Bkemv

Bkemv (eculizumab-aeeb) is an interchangeable biosimilar to Soliris, which is used to:

• Treat paroxysmal nocturnal hemoglobinuria (PNH) in adults
• 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])
• Treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive
• Treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Bkemv's mechanism of action involves blocking 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 was FDA-approved on May 28, 2024, and 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. Bkemv is approved for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

Bkemv is a medicine that affects your immune system. Bkemv 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. Meningococcal infections 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 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 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 and a rash fever with 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 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 Bkemv 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, as discussed above.

Bkemv may also increase the risk of other types of serious infections caused by encapsulated bacteria, 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 also happen if you take Bkemv and have a weak immune system or a low white blood cell count.

For more information about side effects, see "What are the possible side effects of Bkemv?"

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
• have liver disease
• 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.

Serious side effects

Bkemv can cause serious side effects including:

• See "What is the most important information I should know about Bkemv?"
• Serious infusion-related reactions. Serious infusion-related reactions can happen during your Bkemv infusion. Tell your healthcare provider or nurse right away if you get any of these symptoms during your Bkemv infusion: chest pain trouble breathing or shortness of breath swelling of your face, tongue, or throat feel faint or pass out
• Liver injury. Liver problems have been reported in adults and children with aHUS who were treated with this medicine. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems.

If you have an infusion-related reaction to Bkemv, your healthcare provider may need to infuse Bkemv more slowly or stop Bkemv. See "How should I receive Bkemv?"

Common side effects

The most common side effects of Bkemv in people taking it for PNH are:

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

The most common side effects of Bkemv in people taking it for aHUS are:

• 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.

The most common side effect of Bkemv in people with gMG is:

• muscle and joint (musculoskeletal) pain.

The most common side effects of Bkemv in people with NMOSD are:

• upper respiratory infection
• nasopharyngitis (inflammation of the nose and throat)
• diarrhea
• back pain
• dizziness
• influenza (flu)
• arthralgia (joint pain)
• pharyngitis (sore throat)
• contusion (bruising).

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.

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.

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 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.

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

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.

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.

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.

Bkemv (eculizumab-aeeb) is manufactured by Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799, U.S.A. U.S. License Number 1080

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Bkemv.

Soliris (eculizumab) - Alexion Pharmaceuticals, Inc.

View Soliris information in detail.

Soliris interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Bkemv (eculizumab-aeeb) - Amgen Inc.

Epysqli (eculizumab-aagh) - Samsung Bioepis Co., Ltd.

View Epysqli information in detail.