Endocrinology
Familial chylomicronemia syndrome (FCS): the approved drugs compared for prescribers
Redemplo, Tryngolza side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for familial chylomicronemia syndrome (FCS).
When to suspect familial chylomicronemia syndrome (FCS) and what to test →The 2 familial chylomicronemia syndrome (FCS) prescribing guides
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Redemploplozasiran | Tryngolzaolezarsen | |
|---|---|---|
| Label dated | August 25, 2026 | July 3, 2026 |
| Starting dose | 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. | 80mg subcutaneously once monthly in adults. |
| 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 | No REMS; e-prescription or faxed Start Form to a network pharmacy (Accredo, BlinkRx, CVS Specialty or Optum Specialty Pharmacy), prior authorization, the pharmacy's contact with the patient, and injection training before the first dose |
| Required 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 | No scheduled lab monitoring in the label; consider liver enzymes before initiation or a dose increase and when clinically indicated; watch for hypersensitivity; platelet reductions and glucose, HbA1c and LDL-C increases were seen in trials |
| 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 | Cigna example: age 18 or older; documented baseline fasting TG of 880mg/dL or higher; biallelic pathogenic variants, or an inconclusive test with Moulin 10 or more or NAFCS 45 or more, or a clinical diagnosis; low-fat diet; cardiologist, endocrinologist, lipidologist or sHTG-focused physician |
| 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 | Ionis Every Step, 1-844-789-8744, Monday to Friday 8 AM to 8 PM ET (patients select option 2); patient consent page fax 1-877-299-0015; commercial copay as little as $0 per fill; Quick Start free drug during the insurance approval process; Bridge and Patient Assistance Program |
- Label dated
- August 25, 2026
- Starting dose
- 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.
- 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
- Required 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
- 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
- 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
- Label dated
- July 3, 2026
- Starting dose
- 80mg subcutaneously once monthly in adults.
- Dispensing gate
- No REMS; e-prescription or faxed Start Form to a network pharmacy (Accredo, BlinkRx, CVS Specialty or Optum Specialty Pharmacy), prior authorization, the pharmacy's contact with the patient, and injection training before the first dose
- Required monitoring
- No scheduled lab monitoring in the label; consider liver enzymes before initiation or a dose increase and when clinically indicated; watch for hypersensitivity; platelet reductions and glucose, HbA1c and LDL-C increases were seen in trials
- Example PA threshold
- Cigna example: age 18 or older; documented baseline fasting TG of 880mg/dL or higher; biallelic pathogenic variants, or an inconclusive test with Moulin 10 or more or NAFCS 45 or more, or a clinical diagnosis; low-fat diet; cardiologist, endocrinologist, lipidologist or sHTG-focused physician
- Support line
- Ionis Every Step, 1-844-789-8744, Monday to Friday 8 AM to 8 PM ET (patients select option 2); patient consent page fax 1-877-299-0015; commercial copay as little as $0 per fill; Quick Start free drug during the insurance approval process; Bridge and Patient Assistance Program
FDA decisions for familial chylomicronemia syndrome (FCS)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- August 2026Redemplo. 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
- June 2026Tryngolza. The FDA added a second use on June 24th, lowering triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia. The same update added a 50mg dose for that use and a new warning about liver enzyme increases. The dose for FCS stayed the same, at 80mg once a month. FDA letter
- November 2025Redemplo. 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
- December 2024Tryngolza. The FDA first approved Tryngolza on December 19th, as an addition to diet to lower triglycerides in adults with FCS. The approval letter requires Ionis to finish 2 placebo-controlled trials and a 2-year extension trial that look for liver injury. It also asks Ionis to report liver toxicity cases within 15 days through the fifth year after approval. FDA letter
Open trials
Questions prescribers ask about Familial chylomicronemia syndrome (FCS)
Which Familial chylomicronemia syndrome (FCS) drugs require a REMS?
None of the 2 Familial chylomicronemia syndrome (FCS) drugs on this page has a REMS: Redemplo and Tryngolza. Each prescribing guide lists what does gate the first fill.
What monitoring do Familial chylomicronemia syndrome (FCS) drugs require?
Redemplo: 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. Tryngolza: No scheduled lab monitoring in the label; consider liver enzymes before initiation or a dose increase and when clinically indicated; watch for hypersensitivity; platelet reductions and glucose, HbA1c and LDL-C increases were seen in trials.
What do insurers require before covering Redemplo and Tryngolza?
Each answer below is one public insurer policy, an example rather than every plan. Redemplo: 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. Tryngolza: Cigna example: age 18 or older; documented baseline fasting TG of 880mg/dL or higher; biallelic pathogenic variants, or an inconclusive test with Moulin 10 or more or NAFCS 45 or more, or a clinical diagnosis; low-fat diet; cardiologist, endocrinologist, lipidologist or sHTG-focused physician.
Which support programs start Familial chylomicronemia syndrome (FCS) patients on therapy?
Redemplo: 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. Tryngolza: Ionis Every Step, 1-844-789-8744, Monday to Friday 8 AM to 8 PM ET (patients select option 2); patient consent page fax 1-877-299-0015; commercial copay as little as $0 per fill; Quick Start free drug during the insurance approval process; Bridge and Patient Assistance Program.
A reference for licensed professionals, checked on November 13, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Familial chylomicronemia syndrome (FCS) page and the first 90 days pages for Redemplo, Tryngolza.