Clinical Information
Gen. Code and Des.
62479 eculizumab INTRAVEN VIAL 300MG/30ML
GCN and Des.
98255 eculizumab INTRAVEN VIAL 300MG/30ML
Strength
300MG
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
92320800 COMPLEMENT INHIBITORS
Active Ingredients
12087 eculizumab 219685504
Inactive Ingredients
2551 polysorbates 9005645
SOLIRIS- eculizumab injection, solution, concentrate
Alexion Pharmaceuticals Inc.
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 [see Warnings and Precautions (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 meningococcal vaccines 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 Warnings and Precautions (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 [see Warnings and Precautions (5.2) ]. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at solirisrems.com.
1 INDICATIONS AND USAGE
1.1 Paroxysmal Nocturnal Hemoglobinuria (PNH)
Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
1.2 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.
Limitation of Use
Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
2 DOSAGE AND ADMINISTRATION
Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see Warnings and Precautions (5.2) ].
Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection [see Warnings and Precautions (5.1) and (5.2)].
Only administer as an intravenous infusion.
2.1 Recommended Dosage Regimen - PNH
Soliris therapy consists of:
600 mg weekly for the first 4 weeks, followed by
900 mg for the fifth dose 1 week later, then
900 mg every 2 weeks thereafter.
Administer Soliris at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.6) ].
2.2 Recommended Dosage Regimen - aHUS
For patients 18 years of age and older, Soliris therapy consists of:
900 mg weekly for the first 4 weeks, followed by
1200 mg for the fifth dose 1 week later, then
1200 mg every 2 weeks thereafter.
DESCRIPTION
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.
Soliris 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 vial contains 300 mg of eculizumab, 13.8 mg sodium phosphate monobasic, 53.4 mg sodium phosphate dibasic, 263.1 mg sodium chloride, 6.6 mg polysorbate 80 (vegetable origin) and Water for Injection, USP.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Eculizumab, the active ingredient in Soliris, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Soliris inhibits terminal complement mediated intravascular hemolysis in PNH patients and complement-mediated thrombotic microangiopathy (TMA) in patients with aHUS.
