| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (frommouse) |
| Target | Complement component 5 |
| Clinical data | |
| Pronunciation | rav" ue liz' ue mab |
| Trade names | Ultomiris |
| Other names | ALXN1210, ravulizumab-cwvz |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619014 |
| License data | |
| Pregnancy category |
|
| Routes of administration | Intravenous |
| Drug class | Complement inhibitor |
| ATC code | |
| Legal status | |
| Legal status | |
| Pharmacokinetic data | |
| Metabolism | various proteases |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6430H9888N1696O2028S48 |
| Molar mass | 144938.56 g·mol−1 |
Ravulizumab, sold under the brand nameUltomiris, is a humanizedmonoclonal antibody complement inhibitormedication designed for the treatment ofparoxysmal nocturnal hemoglobinuria (PNH) andatypical hemolytic uremic syndrome. It is designed to bind to and prevent the activation ofComplement component 5 (C5).[8][7]
Paroxysmal nocturnal hemoglobinuria is characterized by red blood cell destruction, anemia (red blood cells unable to carry enough oxygen to tissues), blood clots, and impaired bone marrow function (not making enough blood cells).[9] In paroxysmal nocturnal hemoglobinuria, proteins known as the 'complement system', which is part of the immune system, become overactive because of a genetic mutation and start to attack the patients' own red blood cells.[8] Ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system.[8] By attaching to the C5 protein, the medicine blocks its effect and thereby reduces the destruction of red blood cells.[8]
In the United States, ravulizumab isindicated for the treatment of adults and children one month of age and older with paroxysmal nocturnal hemoglobinuria and for the treatment of adults and children one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).[7][9]
In the European Union, ravulizumab is indicated in the treatment of adults with paroxysmal nocturnal haemoglobinuria:
The most common side effects areupper respiratory tract infection (nose and throat infection),nasopharyngitis (inflammation of the nose and throat) and headache.[8][7] The most serious side effect ismeningococcal infection, a bacterial infection caused byNeisseria meningitidis that can cause meningitis andsepsis.[8][7]
Ravulizumab was developed by Alexion Pharmaceuticals, Inc.[10] It was engineered fromeculizumab to have a longer-lasting effect.[11]
Ravulizumab was approved by the USFood and Drug Administration (FDA) in December 2018.[12] In April 2019, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) recommended the granting of a conditional marketing authorization for ravulizumab.[13] Ravulizumab was approved for medical use in the EU in July 2019.[8]
Ravulizumab is theInternational Nonproprietary Name (INN).[14]
This article incorporates text from this source, which is in thepublic domain.
