Global InformationRituximab information
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| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Chimeric (mouse/human) |
| Target | CD20 |
| Clinical data | |
| Trade names | Rituxan, Mabthera, Mabthera SC, others |
| Biosimilars | rituximab-abbs,[1] rituximab-pvvr,[2] rituximab-arrx,[3] Riabni,[3] Rixathon,[4] Riximyo,[5] Ruxience,[2] Truxima[1] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a607038 |
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| Routes of administration | Intravenous |
| Drug class | Monoclonal antibody |
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| Pharmacokinetic data | |
| Bioavailability | 100% (IV) |
| Elimination half-life | 30 to 400 hours (varies by dose and length of treatment) |
| Excretion | Uncertain: may undergo phagocytosis and catabolism in RES |
| Identifiers | |
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| CompTox Dashboard (EPA) |
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| ECHA InfoCard | 100.224.382 |
| Chemical and physical data | |
| Formula | C6416H9874N1688O1987S44 |
| Molar mass | 143860.04 g·mol−1 |
  (what is this?) (verify) | |
Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer.[15] It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia (in children and adults, but not recommended in elderly patients), rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers.[15][16][17][18] It is given by slow intravenous infusion (injected slowly through an IV line).[15] Biosimilars of Rituxan include Blitzima, Riabni, Ritemvia, Rituenza (F.K.A. Tuxella), Rixathon, Ruxience, and Truxima.[19][20]
Common side effects which often occur within two hours of the medication being given include rash, itchiness, low blood pressure, and shortness of breath. Infections are also common.[15]
Severe side effects include reactivation of hepatitis B in those previously infected, progressive multifocal leukoencephalopathy, toxic epidermal necrolysis, and death.[15][21] It is unclear if use during pregnancy is safe for the developing fetus or newborn baby,[6][15] but it is not proven harmful.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells.[22] When it binds to this protein it triggers cell death.[15]
Rituximab was approved for medical use in 1997.[22] It is on the World Health Organization's List of Essential Medicines.[23] Rituximab is co-marketed by Biogen and Genentech in the U.S., by Hoffmann-La Roche in Canada and the European Union, Chugai Pharmaceuticals, Zenyaku Kogyo in Japan and AryoGen in Iran.[24]
- ^ a b c "Truxima- rituximab-abbs injection solution". DailyMed. Retrieved 26 March 2021.
- ^ a b c "Ruxience- rituximab-pvvr injection solution". DailyMed. Retrieved 26 March 2021.
- ^ a b c "Riabni- rituximab-arrx injection solution". DailyMed. Retrieved 26 March 2021.
- ^ "Rixathon EPAR". European Medicines Agency. 15 June 2017. Retrieved 7 January 2024.
- ^ "Summary Basis of Decision (SBD) for Riximyo". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ a b "Rituximab Use During Pregnancy". Drugs.com. 16 December 2019. Retrieved 2 February 2020.
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ Rituximab (rch) (CAS registry number: 174722-31-7) Archived 30 November 2015 at the Wayback Machine
- ^ Australian Product Information. MabThera SC (rituximab) Archived 13 May 2021 at the Wayback Machine
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
- ^ "MabThera 100 mg Concentrate for Solution for Infusion - Summary of Product Characteristics (SmPC)". (emc). 13 March 2021. Retrieved 26 March 2021.
- ^ "MabThera 1400 mg Solution for Subcutaneous Injection - Summary of Product Characteristics (SmPC)". (emc). 13 March 2021. Retrieved 26 March 2021.
- ^ Cite error: The named reference
Rituxan FDA labelwas invoked but never defined (see the help page). - ^ "MabThera EPAR". European Medicines Agency. 17 September 2018. Retrieved 8 September 2021.
- ^ a b c d e f g "Rituximab". The American Society of Health-System Pharmacists. Archived from the original on 27 March 2016. Retrieved 8 December 2016.
- ^ Tandan R, Hehir MK, Waheed W, Howard DB (August 2017). "Rituximab treatment of myasthenia gravis: A systematic review". Muscle & Nerve. 56 (2): 185–196. doi:10.1002/mus.25597. PMID 28164324. S2CID 19504332.
- ^ Singer O, McCune WJ (May 2017). "Update on maintenance therapy for granulomatosis with polyangiitis and microscopic polyangiitis". Current Opinion in Rheumatology. 29 (3): 248–253. doi:10.1097/BOR.0000000000000382. PMID 28306595. S2CID 35805200.
- ^ Dojcinov SD, Fend F, Quintanilla-Martinez L (March 2018). "EBV-Positive Lymphoproliferations of B- T- and NK-Cell Derivation in Non-Immunocompromised Hosts". Pathogens. 7 (1): 28. doi:10.3390/pathogens7010028. PMC 5874754. PMID 29518976.
- ^ "Rituximab Biosimilars Shown to Be Safe and Effective". www.medscape.com. Archived from the original on 15 March 2018. Retrieved 29 November 2017.
- ^ "rituximab | Ligand page | IUPHAR/BPS Guide to PHARMACOLOGY". www.guidetopharmacology.org.
- ^ "Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab)". U.S. Food and Drug Administration (FDA). 29 February 2016. Retrieved 2 February 2020.
- ^ a b Bosch X, Ramos-Casals M, Khamashta MA (2013). Drugs Targeting B-Cells in Autoimmune Diseases. Springer Science & Business Media. pp. 1–4. ISBN 9783034807067. Archived from the original on 5 November 2017.
- ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- ^ "FDA Approves Rituxan Plus Chemotherapy for the Most Common Type of Adult Leukemia" (Press release). Biogen.