Ravulizumab Recombinant Human Monoclonal Antibody, Invitrogen™

Description

• Endotoxin level < 0.01EU/μg by LAL method Use a manual defrost freezer and avoid repeated freeze thaw cycles
• Store at 2 to 8 °C for one week
• Store at -20 to -80 °C for twelve months from the date of receipt
• Ravulizumab is considered a long-acting complement 5 (C5) inhibitor that has been undergoing clinical trials for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) as of 4 February, 2016
• A pharmaceutical similar to ravulizumab (ALXN1210), called eculizumab, is currently approved for the treatment of PNH in 46 countries under the brand name Soliris®
• Ravulizumab is considered by Alexion Pharmaceuticals Inc
• to be a &quotenext-generation&quote eculizumab molecule
• Ravulizumab was subsequently approved by the US FDA in December of 2018 for a variety of beneficial characteristics that make it an advanced, next-generation agent in comparison to eculizumab
• In particular, ravulizumab is currently the first and only long-acting C5 complement inhibitor that can be administered every eight weeks for the treatment of adult patients with PNH whereas eculizumab is a bi-weekly treatment, Label
• Moreover, virtually all of the phase 3 trial results for ravulizumab have demonstrated the equivalent efficacy and safety established by eculizumab and that patients transition safely and effectively from using eculizumab to ravulizumab
• Subsequently, whereas PNH patients may have needed to previously plan their lives rather strictly around the bi-weekly infusion administrations of eculizumab, with ravulizumab such patients can find a more relaxed dosing schedule of only six or seven infusions over an entire year, Label.