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Official Physician Website | EMPAVELI® (pegecetacopan)Empaveli HCP
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<div class="grid"> <div class="cell-md-8 content"> <div class="heading"> <p>If your adult patients with PNH are experiencing<br /> the ongoing effects of hemolysis,<br /> <span>REIMAGINE<span>WHAT’S POSSIBLE</span></span></p> <div class="footnote" data-name="Monica"><span class="name">Monica</span> is a real patient who's taken EMPAVELI.</div> </div> <div class="description"><p>How could improving lab values<br /> impact their lives?<sup>1,2</sup></p> </div> <div class="footnote hide-mobile" data-name="Monica"><span class="name">Monica</span> is a real patient who's taken EMPAVELI.</div> <div class="links"> <a href="/about-empaveli/trial/" class="block"> <div class="icon"><img src="https://empavelihcp.com/wp-content/uploads/2023/01/efficacy_Icon_KO.svg" alt="" /></div> <p>See EMPAVELI <br />efficacy <br />and safety data</p> <div class="link"> <img src="https://empavelihcp.com/wp-content/uploads/2023/01/efficacy_Icon_KO.svg" alt="" /> <span>VIEW the data</span> <img src="https://empavelihcp.com/wp-content/themes/empaveli/img/pink-circle-btn.svg" alt="arrow" class="arrow" /> </div> </a><a href="/administration/" class="block"> <div class="icon"><img src="https://empavelihcp.com/wp-content/uploads/2023/01/Injector_Icon_KO.svg" alt="" /></div> <p>Learn more <br />about the <br />EMPAVELI Injector</p> <div class="link"> <img src="https://empavelihcp.com/wp-content/uploads/2023/01/Injector_Icon_KO.svg" alt="" /> <span>Learn more</span> <img src="https://empavelihcp.com/wp-content/themes/empaveli/img/pink-circle-btn.svg" alt="arrow" class="arrow" /> </div> </a><a href="/support-resources/patient-support/" class="block"> <div class="icon"><img src="https://empavelihcp.com/wp-content/uploads/2023/01/Support_Icon_KO.svg" alt="" /></div> <p>Explore support and <br />resources <br class="hide-desktop" />for you <br />and your patients <br />with PNH</p> <div class="link"> <img src="https://empavelihcp.com/wp-content/uploads/2023/01/Support_Icon_KO.svg" alt="" /> <span>Explore now</span> <img src="https://empavelihcp.com/wp-content/themes/empaveli/img/pink-circle-btn.svg" alt="arrow" class="arrow" /> </div> </a> </div> </div> <div class="cell-md-4 float"> <div class="float-content"> <div class="header-links gradient"> <a target="_blank" href="https://apellis.iassist.com/"> <img src="https://empavelihcp.com/wp-content/themes/empaveli/img/clipboard.svg" alt=""><span><strong>Online enrollment option<br>NOW AVAILABLE.</strong> <br>Complete Start Form.</span> </a> </div> <div class="isi-top enter"> <div class="expand"> <span class="expand-text">expand</span> <span class="collapse-text">collapse</span> </div> <div class="isi container-isi"> <div id="isi"> <h2>IMPORTANT SAFETY INFORMATION</h2> <div class="boxed"> <p>WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA</p> <p>EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as <em>Streptococcus pneumoniae, Neisseria meningitidis</em>, and <em>Haemophilus influenzae</em> 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.</p> <ul> <li>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.</li> <li>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.</li> </ul> <p>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.</p> </div> <h2>CONTRAINDICATIONS</h2> <ul> <li>Hypersensitivity to pegcetacoplan or to any of the excipients</li> <li>For initiation in patients with unresolved serious infection caused by encapsulated bacteria including <em>Streptococcus pneumoniae</em>, <em>Neisseria meningitidis</em>, and <em>Haemophilus influenzae </em>type B</li> </ul> <h2>WARNINGS AND PRECAUTIONS</h2> <p><strong>Serious Infections Caused by Encapsulated Bacteria</strong></p> <p>EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including <em>Streptococcus pneumoniae</em>, <em>Neisseria meningitidis</em> (caused by any serogroup, including non-groupable strains), and<em> Haemophilus influenzae </em>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.</p> <p>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.</p> <p>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.</p> <p>EMPAVELI is available only through a restricted program under a REMS.</p> <p><strong>EMPAVELI REMS</strong></p> <p>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:</p> <p>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.</p> <p>Further information is available at <a href="https://www.empavelirems.com" target="_blank" rel="noopener">www.empavelirems.com</a> or 1-888-343-7073.</p> <p><strong>Infusion-Related Reactions</strong></p> <p>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.</p> <p><strong>Monitoring PNH Manifestations after Discontinuation of EMPAVELI</strong></p> <p>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.</p> <p><strong>Interference with Laboratory Tests</strong></p> <p>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.</p> <h2>ADVERSE REACTIONS</h2> <p>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.</p> <h2>USE IN SPECIFIC POPULATIONS</h2> <p><strong>Females of Reproductive Potential</strong></p> <p>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.</p> <h2>INDICATION</h2> <p>EMPAVELI<sup>®</sup> (pegcetacoplan) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).</p> <p><strong>Please see full <a href="https://pi.apellis.com/files/PI_Empaveli.pdf" target="_blank" rel="noopener">Prescribing Information</a>, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and <a href="https://pi.apellis.com/files/MedGuide_Empaveli.pdf" target="_blank" rel="noopener">Medication Guide</a>.</strong></p> </div> </div> </div> </div> <style> /* Fixed container to hold both the banner and the drawer */ .header-links { height: 94px; min-height: 94px; width: 100%; margin-bottom: 20px; padding: 0 20px; box-sizing: border-box; display: inline-block; border-radius: 10px; background: linear-gradient(90deg, #fc3b6e 0%, #5a4986 100%); } .flex { display: flex; justify-content: space-between; align-items: center; } .header-links a { height: 100%; display: flex; align-items: center; text-decoration: none; background: transparent; } .header-links img { width: 34px !important; height: 50px !important; margin-right: 20px !important; } </style> </div> </div> </div> </div><section class=" " id="section_0" style=""> <div class="container"> <div class="grid"> <div class="cell-md-8"><div class="text-block " style=" margin-bottom: 20px; "> <div class="text"> <h2>Explore the compact, wearable EMPAVELI Injector</h2> <p>The EMPAVELI Injector allows patients to self-administer EMPAVELI when and where works best for them after proper training.<sup>3</sup></p> </div> </div><div class="text-block " style=" margin-bottom: 20px; "> <div class="text"> <div class="left-img"> <p><img decoding="async" class="alignnone size-full wp-image-1017" src="https://empavelihcp.com/wp-content/uploads/2023/02/Injector_with_Reflection.png" alt="EMPAVELI Injector device" width="226" srcset="https://empavelihcp.com/wp-content/uploads/2023/02/Injector_with_Reflection.png 454w, https://empavelihcp.com/wp-content/uploads/2023/02/Injector_with_Reflection-254x300.png 254w" sizes="(max-width: 454px) 100vw, 454px" /></p> <div> <ul class="pink"> <li>Push button starts injection</li> <li>The needle is never seen</li> <li>Compact device with no tubing involved</li> <li>The gauge shows the injection progress</li> </ul> <p><a class="btn" href="/administration/">Learn More</a></p> </div> </div> </div> </div><div class="text-block " style=" "> <div class="text"> <p>Your patients should avoid intense physical activity and should not bump or knock the EMPAVELI Injector or button during the injection.</p> </div> </div></div></div></div></section><section class="references"> <div class="container"> <div class="grid"> <div class="cell-md-8"> <p>PNH=paroxysmal nocturnal hemoglobinuria.</p> <p><strong>References: 1.</strong> Dingli D, Matos JE, Lehrhaupt K, et al. The burden of illness in patients with paroxysmal nocturnal hemoglobinuria receiving treatment with the <span class="no-break">C5-inhibitors</span> eculizumab or ravulizumab: results from a US patient survey. <em>Ann Hematol.</em> 2022;101(2):251-263. <strong>2.</strong> 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. <em>Front Immunol.</em> 2019;10:1157. <strong>3.</strong> EMPAVELI [prescribing information]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2024.</p> <div id="isi-anchor"></div> </div> </div> </div> </section> </main> <div class="isi bottom-isi"> <div class="container"> <div class="grid"> <div class="cell-md-12"> <h2>IMPORTANT SAFETY INFORMATION</h2> <div class="boxed"> <p>WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA</p> <p>EMPAVELI, a complement inhibitor, increases the risk of serious infections, especially those caused by encapsulated bacteria, such as <em>Streptococcus pneumoniae, Neisseria meningitidis</em>, and <em>Haemophilus influenzae</em> 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.</p> <ul> <li>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.</li> <li>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.</li> </ul> <p>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.</p> </div> <h2>CONTRAINDICATIONS</h2> <ul> <li>Hypersensitivity to pegcetacoplan or to any of the excipients</li> <li>For initiation in patients with unresolved serious infection caused by encapsulated bacteria including <em>Streptococcus pneumoniae</em>, <em>Neisseria meningitidis</em>, and <em>Haemophilus influenzae </em>type B</li> </ul> <h2>WARNINGS AND PRECAUTIONS</h2> <p><strong>Serious Infections Caused by Encapsulated Bacteria</strong></p> <p>EMPAVELI, a complement inhibitor, increases a patient’s susceptibility to serious, life-threatening, or fatal infections caused by encapsulated bacteria including <em>Streptococcus pneumoniae</em>, <em>Neisseria meningitidis</em> (caused by any serogroup, including non-groupable strains), and<em> Haemophilus influenzae </em>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.</p> <p>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.</p> <p>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.</p> <p>EMPAVELI is available only through a restricted program under a REMS.</p> <p><strong>EMPAVELI REMS</strong></p> <p>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:</p> <p>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.</p> <p>Further information is available at <a href="https://www.empavelirems.com" target="_blank" rel="noopener">www.empavelirems.com</a> or 1-888-343-7073.</p> <p><strong>Infusion-Related Reactions</strong></p> <p>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.</p> <p><strong>Monitoring PNH Manifestations after Discontinuation of EMPAVELI</strong></p> <p>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.</p> <p><strong>Interference with Laboratory Tests</strong></p> <p>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.</p> <h2>ADVERSE REACTIONS</h2> <p>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.</p> <h2>USE IN SPECIFIC POPULATIONS</h2> <p><strong>Females of Reproductive Potential</strong></p> <p>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.</p> <h2>INDICATION</h2> <p>EMPAVELI<sup>®</sup> (pegcetacoplan) is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).</p> <p><strong>Please see full <a href="https://pi.apellis.com/files/PI_Empaveli.pdf" target="_blank" rel="noopener">Prescribing Information</a>, including Boxed WARNING regarding serious infections caused by encapsulated bacteria, and <a href="https://pi.apellis.com/files/MedGuide_Empaveli.pdf" target="_blank" rel="noopener">Medication Guide</a>.</strong></p> </div> </div> </div> </div> <div class="signup-calout"> <div class="container"> <div class="grid"> <div class="cell-md-12"> <p><strong>Sign up for EMPAVELI Speaker Programs for exclusive information</strong> <a class="btn link" href="https://www.pnhresourcecenter.com/" target="_blank" rel="noopener">Visit now</a></p> </div> </div> </div> </div> <footer> <div class="container"> <div class="grid"> <div class="cell-md-12"> <div class="navigation"> <ul id="menu-footer" class="menu"><li id="menu-item-205" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-205"><a target="_blank" rel="noopener" href="https://apellis.com/">Apellis</a></li> <li id="menu-item-206" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-206"><a target="_blank" rel="noopener" href="https://apellis.com/privacy-policy/">Privacy Policy</a></li> <li id="menu-item-207" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-207"><a target="_blank" rel="noopener" href="https://apellis.com/contact-us/">Contact Us</a></li> <li id="menu-item-208" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-208"><a href="/site-map">Sitemap</a></li> </ul> </div> <div class="social-networks"> <a href="https://www.facebook.com/EMPAVELI" target="_blank" class="external"><img src="https://empavelihcp.com/wp-content/themes/empaveli/img/facebook.svg" alt="Facebook" class="fb" /></a><a href="https://www.youtube.com/channel/UCMNpLjdTDgpHGYK3YU3a7qg" target="_blank" class="external"><img src="https://empavelihcp.com/wp-content/themes/empaveli/img/youtube.svg" alt="YouTube" class="yt" /></a> </div> <div class="logo"> <a href="https://apellis.com/" target="_blank"><img src="https://empavelihcp.com/wp-content/uploads/2023/01/Apellis_Logo_KO.svg" alt="" /></a> </div> <div class="copyright"> <p>APELLIS, APELLISASSIST, EMPAVELI, and their respective logos are registered trademarks of Apellis Pharmaceuticals, Inc.<br /> Other trademarks referenced herein are the property of their respective owners.<br /> ©2021-2024 Apellis Pharmaceuticals, Inc. 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