
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Can I use it if I'm pregnant or breastfeeding?
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Will it interact with my other medicines?
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Is Plozasiran available over the counter?
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When was Plozasiran first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Plozasiran on HelloPharmacist
Plozasiran forms and strengths (how it comes)
Plozasiran is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Plozasiran inactive ingredients by manufacturer.
Injection
How this form is used
- Redemplo is used with diet to lower triglycerides in adults with familial chylomicronemia syndrome (FCS).
- Redemplo is given as an injection under the skin once every 3 months.
- Redemplo is injected into the front of the thigh or abdomen. The outer upper arm can be used only if a healthcare provider or caregiver gives the injection.
- Check the Redemplo pre-filled syringe first. The liquid should be clear and colorless to yellow. Do not use it if cloudy, discolored, or containing particles.
- Do not inject Redemplo into skin that is damaged, scarred, or has stretch marks.
Plozasiran on the U.S. market: products, makers and brands
How Plozasiran appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Plozasiran product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2025. Brand names on the directory include Redemplo; the rest are generics.
Compare Plozasiran products
A representative set of FDA-listed product records for Plozasiran — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 25 mg/0.5 mL | Subcutaneous | Arrowhead Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Plozasiran NDCs →
Plozasiran side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Plozasiran — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Plozasiran in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Plozasiran FDA approval history
How Plozasiran went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Plozasiran recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Plozasiran recalls since July 2021.
✅No Plozasiran recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2727175 1 dose form · 1 strength
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Dose form (SCDF) Prefilled Syringe RxCUI 2727340No current FDA listingClinical drug / strength (SCD) 0.5 ML plozasiran 50 MG/MLRxCUI 2728183
Look up RxCUI 2727175 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Plozasiran supply and shortage status
Whether Plozasiran is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Plozasiran brand names
Plozasiran is sold under one brand name in the FDA directory — Redemplo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Plozasiran: manufacturers and labelers
One company lists Plozasiran products with the FDA. By number of product records, the largest are Arrowhead Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Plozasiran drug class (RxNorm)
Plozasiran belongs to the Small Interfering RNA class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Plozasiran page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Arrowhead Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →