Rituximab

Therapeutic Rituximab antibody from the original Mabthera® commercial drug

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CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
05/2018
217,00 
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CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
09/2018
217,00 
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Min: 1
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CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
12/2018
217,00 
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CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
02/2019
217,00 
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Max: 10
Min: 1
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CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
02/2019
217,00 
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Max: 10
Min: 1
Step: 1
CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
08/2019
217,00 
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Max: 10
Min: 1
Step: 1
CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
12/2019
217,00 
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Max: 10
Min: 1
Step: 1
CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
-80°C
07/2021
250,00 
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Max: 10
Min: 1
Step: 1
CD20
Monoclonal Antibody
MabThera®
10 mg/mL
200 µL
2 mg
2-8°C / -80°C
02/2023
250,00 
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Max: 10
Min: 1
Step: 1

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Mabthera® / Rituximab Reference Product

Drug nameMabthera®
INNRituximab
API typeRituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences. The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Pharmacotherapeutic group
Antineoplastic agents, monoclonal antibodies
ATC code
L01XC02
Target of antibody
CD20; Synonyms: B1, Bp35,  CVID5, LEU-16, MS4A2, S7, AA960661, Cd20, Ly-44, Ms4a2, MS4A1, bp35, cd20, ms4a2, leu-16, ms4a4c, cd20-like
General function
Short descriptionRituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes. The antigen is expressed on >95 % of all B cell non-Hodgkin’s lymphomas. CD20 is found on both normal and malignant B cells, but not on haematopoietic stem cells, pro-B cells, normal plasma cells or other normal tissue. This antigen does not internalise upon antibody binding and is not shed from the cell surface. CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding.
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis. Possible mechanisms of effector-mediated cell lysis include complement-dependent cytotoxicity (CDC) resulting from C1q binding, and antibody-dependent cellular cytotoxicity (ADCC) mediated by one or more of the Fcγ receptors on the
surface of granulocytes, macrophages and NK cells. Rituximab binding to CD 20 antigen on B lymphocytes has also been demonstrated to induce cell death via apoptosis.
Peripheral B cell counts declined below normal following completion of the first dose of MabThera. In patients treated for haematological malignancies, B cell recovery began within 6 months of treatment and generally returned to normal levels within 12 months after completion of therapy, although in some patients this may take longer (up to a median recovery time of 23 months post-induction therapy). In rheumatoid arthritis patients, immediate depletion of B cells in the peripheral blood was observed following two infusions of 1000 mg MabThera separated by a 14 day interval. Peripheral blood B cell counts begin to increase from week 24 and evidence for repopulation is observed in the majority of patients by week 40, whether MabThera was administered as monotherapy or in combination with methotrexate. A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of MabThera. In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to <10cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month timepoint. The majority of patients (81%) showed signs of B cell return,
with counts >10 cells/μL by month 12, increasing to 87% of patients by month 18.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)
Original license holder
Marketing authorisation numbers
EU/1/98/067/001 - 003
Marketing authorisation holder
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
Name of the manufacturer of the biological active substance
Genentech Inc.
1000 New Horizons Way
Vacaville, CA 95688
USA

Genentech, Inc.
1 Antibody Way
Oceanside, CA 92056 5802
USA
Name and address of the manufacturer(s) responsible for batch releaseRoche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
Max shelf life
30 months
Storage conditions
2°C – 8°C
List of excipients
Recombinant human hyaluronidase (rHuPH20)
L-histidine
L-histidine hydrochloride monohydrate
α,α-trehalose dihydrate
L-methionine
Polysorbate 80
Water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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