Generic Name
Eculizumab
Brand Names
Epysqli, BKEMV, Soliris
FDA approval date: April 02, 2007
Classification: Complement Inhibitor
Form: Injection
What is Epysqli (Eculizumab)?
SOLIRIS 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 Clinical Trials
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Related Latest Advances
Brand Information
EPYSQLI (Eculizumab-aagh)
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Eculizumab products, complement inhibitors, increase the risk of serious infections caused byNeisseria meningitidis[see Warnings and Precautions (]. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early.
- 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 EPYSQLI, unless the risks of delaying therapy with EPYSQLI 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. SeeWarnings and Precautions(
- Patients receiving eculizumab products are at increased risk for invasive disease caused byNeisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected.
Because of the risk of serious meningococcal infections, EPYSQLI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called EPYSQLI REMS [see Warnings and Precautions (].
1DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/30 mL (10 mg/mL) as a clear to slightly opalescent, and colorless solution in a single-dose vial.
2CONTRAINDICATIONS
EPYSQLI 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 EPYSQLI 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-aagh, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4
Eculizumab-aagh 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-aagh 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.
EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution for intravenous infusion and is supplied in a 30 mL single-dose vial. Each mL contains 10 mg of eculizumab-aagh, dibasic sodium phosphate (0.77 mg), monobasic sodium phosphate (0.55 mg), polysorbate 80 (0.22 mg) (vegetable origin), trehalose (86 mg), and Water for Injection, USP. The pH is 7.
5HOW SUPPLIED/STORAGE AND HANDLING
EPYSQLI (eculizumab-aagh) injection is a sterile, preservative-free, clear to slightly opalescent and colorless solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton (NDC 51759-208-13).
- Store EPYSQLI vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. DO NOT FREEZE. DO NOT SHAKE.
- Prior to administration, if needed, unopened vials of EPYSQLI may be stored in the original carton at controlled room temperature [not more than 30°C (86°F)] for a single 1 month period and then returned to refrigeration for 3 days.
- Do not use beyond the expiration date shown on the carton.
Refer to
6PATIENT COUNSELING INFORMATION
Advise the patients and/or caregivers to read the FDA-approved patient labeling (
7PRINCIPAL DISPLAY PANEL - 30 mL Vial Label
NDC 51759-208-13
Epysqli
For Intravenous Infusion
000303748-01
8PRINCIPAL DISPLAY PANEL - 30 mL Vial Carton
NDC 51759-208-13
Epysqli
For Intravenous Infusion
Must dilute before use.
ATTENTION PHARMACIST:
One 30 mL Single-Dose Vial.
Discard Unused Portion.
SAMSUNG
