WARNING: SERIOUS MENINGOCOCCAL INFECTIONS
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early (5.1).
- Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
- Immunize patients with a meningococcal vaccine at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections (5.1) for additional guidance on the management of the risk of meningococcal infection.)
- Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program (5.2). Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747).
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SOLIRIS SUMMARY
Soliris, a complement inhibitor, is a formulation of eculizumab which is a recombinant humanized monoclonal IgG2/4κ antibody produced by murine myeloma cell culture and purified by standard bioprocess technology. Eculizumab 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 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.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
Atypical Hemolytic Uremic Syndrome (aHUS)
Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
The effectiveness of Soliris in aHUS is based on the effects on thrombotic microangiopathy (TMA) and renal function. Prospective clinical trials in additional patients are ongoing to confirm the benefit of Soliris in patients with aHUS.
Limitation of Use
Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
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NEWS HIGHLIGHTS
Published Studies Related to Soliris (Eculizumab)
A randomized, double-blind, placebo-controlled phase II study of eculizumab in
patients with refractory generalized myasthenia gravis. [2013] cleavage of complement 5 (C5)... CONCLUSION: The data suggest that eculizumab may have a role in treating severe,
Eculizumab for paroxysmal nocturnal haemoglobinuria. [2009] The complement system plays a central part in both innate and acquired immunity,
but the contribution of complement activation to pathobiology is largely
ancillary.Moreover, due to
the heterogeneous nature of the disease, treatment with eculizumab is not
appropriate for all patients with PNH.
FDA report: eculizumab (Soliris) for the treatment of patients with paroxysmal
nocturnal hemoglobinuria. [2008] On March 16, 2007, eculizumab (Soliris; Alexion Pharmaceuticals, Inc... Patients must be monitored and evaluated immediately for early signs
of meningococcal infections and treated with antibiotics as indicated.
Eculizumab therapy results in rapid and sustained decreases in markers of
thrombin generation and inflammation in patients with PNH independent of its
effects on hemolysis and microparticle formation. [2012] Paroxysmal Nocturnal Hemoglobinuria (PNH) is a clonal bone marrow disorder which
results in the loss of glycosylphosphatidyl inositol (GPI) anchors from cell
membranes... Ex
vivo total microparticle FXa generation was found to have an inverse correlation
with markers of thrombin generation, suggesting that in PNH patients in vivo
thrombin generation occurs by a pathway independent of hemolysis and
microparticle generation.
Long-term effect of the complement inhibitor eculizumab on kidney function in
patients with paroxysmal nocturnal hemoglobinuria. [2010] Paroxysmal nocturnal hemoglobinuria (PNH) is a debilitating and life-threatening
disease in which lysis of PNH red blood cells frequently manifests with chronic
hemolysis, anemia, and thrombosis. Renal damage in PNH is associated with chronic
hemosiderosis and/or microvascular thrombosis...
Clinical Trials Related to Soliris (Eculizumab)
An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica [Completed]
The purpose of this study is to determine if the drug eculizumab reduces the attack rate and
improves outcome in patients with neuromyelitis optica.
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients [Completed]
The objective of this study is to assess the long term safety of Eculizumab in hemolytic PNH
patients who completed the 4 weeks screening and 12 weeks treatment period of C07-001 study.
In addition, pharmacokinetic and pharmacodynamic assessments of Eculizumab will be
conducted.
Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury [Recruiting]
Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation [Active, not recruiting]
This study is designed to assess the effectiveness of eculizumab in recipients of kidney
transplantation with donor-specific antibodies (DSA) and worsening kidney function and to
assess if eculizumab improves endothelial cell injury in the kidney.
The investigators hypothesize that complement inhibition with eculizumab will reduce
allograft injury, resulting from less complement-mediated injury of endothelial cells and
less endothelial cell activation.
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients [Enrolling by invitation]
The purpose of this study is to determine whether eculizumab long-term use is safe and
effective in patients with relapsing NMO.
Reports of Suspected Soliris (Eculizumab) Side Effects
Haemoglobin Decreased (203),
Fatigue (160),
Headache (145),
Pyrexia (113),
Nausea (102),
Platelet Count Decreased (78),
Haemolysis (77),
Condition Aggravated (76),
Nasopharyngitis (73),
Vomiting (72), more >>
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Page last updated: 2014-11-30
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