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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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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
PNH
The data described below reflect exposure to eculizumab in 196 adult patients with PNH, age 18-85, of whom 55% were female. All had signs or symptoms of intravascular hemolysis. Eculizumab was studied in a placebo-controlled clinical study (PNH Study 1, in which 43 patients received eculizumab and 44, placebo); a single arm clinical study (PNH Study 2); and a long-term extension study (E05-001). One hundred and eighty two patients were exposed for greater than one year. All patients received the recommended eculizumab dose regimen.
Table 5 summarizes the adverse reactions that occurred at a numerically higher rate in the eculizumab group than the placebo group and at a rate of 5% or more among patients treated with eculizumab.
In the placebo-controlled clinical study, serious adverse reactions occurred among 4 (9%) patients receiving eculizumab and 9 (21%) patients receiving placebo. The serious reactions included infections and progression of PNH. No deaths occurred in the study and no patients receiving eculizumab experienced a thrombotic event; one thrombotic event occurred in a patient receiving placebo.
Among 193 patients with PNH treated with eculizumab in the single arm, clinical study or the follow-up study, the adverse reactions were similar to those reported in the placebo-controlled clinical study. Serious adverse reactions occurred among 16% of the patients in these studies. The most common serious adverse reactions were: viral infection (2%), headache (2%), anemia (2%), and pyrexia (2%).
aHUS
The safety of eculizumab therapy in patients with aHUS was evaluated in four prospective, single-arm studies, three in adult and adolescent patients (Studies C08-002A/B, C08-003A/B, and C10-004), one in pediatric and adolescent patients (Study C10-003), and one retrospective study (Study C09-001r).
The data described below were derived from 78 adult and adolescent patients with aHUS in Studies C08-002A/B, C08-003A/B and C10-004. All patients received the recommended dosage of eculizumab. Median exposure was 67 weeks (range: 2-145 weeks). Table 6 summarizes all adverse events reported in at least 10% of patients in Studies C08-002A/B, C08-003A/B and C10-004 combined.
In Studies C08-002A/B, C08-003A/B and C10-004 combined, 60% (47/78) of patients experienced a serious adverse event (SAE). The most commonly reported SAEs were infections (24%), hypertension (5%), chronic renal failure (5%), and renal impairment (5%). Five patients discontinued eculizumab due to adverse events; three due to worsening renal function, one due to new diagnosis of Systemic Lupus Erythematosus, and one due to meningococcal meningitis.
Study C10-003 included 22 pediatric and adolescent patients, of which 18 patients were less than 12 years of age. All patients received the recommended dosage of eculizumab. Median exposure was 44 weeks (range: 1 dose-87 weeks).
Table 7 summarizes all adverse events reported in at least 10% of patients enrolled in Study C10-003.
In Study C10-003, 59% (13/22) of patients experienced a serious adverse event (SAE). The most commonly reported SAEs were hypertension (9%), viral gastroenteritis (9%), pyrexia (9%), and upper respiratory infection (9%). One patient discontinued eculizumab due to an adverse event (severe agitation).
Analysis of retrospectively collected adverse event data from pediatric and adult patients enrolled in Study C09-001r (N = 30) revealed a safety profile that was similar to that which was observed in the two prospective studies. Study C09-001r included 19 pediatric patients less than 18 years of age. Overall, the safety of eculizumab in pediatric patients with aHUS enrolled in Study C09-001r appeared similar to that observed in adult patients. The most common (≥ 15%) adverse events occurring in pediatric patients are presented in Table 8.
Generalized Myasthenia Gravis (gMG)
Adults
In a 26-week placebo-controlled trial evaluating the effect of eculizumab for the treatment of adult patients with gMG (Study ECU-MG-301), 62 patients received eculizumab at the recommended dosage regimen and 63 patients received placebo
The most common adverse reactions (≥ 10%) that occurred in eculizumab-treated patients in the long-term extension to Study ECU-MG-301, Study ECU-MG-302, and that are not included in Table 9 were headache (26%), nasopharyngitis (24%), diarrhea (15%), arthralgia (12%), upper respiratory tract infection (11%), and nausea (10%).
Neuromyelitis Optica Spectrum Disorder (NMOSD)
In a placebo-controlled trial evaluating the effect of eculizumab for the treatment of NMOSD (NMOSD Study 1), 96 patients received eculizumab at the recommended dosage regimen and 47 patients received placebo
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 mg), polysorbate 80 (3 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).
Serious Meningococcal Infections
Advise patients of the risk of serious meningococcal infection.
Inform patients of the need to complete or update their meningococcal vaccinations at least 2 weeks prior to receiving the first dose of BKEMV or receive antibacterial drug prophylaxis if BKEMV treatment must be initiated immediately and they have not been previously vaccinated. Inform patients of the requirement to be revaccinated according to current ACIP recommendations for meningococcal infection while on BKEMV therapy
Inform patients that vaccination may not prevent serious meningococcal infection and to seek immediate medical attention if the following signs or symptoms occur
- fever
- fever and a rash
- fever with high heart rate
- headache with nausea or vomiting
- headache and a fever
- headache with a stiff neck or stiff back
- confusion
- muscle aches with flu-like symptoms
- eyes sensitive to light
Inform patients that they will be given a Patient Safety Card for BKEMV that they should carry with them at all times during and for 3 months following treatment with BKEMV. This card describes symptoms which, if experienced, should prompt the patient to immediately seek medical evaluation.
BKEMV REMS
BKEMV is available only through a restricted program called BKEMV REMS
Inform the patient of the following notable requirements:
- Patients must receive counseling about the risk of serious meningococcal infections.
- Patients must receive written educational materials about this risk.
- Patients must be instructed to carry the Patient Safety Card with them at all times during and for 3 months following treatment with BKEMV.
- Patients must be instructed to complete or update meningococcal vaccines for serogroups A, C, W, Y and B per ACIP recommendations as directed by the prescriber prior to treatment with BKEMV.
- Patients must receive antibiotics as directed by the prescriber if they are not up to date with meningococcal vaccines and have to start BKEMV right away.
Other Infections
Counsel patients about gonorrhea prevention and advise regular testing for patients at-risk.
Inform patients that there may be an increased risk of other types of infections, particularly those due to encapsulated bacteria.
Aspergillus infections have occurred in immunocompromised and neutropenic patients.
Inform parents or caregivers of children receiving BKEMV for the treatment of aHUS that their child should be vaccinated against
Infusion-Related Reactions
Advise patients that administration of BKEMV may result in infusion-related reactions.
Discontinuation
Inform patients with PNH that they may develop serious hemolysis due to PNH when BKEMV is discontinued and that they will be monitored by their healthcare professional for at least 8 weeks following BKEMV discontinuation.
Inform patients with aHUS that there is a potential for TMA complications due to aHUS when BKEMV is discontinued and that they will be monitored by their healthcare professional for at least 12 weeks following BKEMV discontinuation. Inform patients who discontinue BKEMV to keep the Patient Safety Card with them for three months after the last BKEMV dose, because the increased risk of meningococcal infection persists for several weeks following discontinuation of BKEMV.
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
