Bkemv

Pronunciation: bee-KEM-vee
Generic name: eculizumab
Dosage form: injection for intravenous use
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on May 30, 2024.

What is Bkemv?

Bkemv (eculizumab-aeeb) is an injectable complement inhibitor that is an interchangeable biosimilar to Soliris which may be used to:

• Treat paroxysmal nocturnal hemoglobinuria (PNH) in adults and children 
• Inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and children with atypical hemolytic uremic syndrome (aHUS) (does not include Shiga toxin E. coli-related hemolytic uremic syndrome [STEC-HUS]).

Bkemv works by inhibiting the activity of the complement system, which is part of the immune system. It specifically binds to complement protein C5 with high affinity, inhibiting its cleavage to C5a (a proinflammatory toxin) and C5b (which initiates the membrane attack complex (MAC or C5b-9) which leads to osmolysis and the rupture of the cell wall. Bkemv prevents complement-mediated red blood cell rupture in patients with PNH and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS.

Bkemv is a monoclonal antibody. Monoclonal antibodies are man-made antibodies that fight antigens (harmful substances) in the body. It affects your immune system and may lower the ability of your body to fight infections.

Bkemv is available only under a special program called the Bkemv REMS. Before you can receive it, 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 was FDA-approved on May 28, 2024. It is an interchangeable biosimilar to Soliris which was approved on March 16, 2007. An interchangeable biosimilar is a biological product that can be substituted in the pharmacy for the reference biologic (in this case, Soliris) because there are no clinically meaningful differences in safety, purity, and potency. Note that Bkemy is only approved for PNH and aHUS so it can only be substituted for Soliris for these conditions.

What are the side effects of Bkemv?

Bkemv can cause serious side effects including an increased risk of developing serious meningococcal infections, other serious infections, or infusion-related reactions.

The most common side effects of Bkemv affecting 10% or more people taking it for PNH include:

• headache
• viral infections, such as a cold
• back pain
• nausea.

The most common side effects of Bkemv affecting 20% or more people taking it for aHUS include:

• headache
• diarrhea
• high blood pressure
• upper respiratory tract infections or other viral infections, such as a cold
• abdominal pain
• vomiting 
• low red blood cell counts (anemia)
• cough
• swelling in the feet and hands
• nausea
• urinary tract infections
• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Amgen at 1-800-77-AMGEN (1-800-772-6436) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings

Bkemv can cause the following serious side effects.

An increased risk of developing serious meningococcal infections caused by Neisseria meningitidis bacteria.

These may quickly become life-threatening or cause death if not recognized and treated early.

Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or if your eyes are more sensitive to light.

• You must complete or update your meningococcal vaccine(s) at least 2 weeks before your first dose.

You will need to receive certain vaccinations, including vaccinations to protect against meningococcal disease, at least 2 weeks before you start using Bkemv unless the risks of delaying Bkemv outweigh the risks of a serious infection.

• If you have not completed your meningococcal vaccines 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 to take for as long as your healthcare provider tells you.
• If you previously had a meningococcal vaccine, you might need additional vaccines before starting Bkemv treatment. 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 with or without a rash
  • fever with a high heart rate
  • headache with nausea or vomiting
  • headache and fever
  • headache with a stiff neck or stiff back
  • confusion
  • eyes sensitive to light
  • muscle aches with flu-like symptoms.
• 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 months after your last dose. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

Other serious infections

Other types of serious infections caused by encapsulated bacteria, including Streptococcus pneumoniae, Haemophilus influenzae, and possibly Neisseria gonorrhoeae.

• If your child is treated with Bkemv, your child should receive vaccines against S. pneumonia and H. influenzae type b (Hib).

Gonorrhea

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 also happen if you take Bkemv and have a weak immune system or a low white blood cell count.

Infusion-related reactions

These may happen during the IV infusion or after. Symptoms may include lower back pain, abdominal pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, bad taste, or drowsiness. Stop Bkemv and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your infusion that may mean you are having a serious infusion-related reaction, including:

• chest pain
• swelling of your face, tongue, or throat
• Trouble breathing, or shortness of breath
• feeling faint or like you might pass out.

Before taking

Before you receive Bkemv, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to eculizumab, Bkemv, or Soliris
• have a meningococcal infection (such as meningitis or sepsis), or if you are not currently vaccinated against meningitis (unless the risks of delaying treatment outweigh the risks of developing meningitis). You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using Bkemv. If your child is treated with this medicine, make sure he or she is vaccinated against pneumonia and influenza type B (Hib). If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of Bkemv treatment
• have recently had any symptoms of an infection (fever, chills, or flu-like symptoms) or recently have had meningitis
• are pregnant or intend to become pregnant
• are breastfeeding or intend to breastfeed.

Pregnancy

It is not known if Bkemv will harm your unborn baby. Tell your doctor if you are pregnant. It is not known whether eculizumab will harm an unborn baby. However, having PNH during pregnancy may cause complications in the baby or the mother, including blood clots, infections, bleeding, miscarriage, premature delivery, or death. The benefit of treating PNH may outweigh any risks to the baby or the mother.

Breastfeeding

It is not known if Bkemv passes into your breast milk.

How is Bkemv administered?

Bkemv is administered as an intravenous (into a vein) infusion by a healthcare provider.

• This usually takes approximately 35 minutes in adults and 1 to 4 hours in children.
• Adults will usually receive a Bkemv infusion weekly for 5 weeks then every 2 weeks.
• If your child is receiving Bkemv your healthcare provider will decide how often they receive Bkemv depending on their age and body weight.
• After each infusion, you will be watched closely for at least 1 hour to ensure you do not have an allergic reaction.

Stopping treatment

Your healthcare provider will tell you how long you should stay on Bkemv.

• If you have PNH and you stop receiving Bkemv, your healthcare provider will need to monitor you closely for at least 8 weeks after you stop receiving it.
• Stopping Bkemv may cause a breakdown of your red blood cells due to PNH. Symptoms or problems that can happen due to red blood cell breakdown include:
• a drop in your red blood cell count counts
• a drop in your platelet counts
• confusion
• difficulty breathing
• kidney problems
• blood clots
• chest pain.

If you have aHUS, your healthcare provider will need to monitor you closely for at least 12 weeks after stopping Bkemv for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). Symptoms or problems that can happen with TMA may include:

• confusion or loss of consciousness
• difficulty breathing
• seizures
• blood clots or stroke
• chest pain (angina)
• kidney problems
• a drop in your platelet counts
• swelling in your arms or legs.

What happens if I miss a dose?

If you miss a Bkemv dose call your healthcare provider right away to reschedule your appointment.

What other drugs will affect Bkemv?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bkemv and other medicines can affect each other causing side effects.

• A supplemental dose of Bkemv is required for patients administered intravenous immunoglobulins or undergoing plasma exchange, plasmapheresis.
• Monitor patients taking neonatal Fc Receptor Blockers (FcRn), such as efgartigimod or rozanolixizumab, closely for reduced effectiveness of Bkemv.

Know the medicines 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. See the prescribing information for a full list of interactions.

Storage

Store refrigerated at 2° C - 8° C (36° F - 46° F) in the original carton to protect from light. Do not freeze. Do not shake.

Bkemv vials may be stored in the original carton at controlled room temperature (not more than 25°C [77°F]) for only a single period of up to 7 days.

Ingredients

Active ingredient: eculizumab-aeeb.

Inactive ingredients: sorbitol (E420), acetic acid, polysorbate 80 (vegetable origin), edetate disodium (EDTA), sodium hydroxide may be added to adjust pH, and Water for Injection, USP.

Manufacturer

Amgen Inc.

Popular FAQ

More FAQ

• How many biosimilars have been approved in the United States?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer