Your first 90 days
Your first 90 days on Redemplo for familial chylomicronemia syndrome
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Redemplo is an injection that you or a caregiver give at home once every 3 months, after a healthcare provider has shown you how. The low-fat diet stays in place alongside it, and the label reports rises in blood sugar in its trial. This page lays out the first 90 days from the FDA label, Arrowhead's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Redemplo has no REMS, and its label requires no blood test before a dose. The first dose waits on a Start Form, an insurance approval, one specialty pharmacy and injection training. These are the 8 things in the way, in order.
A Start Form from your endocrinologist's office
Your doctor prescribes Redemplo on the Redemplo Start Form, sent online or by fax.
- Arrowhead says the form captures the information your health plan needs to decide on coverage.
- The same form can enroll you in the Rely On Redemplo Patient Support Program.
- Arrowhead says enrollment in the program is not required to have the prescription filled.Program enrollment
Your consent, if you want the support program
Enrollment needs your consent, signed digitally or on the printed form.
- The Start Form says the office can send it without your signature to start the prescription.
- You can then complete a Patient Consent form online, or a Care Coordinator will contact you to obtain consent.Redemplo Start Form
The records the form asks for
The Start Form has a box for a fasting triglyceride level of 880mg/dL or higher, with the level and test date.
- It also asks which tests confirmed the diagnosis and whether there were acute pancreatitis episodes not caused by alcohol or gallstones.
- The office attaches the test results and copies of your insurance cards.Redemplo Start Form
The insurance approval
Cigna's policy, one example, requires prior authorization and approves Redemplo for 6 months at first.
- It asks for a triglyceride result, proof of FCS and a specialist prescriber, and its full list is further down this page.Cigna policy
Quick Start, if the approval is slow
The Start Form has a Quick Start box.
- It says an eligible patient may be able to receive a dose of Redemplo during an insurance delay, at no cost.
- All the information for the prior authorization must be in first.
- The form gives 1-844-733-3675 for full program details and eligibility.Redemplo Start Form
One specialty pharmacy
Arrowhead says Redemplo is centrally dispensed by Vanscoy Rare Specialty Pharmacy.
- Redemplo Care Coordinators help with filling the prescription, and the same phone line reaches them.Redemplo prescriber site
Training on the injection
The label says patients or caregivers are trained on preparing and injecting Redemplo before the first dose.
- The Patient Information says your healthcare provider will show you or your caregiver how to inject it the first time.
- The Instructions for Use come with every syringe.FDA label
No REMS and no required blood test
Redemplo is not on the FDA's list of approved REMS programs, so no safety program enrollment stands before the first dose.
- Its label has no boxed warning and no contraindications, and it requires no blood test before a dose.FDA REMS list
The days that matter
Counted from the first injection, with the low-fat diet, the next carton and dose 2 at 3 months. Days before the first dose are estimates, because paperwork and insurance set the pace. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Start Form sent
Your endocrinologist's office completes the Redemplo Start Form online or by fax.
- It carries the prescription, your triglyceride result and the records that confirm the diagnosis.
Benefits review and prior authorization
A Redemplo Care Coordinator can review your benefits and explain your plan's requirements.
- Arrowhead says the coordinator can also help you and your doctor through the approval process.
Quick Start, for an insurance delay
An eligible patient may be able to receive a dose at no cost while the insurer decides.
- The Start Form says the prior authorization information must be received first.
The carton and the Starter Kit
Arrowhead says Vanscoy Rare Specialty Pharmacy dispenses Redemplo.
- A Starter Kit can be shipped to your home with the first dose, with instructions and other resources.
Dose 1, one 25mg injection
One prefilled syringe holds the full 25mg dose.
- Your healthcare provider shows you or your caregiver how to inject it the first time.
The low-fat diet continues
The label says to keep to a low-fat diet of 20g of fat or less a day with Redemplo.
- Its counseling section says lipid medicines do not make the diet less important.
The injection site
In the trial, 10% of people on Redemplo had an injection site reaction, against 4% on placebo.
- The Patient Information describes it as pain, redness or swelling.
What the trial measured by now
In the trial, apoC-III, the protein Redemplo lowers, was 90% lower than on placebo at 1 month.
- The label sets no blood test schedule, so your endocrinologist decides when to check triglycerides.
Next carton, one syringe in each
Each carton holds one single-dose syringe, so every dose is a new fill.
- The Start Form has a box for 3 refills, which with the first fill makes 4 doses.
Blood sugar and liver enzymes in the trial
The label reports that liver enzymes rose within the normal range in the first 3 months, then stabilized.
- It also reports rises in blood sugar and HbA1c over time, and sets no schedule for testing them.
Dose 2, then every 3 months
The label's schedule is one injection every 3 months.
- A missed dose is given as soon as possible, and the next one comes 3 months after that date.
Dose 2, number 2
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Redemplo label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated August 25, 2026, read from the FDA's label database today. FDA label
- August 2026
DailyMed lists the current version of the label with an updated date of August 25, 2026. The prescribing information inside still carries its November 2025 revision date, and it lists no recent major changes.FDA label
- November 2025
First FDA approval, on November 18, 2025, to reduce triglycerides in adults with FCS as an addition to diet. The FDA required Arrowhead to finish 2 trials in severe hypertriglyceridemia that look at liver injury and blood sugar problems, with a final report due in June 2027.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- One 25mg injection every 3 months
The label's dose is 25mg under the skin once every 3 months.
- There is one strength, and each syringe is used once.FDA label
- Where it goes
The front of the thigh or the belly, staying at least 2 inches from the belly button.
- Only a healthcare provider or a caregiver may use the outer upper arm.
- The Instructions for Use say not to inject skin that is tender, bruised, red, hard or cut, or areas with scars or stretch marks.FDA label
- Before each injection
The Instructions for Use say to wait 30 minutes after taking the syringe out of the refrigerator.
- They say not to warm it with hot water or a microwave.
- The medicine should be clear and colorless to yellow.
- They say not to use a syringe that is cloudy, discolored or has particles, and that air bubbles are normal.FDA label
- A dropped or damaged syringe
The Instructions for Use say not to use a syringe that looks cracked or broken, has a loose or missing needle cap, or was dropped on a hard surface.
- For any of these they say to call 1-844-733-3675, printed as 1-844-REDEMPLO.
- They also say not to use a syringe if the carton looks damaged or its seal is broken.FDA label
- If you miss a dose
The Patient Information says to take the missed dose as soon as possible.
- The next injection is then 3 months from that date, which resets the every-3-month schedule.FDA label
- The low-fat diet stays
The label says to follow a low-fat diet of 20g of fat or less each day while using Redemplo.
- The approved use is as an addition to diet, and the trial enrolled people who were kept on that diet.FDA label
- Your other lipid medicines
Arrowhead's patient site says to continue other lipid-lowering medicines your healthcare provider has prescribed unless that provider tells you otherwise.
- The same page suggests marking the next dose on a calendar, 3 months after the last one.Redemplo dosing page
- Other medicines
The label has no drug interactions section.
- In the trial, 69% of patients were also taking a fibrate, 43% a statin and 29% omega-3 fatty acids.
- The Patient Information says to tell your healthcare provider about every medicine, vitamin and herbal supplement you take.FDA label
- Storage
Keep the syringe in its original carton in the refrigerator, at 36 to 46 degrees Fahrenheit.
- It can also stay in the carton at room temperature, 68 to 77 degrees, for up to 30 days.
- The label says to throw it away if it is not used within those 30 days.
- The Instructions for Use say not to let it get warmer than 77 degrees.FDA label
- After the injection
The used syringe and cap go into a sharps disposal container right away.
- The Instructions for Use say not to put the needle cap back on and not to rub the injection site.FDA label
- Pregnancy and breastfeeding
The label says there is not enough information to know the risk in pregnancy.
- It adds that people with FCS are at risk of pancreatitis during pregnancy, because triglycerides rise in the third trimester.
- The Patient Information says to tell your healthcare provider if you are pregnant, plan to be, or are breastfeeding.FDA label
- Kidney and liver problems
The label gives the same dose for mild or moderate kidney impairment and for mild liver impairment.
- It says the effect of severe kidney disease, or of moderate or severe liver impairment, is not known.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
High blood sugar
High blood sugar was the most common side effect in the trial, in 20% of people on Redemplo against 8% on placebo.
- Among people on the 25mg dose with no history of diabetes, 40% met the label's broad definition against 20% on placebo.
- That definition counts side effect reports, new diabetes medicine and lab values.
- Average HbA1c rose by up to 0.36 percentage points.
- The Patient Information says to tell your healthcare provider if you have this side effect.FDA label
Headache, nausea and injection site reactions
Headache occurred in 16% of people on Redemplo against 8% on placebo, and nausea in 14% against 8%.
- Injection site reactions, meaning pain, redness or swelling, occurred in 10% against 4%.
- The Patient Information lists these as the most common side effects and says to tell your healthcare provider about them.FDA label
Side effects that ended treatment in the trial
Three of 50 people on Redemplo, 6%, stopped treatment because of a side effect, and nobody on placebo did.
- The label gives the reasons as high blood sugar and hives.FDA label
Changes that show on blood tests
The label reports that LDL cholesterol rose on Redemplo, though the average stayed under 50mg/dL at 12 months on the 25mg dose.
- Liver enzymes rose within the normal range during the first 3 months and then stabilized.
- These show on a blood test, not as a symptom.FDA label
What the FDA asked Arrowhead to keep studying
The FDA's approval letter required Arrowhead to complete 2 trials in severe hypertriglyceridemia that were ongoing at approval.
- The letter says they must evaluate the potential for liver injury and for blood sugar problems, including new diabetes.
- The final report is due in June 2027.FDA letter
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.Rely On Redemplo
- 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.Cigna policy
- 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.Cigna policy
- 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.Redemplo prescriber site
- 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.Redemplo Start Form
- 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
Cigna prior authorization policy, September 1, 2026
- Age 18 or older
- A fasting triglyceride level of 880mg/dL or higher before any triglyceride-lowering medicine, with records
- FCS shown in 1 of 3 ways, each listed next
- Way 1: a gene test showing disease-causing variants in both copies of an FCS gene, with records
- Way 2: an inconclusive gene test, with a Moulin FCS score of 10 or more or a North American FCS score of 45 or more
- Way 3: a clinical diagnosis, with pancreatitis not caused by alcohol or gallstones, or repeated hospital stays for severe unexplained abdominal pain
- Way 3 also needs no secondary cause, such as obesity or uncontrolled diabetes, and no response to a traditional triglyceride-lowering medicine
- Used together with a low-fat diet
- Prescribed by a cardiologist, an endocrinologist, a lipidologist or a physician who focuses on severe hypertriglyceridemia
- Employer plans: Tryngolza received for at least 1 year unless not tolerated, or the prescriber states the patient has thrombocytopenia (low platelets) or is at risk of it
Approval length. 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. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. Rely On Redemplo
Five questions for the pharmacist or the support line
- When will my first carton ship, and does the Starter Kit come in the same delivery?
- How should the carton be kept if I travel, and how do I count the 30 days at room temperature?
- What should I do if a syringe was dropped, looks cloudy or was left out longer than 30 days?
- I take these other medicines. Does the Redemplo label list any interactions with them?
- How far ahead of my next 3-month dose will you call, and how many refills are on file?
Questions people ask in the first weeks
How long does it take to get Redemplo after it is prescribed?
Arrowhead does not publish a set time. The steps are the Start Form, the insurer's prior authorization and shipment from Vanscoy Rare Specialty Pharmacy. The Start Form's Quick Start box says an eligible patient may be able to receive a dose at no cost during an insurance delay.
Can I inject Redemplo myself?
Yes, by the label, once a healthcare provider has shown you or your caregiver how. You can use the front of the thigh or the belly. Only a healthcare provider or caregiver may inject the outer upper arm.
What if I miss a dose of Redemplo?
The Patient Information says to take the missed dose as soon as possible. The next injection is then 3 months from that date.
Do I still need the low-fat diet on Redemplo?
The label says yes. Redemplo is approved as an addition to diet, and the label says to keep to 20g of fat or less a day while using it. The trial enrolled people who were kept on that diet.
Does Redemplo raise blood sugar?
It did in the trial. High blood sugar was reported in 20% of people on Redemplo against 8% on placebo, and average HbA1c rose by up to 0.36 percentage points. The label sets no testing schedule, so your endocrinologist decides how often to check.
How well did Redemplo work in its trial?
In the label's trial, 26 adults with FCS took the 25mg dose and 25 took placebo. Median triglycerides fell 80% at 10 months on Redemplo against 17% on placebo. Over 12 months, acute pancreatitis occurred in 2 people on Redemplo (8%) and 5 on placebo (20%), a difference the label calls numerical.
Can I pick up Redemplo at my regular pharmacy?
Arrowhead says Redemplo is centrally dispensed by Vanscoy Rare Specialty Pharmacy. Redemplo Care Coordinators help with filling the prescription, on 1-844-733-3675.
Why was Redemplo denied by my insurance?
Each plan sets its own rules. Cigna's policy, one example, asks for a fasting triglyceride result of 880mg/dL or higher, proof of FCS and a specialist prescriber. Cigna's employer plans also ask for a year of Tryngolza first, unless it was not tolerated or low platelets are a concern.
Does Redemplo require blood tests?
No blood test is written into the label as a requirement before or between doses. The label does report rises in blood sugar, LDL cholesterol and liver enzymes in the trial. Insurers such as Cigna ask for triglyceride results to approve and renew coverage.
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Sources
- REDEMPLO (plozasiran) injection, for subcutaneous use: prescribing information, Patient Information and Instructions for Use, revised November 2025, Arrowhead Pharmaceuticals, via DailyMed and openFDA, August 25, 2026.
- Help With Insurance | REDEMPLO (plozasiran), Arrowhead Pharmaceuticals, November 13, 2026.
- Rely On Redemplo Patient Support | REDEMPLO, Arrowhead Pharmaceuticals, November 13, 2026.
- Program Enrollment | REDEMPLO (plozasiran), Arrowhead Pharmaceuticals, November 13, 2026.
- Support Services | REDEMPLO (plozasiran), Arrowhead Pharmaceuticals, November 13, 2026.
- Dosing & Administration | Redemplo (plozasiran), Arrowhead Pharmaceuticals, November 13, 2026.
- Rely On Redemplo Patient Support Program | HCP, Arrowhead Pharmaceuticals, November 13, 2026.
- Redemplo (plozasiran) Start Form, MAT-0280-v2.0-2/2026, Arrowhead Pharmaceuticals, February 1, 2026.
- Drug Coverage Policy IP0773, Hypertriglyceridemia - Redemplo, Cigna, September 1, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, November 13, 2026.
- NDA 219947 approval letter, FDA, November 18, 2025.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing endocrinologist. Found an error? Use the report link in the footer and it will be checked against the source.