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

BKEMV™ has an established Q-CODE: Q5152

interchangeable

The first and only
interchangeable
biosimilar to
Soliris

demonstrated

Demonstrated
safety and efficacy
in Soliris-stable
patients2

extended

Extended IV
bag storage
time1,3
backed

Backed by Amgen’s
40+ years of
experience in
biologics

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

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.