Brand Name
Soliris
Generic Name
Eculizumab
View Brand Information FDA approval date: April 02, 2007
Classification: Complement Inhibitor
Form: Injection
What is Soliris (Eculizumab)?
Soliris is a complement inhibitor indicated for: The treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
Approved To Treat
Related Clinical Trials
A Randomized, Open-Label, C5 Inhibitor-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy
Summary: This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on patients with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for patients with PNH and how the combination compares with 2 existing treatments, one called ravulizum...
A Phase III, Multicenter, Randomized, Open Label, Active-Controlled Study to Evaluate the Efficacy and Safety of HSK39297 Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Naive to Complement Inhibitor Therapy
Summary: The purpose of this study is to evaluate the efficacy and safety of HSK39297 tablets compared to eculizumab in Patients with PNH who Are Naive to Complement Inhibitor Therapy.
An Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Participants With Refractory Generalized Myasthenia Gravis (gMG)
Summary: This is an open-label, single-arm, multi-center study to evaluate the efficacy, safety, PK, PD, and immunogenicity of eculizumab in Chinese participants with refractory gMG. Approximately 15 participants will be enrolled in the study.
Related Latest Advances
Brand Information
SOLIRIS (ECULIZUMAB)
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
SOLIRIS, a complement inhibitor, increases 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 SOLIRIS, unless the risks of delaying therapy with SOLIRIS 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 SOLIRIS are at increased risk for invasive disease caused by
Because of the risk of serious meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called ULTOMIRIS and SOLIRIS REMS
1DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/30 mL (10 mg/mL) as a clear, colorless solution in a single-dose vial.
2CONTRAINDICATIONS
SOLIRIS 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 SOLIRIS 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 SOLIRIS. 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 SOLIRIS. 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 SOLIRIS exposure.
4DESCRIPTION
Eculizumab, a complement inhibitor, is a recombinant humanized monoclonal IgG2/4
SOLIRIS (eculizumab) injection is a sterile, clear, colorless, preservative-free 10 mg/mL solution for intravenous infusion and is supplied in 30-mL single-dose vials. The product is formulated at pH 7 and each 30 mL vial contains 300 mg of eculizumab, polysorbate 80 (6.6 mg) (vegetable origin), sodium chloride (263.1 mg), sodium phosphate dibasic (53.4 mg), sodium phosphate monobasic (13.8 mg), and Water for Injection, USP.
5HOW SUPPLIED/STORAGE AND HANDLING
SOLIRIS (eculizumab) injection is a sterile, preservative-free, clear, colorless solution supplied as one 300 mg/30 mL (10 mg/mL) single-dose vial per carton (NDC 25682-001-01).
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
Rx only
NDC 25682-001-01
Soliris
300 mg/30 mL
For Intravenous Use
Must be diluted prior to use.
ATTENTION: Dispense the
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