Rituximab® (MabThera) MTH

Roche Pharma AG

Chimeric mouse human monoclonal anti CD20 antibody

Lymphomas: - Primary cutaneous germinal center lymphoma - Primary cutaneous marginal zone lymphoma - Primary cutaneous diffuse large cell B-cell lymphoma Off label: (After syst. Pemphigus vulgaris, Paraneoplastic Pemphigus, Pemphigus foliaceus - Bullous Pemphigoid, Mucosal Pemphigoid - Epiodermolysis bullosa aquisita (EBA) - Graft-versus-host Disease (GvHD) - Dermatomyositis - Scleroderma - Atopic Dermatitis - ANCA-Ass. Vasculitis


No dermatological disease in the list of specialties

Infusion solution

HBV, HCV, chest x-rays, quantiferon test, BB-Diff and liver and kidney values and immunoglobulin mirror gel (low IgG levels increase the risk of severe infections among rituximab), CRP, BSR. HBV: Use possible if no DNA detection Further recommendation: Refresh vaccinations 4 weeks before start of therapy.

BB-Diff, BSR und CRP

Month 3 and 6: BB-Diff, BSR and CRP

Month 3 and 6: BB-Diff, BSR and CRP


Two dosing schemes according to literature: autoimmune protocol: Two cycles of 1000 mg a day 0 and 14 first infusion: The recommended initial infusion rate is 50 mg/h; it can be gradually increased by 50 mg/h every 30 minutes after the first 60 minutes to a maximum of 400 mg/h every 50 minutes. Further infusions: Further infusions of MabThera may be administered at an infusion rate of 100 mg/h. Neoplasia protocol: 375 mg/m2 weekly for 4 - 8 weeks.

Pemphigus foliaceus: 2 weeks Paraneoplastic pemphigus: Significant improvement after 2 months, symptom-free average after 6 months Pemphigus vulgaris: average within 4 - 6 weeks

Prophylactic administration of 100mg methylprednisolone i.v., an antihistamine (e.g. clemastine 2mg i.v.) and paracetamol 1g per os, 30 minutes before infusion to prevent infusion reactions. Due to the increased risk of infection, vaccination with live vaccines is not recommended. Patients treated with Rituximab may be vaccinated with inactive vaccines. After completion of treatment with MabThera, no TNF inhibitors should be administered for at least 8 weeks.

2 ampoules 10 mL: 100mg/10mL: 778,60 ampoule 50 mL: 500 mg/50 mL: 1875.80 piercing ash 1 piece: 1400 mg/11.7mL: 2603.95

Not recommended during treatment cycle

Evaluation recommended after 16 weeks

Extremely rare, case reports only

Pregnancy (use effective contraceptive methods 12 months after MabThera treatment), lactation, severe heart condition (NYHA IV)

Fever (48.3%), chills (31.3%), asthenia, headache. Increased ALT value (13.1 %). Bacterial infections, viral infections, bronchitis, neutropenia, leukopenia, febrile neutropenia, thrombocytopenia, angioedema, nausea, pruritis, skin rash, alopecia.

No data

No data

No data

Patients with titres of human anti-mouse antibodies or human antichimeric antibodies (HAMA/HACA) may develop allergic or over-empirical reactions if additionally treated with other diagnostic or therapeutic monoclonal antibodies.

No increased risk of cancer

Inf Conc.