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Anti-CD20 Monoclonal Antibody Pregnancy: There are no adequate and well-controlled data in pregnant women; IgG crosses the placenta and transient B-cell depletion and lymphocytopenia have been reported in some infants born to exposed mothers. Rituximab should not be given to pregnant women unless the possible benefit outweighs the potential risk. Women of childbearing potential should use effective contraception during treatment and for 12 months afterwards. Breast-feeding is not recommended during treatment and optimally for 6 months after treatment.

Rituximab (Haematology)

Brand names: MabThera, Rixathon, Truxima

Rituximab (in its haematology setting) is an anti-CD20 monoclonal antibody given intravenously or subcutaneously to treat CD20-positive B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukaemia, often combined with chemotherapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 375 mg/m2 body surface area is the standard dose across the adult non-Hodgkin's lymphoma indications. Chronic lymphocytic leukaemia (in combination with chemotherapy): 375 mg/m2 on Day 0 of the first treatment cycle, followed by 500 mg/m2 on Day 1 of each subsequent cycle, for 6 cycles in total.
Route: Intravenous infusion. Check the product label to ensure the appropriate formulation (intravenous or subcutaneous) is being given as prescribed.
Frequency: Follicular NHL, combination therapy (previously untreated or relapsed/refractory): 375 mg/m2 per cycle on Day 1 of each chemotherapy cycle, for up to 8 cycles. Follicular NHL maintenance (previously untreated): 375 mg/m2 once every 2 months, starting 2 months after the last induction dose, until progression or for a maximum of 2 years (12 infusions in total). Follicular NHL maintenance (relapsed/refractory): 375 mg/m2 once every 3 months, starting 3 months after the last induction dose, until progression or for a maximum of 2 years (8 infusions in total). Relapsed/refractory follicular NHL monotherapy (stage III-IV, chemoresistant or second or subsequent relapse), including retreatment: 375 mg/m2 once weekly for four weeks. Adult diffuse large B-cell NHL: 375 mg/m2 on Day 1 of each CHOP cycle for 8 cycles, after intravenous infusion of the glucocorticoid component of CHOP. CLL: Day 0 of cycle 1, then Day 1 of each subsequent cycle, 6 cycles in total (chemotherapy given after the rituximab infusion).
eMC (MabThera 100 mg Concentrate for Solution for Infusion). Administer under the close supervision of an experienced healthcare professional in an environment where full resuscitation facilities are immediately available. PREMEDICATION: an anti-pyretic and an antihistamine (e.g. paracetamol and diphenhydramine) should always be given before each administration; in adults with NHL or CLL, premedication with glucocorticoids should be considered if rituximab is not given with glucocorticoid-containing chemotherapy. CLL SPECIFIC: prophylaxis with adequate hydration and uricostatics starting 48 hours before therapy is recommended to reduce the risk of tumour lysis syndrome; for CLL patients with lymphocyte counts > 25 x 10^9/L it is recommended to give prednisone/prednisolone 100 mg intravenously shortly before the rituximab infusion to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome. DOSE ADJUSTMENT: no dose reductions of rituximab are recommended; when given with chemotherapy, standard dose reductions for the chemotherapeutic agents should be applied. SCOPE: this page covers the haematology indications. The fetched §4.2 excerpt was truncated before the rheumatoid arthritis, GPA/MPA and pemphigus vulgaris posology and before the paediatric NHL dosing table (Table 1) — clinician to source those from the full SPC. IMPORTANT — DO NOT MISREAD: the per-kg figures in the §4.2 premedication text (methylprednisolone 30 mg/kg/day IV, oral prednisone 1 mg/kg/day) refer to corticosteroid premedication in paediatric GPA/MPA, NOT to rituximab; paedDose has therefore been left null. Pneumocystis jirovecii pneumonia prophylaxis is recommended for adult and paediatric GPA/MPA patients and adult pemphigus vulgaris patients during and following treatment. Clinician to verify any paediatric use against a children's formulary.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to murine proteins, or to any of the excipients
  • Active, severe infections
  • Patients in a severely immunocompromised state
  • Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease — for use in rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris only

Side effects

  • Infusion-related reactions — occurred in the majority of patients during the first infusion; incidence falls substantially with subsequent infusions (<1% after eight doses). May include cytokine-release syndrome and tumour-lysis syndrome
  • Infections — predominantly bacterial and viral, in approximately 30-55% of NHL patients and 30-50% of CLL patients in clinical trials; serious infections including fatalities can occur. Very common: bacterial infections, viral infections, bronchitis
  • Haematological: neutropenia, leucopenia, febrile neutropenia and thrombocytopenia (very common); anaemia, pancytopenia and granulocytopenia (common); late neutropenia and transient increase in serum IgM levels (post-marketing)
  • Cardiovascular events — angina pectoris, cardiac arrhythmias such as atrial flutter and fibrillation, heart failure and/or myocardial infarction
  • Hepatitis B reactivation
  • Progressive multifocal leukoencephalopathy (very rare; cases have been fatal) — suspend dosing if PML is suspected and discontinue permanently if PML is confirmed

Clinical monograph

How it works

It binds the CD20 antigen on B lymphocytes and depletes them through complement-dependent and antibody-dependent cell-mediated cytotoxicity and apoptosis.

Prescribing in practice

  • Severe infusion-related reactions and cytokine release can occur, particularly with the first intravenous infusion and a high tumour burden, so give premedication and infuse with close monitoring at a controlled rate.
  • Screen for hepatitis B before treatment because rituximab can reactivate the virus, sometimes fulminantly; reactivation of other infections including progressive multifocal leukoencephalopathy is also a risk.
  • It causes prolonged B-cell depletion and hypogammaglobulinaemia, increasing infection risk, and live vaccines should be avoided.

Monitoring

Monitor closely for infusion reactions during administration, screen and watch for hepatitis B reactivation and infection, and check the full blood count and immunoglobulins.

Counselling the patient

  • Report any rash, fever, breathlessness, chills or throat tightness during the infusion immediately.
  • Tell the team promptly about any signs of infection, including after treatment finishes.
  • Mention any new neurological symptoms such as confusion, weakness or vision changes.

Evidence & guidelines

Adding rituximab to chemotherapy improves outcomes in CD20-positive B-cell lymphoma and is recommended by NICE for relevant indications.

Reference: NICE TA137; SPC rituximab; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.