Drug Summary
What Is Bkemv?
Bkemv (eculizumab-aeeb) is a complement inhibitor indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
Bkemv is biosimilar to Soliris (eculizumab).
What Are Side Effects of Bkemv?
Side effects of Bkemv include:
- headache,
- runny or stuffy nose,
- back pain,
- nausea,
- diarrhea,
- high blood pressure (hypertension),
- upper respiratory infection,
- abdominal pain,
- vomiting,
- anemia,
- cough,
- fluid retention/swelling in extremities,
- urinary tract infections (UTIs), and
- fever.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Bkemv
The recommended dosage regimen of Bkemv to treat PNH for patients 18 years of age and older consists of:
- 600 mg weekly for the first 4 weeks, followed by
- 900 mg for the fifth dose 1 week later, then
- 900 mg every 2 weeks thereafter
The recommended dosage regimen of Bkemv to treat aHUS for patients 18 years of age and older consists of:
- 900 mg weekly for the first 4 weeks, followed by
- 1200 mg for the fifth dose 1 week later, then
- 1200 mg every 2 weeks thereafter
For patients less than 18 years of age, Bkemv is dosed based upon body weight.
Bkemv In Children
Safety and effectiveness of Bkemv for the treatment of PNH in pediatric patients have not been established.
The safety and effectiveness of Bkemv for the treatment of aHUS have been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Bkemv?
Bkemv may interact with other medicines such as:
- monoclonal antibodies such as eculizumab products.
Tell your doctor all medications and supplements you use.
Bkemv During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Bkemv; it is unknown if it might affect a fetus. There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy. It is unknown if Bkemv passes into breast milk, however, maternal IgG is known to be present in breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Bkemv (eculizumab-aeeb) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 FDA at 1-800-FDA-1088.