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 * Prescribing Information
 * Medication Guide
 * EMPAVELI REMS
 * Patient Site
 * Start Form
 * Request a Rep

 * Unmet Need in PNH
 * About EMPAVELI
   * Trial Design
   * Key Efficacy Endpoints
   * Normalization Data
   * Safety
   * Long-term Integrated Analysis
 * Self-Administration
 * Support & Resources
   * Patient Support
   * Resources




If your adult patients with PNH are experiencing
the ongoing effects of hemolysis,
REIMAGINEWHAT’S POSSIBLE

Monica is a real patient who's taken EMPAVELI.

How could improving lab values
impact their lives?1,2

Monica is a real patient who's taken EMPAVELI.

See EMPAVELI
efficacy
and safety data

VIEW the data


Learn more
about the
EMPAVELI Injector

Learn more


Explore support and
resources
for you
and your patients
with PNH

Explore now
expandcollapse


IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

EMPAVELI, a complement inhibitor, increases the risk of serious infections,
especially those caused by encapsulated bacteria, such as Streptococcus
pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.
Life-threatening and fatal infections with encapsulated bacteria have occurred
in patients treated with complement inhibitors. These infections may become
rapidly life-threatening or fatal if not recognized and treated early.

 * Complete or update vaccination for encapsulated bacteria at least 2 weeks
   prior to the first dose of EMPAVELI, unless the risks of delaying therapy
   with EMPAVELI outweigh the risks of developing a serious infection. Comply
   with the most current Advisory Committee on Immunization Practices (ACIP)
   recommendations for vaccinations against encapsulated bacteria in patients
   receiving a complement inhibitor.
 * Patients receiving EMPAVELI are at increased risk for invasive disease caused
   by encapsulated bacteria, even if they develop antibodies following
   vaccination. Monitor patients for early signs and symptoms of serious
   infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria,
EMPAVELI is available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS) called the EMPAVELI REMS.


CONTRAINDICATIONS

 * Hypersensitivity to pegcetacoplan or to any of the excipients
 * For initiation in patients with unresolved serious infection caused by
   encapsulated bacteria including Streptococcus pneumoniae, Neisseria
   meningitidis, and Haemophilus influenzae type B


WARNINGS AND PRECAUTIONS

Serious Infections Caused by Encapsulated Bacteria

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 initiation 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. 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.

EMPAVELI is available only through a restricted program under a REMS.

EMPAVELI REMS

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. Notable requirements of the EMPAVELI REMS include the following:

Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers
must counsel patients about the risks, signs, and symptoms of serious infections
caused by encapsulated bacteria, provide patients with the REMS educational
materials, ensure patients are vaccinated against encapsulated bacteria at least
2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug
prophylaxis if patients’ vaccine status is not up to date and treatment must be
started urgently, and provide instructions to always carry the Patient Safety
Card both during treatment, as well as for 2 months following last dose of
EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI
REMS and must verify prescribers are certified.

Further information is available at www.empavelirems.com or 1-888-343-7073.

Infusion-Related Reactions

Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria)
have occurred in patients treated with EMPAVELI. One patient (less than 1% in
clinical studies) experienced a serious allergic reaction which resolved after
treatment with antihistamines. If a severe hypersensitivity reaction (including
anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute
appropriate treatment, per standard of care, and monitor until signs and
symptoms are resolved.

Monitoring PNH Manifestations after Discontinuation of EMPAVELI

After discontinuing treatment with EMPAVELI, closely monitor for signs and
symptoms of hemolysis, identified by elevated LDH levels along with sudden
decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as
fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events
(including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient
who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other
reactions. If hemolysis, including elevated LDH, occurs after discontinuation of
EMPAVELI, consider restarting treatment with EMPAVELI.

Interference with Laboratory Tests

There may be interference between silica reagents in coagulation panels and
EMPAVELI that results in artificially prolonged activated partial thromboplastin
time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.


ADVERSE REACTIONS

Most common adverse reactions in patients with PNH (incidence ≥10%) were
injection‑site reactions, infections, diarrhea, abdominal pain, respiratory
tract infection, pain in extremity, hypokalemia, fatigue, viral infection,
cough, arthralgia, dizziness, headache, and rash.


USE IN SPECIFIC POPULATIONS

Females of Reproductive Potential

EMPAVELI may cause embryo-fetal harm when administered to pregnant women.
Pregnancy testing is recommended for females of reproductive potential prior to
treatment with EMPAVELI. Advise female patients of reproductive potential to use
effective contraception during treatment with EMPAVELI and for 40 days after the
last dose.


INDICATION

EMPAVELI® (pegcetacoplan) is indicated for the treatment of adult patients with
paroxysmal nocturnal hemoglobinuria (PNH).

Please see full Prescribing Information, including Boxed WARNING regarding
serious infections caused by encapsulated bacteria, and Medication Guide.




EXPLORE THE COMPACT, WEARABLE EMPAVELI INJECTOR

The EMPAVELI Injector allows patients to self-administer EMPAVELI when and where
works best for them after proper training.3

 * Push button starts injection
 * The needle is never seen
 * Compact device with no tubing involved
 * The gauge shows the injection progress

Learn More

Your patients should avoid intense physical activity and should not bump or
knock the EMPAVELI Injector or button during the injection.

PNH=paroxysmal nocturnal hemoglobinuria.

References: 1. Dingli D, Matos JE, Lehrhaupt K, et al. The burden of illness in
patients with paroxysmal nocturnal hemoglobinuria receiving treatment with the
C5-inhibitors eculizumab or ravulizumab: results from a US patient survey. Ann
Hematol. 2022;101(2):251-263. 2. Risitano AM, Marotta S, Ricci P, et al; Severe
Aplastic Anemia Working Party of the European Group for Bone Marrow
Transplantation. Anti-complement treatment for paroxysmal nocturnal
hemoglobinuria: time for proximal complement inhibition? A position paper from
the SAAWP of the EBMT. Front Immunol. 2019;10:1157. 3. EMPAVELI [prescribing
information]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2024.




IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA

EMPAVELI, a complement inhibitor, increases the risk of serious infections,
especially those caused by encapsulated bacteria, such as Streptococcus
pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B.
Life-threatening and fatal infections with encapsulated bacteria have occurred
in patients treated with complement inhibitors. These infections may become
rapidly life-threatening or fatal if not recognized and treated early.

 * Complete or update vaccination for encapsulated bacteria at least 2 weeks
   prior to the first dose of EMPAVELI, unless the risks of delaying therapy
   with EMPAVELI outweigh the risks of developing a serious infection. Comply
   with the most current Advisory Committee on Immunization Practices (ACIP)
   recommendations for vaccinations against encapsulated bacteria in patients
   receiving a complement inhibitor.
 * Patients receiving EMPAVELI are at increased risk for invasive disease caused
   by encapsulated bacteria, even if they develop antibodies following
   vaccination. Monitor patients for early signs and symptoms of serious
   infections and evaluate immediately if infection is suspected.

Because of the risk of serious infections caused by encapsulated bacteria,
EMPAVELI is available only through a restricted program under a Risk Evaluation
and Mitigation Strategy (REMS) called the EMPAVELI REMS.


CONTRAINDICATIONS

 * Hypersensitivity to pegcetacoplan or to any of the excipients
 * For initiation in patients with unresolved serious infection caused by
   encapsulated bacteria including Streptococcus pneumoniae, Neisseria
   meningitidis, and Haemophilus influenzae type B


WARNINGS AND PRECAUTIONS

Serious Infections Caused by Encapsulated Bacteria

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 initiation 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. 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.

EMPAVELI is available only through a restricted program under a REMS.

EMPAVELI REMS

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. Notable requirements of the EMPAVELI REMS include the following:

Under the EMPAVELI REMS, prescribers must enroll in the program. Prescribers
must counsel patients about the risks, signs, and symptoms of serious infections
caused by encapsulated bacteria, provide patients with the REMS educational
materials, ensure patients are vaccinated against encapsulated bacteria at least
2 weeks prior to the first dose of EMPAVELI, prescribe antibacterial drug
prophylaxis if patients’ vaccine status is not up to date and treatment must be
started urgently, and provide instructions to always carry the Patient Safety
Card both during treatment, as well as for 2 months following last dose of
EMPAVELI. Pharmacies that dispense EMPAVELI must be certified in the EMPAVELI
REMS and must verify prescribers are certified.

Further information is available at www.empavelirems.com or 1-888-343-7073.

Infusion-Related Reactions

Systemic hypersensitivity reactions (e.g., facial swelling, rash, urticaria)
have occurred in patients treated with EMPAVELI. One patient (less than 1% in
clinical studies) experienced a serious allergic reaction which resolved after
treatment with antihistamines. If a severe hypersensitivity reaction (including
anaphylaxis) occurs, discontinue EMPAVELI infusion immediately, institute
appropriate treatment, per standard of care, and monitor until signs and
symptoms are resolved.

Monitoring PNH Manifestations after Discontinuation of EMPAVELI

After discontinuing treatment with EMPAVELI, closely monitor for signs and
symptoms of hemolysis, identified by elevated LDH levels along with sudden
decrease in PNH clone size or hemoglobin, or reappearance of symptoms such as
fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events
(including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient
who discontinues EMPAVELI for at least 8 weeks to detect hemolysis and other
reactions. If hemolysis, including elevated LDH, occurs after discontinuation of
EMPAVELI, consider restarting treatment with EMPAVELI.

Interference with Laboratory Tests

There may be interference between silica reagents in coagulation panels and
EMPAVELI that results in artificially prolonged activated partial thromboplastin
time (aPTT); therefore, avoid the use of silica reagents in coagulation panels.


ADVERSE REACTIONS

Most common adverse reactions in patients with PNH (incidence ≥10%) were
injection‑site reactions, infections, diarrhea, abdominal pain, respiratory
tract infection, pain in extremity, hypokalemia, fatigue, viral infection,
cough, arthralgia, dizziness, headache, and rash.


USE IN SPECIFIC POPULATIONS

Females of Reproductive Potential

EMPAVELI may cause embryo-fetal harm when administered to pregnant women.
Pregnancy testing is recommended for females of reproductive potential prior to
treatment with EMPAVELI. Advise female patients of reproductive potential to use
effective contraception during treatment with EMPAVELI and for 40 days after the
last dose.


INDICATION

EMPAVELI® (pegcetacoplan) is indicated for the treatment of adult patients with
paroxysmal nocturnal hemoglobinuria (PNH).

Please see full Prescribing Information, including Boxed WARNING regarding
serious infections caused by encapsulated bacteria, and Medication Guide.

Sign up for EMPAVELI Speaker Programs for exclusive information Visit now

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   * Resources

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