Rituximab

MabThera® (MTH) Rituximab RTX (Roche Pharma AG)

Biosimilars: Rixathon® (Sandoz), Truxima® (iQone Healthcare)

Chimeric mouse-human monoclonal anti-CD20 antibody.

Severe active ANCA-associated vasculitis Moderate to severe pemphigus vulgaris.

Off-label use for: Paraneoplastic pemphigus, pemphigus foliaceus, bullous pemphigoid, mucosal pemphigoid, epidermolysis bullosa acquisita (EBA), graft-versus-host disease (GvHD), dermatomyositis, scleroderma, atopic dermatitis.

No

Severe active ANCA-associated vasculitis in combination with corticosteroids, subject to the following conditions: history of relapse while on cyclophosphamide or cyclophosphamide failure; in cases of cyclophosphamide intolerance or hypersensitivity, or other contraindications; in patients who have not yet completed their family planning (risk of infertility).

Pre-filled syringe, pre-filled pen.

Complete blood count, liver and kidney function tests, screening for HBV, HCV, HIV and TB (optional: including chest X-ray), immunoglobulin levels (low IgG levels increase the risk of severe infections during treatment with rituximab), CRP, vaccination status.

Complete blood count, CRP, IgG levels, plus neurological assessment.

In months 3 and 6: complete blood count, CRP and IgG levels.

i.v., s.c. (first dose i.v.).

Autoimmune protocol: 1,000 mg on days 0 and 14 (in combination with a tapering glucocorticoid regimen); maintenance therapy with 500 mg intravenously at months 12 and 18, and, if clinically necessary, repeated every 6 months. First infusion: The recommended initial infusion rate is 50 mg/h; after the first 60 minutes, this may be increased gradually by 50 mg/h every 30 minutes up to a maximum of 400 mg/h. Subsequent infusions of MabThera may be administered at a rate of 100 mg/h and gradually increased every 30 minutes by 100 mg/h up to a maximum of 400 mg/h.

ANCA-associated vasculitis protocol: 375 mg/m² weekly for a duration of 4 weeks; for the treatment of severe symptoms, an additional 1,000 mg of methylprednisolone intravenously for 1–3 days, followed by 1 mg/kg body weight per day of prednisone orally (maximum 80 mg per day, with rapid tapering as clinically indicated).

Pemphigus foliaceus: 2 weeks.

Paraneoplastic pemphigus: significant improvement after 2 months, symptom-free on average after 6 months

Pemphigus vulgaris: on average within 6 weeks.

→Data vary considerably between studies.

Premedication with an analgesic/antipyretic (e.g. paracetamol/acetaminophen) and an antihistamine (e.g. diphenhydramine) and, if necessary, glucocorticoids. Due to the increased risk of infection, vaccination with live vaccines is not recommended; vaccination with inactivated vaccines is possible, but the immune response may be reduced. Due to limited clinical experience, treatment of patients with neutrophil counts <1.5 × 10⁹/L and/or platelet counts <75 × 10⁹/L should only be undertaken with caution. Administer intravenously as an infusion (not undiluted or as a short infusion)

MabThera®: 2 ampoules of 10 mL: 100 mg/10 mL: 627

Autoimmune regimen (2 infusions of 100 mL, corresponding to 1,000 mg each): 6,062

Rixathon®/Truxima®: 2 ampoules of 10 mL: 100 mg/10 mL: 505

Autoimmune regimen (2 infusions of 100 mL, corresponding to 1,000 mg each): 4,902

Interrupt treatment immediately in the event of hypoxia, severe dyspnoea, hypotension or bronchospasm.

Assessment recommended after 16 weeks.

16 per cent of patients (4/25) developed antibodies against the active substance rituximab (anti-drug antibodies, ADAs). No trend in adverse reactions was observed in these patients.

Pregnancy (use effective methods of contraception for 12 months following treatment with MabThera), breastfeeding, severe heart failure (NYHA Class IV), hypersensitivity.

Fever (48.3 per cent), chills (31.3 per cent), asthenia, headache, elevated ALT levels (13.1 per cent), bacterial infections, viral infections, bronchitis, neutropenia, leucopenia, febrile neutropenia, thrombocytopenia, angioedema, nausea, pruritus, rash, alopecia, progressive multifocal leukoencephalopathy, infusion reactions, anaphylaxis, hypoxia, pulmonary infiltrates, acute respiratory failure, sepsis, depression, SJS, TEN, decrease in IgG levels.

Insufficient data.

Insufficient data.

Insufficient data.

Patients who have titres of human anti-mouse antibodies or human anti-chimeric antibodies (HAMA/HACA) may develop allergic or hypersensitivity reactions if they are additionally treated with other diagnostic or therapeutic monoclonal antibodies. No data are available on the concomitant administration of rituximab and TNF inhibitors: TNF inhibitors should not be started until 8 weeks after completion of therapy.

No increase in the incidence of TB reactivation.

No increased risk of malignancies has been reported.