Indications

    BKEMV™ (eculizumab-aeeb) is indicated for the treatment of:

  • patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  • generalized myasthenia gravis (g...  Read moreMG) in adult patients who are anti- acetylcholine receptor (AchR) antibody positive.

    • BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

    BKEMVTM (eculizumab-aeeb) is indicated for the treatment of:

  • patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • patients with atypical... Read more hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  • generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

    • BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Indications Dosing Storage and Handling Prescribing Information Enroll in BKEMV™ REMS

AMGEN BY YOUR SIDE

ABYS-ActimmuneABYS-Actimmune

Amgen By Your Side is a patient support program for people like you — people who have been prescribed BKEMV™.

While your doctor will take care of all the medical details surrounding your new treatment, the Amgen By Your Side team can provide other education, support, and resources.

After you have enrolled, we’ll pair you with a dedicated Patient Access Liaison(PAL). Your PAL is your partner, committed to providing personalized support to help as you start and continue on treatment, as prescribed.

Our mission is to connect, coordinate, and champion YOU at most important steps along the way:

Connect-Icon<b>CONNECT:</b> You will be connected to one person dedicated to partner with you throughout your treatment experience.
Coordinate-icon<b>COORDINATE:</b> You will receive support across areas from insurance and cost assistance options to coordinating appointments and more.
Champion-Icon<b>CHAMPION:</b> Your dedicated partner will strive to empower you—through education and resources—to be focused, motivated, and committed to maintaining your treatment goals.
Connect-patient-iconOption 1

Option 1

Connect with a Patient Access Liaison (PAL) to help you explore enrollment options. Call 866-402-5622.

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Option 2

Sign up through your
doctor’s office. They can start the enrollment on AmgenByYourSide.com and submit it for you on your behalf. Your consent will also be required.

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Amgen® SupportPlus Co-Pay Program
Amgen® SupportPlus Co-Pay Program

The Amgen SupportPlus Co-Pay Program may help eligible patients with private or commercial insurance lower their out-of-pocket costs.

  • Pay as little as $0* out-of-pocket per month/for each dose
  • Can be applied to deductible, co-insurance, and co-payment*
  • No income eligibility requirement

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/Copay for full Terms and Conditions.

VISIT AMGEN SUPPORTPLUS CO-PAY
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Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections 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 meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of BKEMV, unless the risks of delaying therapy with BKEMV outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria.
  • Patients receiving eculizumab products are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.

Because of the risk of serious meningococcal infections, BKEMV is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS.

Contraindications:BKEMV is contraindicated for initiation in patients with unresolved serious Neisseria meningitidis infection.

Other Infections

Use caution when administering BKEMV to patients with any other systemic infection. Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported.

Eculizumab products block terminal complement activation; therefore, patients may have increased susceptibility to infections, especially with encapsulated bacteria, such as infections with Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with eculizumab products may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP recommendations. Patients receiving eculizumab products are at increased risk for infections due to these organisms, even if they develop antibodies following vaccination.

Monitoring Disease Manifestations after BKEMV Discontinuation

Treatment Discontinuation for PNH:

Monitor patients after discontinuing BKEMV for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS:

After discontinuing BKEMV, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis.

In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of two, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during BKEMV treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during BKEMV treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during BKEMV treatment.

If TMA complications occur after BKEMV discontinuation, consider reinstitution of BKEMV treatment, plasma therapy, or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during eculizumab products treatment has not been established. Therefore, treatment with eculizumab products should not alter anticoagulant management.

Infusion-Related Reactions

Administration of eculizumab products may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion-related reaction which required discontinuation of eculizumab. Interrupt BKEMV infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in:

  • the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea
  • the aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, and pyrexia
  • the gMG placebo-controlled clinical trial (≥10%) is musculoskeletal pain
Drug Interactions
  • Concomitant use of eculizumab products with plasma exchange (PE), plasmapheresis (PP) or fresh frozen plasma infusion (PE/PI) treatment can reduce serum eculizumab products concentrations and requires a supplement dose of BKEMV.
  • Concomitant use of eculizumab products with neonatal Fc receptor (FcRn) blockers may lower systemic exposures and reduce effectiveness of eculizumab products. Closely monitor for reduced effectiveness of BKEMV.

Please see full Prescribing Information for additional Important Safety Information.

INDICATIONS

BKEMV™ (eculizumab-aeeb) is indicated for the treatment:

  • patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
  • patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  • generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive.

BKEMV is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

      *A stable patient was defined as a patient receiving eculizumab for ≥6 months and currently receiving 900 mg of eculizumab every 14 ± 2 days.2

      †BKEMV™ is not indicated for Neuromyelitis Optica Spectrum Disorder (NMOSD), for which Alexion has marketing exclusivity.1,3

References: 1. BKEMV (eculizumab-aeeb) Prescribing Information, Amgen. 2. Kulasekararaj A, et al. Am J Hematol. Published online August 22, 2024. 3. Soliris® (eculizumab) Prescribing Information, Alexion.

References: 1. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/media/82647/download. Accessed January 6, 2025. 2. US Food and Drug Administration. Overview of the regulatory guidance for the development and approval of biosimilar products in the US. www.fda.gov/media/90496/download. Accessed January 6, 2025. 3. Blauvelt A, Cohen AD, Puig L, Vender R, van der Walt J, Wu JJ. Biosimilars for psoriasis: preclinical analytical assessment to determine similarity. Br J Dermatol. 2016;174:282-286. 4. US Food and Drug Administration. Guidance for industry: pharmaceutical development. www.fda.gov/media/71535/download. Accessed January 6, 2025.

References: 1. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/media/82647/download. Accessed January 6, 2025. 2. US Food and Drug Administration. Guidance for industry: pharmaceutical development. www.fda.gov/media/71535/download. Accessed January 6, 2025. 3. US Food and Drug Administration. Generic drug facts. www.fda.gov/drugs/generic-drugs/generic-drug-facts. Accessed January 6, 2025. 4. Aspirin Prescribing Information, Bayer. 5. Taltz® (ixekizumab) Prescribing Information [revised 2021], Eli Lilly. 6. Amgen. A worldwide biologics leader. www.amgenbiosimilars.com/heritage/worldwide-biologics-leader. Accessed January 6, 2025. 7. Desanvicente-Celis Z, Gomez-Lopez A, Anaya JM. Similar biotherapeutic products: overview and reflections. Immunotherapy. 2012;4:1841-1857. 8. Amgen. Amgen Manufacturing. www.amgenbiosimilars.com/expertise/manufacturing. Accessed January 6, 2025.

References: 1. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/media/82647/download. Accessed January 6, 2025. 2. US Food and Drug Administration. Biosimilar product information. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed January 6, 2025. 3. IQVIA. Biosimilars in the United States 2020-2024—competition, savings, and sustainability. October 2020.

Reference: 1. Risk Evaluation and Mitigation Strategy (REMS) Document. https://www.accessdata.fda.gov/drugsatfda_docs. Accessed Feb 24, 2025.
2. BKEMV™ (eculizumab-aeeb) Prescribing Information. Amgen, Inc.

References: 1. BKEMV™ (eculizumab-aeeb) Prescribing Information. Amgen, Inc. 2. US Food and Drug Administration, BKEMV FDA Approval Letter 2023. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed January 17, 2025. 3. US Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. www.fda.gov/downloads/drugs/guidances/ucm291128.pdf. Accessed January 17, 2025. 4. US Food and Drug Administration. FDA webinar - overview of the regulatory framework and FDA's guidance for the development and approval of biosimilar and interchangeable products in the US. www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm610901.htm. 5. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. April 2015. Accessed January 17, 2025. www.fda.gov/downloads/drugs/ guidances/ucm291128.pdf. 6. Lai Z, La Noce A. Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example. RMD Open. 2016;2:e000154. 7. Hutterer KM, Ip A, Kuhns S, Cao S, Wikström M, Liu J. Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product. BioDrugs. 2021;35(5):563-577. 8. McBride HJ, Frazer-Abel A, Thiemann S, Lehto SG, Hutterer KM, Liu J. Functional similarity of ABP 959 and eculizumab in simulated serum models of aHUS and NMOSD. Ann Hematol. 2023;102(12):3299-3309. 9. Kenawy HI, Boral I, Bevington A. Complement-Coagulation Cross-Talk: A Potential Mediator of the Physiological Activation of Complement by Low pH. Front Immunol. 2015;6:215. 10. Chow V, Pan J, Chien D, Mytych DT, Hanes V. A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris®) in healthy male subjects. Eur J Haematol. 2020;105(1):66-74. 11. Kulasekararaj A, Lanza F, Arvanitakis A, et al. Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria. Am J Hematol. 2024;99(11):2108-2117.

References: 1. Kulasekararaj A, Lanza F, Arvanitakis A, et al. Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria. Am J Hematol. 2024,99(11):2108-2117. 2. Kulasekararaj A, Lanza F, Arvanitakis A, et al. Efficacy and safety of biosimilar candidate ABP959 as compared with eculizumab reference product in paroxysmal nocturnal hemoglobinuría.

Reference: 1. Kulasekararaj A, Lanza F, Arvanitakis A, et al. Efficacy and safety of biosimilar candidate ABP 959 as compared with eculizumab reference product in paroxysmal nocturnal hemoglobinuria.

References: 1. Kulasekararaj A, Lanza F, Arvanitakis A, et al. Efficacy and safety of biosimilar candidate ABP 959 as compared with eculizumab reference product in paroxysmal nocturnal hemoglobinuria. Presented at: 64th American Society of Hematology Annual Meeting and Exposition; December 10-13, 2022; New Orleans, LA. Abstract 3893. 2. Kulasekararaj A, Lanza F, Arvanitakis A, et al. Comparative clinical efficacy and safety of biosimilar ABP 959 and eculizumab reference product in patients with paroxysmal nocturnal hemoglobinuria. Am J Hematol. 2024;99(11):2108-2117.

Reference: 1. Chow V, Pan J, Chien D, Mytych DT, Hanes V. A randomized, double-blind, single-dose, three-arm, parallel group study to determine pharmacokinetic similarity of ABP 959 and eculizumab (Soliris®) in healthy male subjects. Eur J Haematol. 2020;105:66-74

References: 1. Amgen Biosimilars. Manufacturing. https://www.amgenbiosimilars.com/heritage/worldwide-biologics-leader. Accessed January 17, 2025. 2. Amgen Biosimilars. Amgen’s Heritage and Legacy. Available at: https://www.amgen.com.hk/science/biosimilars Accessed January 17, 2025.

References: 1. AVSOLA® (infliximab-axxq) Prescribing Information, Amgen Inc. 2. AMJEVITA™ (adalimumab-atto) Prescribing Information, Amgen Inc. 3. KANJINTI® (trastuzumab-anns) Prescribing Information, Amgen Inc. 4. MVASI® (bevacizumab-awwb) Prescribing Information, Amgen Inc. 5. RIABNI® (rituximab-arrx) Prescribing Information, Amgen Inc. 6. PAVBLUTM (aflibercept-ayyh) Prescribing Information, Amgen Inc. 7. BKEMV™ (eculizumabaeeb). Prescribing Information Amgen Inc. 8. Data on file, Amgen [Biosimilars Product Sales]; 2021. 9.Data on file, Amgen; [1]; 2024.

Reference: 1. Amgen. Amgen biosimilars. www.amgen.com/science/biosimilars.

Reference: 1. BKEMV™ (eculizumab-aeeb). Prescribing Information. Amgen Inc. 2. Kulasekararaj A, et al. Am J Hematol. Published online August 22, 2024

Reference: 1. BKEMV™ (eculizumab-aeeb). Prescribing Information. Amgen Inc.

References: 1. US Food and Drug Administration. FDA approves first interchangeable biosimilar for two rare diseases. https://www.fda.gov/news-events/ press-announcements/fda-approves-first-interchangeable-biosimilar-two-rare-diseases. 2. Amgen Biosimilars. Manufacturing. https://www.amgenbiosimilars.com/heritage/worldwide-biologics-leader. Accessed January 17, 2025. 3. Amgen Biosimilars. Amgen’s Heritage and Legacy Available at: https://www.amgen.com.hk/science/biosimilars Accessed January 17, 2025. 4. Amgen. Amgen History. Available at: https://www.amgen.com/about/%20amgen-history#:-:text=Over. Accessed January 17, 2025.

Important Safety Information

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

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

  • BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria that may quickly become life-threatening or cause death if not recognized and treated early.
  • You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose of BKEMV.
  • If you have not been vaccinated and BKEMV must be started right away, you should receive the required vaccine(s) as soon as possible.
  • If you have not been vaccinated and BKEMV must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
  • If you had a meningococcal vaccine in the past, you might need additional vaccines before starting BKEMV. Your healthcare provider will decide if you need additional meningococcal vaccines.
  • Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 3 months after your last dose of BKEMV. Your risk of meningococcal infection may continue for several weeks after your last dose of BKEMV. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

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

  • enroll in the REMS program
  • counsel you about the risk of serious meningococcal infections
  • give you information about the signs and symptoms of serious meningococcal infection
  • make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start BKEMV right away and you are not up to date on your vaccines
  • give you a Patient Safety Card about your risk of meningococcal infection.

BKEMV may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

  • If your child is treated with BKEMV, your child should receive vaccines against Streptococcus pneumoniae and Haemophilus influenzae type b (Hib).
  • Certain people may be at risk of serious infections with gonorrhea. Talk to your healthcare provider about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing.
  • Certain fungal infections (Aspergillus) may occur if you take BKEMV and have a weak immune system or a low white blood cell count.

Who should not receive BKEMV?

Do not receive BKEMV if you have a serious meningococcal infection when you are starting BKEMV.

Before you receive BKEMV, 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, and are breastfeeding or plan to breastfeed. It is not known if BKEMV will harm your unborn baby or if it passes into your breast milk.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. BKEMV and other medicines can affect each other causing side effects. Know the medications 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.

What are the possible side effects of BKEMV?

BKEMV can cause serious side effects, including serious infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of these symptoms during your BKEMV infusion: headache, back pain, diarrhea, upper respiratory infection, urinary tract infections, fever, pain in your abdomen, pain or swelling of your nose or throat, common cold, cough, nausea, vomiting, chest pain, high blood pressure, low red blood cell count, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, swelling of legs or feet, muscle and joint pain, and feeling faint or passing out. If you have an infusion-related reaction to BKEMV, your healthcare provider may need to infuse BKEMV more slowly, or stop BKEMV. Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of BKEMV. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Medication Guide for BKEMV.

APPROVED USE

BKEMV is a prescription medicine used to treat:

  • people with paroxysmal nocturnal hemoglobinuria (PNH).
  • people with atypical hemolytic uremic syndrome (aHUS).

BKEMV is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

  • adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive.

It is not known if BKEMV is safe and effective in children with PNH or gMG.

Important Safety Information

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
  • Eculizumab products, complement inhibitors, increase the risk of serious infections caused by Neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.

Important Safety Information

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

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

  • BKEMV increases your chance of getting serious meningococcal infections caused by Neisseria meningitidis bacteria that may quickly become life-threatening or cause death if not recognized and treated early.