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).

    BKEMV® (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).

BKEMV HAS STRONG COVERAGE

+85%

COMMERCIAL

Patients*

+95%

MEDICARE

Patients*

*Based on BKEMV data from Managed Markets Insights and Technology (MMIT) as of December 2025. Coverage may vary by indication. Covered represents on formulary on any tier with or without restrictions and may include quantity limits, prior authorizations and/or step edit restrictions.

REVIEW MORE COVERAGE INFORMATION

Reference: Data on file, Amgen; 2025.

ABOUT BIOSIMILARS

FDA APPROVAL REQUIRES RIGOROUS EVALUATION OF BIOSIMILARS1

Biosimilars have the potential to reduce healthcare costs2,3

safety

Biosimilars have a highly similar safety and efficacy profile to their reference products1

Biosimilars allow for the entry of potentially lower-cost treatment options while providing highly similar efficacy and safety2,3

  • Provide patients with more treatment options
  • Increase competition in the marketplace
  • Potentially lower healthcare costs to the system
  • Potentially reduce costs for some patients

Our Commitment

As a world leader and innovator in biologics for patients with life-threatening and chronic diseases, Amgen is proud to also produce biosimilar medicines in pursuit of our mission to serve patients.

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%) in adult patients is musculoskeletal pain
Drug Interactions
  • Concomitant use of eculizumab products with plasma exchange (PE), plasmapheresis (PP), fresh frozen plasma infusion (PE/PI), or in patients with gMG on concomitant IVIg treatment can reduce serum eculizumab product concentrations and requires a supplemental 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 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 (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

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 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.

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.

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 13, 2026. 2. US Food and Drug Administration. Biosimilar product information. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed January 13, 2026. 3. IQVIA. Biosimilars in the United States 2020-2024—competition, savings, and sustainability. October 2020.

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