Paroxysmal Cold Hemoglobinuria Treatments
Find Paroxysmal Cold Hemoglobinuria Treatments
Generic Name
Eculizumab
Brand Names
BKEMV, Epysqli, Soliris
FDA approval date: April 02, 2007
Classification: Complement Inhibitor
Form: Injection
What is BKEMV (Eculizumab)?
BKEMV is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
Approved To Treat
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Related Latest Advances
Brand Information
BKEMV (eculizumab-aeeb)
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Eculizumab products, complement inhibitors, increase the risk of serious infections caused by
- 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
- Patients receiving eculizumab products are at increased risk for invasive disease caused by
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 [
1DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/30 mL (10 mg/mL) as a clear to opalescent and colorless to slightly yellow solution in a single-dose vial.
2CONTRAINDICATIONS
BKEMV is contraindicated for initiation in patients with unresolved serious
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Serious Meningococcal Infections [
- Other Infections [
- Monitoring Disease Manifestations after BKEMV Discontinuation [
- Thrombosis Prevention and Management [
- Infusion-Related Reactions [
3.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Meningococcal infections are the most important adverse reactions experienced by patients receiving eculizumab. In PNH clinical studies, two patients experienced meningococcal sepsis. Both patients had previously received a meningococcal vaccine. In clinical studies among patients without PNH, meningococcal meningitis occurred in one unvaccinated patient. Meningococcal sepsis occurred in one previously vaccinated patient enrolled in the retrospective aHUS study during the post-study follow-up period [
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of eculizumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to eculizumab products exposure.
Adverse Reactions from Postmarketing Spontaneous Reports
- Fatal or serious infections:
- Cases of cholestatic or mixed pattern liver injury with increased serum liver enzymes and bilirubin levels have been reported in adult and pediatric patients with aHUS who were treated with eculizumab products. These events occurred within 3 to 27 days after starting treatment. The median time to resolution (or return to baseline) was approximately 3 weeks.
4DESCRIPTION
Eculizumab-aeeb, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4κ antibody produced by Chinese Hamster Ovary (CHO) cell culture and purified by standard bioprocess technology. Eculizumab-aeeb contains human constant regions from human IgG2 sequences and human IgG4 sequences and murine complementarity-determining regions grafted onto the human framework light- and heavy-chain variable regions. Eculizumab-aeeb is composed of two 448 amino acid heavy chains and two 214 amino acid light chains and has a molecular weight of approximately 148 kDa.
BKEMV (eculizumab-aeeb) injection is a sterile, clear to opalescent, colorless to slightly yellow, preservative-free 10 mg/mL solution for intravenous infusion and is supplied in 30 mL single-dose vials. The product is formulated at pH 5.2 and each 30 mL vial contains 300 mg of eculizumab-aeeb, sorbitol (E420) (1500 mg), acetic acid (18.0 mg), polysorbate 80 (3.0 mg) (vegetable origin), edetate disodium (EDTA) (0.6 mg), sodium hydroxide may be added to adjust pH, and Water for Injection, USP.
5HOW SUPPLIED/STORAGE AND HANDLING
BKEMV (eculizumab-aeeb) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton (NDC 55513-180-01).
6PATIENT COUNSELING INFORMATION
Advise the patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide).
7PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton
300
BKEMV™
NDC 55513-180-01
300 mg/30 mL
For Intravenous Infusion Only
Must be diluted prior to use.
AMGEN
Rx Only
