Your first 90 days
Your first 90 days on Empaveli for PNH
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.
Empaveli is the PNH drug you give yourself at home, twice a week, after a nurse shows you how. Before the first box ships, the label requires vaccines against 2 kinds of bacteria, and the pharmacy checks with your doctor that they happened. If you are coming from Soliris or Ultomiris, the label also sets how the 2 drugs overlap. This page lays out those first 3 months from the FDA label, the REMS, Apellis's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Empaveli is a specialty drug under a REMS, so the first shipment waits on vaccines, a certified prescriber, a Start Form and an insurance approval, not on a pharmacy counter. These are the 6 things in the way, in order.
Vaccines, at least 2 weeks before the first dose
Empaveli blocks part of the complement system, which the body uses against encapsulated bacteria.
- The label requires vaccines at least 2 weeks before day 1.
- One is against Streptococcus pneumoniae, a pneumococcal shot.
- The others are against Neisseria meningitidis serogroups A, C, W, Y and B, the MenACWY and MenB shots.
- The schedule is the ACIP one for people on a complement inhibitor, which differs from the usual one.
- Shots you had before may not be enough, and your hematologist decides what else you need.FDA label
Or antibiotics, if treatment cannot wait
If you are not up to date and Empaveli has to start right away, the label says to give the vaccines as soon as possible along with antibiotics.
- The REMS requires the prescriber to write that antibiotic prescription.
- The Medication Guide says to take the antibiotics for as long as your doctor says.FDA label
A certified prescriber, and the counseling the REMS requires
Your hematologist must be enrolled in the EMPAVELI REMS.
- The REMS requires them to check for an untreated serious infection, review your vaccines, counsel you with the Patient Guide, and hand you the Patient Safety Card.
- There is no patient enrollment form for this REMS.
- The label lists the REMS line as 1-888-343-7073.FDA REMS page
The Start Form, which you sign too
Your doctor's office sends the EMPAVELI PNH Start Form to ApellisAssist, Apellis's support program, by fax.
- You sign the consent section first.
- The form lists your vaccine history and can include orders for missing shots.
- It also tells the pharmacy whether to ship at once or hold the box until your vaccines are confirmed.PNH Start Form
The pharmacy's check, then delivery
The Start Form says PANTHERx Specialty Pharmacy fills the prescription.
- Before the first shipment, the pharmacy must confirm your prescriber is certified and contact the office to document your vaccines or the antibiotic plan.
- If you were not up to date at the start, it keeps checking before each shipment for up to 6 months.FDA REMS page
Insurance approval, and help while you wait
The Start Form has a box for the office to ask for prior authorization support.
- On the same form, the doctor can authorize the QuickStart program, which can send a temporary supply at no cost if insurance is delayed, under its terms.
- Your ApellisAssist Care Coordinator walks you through your benefits and helps schedule deliveries.PNH Start Form
The days that matter
Counted from the first dose, with the vaccine deadline 2 weeks before it and the 4-week overlap for anyone switching from Soliris. Refills come about every 28 days, and the Safety Card outlasts the last dose. 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, vaccine history, REMS
The office sends the Start Form with your vaccine dates, or with orders for the shots you still need.
- ApellisAssist can help find a nearby pharmacy that has the vaccines in stock.
Vaccines done, or scheduled
The pneumococcal, MenACWY and MenB shots need at least 2 weeks before day 1 to count.
- Some of these vaccines come as a series, so ask which doses are due now and which come later.
Insurance approval, pharmacy check, training booked
The pharmacy confirms your prescriber's REMS certification and documents your vaccines with the office.
- ApellisAssist assigns an Apellis Care Educator, a trained professional with a nursing background, who trains you at home or by video.
First dose, with training
One 1,080mg vial infused under the skin, after the vial sits out of the fridge for about 30 minutes.
- With a pump it takes about 30 minutes using 2 sites, or 60 minutes using 1.
- The Injector takes about 30 to 60 minutes.
- Put the Patient Safety Card in your wallet the same day.
Second dose of the week
Twice a week means 2 doses in every week.
- Rotate the spot each time, and avoid skin that is tender, bruised, red, hard, scarred or tattooed.
- If you miss a dose, the label says to give it as soon as possible, then go back to your usual days.
If you came from Soliris, it ends here
The label says people switching from eculizumab start Empaveli while still on their usual eculizumab dose.
- After 4 weeks, eculizumab stops and Empaveli continues alone.
- The overlap lowers the risk of hemolysis from stopping a C5 inhibitor suddenly.
- Your hematologist sets the exact date.
Refill, then about every 28 days
A carton holds 8 vials, which is 4 weeks of twice-weekly doses.
- The Care Coordinator schedules each delivery of vials and supplies.
- Keep the vials in the fridge in their carton.
Blood levels settle, LDH matters
The label says Empaveli reaches a steady level in the blood about 4 to 6 weeks after the first dose.
- It also sets the dose by LDH, a blood marker of red cell breakdown.
- If LDH runs above 2 times the upper limit of normal, the dose can change to every 3 days, with LDH checked twice a week for at least 4 weeks.
Refill, number 2
The next vaccine doses
Apellis prints the vaccine schedule for complement inhibitor patients on its Start Form.
- There, MenACWY is 2 doses at least 8 weeks apart, and MenB is a 3-dose series at 0, 1 to 2, and 6 months.
- Some of those doses can fall in the first 3 months.
- The label says to keep up with boosters for as long as treatment lasts.
Refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Empaveli 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 21, 2026, read from the FDA's label database today. FDA label
- August 2026
The kidney use for C3G and IC-MPGN was widened to include reducing the loss of kidney function. The label's revision list names only that section, so the PNH use and dose did not change. The REMS materials were updated the same day.FDA label
- July 2025
C3 glomerulopathy and primary IC-MPGN were added as a second use, for adults and children 12 and older.FDA REMS page
- February 2024
The FDA's safety labeling change removed the Hib vaccine requirement, leaving pneumococcal and meningococcal vaccination. The REMS followed in October 2024. Some insurer policies still list Hib.FDA REMS page
- October 2023
Apellis announced FDA approval of the EMPAVELI Injector, a single-use device worn on the belly, as an option to the infusion pump.Apellis release
- May 2021
First approval, for adults with PNH. The FDA approved the EMPAVELI REMS on the same day.FDA REMS page
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.
- Twice a week, under the skin, at home
The label dose for adults with PNH is 1,080mg twice weekly, given with a pump that holds at least 20mL or with the EMPAVELI Injector.
- You or a caregiver can give it after training by a healthcare professional.
- The Injector goes only on the belly.
- With a pump, the sites are the belly, thighs, hips or upper arms.FDA label
- If you miss a dose
The Medication Guide says to take the missed dose as soon as possible, then take the next dose at your regular time.FDA label
- Fever is a call, not a wait
The Medication Guide lists fever with or without chills, and fever with chest pain, cough, fast breathing or a fast heartbeat.
- It also lists headache with fever or a stiff neck or back.
- Confusion, clammy skin, a rash with fever, flu-like body aches and eyes sensitive to light are on the list too.
- It says to call your doctor or get emergency care right away, and to show the Patient Safety Card.FDA label
- The card outlasts the drug
The label requires carrying the Patient Safety Card at all times during treatment and for 2 months after the last dose.
- The infection risk can continue for several weeks after stopping.FDA label
- Stopping has its own watch period
The label says stopping Empaveli can bring back red blood cell breakdown from PNH.
- Anyone who stops is monitored closely for at least 8 weeks.
- The Medication Guide lists blood in the urine, tiredness, shortness of breath, belly pain, trouble swallowing, blood clots and erectile dysfunction as signs.
- Any change to treatment is a decision for your hematologist.FDA label
- Boosters
The label says to revaccinate on the ACIP schedule for as long as treatment lasts.
- Vaccines lower the risk but do not remove it, which is why the fever rule never goes away.FDA label
- Pregnancy and breastfeeding
The label recommends a pregnancy test before starting for anyone who can become pregnant, and effective birth control during treatment and for 40 days after the last dose.
- It says not to breastfeed during treatment and for 40 days after.
- It also notes that PNH itself carries risks in pregnancy, so the decision is a risk and benefit talk with the hematologist.FDA label
- A blood clotting test can read wrong
The label says Empaveli can make one clotting test, the aPTT, look falsely long when the lab uses silica reagents.
- Anyone ordering clotting tests for you should know you take Empaveli.FDA label
- Storage
In the refrigerator, 36 to 46 degrees Fahrenheit, in the original carton to protect it from light.
- Let a vial reach room temperature for about 30 minutes before use.
- The liquid should be clear and colorless to slightly yellow, never cloudy, dark yellow or with particles.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.
Signs the label ties to serious infection
Fever of any kind, with or without chills, or with chest pain, cough, fast breathing or a fast heartbeat.
- Headache with fever, nausea or a stiff neck or back.
- Confusion, clammy skin, a rash with fever, flu-like body aches, or light hurting the eyes.
- The Medication Guide says these can become life-threatening quickly.
- Call your doctor or get emergency care at once, card in hand.FDA label
An allergic reaction during an infusion
Chest pain, trouble breathing or wheezing, swelling of the face, tongue or throat, feeling faint, a fast heartbeat, nausea, confusion, or hives and itching.
- The Medication Guide says to stop the infusion and get emergency care right away.
- The label reports cases of anaphylaxis that led to stopping treatment.FDA label
Shot site reactions and stomach upset
In the trial against eculizumab, reactions where the needle went in occurred in 39% of people on Empaveli against 5% on eculizumab, all mild or moderate.
- Diarrhea was 22% against 3%, and belly pain 20% against 10%.
- Infections were 29% against 26%, and tiredness 12% against 23%.FDA label
Signs of hemolysis
Blood in the urine, more tiredness, shortness of breath, belly pain, trouble swallowing or a blood clot can mean red blood cells are breaking down again.
- The label ties this most to stopping Empaveli.
- In the trial against eculizumab, 3 of 41 people on Empaveli left the 16-week comparison because of hemolysis.
- Tell your hematologist about any of these.FDA label
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.
- 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.PNH Start Form
- 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.FDA REMS page
- 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.PNH Start Form
- 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.FEP Blue policy
- 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
Blue Cross Blue Shield Federal Employee Program prior authorization policy, April 1, 2026
- PNH, age 18 or older
- A baseline hemoglobin on record
- Not used together with another PNH drug that needs prior approval: Soliris, Ultomiris or Fabhalta
- Vaccinated against pneumococcus, meningococcus and Hib at least 2 weeks before starting, unless treatment cannot be delayed
- The prescriber is enrolled in the Empaveli REMS
Approval length. 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. FEP Blue 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.
- 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
Details as the drugmaker publishes them. ApellisAssist
Five questions for the pharmacist or the support line
- Have you documented my vaccine dates with my hematologist's office, and is my shipment set to go or on hold?
- Which number will PANTHERx and my Care Coordinator call me from?
- Am I using a pump or the EMPAVELI Injector, and do the supplies come in the same box as the vials?
- If I switch from Soliris, which date is my last eculizumab dose, and does my plan cover both for those 4 weeks?
- When are my next MenACWY and MenB doses due, and who gives them?
Questions people ask in the first weeks
How long does it take to get Empaveli after it is prescribed?
The vaccines set the floor: at least 2 weeks between the shots and the first dose, by the label, unless the hematologist starts antibiotics instead. The Start Form, prior authorization and the pharmacy's REMS check run alongside. If insurance is slow, the QuickStart program may send a temporary supply under its terms.
Which vaccines do I need before Empaveli?
By the label, vaccines against Streptococcus pneumoniae and Neisseria meningitidis serogroups A, C, W, Y and B, at least 2 weeks before the first dose. In plain terms, that is a pneumococcal shot plus the MenACWY and MenB shots. Earlier shots may not count, because the schedule for complement inhibitors differs from the standard one.
How do I switch from Soliris or Ultomiris to Empaveli?
The label says people on eculizumab (Soliris) start Empaveli and keep their usual eculizumab dose for 4 weeks, then stop eculizumab. People on ravulizumab (Ultomiris) start Empaveli no more than 4 weeks after their last ravulizumab dose. Your hematologist sets the dates.
Can I give Empaveli myself?
Yes. The label says patients or caregivers may give it after proper training by a healthcare professional. ApellisAssist sends an Apellis Care Educator to train you at home or by video, with either a pump or the single-use EMPAVELI Injector worn on the belly.
What if I miss a dose of Empaveli?
The label says to give the missed dose as soon as possible, then go back to the regular schedule. The Medication Guide uses the same wording.
What is the Patient Safety Card?
A card from your prescriber that lists the signs of serious infection and tells anyone treating you that you take Empaveli. The label requires carrying it at all times during treatment and for 2 months after the last dose.
Why was Empaveli denied by my insurance?
One federal employee plan's policy asks for a baseline hemoglobin, proof of the vaccines, the prescriber's REMS enrollment, and proof you are not on a second PNH drug. The 4-week overlap with Soliris can trip that last rule. The hematologist's records usually resolve it.
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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, August 21, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Empaveli (pegcetacoplan), NDA 215014, FDA, August 20, 2026.
- Learn About ApellisAssist & Support | EMPAVELI (pegcetacoplan), Apellis Pharmaceuticals, November 7, 2026.
- How & When to Take EMPAVELI | EMPAVELI (pegcetacoplan), Apellis Pharmaceuticals, November 7, 2026.
- EMPAVELI (pegcetacoplan) PNH Start Form, US-PEGPNH-2300129 v7.0, Apellis Pharmaceuticals, September 1, 2026.
- Pharmacy Policy 5.85.042, Empaveli (pegcetacoplan), Blue Cross Blue Shield Federal Employee Program, April 1, 2026.
- Apellis Announces U.S. FDA Approval of the EMPAVELI Injector, a Device to Streamline Self-Administration, Apellis Pharmaceuticals, October 2, 2023.
- Drugs@FDA: FDA-Approved Drugs, EMPAVELI, NDA 215014, FDA, August 20, 2026.
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 hematologist. Found an error? Use the report link in the footer and it will be checked against the source.