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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
EMPAVELI (NDA-215014)
(PEGCETACOPLAN)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
08/20/2026 (SUPPL-12)
6 Adverse Reactions
6.1 Clinical Trials Experience
Additions and/or revisions underlined:
. . .
C3 Glomerulopathy or Primary IC-MPGN
Study in Adult and Pediatric Patients 12 Years of Age and Older with C3G or Primary IC-MPGN (Study APL2-C3G-310)
The data described below reflects the exposure in adult (n=35) and pediatric patients 12 years of age and older (n=28) with native kidney C3G (n=46), native kidney primary IC-MPGN (n=12), or recurrent C3G following kidney transplant (n=5) who received EMPAVELI at the recommended dosing regimens during the 26-week placebo-controlled period of Study APL2-C3G-310. Serious adverse reactions due to viral infections resulting in hospitalizations occurred in 2 (3%) patients with C3G or primary IC-MPGN receiving EMPAVELI and 1 (2%) patient on placebo. One patient (2%) on EMPAVELI with native kidney C3G died because of respiratory failure due to COVID-19 pneumonia; there were no deaths in the placebo arm.
Table 4 describes the adverse reactions that were reported in greater than or equal to 5% of patients (adults and pediatric patients 12 years of age and older) treated with EMPAVELI and at a greater incidence than placebo in Study APL2-C3G-310. Adverse reactions in pediatric patients were similar to those seen in adults.
Following the 26-week placebo-controlled period in Study APL2-C3G-310, 118 patients were treated with EMPAVELI at the recommended dosing regimen for a 26-week open-label period. The safety profile was consistent with that observed during the 26-week placebo-controlled period. During the open-label period, one patient with native kidney C3G had a serious adverse event of pneumonia secondary to Streptococcus pneumoniae, and one patient with recurrent C3G following kidney transplant developed herpes zoster meningoencephalitis while on concomitant immunosuppression, leading to treatment discontinuation.
. . .
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of EMPAVELI for the treatment of C3G or primary IC-MPGN have been established in pediatric patients aged 12 years and older. Use of EMPAVELI for this indication is supported by evidence from an adequate and well controlled trial that enrolled 55 pediatric patients aged 12 years and older [see Adverse Reactions (6.1), and Clinical Studies (14.2)]. The safety and effectiveness of EMPAVELI in pediatric patients less than 12 years of age with C3G or primary IC-MPGN have not been established.
Safety and effectiveness of EMPAVELI in pediatric patients with PNH have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
. . .
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.
07/28/2025 (SUPPL-11)
5 Warnings and Precautions
5.3 Infusion-Related Reactions
Additions and/or revisions underlined:
Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria, pyrexia) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines.
. . .
6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
The safety and effectiveness of EMPAVELI for the treatment of C3G or primary IC-MPGN have been established in pediatric patients aged 12 years and older. Use of EMPAVELI for this indication is supported by evidence from an adequate and well controlled trial that enrolled 55 pediatric patients aged 12 years and older [see Adverse Reactions (6.1), and Clinical Studies (14.2)]. The safety and effectiveness of EMPAVELI in pediatric patients less than 12 years of age with C3G or IC-MPGN have not been established.
Safety and effectiveness of EMPAVELI in pediatric patients with PNH have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Dosing
For weight-based dosing, instruct caregivers and patients on the proper techniques for preparing, storing, measuring, and administering EMPAVELI via EMPAVELI Injector or commercially available infusion pump.
. . .
MEDICATION GUIDE
Additions and/or revisions underlined:
. . .
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).
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.
. . .
Females who are able to become pregnant:
- should have a pregnancy test before starting treatment with EMPAVELI.
. . .
For adults with PNH:
. . .
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
. . .
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
flu
fever
cough
common cold
nausea
. . .
06/10/2025 (SUPPL-10)
5 Warnings and Precautions
5.3 Infusion-Related Reactions
Additions and/or revisions underlined:
Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria) have occurred in patients treated with EMPAVELI, which may resolve after treatment with antihistamines. Cases of anaphylaxis leading to treatment discontinuation have been reported.
. . .
6 Adverse Reactions
6.2 Postmarketing Experience
Newly added subsection:
The following adverse reactions have been identified during post-approval use of EMPAVELI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to EMPAVELI exposure.
Anaphylaxis and urticaria [see Warnings and Precautions (5.3)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
. . .
Allergic reactions. Allergic reactions can happen during your EMPAVELI infusion. Stop your EMPAVELI infusion and tell your healthcare provider or get emergency medical care right away if you get any of these symptoms during your EMPAVELI infusion:
chest pain
fast heart rate
trouble breathing or shortness of breath
nausea or vomiting
wheezing
feel confused or anxious
swelling of your face, tongue, or throat
skin reactions, including rash, hives, and itching
feel dizzy or faint or pass out
. . .
02/08/2024 (SUPPL-6)
Boxed Warning
5 Warnings and Precautions
5.1 Serious Infections Caused by Encapsulated Bacteria
Additions and/or revisions underlined:
EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis (caused by any serogroup, including non-groupable strains), and Haemophilus influenzae type B. Life- threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors. The initation of EMPAVELI treatment is contraindicated in patients with unresolved serious infection caused by encapsulated bacteria.
Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of EMPAVELI, according to the most current ACIP recommendations for patients receiving a complement inhibitor. Revaccinate patients in accordance with ACIP recommendations considering the duration of therapy with EMPAVELI. Note that, ACIP recommends an administration schedule in patients receiving complement inhibitors that differs from the administration schedule in the vaccine prescribing information. If urgent EMPAVELI therapy is indicated in a patient who is not up to date with vaccines against encapsulated bacteria according to ACIP recommendations, provide the patient with antibacterial drug prophylaxis and administer these vaccines as soon as possible. Various durations and regimens of antibacterial drug prophylaxis have been considered, but the optimal durations and drug regimens for prophylaxis and their efficacy have not been studied in unvaccinated or vaccinated patients receiving complement inhibitors, including EMPAVELI. The benefits and risks of treatment with EMPAVELI, as well as the benefits and risks of antibacterial drug prophylaxis in unvaccinated or vaccinated patients, must be considered against the known risks for serious infections caused by encapsulated bacteria.
Vaccination does not eliminate the risk of serious encapsulated bacterial infections, despite development of antibodies following vaccination. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Inform patients of these signs and symptoms and instruct patients to seek immediate medical care if these signs and symptoms occur. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider interruption of EMPAVELI in patients who are undergoing treatment for serious infections.
5.2 EMPAVELI REMS
Additions and/or revisions underlined:
EMPAVELI is available only through a restricted program under a REMS called EMPAVELI REMS, because of the risk of serious infections caused by encapsulated bacteria [see Warnings and Precautions (5.1)].
Notable requirements of the EMPAVELI REMS include the following:
Prescribers must enroll in the REMS.
Prescribers must counsel patients about the risk of serious infections caused by encapsulated bacteria.
Prescribers must provide the patients with the REMS educational materials.
Prescribers must assess patient vaccination status for encapsulated bacteria and vaccinate if needed according to current ACIP recommendations two weeks prior to the first dose of EMPAVELI.
Prescribers must provide a prescription for antibacterial drug prophylaxis if treatment must be started urgently, and the patient is not up to date with vaccinations against encapsulated bacteria according to current ACIP recommendations at least two weeks prior to the first dose of EMPAVELI.
Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI REMS and must verify prescribers are certified.
Patients must receive counseling from the prescriber about the need to receive vaccinations against encapsulated bacteria per ACIP recommendations, the need to take antibiotics as directed by the prescriber, and the signs and symptoms of serious infections.
- Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following treatment discontinuation with EMPAVELI.
Further information is available at www.empavelirems.com or 1-888-343-7073
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Additions and/or revisions underlined:
Serious Infections Caused by Encapsulated Bacteria
Advise patients of the risk of serious infection. Inform patients of the need to complete or update their vaccinations against encapsulated bacteria at least 2 weeks prior to receiving the first dose of EMPAVELI or receive antibacterial drug prophylaxis if EMPAVELI treatment must be initiated immediately and they have not been previously vaccinated. Inform the patient that they are required to be revaccinated according to current ACIP recommendations for encapsulated bacteria while on EMPAVELI therapy [see Warnings and Precautions (5.1)].
Inform patients that vaccination may not prevent serious infection and strongly advise patients to seek immediate medical attention if these signs or symptoms occur. These signs and symptoms include the following:
fever with or without shivers or the chills
fever with chest pain and cough
fever with breathlessness/fast breathing
fever with high heart rate
headache and a fever
headache with a stiff neck or stiff back
fever and a rash
confusion
headache with nausea or vomiting
body aches with flu-like symptoms
clammy skin
- eyes sensitive to light
…
EMPAVELI REMS
EMPAVELI is available only through a restricted program called EMPAVELI REMS [see Warnings and Precautions (5.2)].
Inform the patient of the following notable requirements:
Patients must receive counseling about the risk of serious infections caused by encapsulated bacteria.
Patients must receive written educational materials about this risk.
Patients must be instructed to carry the Patient Safety Card with them at all times during and for 2 months following treatment with EMPAVELI.
Patients must be instructed to complete or update vaccinations against encapsulated bacteria per ACIP recommendations as directed by the prescriber prior to treatment with EMPAVELI.
- Patients must receive antibiotics as directed by the prescriber if they are not up to date with vaccinations against encapsulated bacteria and have to start EMPAVELI right away.
MEDICATION GUIDE
Additions and/or revisions underlined:
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.
o 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.
o If you have not completed your vaccines and EMPAVELI must be started right away, you should receive the required vaccines as soon as possible.
o 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.
o 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.
o 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
…
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?”
…
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.
…
09/28/2023 (SUPPL-3)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
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.
…
02/08/2023 (SUPPL-2)
6 Adverse Reactions
6.1 Clinical Trials Experience
Extensive changes; please refer to label for complete information
8 Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
Safety and effectiveness in pediatric patients have not been established.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
…
The most common side effects in people with PNH treated with EMPAVELI include:
• injection-site reactions
• infections
• tiredness
• viral infection
• diarrhea
• pain in the stomach (abdomen)
• respiratory tract infection
• pain in the arms, hands, legs or feet
• low potassium in blood
• cough
• joint pain
• dizziness
• headache
• rash
…