Prescribing guide
Empaveli (pegcetacoplan)Vaccine requirements, REMS, C5 inhibitor switching, monitoring and prior authorization criteria for PNHFor prescribers and their offices treating paroxysmal nocturnal hemoglobinuria (PNH): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
REMS-certified prescriber, pneumococcal and meningococcal (ACWY and B) vaccination at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, no unresolved encapsulated bacterial infection, counseling with the Patient Guide and Patient Safety Card, and the pharmacy's documentation of vaccination status with the office.
Example PA threshold
FEP example: PNH, age 18 or older, documented baseline hemoglobin, no dual therapy with another PA drug for PNH, vaccination including Hib, prescriber REMS enrollment; 12 months, 30 vials per 90 days.
Monitoring
Serious infection with encapsulated bacteria at any time; LDH, which sets the dose (every 3 days above 2 times ULN, then LDH twice weekly for 4 weeks); hemolysis for at least 8 weeks after any discontinuation; boosters on the ACIP schedule.
Support line
ApellisAssist, 1-866-692-7527, Start Form by fax to 1-888-754-1285, Apellis Care Educator self-infusion training, QuickStart supply on insurance delay, copay to $0 for commercial plans; REMS line 1-888-343-7073.
Give your patient their plan
A one-page handout for starting Empaveli, 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/empaveliBefore 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 |
|---|---|---|
| Certify in the EMPAVELI REMS | Review the Prescribing Information, the Healthcare Provider Safety Brochure, Patient Guide and Patient Safety Card, then submit the Prescriber Enrollment Form. Apellis's Start Form says certification is a one-time registration at EMPAVELIREMS.com and is required before the first prescription. | PNH Start Form |
| Rule out active infection | Initiation is contraindicated with an unresolved serious infection caused by encapsulated bacteria, and the REMS requires the prescriber to assess for one before starting. | FDA label |
| Vaccinate | Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y and B, at least 2 weeks before the first dose, on the ACIP complement inhibitor schedule, which differs from the vaccine prescribing information. The label recommends revaccination for the duration of therapy. | FDA label |
| Or prophylaxis | If treatment is urgent and the patient is not up to date, give antibacterial prophylaxis and the vaccines as soon as possible. The REMS requires the prescriber to provide the prophylaxis prescription. The label notes the optimal prophylaxis regimen and duration have not been studied. | FDA label |
| Counsel and hand over the card | Counsel with the Patient Guide and Patient Safety Card and give copies. The card is carried at all times during treatment and for 2 months after the last dose. | FDA REMS page |
| Start Form to ApellisAssist | Patient signs the consents first. Attach flow cytometry confirming PNH, hemoglobin, LDH and transfusion history; list current PNH therapy and last infusion date; record vaccine brands and dates or write vaccine orders. Choose ship as soon as authorized, or hold until vaccination is confirmed. Fax 1-888-754-1285. The form routes the prescription to PANTHERx Specialty Pharmacy. | PNH Start Form |
| Expect the pharmacy's call | The certified pharmacy obtains REMS authorization for every dispense and contacts the office to document vaccination status or the prophylaxis plan before the first fill. For patients not up to date at the start, it repeats that check before each dispense for up to 6 months. | FDA REMS page |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, April 1, 2026. Approval twelve months at a time, renewed if hemoglobin has risen from the starting level with no unacceptable side effects, with a limit of 30 vials every 90 days. This policy took effect April 1, 2026 and cites the July 2025 label, so it predates the August 2026 label. That later change was to the kidney use, not PNH. It still lists the Hib vaccine, which the FDA dropped from the REMS vaccine requirement in 2024. Its no-dual-therapy rule does not say how it treats the label's 4-week overlap with eculizumab. 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 |
|---|---|---|---|
| Diagnosis and age | PNH, age 18 or older; the label states safety and effectiveness in pediatric PNH have not been established | Flow cytometry confirming PNH, which the Apellis Start Form asks to attach | FEP Blue policy |
| Baseline hemoglobin | A documented pretreatment hemoglobin; renewal requires an increase from it | Hemoglobin with date, before the first dose and at renewal | FEP Blue policy |
| No dual therapy | Not used with another PNH drug requiring PA: eculizumab, iptacopan or ravulizumab | Medication list; for an eculizumab switch, document the planned 4-week overlap and stop date, since the policy does not address it | FEP Blue policy |
| Vaccination | Streptococcus pneumoniae, Neisseria meningitidis and Hib at least 2 weeks before starting unless treatment cannot be delayed; the policy still lists Hib, which the labeling dropped in February 2024 | Vaccine names and dates, or the prophylaxis prescription | FEP Blue policy |
| REMS | Prescriber enrolled in the Empaveli REMS | Enrollment confirmation | FEP Blue policy |
| Quantity | 30 vials every 90 days, 12 months at a time | Twice weekly uses about 26 vials per 91 days; every-3-days dosing uses 30 per 90 | FEP Blue policy |
Empaveli dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 1,080mg (20mL) SC twice weekly, by a commercial infusion pump with a reservoir of at least 20mL or the single-use EMPAVELI Injector (abdomen only). Pump infusion about 30 minutes with 2 sites or 60 minutes with 1; Injector about 30 to 60 minutes. Supplied in 8-vial cartons, a 28-day supply. | FDA label |
| From eculizumab | Start Empaveli while continuing eculizumab at its current dose; after 4 weeks discontinue eculizumab and continue Empaveli monotherapy. | FDA label |
| From ravulizumab | Start Empaveli no more than 4 weeks after the last ravulizumab dose. | FDA label |
| LDH above 2 times ULN | Adjust to 1,080mg every 3 days; monitor LDH twice weekly for at least 4 weeks after the increase. In APL2-302, 2 of 41 needed the adjustment during the randomized period and 13 between weeks 16 and 48 of the open-label period. | FDA label |
| Missed dose | Administer as soon as possible, then resume the regular schedule. | FDA label |
| Self-administration | Patient or caregiver after training by a healthcare professional; ApellisAssist provides an Apellis Care Educator for training at home or virtually. | ApellisAssist |
Monitoring the Empaveli label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before day 1 | Vaccination status against the complement inhibitor schedule; unresolved encapsulated bacterial infection; pregnancy test for females of reproductive potential | Required or recommended by the label; vaccination is documented by the pharmacy with the office | FDA label |
| Any time | Serious infection: fever with or without chills, fever with chest pain and cough, tachypnea or tachycardia, headache with fever, nausea or stiff neck or back, confusion, rash with fever, flu-like myalgia, clammy skin, photophobia | Evaluate immediately; consider interruption during treatment of a serious infection. In APL2-308, 1 patient on Empaveli died of septic shock | FDA label |
| During infusion | Hypersensitivity: facial swelling, rash, urticaria, pyrexia; anaphylaxis has led to discontinuation | For severe reactions, stop the infusion immediately and treat per standard of care | FDA label |
| LDH | Sets the dose; steady state is reached about 4 to 6 weeks after the first dose | Above 2 times ULN, move to every 3 days and check LDH twice weekly for at least 4 weeks | FDA label |
| After any discontinuation | LDH, hemoglobin, PNH clone size; fatigue, hemoglobinuria, abdominal pain, dyspnea, thrombosis, dysphagia, erectile dysfunction | Monitor at least 8 weeks; consider restarting if hemolysis occurs | FDA label |
| Coagulation labs | aPTT | Silica reagents can falsely prolong aPTT; the label says to avoid them in coagulation panels | FDA label |
| Per ACIP | Boosters | Revaccinate for the duration of therapy; Apellis's Start Form prints MenACWY revaccination every 5 years and a MenB booster 1 year after the primary series, then every 2 to 3 years, while risk remains | PNH Start Form |
Empaveli drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| No interaction section | The label has no drug interaction section; the Medication Guide asks patients to disclose all medicines, vitamins, supplements and vaccines | FDA label |
| C5 inhibitors | Overlap with eculizumab for 4 weeks when switching; start within 4 weeks of the last ravulizumab dose | FDA label |
| Lab interference | Silica-reagent aPTT is artificially prolonged; avoid silica reagents in coagulation panels | FDA label |
| Pregnancy and lactation | Insufficient human data; abortions and stillbirths increased in monkeys at 2.9 times human exposure; pregnancy test before treatment, effective contraception during and for 40 days after the last dose; no breastfeeding during and for 40 days after | FDA label |
Why a first fill stalls, and the fix
- The pharmacy cannot document the vaccinesThe REMS requires the pharmacy to check your vaccines or antibiotic plan with the prescriber before the first shipment. The Start Form lets the office either authorize shipping at once or ask the pharmacy to hold until the shots are confirmed. Sending the vaccine dates, or the antibiotic prescription, clears it.
- The prescription went to the wrong pharmacyOnly REMS-certified pharmacies may dispense Empaveli, and the Start Form routes it to PANTHERx Specialty Pharmacy. A prescription sent to a local pharmacy is a routing problem, not a denial. The office resends it.
- Prior authorization pending or deniedThe FEP policy below asks for a baseline hemoglobin, proof of the vaccines, and the prescriber's REMS enrollment. The Start Form asks the office to attach flow cytometry confirming PNH, hemoglobin, LDH and transfusion history. While insurance is delayed, the QuickStart program may send a temporary supply at no cost under its terms.
- The plan does not allow 2 PNH drugs at onceThe FEP policy below rules out dual therapy with Soliris, Ultomiris or Fabhalta. The label's switch from eculizumab overlaps the 2 drugs for 4 weeks. Ask the office and the plan how that overlap is approved before day 1.
- A copay you cannot payCommercial insurance: the Apellis Copay Program, as little as $0, subject to a yearly limit. Medicare, Medicaid, CHIP, VA, DoD and TRICARE are excluded. If you have no insurance or limited coverage, the Apellis Patient Assistance Program may supply it at no cost. Our help paying page lists the charity funds that are open.
ApellisAssist
- An Apellis Care Educator, a trained professional with a nursing background, who teaches self-infusion at home or by video and keeps checking in
- A Care Coordinator who walks you through your benefits and helps schedule deliveries of medicine and supplies
- A pharmacist available 24 hours a day, through ApellisAssist
- Apellis Copay Program for commercial insurance, as little as $0 subject to a yearly limit, not valid under Medicaid, Medicare, CHIP, VA, DoD or TRICARE
- Apellis Patient Assistance Program, which may supply Empaveli at no cost if you have no insurance or limited coverage, and a Bridge Program for a gap when insurance changes
- A Vaccine Coordinator, through a specialty pharmacy, who finds local pharmacies with the vaccines in stock and makes sure they have the correct prescription information
Questions prescribers' offices ask about Empaveli
Which vaccines are required before Empaveli?
Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y and B, at least 2 weeks before the first dose, on the ACIP schedule for complement inhibitor recipients, per the August 2026 label. The Hib requirement was removed in the February 2024 safety labeling change, though the boxed warning still names Hib among the organisms.
How do patients switch from eculizumab or ravulizumab to Empaveli?
From eculizumab, start Empaveli and continue eculizumab at the current dose for 4 weeks, then discontinue eculizumab, per the August 2026 label. From ravulizumab, start Empaveli no more than 4 weeks after the last ravulizumab dose.
What does the Empaveli REMS require?
A certified prescriber who assesses for unresolved encapsulated bacterial infection, checks and completes vaccination, writes antibacterial prophylaxis if treatment is urgent, and counsels with the Patient Guide and Patient Safety Card, per the REMS last updated August 20, 2026. There is no patient enrollment. The certified pharmacy verifies prescriber certification for every dispense and documents vaccination status with the office. The REMS line is 1-888-343-7073.
When should the Empaveli dose be increased?
When LDH exceeds 2 times the upper limit of normal, the August 2026 label says to adjust to 1,080mg every 3 days. After a dose increase, monitor LDH twice weekly for at least 4 weeks.
What do insurers ask for to approve Empaveli for PNH?
The FEP policy shown on this page, effective April 1, 2026, asks for age 18 or older, a documented baseline hemoglobin, no dual therapy with Soliris, Ultomiris or Fabhalta, vaccination including Hib at least 2 weeks before starting, and REMS enrollment. It approves 12 months at 30 vials per 90 days, renewed on a hemoglobin increase.
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Sources
- EMPAVELI (pegcetacoplan) injection, for subcutaneous use: prescribing information and Medication Guide, revised August 2026, Apellis Pharmaceuticals, via openFDA and DailyMed, 2026-08-21.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Empaveli (pegcetacoplan), NDA 215014, FDA, 2026-08-20.
- Learn About ApellisAssist & Support | EMPAVELI (pegcetacoplan), Apellis Pharmaceuticals, 2026-11-07.
- How & When to Take EMPAVELI | EMPAVELI (pegcetacoplan), Apellis Pharmaceuticals, 2026-11-07.
- EMPAVELI (pegcetacoplan) PNH Start Form, US-PEGPNH-2300129 v7.0, Apellis Pharmaceuticals, 2026-09-01.
- Pharmacy Policy 5.85.042, Empaveli (pegcetacoplan), Blue Cross Blue Shield Federal Employee Program, 2026-04-01.
- Apellis Announces U.S. FDA Approval of the EMPAVELI Injector, a Device to Streamline Self-Administration, Apellis Pharmaceuticals, 2023-10-02.
- Drugs@FDA: FDA-Approved Drugs, EMPAVELI, NDA 215014, FDA, 2026-08-20.
A reference drawn from the August 21, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 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.