Prescribing guide
Redemplo (plozasiran)For FCS: dosing, glucose and lipid findings, central dispensing and prior authorization criteriaFor prescribers and their offices treating familial chylomicronemia syndrome (FCS): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS and no label-required labs; the first dose waits on the Redemplo Start Form, prior authorization, central dispensing by Vanscoy Rare Specialty Pharmacy and injection training for the patient or caregiver.
Example PA threshold
Cigna example: age 18 or older, baseline fasting triglycerides 880mg/dL or higher, FCS by genetics, score or clinical criteria, low-fat diet, specialist prescriber, and for employer plans Tryngolza for 1 year or more first.
Monitoring
No monitoring schedule in the label; it reports hyperglycemia (20% against 8% on placebo), HbA1c up to 0.36% higher, LDL-C and apoB increases, and liver enzyme rises within the normal range in the first 3 months.
Support line
Rely On Redemplo, 1-844-733-3675, Monday to Friday, 8 AM to 8 PM ET; Care Coordinator, copay card to $0 for eligible commercial patients, Quick Start dose for insurance delays, Starter Kit and pharmacist injection training; Start Form fax 1-844-673-3367.
Give your patient their plan
A one-page handout for starting Redemplo, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/redemploBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Submit the Redemplo Start Form | The form is the prescription, the program enrollment and the patient consent. It can be completed and signed online, or printed and faxed to 1-844-673-3367. It can be submitted without the patient's signature to start the prescription; a Care Coordinator then contacts the patient for consent. | Redemplo Start Form |
| Attach the clinical documentation | The form asks for the ICD-10-CM code (E78.3 is listed as most commonly used), the fasting triglyceride level of 880mg/dL or higher with its date, the tests that confirmed the diagnosis, any acute pancreatitis episodes not caused by alcohol or cholelithiasis, and copies of the insurance cards. | Redemplo Start Form |
| Write the prescription as the form prints it | 25mg prefilled syringe subcutaneously into the front of the thigh or abdomen once every 3 months; quantity one carton of one syringe; a 3-refill box. New York prescribers must send it electronically, to Vanscoy Pharmacy. | Redemplo Start Form |
| Central dispensing | Arrowhead says Redemplo is centrally dispensed by Vanscoy Rare Specialty Pharmacy. Redemplo Care Coordinators assist with fulfilling prescriptions, on 1-844-733-3675. | Redemplo prescriber site |
| Quick Start for an insurance delay | Check the Quick Start box. If eligible, the patient may receive a dose at no cost during a payer delay, once all information required for the prior authorization is received. Neither the prescriber nor the patient may seek reimbursement for it. Arrowhead reserves the right to amend or end the program without notice. | Redemplo Start Form |
| Train the patient or caregiver | The label says to train patients and caregivers on preparation and administration before initiation. The Patient Information says the healthcare provider shows the patient or caregiver how to inject the first time. | FDA label |
| Appeals | Arrowhead posts a sample letter of medical necessity, a prescriber letter of appeal and a patient appeal letter on its prescriber site. | Redemplo prescriber site |
| No REMS | Redemplo is not on the FDA's list of approved REMS programs, and the approval letter names none. | FDA REMS list |
Prior authorization criteria and what to document
One public policy as the example: Cigna, September 1, 2026. Approval the first approval is 6 months, then 1 year at a time if there has been a response, such as lower triglycerides or fewer pancreatitis episodes. This version was reviewed on July 23, 2026 and cites the November 2025 prescribing information, which is still the current text. The first version, effective June 1, 2026, approved 1 year at the start and asked only that Tryngolza had been tried. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 18 or older | Date of birth on the request | Cigna policy |
| Baseline triglycerides | Fasting triglyceride level of 880mg/dL or higher before any triglyceride-lowering medication, documentation required | Lab report with date, and a note that it predates statins, niacin, fibrates or omega-3 fatty acids | Cigna policy |
| Diagnosis, genetic route | Biallelic pathogenic variants in an FCS gene such as LPL, GPIHBP1, APOA5, APOC2 or LMF1, documentation required | Genetic test report | Cigna policy |
| Diagnosis, score route | Inconclusive genetic test plus a Moulin FCS score of 10 or more, or a North American FCS score of 45 or more, documentation required | Genetic test report and the scored worksheet | Cigna policy |
| Diagnosis, clinical route | All 3: acute pancreatitis not caused by alcohol or cholelithiasis, or recurrent hospitalizations for severe unexplained abdominal pain; absence of secondary hypertriglyceridemia such as obesity or uncontrolled diabetes; and lack of response to a traditional triglyceride-lowering medication | Admission records, the secondary-cause workup, and the medication trial with triglycerides before and after | Cigna policy |
| Diet | Used concomitantly with a low-fat diet | Diet counseling in the note; the label specifies 20g of fat or less a day | Cigna policy |
| Prescriber | Cardiologist, endocrinologist, lipidologist or a physician who focuses on disorders related to severe hypertriglyceridemia | Specialty on the request | Cigna policy |
| Preferred product, employer plans | Tryngolza received for 1 year or more unless not tolerated, documentation required; or, according to the prescriber, thrombocytopenia or risk of it | Tryngolza fill history or the intolerance note; platelet counts | Cigna policy |
| Renewal | 1 year if the patient has experienced a response, such as lower triglycerides or fewer pancreatitis episodes; the first approval is 6 months | Triglycerides before and on treatment, and pancreatitis history | Cigna policy |
| Not covered | Hypertriglyceridemia without a confirmed FCS diagnosis; the policy notes Redemplo is not FDA-approved for severe hypertriglyceridemia | Diagnosis on the request | Cigna policy |
Redemplo dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 25mg (0.5mL) subcutaneously from a single-dose prefilled syringe, into the front of the thigh or abdomen; outer upper arm only if a healthcare provider or caregiver injects. Inspect first: clear, colorless to yellow, no particles. | FDA label |
| Every 3 months | 25mg; no titration. Same dose in mild or moderate renal impairment (eGFR 30 to under 90mL/min) and mild hepatic impairment. The 50mg dose studied in the trial is not an approved regimen for FCS. | FDA label |
| Missed dose | Administer as soon as possible, then resume every 3 months from the date of the most recently administered dose. | FDA label |
| Diet | Adhere to a low-fat diet of 20g of fat or less a day in conjunction with Redemplo; the label's counseling section says lipid-regulating agents do not reduce its importance. | FDA label |
| Supply and storage | One syringe per carton, NDC 84141-025-01. Refrigerate at 2 to 8 degrees C (36 to 46 degrees F) in the original carton, or keep at 20 to 25 degrees C (68 to 77 degrees F) in the carton for up to 30 days, then discard. The Instructions for Use say to let it sit 30 minutes at room temperature before injecting. | FDA label |
Monitoring the Redemplo label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| No schedule in the label | Glucose and HbA1c | Hyperglycemia in 10 of 50 plozasiran-treated patients (20%) against 2 of 25 on placebo (8%). Mean HbA1c rose by up to 0.36% and fasting glucose by up to 9mg/dL on 25mg. Among patients without diabetes at baseline, 40% on 25mg against 20% on placebo met the label's hyperglycemia definition. | FDA label |
| No schedule in the label | LDL-C and apoB | LDL-C rose a mean 112% from a baseline of 24mg/dL at Month 10 against 20% on placebo; mean LDL-C at Month 12 was under 50mg/dL on 25mg. Total apoB rose 27% against 12%. | FDA label |
| First 3 months | Liver enzymes | Increases within the normal range, occurring within the first 3 months and then stabilizing | FDA label |
| After each dose | Injection site reaction, headache, nausea | 10% against 4%, 16% against 8% and 14% against 8% across both plozasiran doses. Adverse reactions led 3 of 50 (6%) to discontinue, for hyperglycemia and urticaria. | FDA label |
| Efficacy | Fasting triglycerides | Median change at Month 10 of -80% on 25mg (n=26) against -17% on placebo (n=25), difference -59% (95% CI -90 to -28). Acute pancreatitis over 12 months in 2 patients (8%) against 5 (20%), which the label calls numerical. Cigna renews on a triglyceride or pancreatitis response. | FDA label |
| Postmarketing | Liver injury and dysglycemia | The approval letter requires completion of SHASTA-3 and SHASTA-4 in severe hypertriglyceridemia to evaluate drug-induced liver injury and dysglycemia, including new-onset diabetes, with the final report due June 2027. | FDA letter |
Redemplo drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Drug interactions | The label has no drug interactions section. In vitro, plozasiran is not a substrate, inhibitor or inducer of CYP450 enzymes, and not a substrate or inhibitor of P-gp, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1 or MATE2-K. | FDA label |
| Background lipid therapy | In the trial, patients were on fibrates (69%), statins (43%), omega-3 fatty acids (29%) or no triglyceride-lowering therapy (25%) at entry. | FDA label |
| Pregnancy | Insufficient human data. The label notes that triglycerides rise in the third trimester and that FCS carries a risk of acute pancreatitis in pregnancy. | FDA label |
| Lactation | No data on presence in milk; the label considers clinically relevant infant exposure unlikely because oligonucleotides have poor oral bioavailability. | FDA label |
| Renal and hepatic impairment | The impact of severe renal impairment, end-stage renal disease, and moderate or severe hepatic impairment is not known. | FDA label |
| Pediatric and geriatric | Safety and effectiveness not established in pediatric patients. No overall differences in patients 65 and older, who were 9 of 75 in the trial. | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedCigna's policy, one example, asks for the criteria below, including a fasting triglyceride result of 880mg/dL or higher and proof of FCS. A Redemplo Care Coordinator can help you and your doctor through approvals and appeals. Arrowhead also posts a sample appeal letter for patients on its site.
- The plan wants Tryngolza firstCigna's employer plans ask that Tryngolza was received for at least 1 year, unless it was not tolerated. The other route is the prescriber stating that the patient has low platelets or is at risk of them. The prescriber's office supplies the records.
- No gene test, or an inconclusive oneCigna's policy accepts 3 routes. They are a gene test, an inconclusive gene test with a qualifying FCS score, or a clinical diagnosis with listed features. The endocrinologist's records decide which route fits.
- The prescription went to a local pharmacyArrowhead says Redemplo is centrally dispensed by Vanscoy Rare Specialty Pharmacy. Redemplo Care Coordinators help with filling the prescription, on 1-844-733-3675.
- The approval is taking too longThe Start Form's Quick Start box says an eligible patient may be able to receive a dose at no cost during an insurance delay. The prescriber checks the box, and the prior authorization information must already be in. Arrowhead says it can change or end the program without notice.
- A copay you cannot payCommercial insurance: the Rely On Redemplo Copay Card Program, as little as $0 out of pocket for eligible patients. Arrowhead's site says eligibility requirements and terms apply and does not print them in full. For other insurance, a Care Coordinator can explain which financial assistance options you are eligible for.
Rely On Redemplo Patient Support Program
- A Redemplo Care Coordinator who reviews your benefits, explains your plan's requirements and any out-of-pocket costs, and helps with approvals and appeals
- Rely On Redemplo Copay Card Program for eligible patients with commercial insurance, as little as $0 out of pocket for Redemplo 25mg
- Eligibility requirements and terms apply to the copay card, and the site does not print them in full
- Quick Start: an eligible patient may be able to receive a dose at no cost during an insurance delay, once the prior authorization information is in Redemplo Start Form
- A Starter Kit shipped to your home for the first dose, an injection training video, and a pharmacist for questions and extra injection training Support services
- Central dispensing through Vanscoy Rare Specialty Pharmacy Redemplo prescriber site
- Help through coverage delays or denials, and a connection to pharmacy support and educational resources Rely On Redemplo overview
Questions prescribers' offices ask about Redemplo
What is the Redemplo dose for FCS?
The dose is 25mg subcutaneously once every 3 months from a single-dose prefilled syringe, as an adjunct to a low-fat diet of 20g of fat or less a day, per the label revised November 2025 (DailyMed version of August 25, 2026). There is no titration. A missed dose is given as soon as possible, and dosing resumes every 3 months from that date.
Does Redemplo have a REMS or required lab monitoring?
No on both counts in the November 2025 label: Redemplo is not on the FDA's REMS list, and the label has no boxed warning, no contraindications, no Warnings and Precautions section and no monitoring schedule. It does report hyperglycemia in 20% of plozasiran-treated patients against 8% on placebo, mean HbA1c increases of up to 0.36%, LDL-C and apoB increases, and liver enzyme rises within the normal range.
Who can inject Redemplo, and where?
Patients or caregivers, after the training the November 2025 label requires before initiation, into the front of the thigh or the abdomen. The outer upper arm is for a healthcare provider or caregiver only. The label says to avoid damaged skin, scars and stretch marks.
How is Redemplo dispensed and stored?
One 25mg/0.5mL single-dose prefilled syringe per carton (NDC 84141-025-01), so each fill is one 3-month dose, per the November 2025 label. Arrowhead says Redemplo is centrally dispensed by Vanscoy Rare Specialty Pharmacy. Storage is 2 to 8 degrees C in the original carton, or 20 to 25 degrees C in the carton for up to 30 days, then discard.
What do insurers ask for to approve Redemplo for FCS?
Cigna policy IP0773, effective September 1, 2026, asks for age 18 or older, a baseline fasting triglyceride level of 880mg/dL or higher, and FCS by biallelic pathogenic variants, by an inconclusive test with a Moulin score of 10 or more or NAFCS score of 45 or more, or by listed clinical criteria. It also asks for a low-fat diet and a cardiologist, endocrinologist, lipidologist or physician focused on severe hypertriglyceridemia. Employer plans add Tryngolza for 1 year or more unless not tolerated, or thrombocytopenia or its risk. Initial approval is 6 months, then 1 year with a response.
Free email alert
Get an email when the Redemplo label changes
One email the day the FDA revises the Redemplo prescribing information, with a summary of what changed. No trial alerts or newsletter, and you can stop anytime.
Label changes for Redemplo only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
Sources
- REDEMPLO (plozasiran) injection, for subcutaneous use: prescribing information, Patient Information and Instructions for Use, revised November 2025, Arrowhead Pharmaceuticals, via DailyMed and openFDA, 2026-08-25.
- Help With Insurance | REDEMPLO (plozasiran), Arrowhead Pharmaceuticals, 2026-11-13.
- Rely On Redemplo Patient Support | REDEMPLO, Arrowhead Pharmaceuticals, 2026-11-13.
- Program Enrollment | REDEMPLO (plozasiran), Arrowhead Pharmaceuticals, 2026-11-13.
- Support Services | REDEMPLO (plozasiran), Arrowhead Pharmaceuticals, 2026-11-13.
- Dosing & Administration | Redemplo (plozasiran), Arrowhead Pharmaceuticals, 2026-11-13.
- Rely On Redemplo Patient Support Program | HCP, Arrowhead Pharmaceuticals, 2026-11-13.
- Redemplo (plozasiran) Start Form, MAT-0280-v2.0-2/2026, Arrowhead Pharmaceuticals, 2026-02.
- Drug Coverage Policy IP0773, Hypertriglyceridemia - Redemplo, Cigna, 2026-09-01.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, 2026-11-13.
- NDA 219947 approval letter, FDA, 2025-11-18.
A reference drawn from the August 25, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 13, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.