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Empaveli (Pegcetacoplan): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Boxed warning
Strength:
1080 mg/20 mL
Other brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Empaveli

What is the most important information I should know about EMPAVELI?

EMPAVELI is a medicine that affects your immune system. EMPAVELI may lower the ability of your immune system to fight infections.

  • EMPAVELI increases your chance of getting serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B. These serious infections may quickly become life-threatening or cause death if not recognized and treated early.

    • You must complete or be up to date with the vaccines against Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks before your first dose of EMPAVELI.
    • If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
    • If you have not been vaccinated and EMPAVELI must be started right away, you should also receive antibiotics to take for as long as your healthcare provider tells you.
    • If you have been vaccinated against these bacteria in the past, you might need additional vaccines before starting EMPAVELI. Your healthcare provider will decide if you need additional vaccines.
    • Vaccines do not prevent all infections caused by encapsulated bacteria. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious infection:
  • fever with or without shivers or the chills
  • fever with chest pain and cough
  • fever with high heart rate
  • headache and fever
  • confusion
  • clammy skin
  • fever and a rash
  • fever with breathlessness or fast breathing
  • headache with nausea or vomiting
  • headache with a stiff neck or stiff back
  • body aches with flu-like symptoms
  • eyes sensitive to light

Your healthcare provider will give you a Patient Safety Card about the risk of serious infections. Carry it with you at all times during treatment and for 2 months after your last dose of EMPAVELI. Your risk of serious infections may continue for several weeks after your last dose of EMPAVELI. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

EMPAVELI is only available through a program called the EMPAVELI Risk Evaluation and Mitigation Strategy (REMS). Before you can take EMPAVELI, your healthcare provider must:

  • enroll in the EMPAVELI REMS program
  • counsel you about the risk of serious infections caused by certain bacteria
  • give you information about the symptoms of serious infections
  • make sure that you are vaccinated against serious infections caused by encapsulated bacteria and that you receive antibiotics if you need to start EMPAVELI right away and you are not up to date on your vaccines
  • give you a Patient Safety Card about your risk of serious infections, as discussed above
  • For more information about side effects, see "What are the possible side effects of EMPAVELI?"

What is EMPAVELI?

EMPAVELI is a prescription medicine used to:

  • treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).
  • treat adults and children 12 years of age and older with a kidney disease called complement 3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce levels of protein in the urine (proteinuria) and the loss of kidney function.

It is not known if EMPAVELI is safe and effective in children with PNH.

It is not known if EMPAVELI is safe and effective in children under 12 years of age with C3G or primary IC-MPGN.

Do not take EMPAVELI if you:

  • are allergic to pegcetacoplan or any of the ingredients in EMPAVELI. See the end of this Medication Guide for a complete list of ingredients in EMPAVELI.
  • have a serious infection caused by encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis, or Haemophilus influenzae type B when you are starting EMPAVELI treatment.

Before you take EMPAVELI, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection or fever.

  • are pregnant or plan to become pregnant. EMPAVELI may harm your unborn baby.

    Females who are able to become pregnant:

    • should have a pregnancy test before starting treatment with EMPAVELI.
    • use an effective method of birth control (contraception) during treatment with EMPAVELI and for 40 days after the last dose.
  • are breastfeeding or plan to breastfeed. It is not known if EMPAVELI passes into your breast milk. You should not breastfeed during treatment with EMPAVELI and for 40 days after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. EMPAVELI and other medicines can affect each other, causing side effects.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take EMPAVELI?

  • See the detailed Instructions for Use that comes with your EMPAVELI for information about how to prepare and infuse your dose of EMPAVELI with your infusion pump.
  • See the detailed Instructions for Use that comes with your EMPAVELI Injector for information about how to prepare and inject your dose of EMPAVELI with your EMPAVELI Injector.
  • Your healthcare provider should show you how to prepare and administer EMPAVELI before you use it for the first time.
  • Use EMPAVELI exactly as your healthcare provider tells you. Do not use more or less than your healthcare provider tells you to.
  • If you miss a dose of EMPAVELI, take the missed dose as soon as possible. Take your next dose at your regularly scheduled time.

For adults with PNH:

  • EMPAVELI is given under the skin (subcutaneously) 2 times each week. If there is an increase in your LDH, an enzyme in your blood, your healthcare provider may tell you to take EMPAVELI every 3 days.
  • If you are changing treatment from eculizumab to EMPAVELI, you should continue eculizumab for 4 weeks after your first dose of EMPAVELI. After 4 weeks, you should stop treatment with eculizumab.
  • If you are changing treatment from ravulizumab to EMPAVELI, you should take your starting dose of EMPAVELI no more than 4 weeks after your last dose of ravulizumab.

  • If you have PNH and you stop taking EMPAVELI, your healthcare provider will need to monitor you closely for at least 8 weeks after stopping EMPAVELI. Stopping treatment with EMPAVELI may cause a breakdown of red blood cells due to PNH.

    Symptoms or problems that can happen due to red blood cell breakdown include:

  • decreased hemoglobin level in your blood
  • blood in your urine
  • shortness of breath
  • trouble swallowing
  • tiredness
  • pain in the stomach (abdomen)
  • blood clots
  • erectile dysfunction (ED)

For adults and children 12 years of age and older with C3G or primary IC-MPGN:

  • EMPAVELI is given under the skin (subcutaneously) 2 times each week.

What are the possible side effects of EMPAVELI?

EMPAVELI can cause serious side effects including:

  • See "What is the most important information I should know about EMPAVELI?"
  • Allergic reactions. Allergic reactions can happen during your EMPAVELI infusion and can be life-threatening. Stop your EMPAVELI infusion and get emergency medical care right away if you get any of these symptoms during your EMPAVELI infusion:
  • chest pain
  • trouble breathing or shortness of breath
  • wheezing
  • swelling of your face, tongue, or throat
  • feel dizzy or faint or pass out
  • fast heart rate
  • nausea or vomiting
  • feel confused or anxious
  • skin reactions, including rash, hives, and itching

The most common side effects in adults with PNH treated with EMPAVELI include:

  • injection-site reactions
  • infections
  • diarrhea
  • pain in the stomach (abdomen)
  • respiratory tract infection
  • pain in the arms, hands, legs or feet
  • low potassium in blood
  • tiredness
  • viral infection
  • cough
  • joint pain
  • dizziness
  • headache
  • rash

The most common side effects in adults and children 12 years of age and older with C3G or primary IC-MPGN treated with EMPAVELI include:

  • injection-site reactions
  • fever
  • common cold
  • flu
  • cough
  • nausea

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of EMPAVELI.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EMPAVELI?

  • Store vials of EMPAVELI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
  • Do not use EMPAVELI past the expiration date stamped on the carton.

Keep EMPAVELI and all medicines out of the reach of children.

General information about the safe and effective use of EMPAVELI.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EMPAVELI for a condition for which it was not prescribed. Do not give EMPAVELI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about EMPAVELI that is written for health professionals.

What are the ingredients in EMPAVELI?

Active ingredient: pegcetacoplan

Inactive ingredients: sorbitol, glacial acetic acid, sodium acetate trihydrate, Water for Injection USP. EMPAVELI may also contain sodium hydroxide and/or additional glacial acetic acid for pH adjustment.

Manufactured for:

Apellis Pharmaceuticals, Inc. 100 Fifth Avenue Waltham, MA 02451

For patent information: www.apellis.com/productpatent

Copyright © 2026 Apellis Pharmaceuticals, Inc. All rights reserved.

EMPAVELI is a registered trademark of Apellis Pharmaceuticals, Inc.

For more information, go to www.EMPAVELI.com or call 1-866-692-7527.

EMP-MG-20Aug2026-8.0

INSTRUCTIONS FOR USE

EMPAVELI® (em-puh-vel-ee)

(pegcetacoplan)

injection, for subcutaneous use

infusion pump

Important Information

This Instructions for Use is for the infusion pump only. If using EMPAVELI Injector, follow the Instructions for Use that comes with the EMPAVELI Injector.

Read this Instructions for Use before you start using EMPAVELI with an infusion pump and each time you get a refill as there may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to infuse EMPAVELI the right way before you use it for the first time. Ask your healthcare provider about any instructions you do not understand.

How should I store EMPAVELI?

  • Store vials of EMPAVELI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
  • Do not use EMPAVELI past the expiration date stamped on the carton.

Keep EMPAVELI and all medicines out of the reach of children.

Step 1

Prepare for infusion

Before you start:

  • Find a well-lit, flat work surface area, like a table.
  • Remove a single vial carton from the refrigerator. Keep the vial in the carton at room temperature 68°F to 77°F (20°C to 25°C) and allow it to warm up for about 30 minutes.
  • Do not try to speed up the warming process.

Gather your supplies (See Figure A ):

  • Infusion pump and manufacturer's instructions (not shown)
  • Compatible syringe for your infusion pump
  • Transfer needle OR
  • Needleless transfer device to draw up the medicine from the vial
  • Infusion set (not shown; varies according to device manufacturer's instructions)
  • Infusion tubing
  • Sharps container
  • Alcohol wipes
  • Gauze and tape, or transparent dressing

Figure A: Supplies

Clean your work surface well using an alcohol wipe.
Wash your hands well with soap and water. Dry your hands.
Step 2

Check the vial and liquid

  • Remove the vial from the carton. Carefully look at the liquid in the vial of EMPAVELI.

    • EMPAVELI is a clear, colorless to slightly yellowish liquid. Check for particles or color changes (See Figure B ).

Do not use the vial and call ApellisAssist at 1-866-MY-APL-ASSIST (1-866-692-7527) if:

  • The liquid looks cloudy, contains particles, or is dark yellow.
  • The protective flip cap is missing or damaged.
  • The expiration date on the label has passed.

Figure B

Step 3

Prepare and fill syringe

  • Remove the protective flip cap from the top of the vial to show the middle part of the gray rubber stopper of the EMPAVELI vial (See Figure C ). Throw away the protective flip cap.
  • Clean the gray rubber stopper with a new alcohol wipe and allow the gray rubber stopper to dry for at least 30 seconds.

Do not touch the exposed gray rubber stopper after wiping.

Figure C

Option 1: If using a needleless transfer device (such as a vial adapter), follow the instructions provided by the device manufacturer.

OR

Option 2: If transfer is done using a transfer needle and a syringe, follow the instructions below:

  • Attach a sterile transfer needle to a sterile syringe.
  • Pull back the plunger to the 20-mL mark to fill the syringe with air (See Figure D ).
  • Push the air-filled syringe with transfer needle attached down through the center of the vial gray rubber stopper.
  • The tip of the transfer needle should not be in the solution to avoid creating air bubble(s) (See Figure E ).
  • Gently push the air from the syringe into the vial. This will inject the air from the syringe into the vial.

Figure D

Figure E

  • Turn the vial upside down and insert the transfer needle in the EMPAVELI solution (See Figure F ).

Figure F

  • With the transfer needle tip in the EMPAVELI solution, slowly pull the plunger back to fill the syringe with your prescribed dose (See Figure G ). Your first dose, second dose, and maintenance dose may be different.
  • Double check that you have withdrawn your prescribed dose.
  • Remove the filled syringe with EMPAVELI and the transfer needle from the vial.
  • Throw away the vial with the needleless transfer device attached and any remaining EMPAVELI solution into the household trash.

Figure G

  • Remove the transfer needle by using 1 hand to slide the needle into the needle cap and scoop upwards to cover the needle (See Figure H ).

Figure H

  • After the needle is covered, push the needle cap down towards the syringe to fully attach it with 1 hand to prevent an accidental stick with the needle (See Figure I ).

Figure I

  • Twist off and remove the transfer needle (See Figure J ).

Figure J

Step 4

Prepare infusion pump and tubing

  • Gather the infusion pump supplies and follow the device manufacturer's instructions to prepare the pump and tubing.
Step 5

Prepare the infusion site(s)

  • Select an area on your stomach (abdomen), thighs, hips, or upper arms for the infusion(s) (See Figure K ).

    Avoid the following infusion areas:

    • Do not infuse into areas where the skin is tender, bruised, red, or hard.
    • Avoid infusing into tattoos, scars, or stretch marks.

Figure K

  • Use a different site(s) from the last time you infused EMPAVELI. If there are multiple infusion sites, they should be at least 3 inches apart. Change (rotate) infusion sites in between each infusion (See Figure L ).

Figure L

  • Clean the skin at each infusion site(s) with a new alcohol wipe, starting at the center of each infusion site and working outward in a circular motion (See Figure M ).
  • Let the skin dry.

Figure M

Step 6

Insert and secure the infusion needle(s)

  • Pinch the skin between your thumb and forefinger around the infusion site (where you plan to insert the needle).
  • Insert the needle into the skin (See Figure N ).

Figure N

  • Secure the needle(s) using gauze and tape or a transparent dressing placed over the infusion site(s) (See Figure O ).

Figure O

Step 7

Start infusion

  • Follow the device manufacturer's instructions to start the infusion.
  • Start the infusion right away after drawing EMPAVELI into the syringe.
  • EMPAVELI infusion takes about 30 minutes (if using 2 infusion sites) or about 60 minutes (if using 1 infusion site) to complete.
Step 8

Complete infusion

  • Follow the device manufacturer's instructions to complete the infusion.
Step 9

Record infusion

  • Record your treatment as directed by your healthcare provider.
Step 10

Clean up

  • After the infusion is complete, remove the dressing and slowly take out the needle(s). Cover the infusion site with a new dressing.
  • Remove the infusion set from the pump and throw it away into the sharps container (See Figure P ).
  • Clean and store the infusion pump according to the device manufacturer's instructions.
Step 11

Dispose of (throw away) used needles and syringes and EMPAVELI infusion tubing.

  • Put the used needles, syringes, and EMPAVELI infusion tubing in an FDA-cleared sharps disposal container right away after use (See Figure P ).
  • Do not dispose of (throw away) the used needles, syringes, and EMPAVELI infusion tubing in your household trash.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
  • For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
  • Do not throw away your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.

Figure P

Call 1-866-692-7527 to speak with an Apellis representative.

Manufactured for:

Apellis Pharmaceuticals, Inc. 100 Fifth Avenue Waltham, MA 02451

Copyright © 2025 Apellis Pharmaceuticals, Inc. All rights reserved.

EMPAVELI is a registered trademark of Apellis Pharmaceuticals, Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised 7/2025

EMP-IFU-28Jul2025-5.0

INSTRUCTIONS FOR USE

EMPAVELI® Injector

(pegcetacoplan)

injection, for subcutaneous use

Single-use on-body injector

Important Information

This Instructions for Use is for the EMPAVELI Injector only.

Read this Instructions for Use before you start using the Injector and each time you get a refill as there may be new information. The EMPAVELI Injector is placed on your body to give medicine under the skin. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to inject EMPAVELI the right way before you use it for the first time. It is important that you do not try to give yourself or someone else the injection unless you have received training from your healthcare provider. Ask your healthcare provider about any instructions you do not understand.

If you have questions, concerns, or need of help, please call ApellisAssist® at 1-866-MY-APL-ASSIST (1-866-692-7527).

SIDE 1:

Filling the Syringe

Start Here

Complete these instructions on how to prepare EMPAVELI before completing EMPAVELI Injector administration instructions on the back of this page.

How should I store EMPAVELI?

  • Store vials of EMPAVELI in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.
  • Do not use EMPAVELI past the expiration date stamped on the carton.

Keep EMPAVELI, EMPAVELI Injector, and all medicines out of the reach of children.

Prepare for injection

1 Before you start:

  • Find a well-lit, flat work surface area, like a table.

  • Remove a single vial carton of EMPAVELI from the refrigerator. Keep the vial in the carton at room temperature 68°F to 77°F (20°C to 25°C) and allow it to warm up for about 30 minutes.

    Do not try to speed up the warming process.

2

  • Wash your hands well with soap and water.
  • Dry your hands.
Check the vial and liquid

3

  • Remove the vial from the carton. Carefully look at the liquid in the vial of EMPAVELI.
  • EMPAVELI is a clear, colorless to slightly yellowish liquid. Check for particles or color changes.

Do not use and call ApellisAssist if:

  • The liquid looks cloudy, contains particles, or is dark yellow.
  • The protective flip cap is missing from the top of the vial or damaged.
  • The expiration date on the label has passed.

4

  • Flip up to remove the protective flip cap from the top of the vial to show the exposed middle part of the gray rubber stopper of the EMPAVELI vial.
  • Throw away the protective flip cap.

5

  • Clean the gray rubber stopper on the top of the EMPAVELI vial with a new alcohol wipe.
  • Allow the gray rubber stopper to dry for at least 30 seconds.

Do not touch the exposed gray rubber stopper after wiping.

Prepare and fill the syringe with EMPAVELI using a needleless transfer device (such as a vial adapter)

6

Always follow the Instructions for Use provided by the needleless transfer device's manufacturer (as they may differ from the following steps).

Do not remove the needleless transfer device from the blister package.

Do not touch the spike or the inside of the needleless transfer device.

Do not use the needleless transfer device if it comes out or is dropped out of the package.

Do not use the needleless transfer device if the package is opened.

7

  • Remove the cover of the needleless transfer device package.
  • Place the vial on a clean, flat surface and hold the vial by the base with one hand.
  • Using the outside of the blister package to firmly hold the needleless transfer device, push needleless transfer device straight down onto the vial top until it snaps securely into place.

8

  • Remove the blister package from the needleless transfer device and throw the blister package away.

Do not touch the connector at the top of the transfer device.

9

  • Remove the syringe from its packaging.

Do not touch the tip of the syringe.

  • Attach the syringe to the needleless transfer device by twisting the tip of the syringe to the right (clockwise) onto the top of the needleless transfer device.

10

  • Turn the EMPAVELI vial upside down.

11

  • Slowly pull the syringe plunger down to about the 5 mL mark to partially fill the syringe.
  • Remove air from the syringe by gently pushing on the plunger.

12

  • Double check your prescribed dose.

    • Your first dose, second dose and maintenance dose may be different.
  • Slowly pull the syringe plunger down to withdraw your prescribed dose of EMPAVELI to the correct marking amount (mL) of medicine that matches the dose your healthcare provider prescribed. Your dose may be different than the example shown.
  • Double check that you have withdrawn your prescribed dose. Your dose cannot be changed after it is filled in the EMPAVELI injector.

13

  • While holding the EMPAVELI vial and syringe, turn the EMPAVELI vial and filled syringe upright and place the bottom of the EMPAVELI vial on a flat surface.

14

  • Remove the filled syringe from the needleless transfer device with one hand while holding the EMPAVELI vial with the other hand and twisting the filled syringe to the left (counterclockwise).

15

  • Place the syringe on a clean, flat surface while you prepare the EMPAVELI Injector. The syringe will not leak when set down.

Do not touch the tip of the filled syringe.

16

Do not remove the needleless transfer device from the vial.

  • Throw away the vial with the needleless transfer device attached and any remaining EMPAVELI solution into the household trash.

SIDE 2:

Injector Administration

Complete these instructions for administering the EMPAVELI Injector after completing syringe filling instructions on the front of this page.

Important information for administration with EMPAVELI Injector

General use:

  • Do not use EMPAVELI Injector if tamper-proof label has been broken.
  • Do not use EMPAVELI Injector if you have a skin condition on your stomach (injection site).
  • Do not use if you dropped EMPAVELI Injector.
  • Do not use if the sealed plastic tray is open or damaged.
  • Do not use if the expiration date on the box has passed.
  • Do not use if you have an acrylic allergy. Tell your healthcare provider if you are allergic to acrylic.
  • Do not reuse EMPAVELI Injector.
  • Do not store the filled EMPAVELI Injector.
  • Wear loose clothes so that they do not get in the way of the EMPAVELI Injector.
  • Do not store the EMPAVELI Injector in direct sunlight. If the EMPAVELI Injector is stored in direct sunlight, do not use it and call ApellisAssist at 1-866-MY-APL-ASSIST (1-866-692-7527).

Using EMPAVELI Injector:

  • Do not apply EMPAVELI Injector along the belt line or on areas where the injector will be affected by folds in the skin.
  • Do not touch the white adhesive on the bottom of EMPAVELI Injector before attaching to stomach.
  • Do not let your clothes touch the clean site.
  • Do not remove the Red Safety Tab until EMPAVELI Injector is attached to body.
  • Do not remove EMPAVELI Injector from the skin until the button pops out.
  • Do not throw away (dispose of) the EMPAVELI Injector into household trash. See the section "Remove and Dispose of EMPAVELI Injector" for information on how to dispose of the EMPAVELI Injector.
  • Choose an injection site at least 1 inch from the edge of your belly button and the edge of the EMPAVELI Injector, and 1 inch from last injection site.
  • Use the EMPAVELI Injector on stomach only.

During injection:

  • Do not remove EMPAVELI Injector from the skin during injection.
  • Do not bathe, shower, exercise, use hot tubs, whirlpools, or saunas. Avoid getting your stomach wet. The EMPAVELI Injector is not waterproof. Water or sweat may loosen EMPAVELI Injector from skin.
  • Do not sleep or bathe during injection.
  • Avoid intense physical activity.
  • Do not bump or knock the EMPAVELI Injector.
  • Do not bump the EMPAVELI Injector Button.
  • Do not use anything to hold the EMPAVELI Injector in place.
Fill injector with EMPAVELI liquid

17

Peel back the cover and remove the clear packaging insert.

Remove the EMPAVELI Injector and the surrounding Filling Base from the packaging. Place it on a clean, flat surface.

18

  • Pick up the syringe filled with EMPAVELI.
  • Twist the filled syringe tip to the right (clockwise) into the Fill Port until it is tight.

19

  • Firmly push the syringe plunger down.
  • The syringe plunger may be hard to push.
  • Watch the Fill Gauge move as EMPAVELI is pushed into the injector.

20

  • Make sure the syringe is empty. If needed, press firmly down on the syringe plunger again.

Do not remove syringe from Filling Base. After the EMPAVELI Injector is filled, continue with the preparation and injection.

Do not store filled EMPAVELI Injector.

Attach EMPAVELI Injector to stomach

21

  • Select an area on your stomach to place the EMPAVELI Injector.

Use the EMPAVELI Injector on your stomach only.

  • Choose an injection site at least:

    • 1 inch from the edge of your belly button and the edge of the EMPAVELI Injector.

      and

    • 1 inch from your last injection site.

Avoid an injection site that is tender, bruised, red, hard, irritated, scarred, tattooed, or has stretch marks.

Do not apply the EMPAVELI Injector along the belt line or on areas where the EMPAVELI injector will be affected by folds in the skin.

Wear loose clothes so that they do not get in the way of the EMPAVELI Injector.

22

  • Clean the injection site with an alcohol wipe.
  • Allow the injection site to dry for at least 30 seconds.

Do not let your clothes touch the clean injection site.

23

  • Hold the Gray Pull Tab and pull. Allow both the Gray and Clear Pull Tabs to fall to the side.
  • Both tabs may fall to the side or come off completely.

Do not remove the Red Safety Tab until the EMPAVELI Injector is attached to the body.

24

  • Hold the sides of the EMPAVELI Injector and pull it straight up to remove it from the Filling Base.

Do not touch the adhesive on the bottom of the EMPAVELI Injector or fold the adhesive onto itself.

  • The White Adhesive will stay attached to the EMPAVELI Injector and the Clear Liner will stay attached to the Filling Base.

Do not remove the Red Safety Tab until the EMPAVELI Injector is attached to your body.

Ensure the injection site has been cleaned before attaching EMPAVELI Injector.

25

  • Position the EMPAVELI Injector so that the Fill Window is pointed up toward your face.
  • Press firmly on the clear portion of the EMPAVELI Injector to attach to stomach.

Do not use anything to hold the EMPAVELI Injector in place.

Start Injection

26

  • Hold the EMPAVELI Injector with 1 hand. Use the other hand to pull the Red Safety Tab off.
  • The EMPAVELI injection will not start until the Red Safety Tab is removed.

27

  • Right away, Press the button in firmly until it stays in place to start the EMPAVELI injection.

Pushing the Button in will insert the needle into your skin. You may feel the needle go into your skin.

  • Light daily activities can be done during the EMPAVELI injection.

Be careful not to bump or knock the EMPAVELI Injector or button during the EMPAVELI injection.

Keep your stomach dry. Avoid intense physical activity. Do not sleep or bathe during your EMPAVELI injection.

28

  • Your EMPAVELI injection will continue as long as the button is pushed in. It may take about 30 to 60 minutes to complete.
  • To track progress, watch the Fill Gauge move across Fill Window toward empty. It may take some time to move and may move slowly.

Do not remove the EMPAVELI Injector until the button pops out.

If the button does not pop out after 2 hours (120 minutes), refer to Questions and Answers.

If the EMPAVELI Injector falls off of your body, refer to Questions and Answers.

Caution: Holding down the button will stop the flow of medicine. Injection will begin again when the button is released.

If you have an allergic reaction to the adhesive, call your healthcare provider right away.

29

  • When the button pops out, the EMPAVELI injection is done. The needle will be pulled out of the skin and back into the EMPAVELI Injector.

The button popping out is the only way to know if the EMPAVELI injection is complete. Do not remove the EMPAVELI Injector until the Button pops out.

Remove and dispose of EMPAVELI Injector

30

  • Use your thumb to lift the Adhesive Tab. Hold the Adhesive Tab against the EMPAVELI Injector.
  • Slowly peel the EMPAVELI Injector away from your skin.

31

  • Put your used EMPAVELI Injector in an FDA-cleared sharps disposal container right away after use.

Do not throw away the EMPAVELI Injector in the household trash.

The Filling Base with the syringe attached, alcohol wipe, and packaging may be placed in your household trash.

  • If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

    • made of heavy-duty plastic,
    • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
    • upright and stable during use,
    • leak-resistant, and
    • properly labeled to warn of hazardous waste inside the container.
  • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
  • For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http:/www.fda.gov/safesharpsdisposal.
  • Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
  • Do not recycle your used sharps disposal container.
  • Keep the used EMPAVELI Injector and sharps disposal container out of the reach of children.

How to store the EMPAVELI Injector

  • Keep the EMPAVELI Injector in unopened tray inside the original box.
  • Do not open the tray until ready for EMPAVELI injection.
  • Store the EMPAVELI Injector unit in clean, dry area away from heat and sunlight, at a temperature between 36°F to 86°F (2°C to 30°C).
  • Use the EMPAVELI Injector where the temperature is between 41°F to 104°F (5°C to 40°C).

Questions and answers

Can I use more than 1 syringe to fill the EMPAVELI Injector?

No, use only 1 syringe per EMPAVELI Injector.

What should I do if the syringe plunger will not push down to fill the EMPAVELI Injector?

You must firmly press down on the plunger to fill the EMPAVELI Injector. It will feel like there is resistance.

Can I remove the EMPAVELI Injector from my stomach and put it on later to finish injection?

No. The EMPAVELI Injector cannot be reattached. If you take it off, you may not get your full dose.

How long should the injection take?

The injection time is about 30 to 60 minutes.

After 2 hours (120 minutes):

  • If the button has not popped out, press and hold the button while you remove the EMPAVELI Injector from your skin. Do not touch the bottom of the EMPAVELI Injector as the needle will be exposed. Set the EMPAVELI Injector aside
  • If you forgot to start the injection, do not push the button. Remove the EMPAVELI Injector and set it aside.

Call ApellisAssist at 1-866-MY-APL-ASSIST (1-866-692-7527) right away after putting your device aside.

What if the Button will not push in and lock?

Make sure that you have taken off the Red Safety Tab. If the Red Safety Tab is removed, make sure you have tried to push the Button in all the way. If you still cannot push the button all the way in, then the EMPAVELI Injector is damaged. Remove your EMPAVELI Injector and set aside. Open a new EMPAVELI Injector and start over. Call ApellisAssist at 1-866-MY-APL-ASSIST (1-866-692-7527).

What if the EMPAVELI Injector falls off of my body?

If the EMPAVELI Injector falls off of your body, pick it up carefully. Do not touch the needle or any medicine that may be on the EMPAVELI Injector. Set the EMPAVELI Injector aside and out of the reach of children. Call ApellisAssist at 1-866-MY-APLASSIST (1-866-692-7527) right away.

Is it normal for skin to be bumpy or irritated during an injection?

No. Your body may be sensitive to the adhesive on the EMPAVELI Injector or to the medicine. Call your healthcare provider right away.

Is it normal for skin to be red after an injection?

Your skin may be slightly red after adhesive removal. If the redness does not go away after 1 to 2 days, call your healthcare provider.

Manufactured for:

Apellis Pharmaceuticals, Inc. 100 Fifth Avenue Waltham, MA 02451

Manufactured by:

Enable Injections, Inc. 2863 E. Sharon Road Cincinnati, OH 45421, USA

10130600 Rev 04

Patent: EnableInjections.com/patent

Copyright © 2025 Apellis Pharmaceuticals, Inc. All rights reserved.

APELLIS, APELLISASSIST, EMPAVELI, and their respective logos are registered trademarks of Apellis Pharmaceuticals, Inc.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 7/2025

EMP INJ-IFU-28Jul2025-2.0

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 215014 · View the label on DailyMed

Revision date stated in the text: July 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Empaveli

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Complement Inhibitor
Active ingredient Pegcetacoplan 1080 mg/20 mL
Dosage form Injection, solution
Route Subcutaneous
Marketing status listed in the FDA NDC Directory
Company (applicant) APELLIS PHARMS
FDA approval NDA 215014New Drug Application (NDA) Approved May 14, 2021
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1080 mg/20 mL – 20 ml in 1 vial / 1 in 1 carton NDC 73606-010-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.