Key points
- Rituximab (Rituxan, MabThera) is an antibody that attaches to B lymphocytes and destroys them; it is given as a drip [1].
- It is used in many types of B-cell non-Hodgkin lymphoma and in chronic lymphocytic leukaemia (CLL) [1].
- In the most common type of lymphoma, adding rituximab to chemotherapy increased the number of patients whose disease disappeared completely and helped them live longer [2].
- The most important risks: a severe reaction during the infusion (mostly with the first infusion), severe skin reactions, reactivation of hepatitis B and, rarely, a brain infection [1].
- Before starting, everyone needs a hepatitis B test [1].
What is this drug and how does it work?
For physicians
Rituximab is a monoclonal antibody that binds to the CD20 protein on the surface of immature (pre-B) and mature B lymphocytes and causes these cells to be destroyed [1]. Possible mechanisms include complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC) [1]. Because many B-cell lymphomas and CLL express CD20, rituximab has become one of the cornerstones of treatment for these cancers.
Rituximab was first approved in the United States in 1997 [1]. In the original pivotal trial, 48% of patients with relapsed low-grade or follicular lymphoma responded to four weekly doses [3]. Besides cancer, rituximab is also approved for some autoimmune diseases: rheumatoid arthritis (with methotrexate), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris [1]. This page focuses on its use in cancer.
Which cancers is it used for?
Your doctor may prescribe this drug for:
- Low-grade or follicular non-Hodgkin lymphoma (CD20-positive) [3]
- Previously untreated follicular lymphoma (CD20-positive) [1, 4]
- Low-grade non-Hodgkin lymphoma that has not progressed [1]
- Previously untreated diffuse large B-cell lymphoma (DLBCL) [2]
- Mature B-cell lymphoma and mature B-cell acute leukaemia in children (6 months and older) [1]
- Chronic lymphocytic leukaemia (CLL, CD20-positive) [5]
Whether it suits you depends on the type and stage of your cancer and your test results. Details of each use are in the section for doctors.
For physicians
| Cancer | Treatment setting | Key evidence |
|---|---|---|
| Low-grade or follicular non-Hodgkin lymphoma (CD20-positive) | Relapsed or refractory; as a single agent | Pivotal trial: response in 48% of patients with four weekly doses [3] |
| Previously untreated follicular lymphoma (CD20-positive) | With first-line chemotherapy, then maintenance in responding patients | R-CVP vs CVP: median progression-free survival 2.4 vs 1.4 years (HR 0.44) [1]. PRIMA: 3-year progression-free survival 74.9% with maintenance vs 57.6% with observation (HR 0.55) [4] |
| Low-grade non-Hodgkin lymphoma that has not progressed | Single agent after first-line CVP chemotherapy | Lower risk of progression, relapse or death compared with no further treatment [1] |
| Previously untreated diffuse large B-cell lymphoma (DLBCL) | With CHOP or other anthracycline-containing regimens | R-CHOP vs CHOP in patients aged 60 to 80: complete response 76% vs 63%; lower risk of treatment failure (0.58) and death (0.64) [2] |
| Mature B-cell lymphoma and mature B-cell acute leukaemia in children (6 months and older) | Advanced stage, previously untreated; with LMB chemotherapy | Lower risk of an event (adjusted HR 0.32) compared with chemotherapy alone [1] |
| Chronic lymphocytic leukaemia (CLL, CD20-positive) | Previously untreated or treated; with fludarabine and cyclophosphamide (FC) | CLL8: 3-year progression-free survival 65% vs 45% (HR 0.56) and overall survival 87% vs 83% [5] |
In the POLARIX trial, pola-R-CHP (vincristine replaced with polatuzumab vedotin, given with rituximab) reduced the risk of progression, relapse or death compared with R-CHOP in previously untreated DLBCL (HR 0.73) [6].
How it is given and dose
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Treatment regimens and doses: index7 regimens
- Rituximab is given only as a slow intravenous infusion at a treatment centre, supervised by staff equipped to manage severe reactions [1].
- Before each infusion, medicines such as paracetamol (acetaminophen) and an antihistamine are given to reduce infusion reactions [1].
- The first infusion is given more slowly than later ones, and the rate is increased gradually if there is no reaction, so it may take several hours [1].
- The number and spacing of doses depend on the disease and the treatment regimen (for example weekly, or once in each chemotherapy cycle) [1]. Do not move or skip appointments without talking to your doctor.
- Before starting, a hepatitis B test and a full blood count are done, and blood counts are repeated during treatment [1].
- Before the first infusion: HBV screening for everyone with HBsAg and anti-HBc (if positive, consult a hepatitis specialist about monitoring and prophylactic antiviral treatment); CBC with platelets; update vaccinations and give non-live vaccines at least 4 weeks before starting; live vaccines are not recommended [1].
- Premedication: paracetamol and an antihistamine before each infusion; for the 90-minute infusion, give the glucocorticoid of the chemotherapy regimen before the infusion [1].
- Infusion rate (IV only; not push or bolus): dilute to 1 to 4 mg/mL in 0.9% sodium chloride or 5% dextrose. First infusion: start at 50 mg/h and increase by 50 mg/h every 30 minutes to a maximum of 400. Later infusions: start at 100 mg/h and increase by 100 every 30 minutes to a maximum of 400. In previously untreated follicular lymphoma and DLBCL, if there was no grade 3 or 4 reaction in cycle 1, a 90-minute infusion (20% of the dose in the first 30 minutes and 80% over the next 60 minutes) can be used from cycle 2 with a glucocorticoid-containing regimen; not allowed with significant cardiovascular disease or lymphocytes of 5000/µL or more before cycle 2. For an infusion reaction: interrupt or slow the infusion and, after recovery, continue at half the previous rate [1].
- Stop the drug: severe mucocutaneous reaction, HBV reactivation (with stopping concurrent chemotherapy), PML, serious or life-threatening arrhythmia, rising creatinine or oliguria, serious infection. At high risk of tumour lysis syndrome: active IV hydration and a uric acid-lowering drug. Combination with cisplatin is not an approved regimen (renal toxicity) [1].
- Monitoring: with monotherapy, CBC with differential and platelets before each cycle; with chemotherapy, weekly to monthly and after the last dose until cytopenias resolve (late cytopenias are possible). Signs of hepatitis for several months after treatment (HBV reactivation has been reported up to 24 months); cardiac monitoring during and after the infusion with a history of arrhythmia or angina; new neurological symptoms (PML) [1]. The label has no renal or hepatic dose adjustment.
For physicians
Standard doses: single agent (FDA label)
Single agent in relapsed/refractory low-grade or follicular lymphoma
CD20-positive B-cell NHLCycle length: Weekly
CD20-positive B-cell NHL
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Rituximab | 375 mg/m² | IV infusion (rate as in the prescribing notes) | Weekly, 4 or 8 doses |
[1]
After first-line CVP (no progression)
CD20-positive low-grade lymphoma after 6 to 8 cycles of CVPCycle length: Every 6 months
CD20-positive low-grade lymphoma after 6 to 8 cycles of CVP
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Rituximab | 375 mg/m² | IV infusion (rate as in the prescribing notes) | 4 weekly doses, repeated every 6 months |
[1]
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Combination regimens and the subcutaneous form (FDA label)
Previously untreated follicular lymphoma: with chemotherapy, then maintenance
Previously untreated CD20-positive follicular lymphoma
Previously untreated CD20-positive follicular lymphoma
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Induction | |||
| Rituximab | 375 mg/m² | IV infusion (rate as in the prescribing notes) | Day 1 of each chemotherapy cycle |
| Maintenance (in complete or partial response) | |||
| Rituximab | 375 mg/m² | IV infusion (rate as in the prescribing notes) | Every 8 weeks |
Evidence: PRIMA (2011)
R-CHOP (or other anthracycline-containing regimens)
Previously untreated diffuse large B-cell lymphomaCycle length: Every 21 days
Previously untreated diffuse large B-cell lymphoma
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Rituximab | 375 mg/m² | IV infusion (rate as in the prescribing notes) | Day 1 of each cycle |
| CHOP | According to protocol | IV/oral | Every 3 weeks |
Evidence: GELA LNH98-5 (2002)
FCR
CD20-positive chronic lymphocytic leukaemia, previously untreated or treatedCycle length: Every 28 days
CD20-positive chronic lymphocytic leukaemia, previously untreated or treated
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Cycle 1 | |||
| Rituximab | 375 mg/m² | IV infusion | One day before starting FC |
| Cycles 2 to 6 | |||
| Rituximab | 500 mg/m² | IV infusion | Day 1 |
| Fludarabine + cyclophosphamide | 25 mg/m²/day + 250 mg/m²/day | IV | Days 1 to 3 |
Pneumocystis and herpes prophylaxis during treatment and for up to 12 months afterwards as needed. In exploratory analyses, no benefit from adding rituximab to FC was shown in patients over 70 [1, 5].
Evidence: CLL8 (2010)
Children: with LMB chemotherapy
Previously untreated mature B-cell lymphoma or acute leukaemia, 6 months and older
Previously untreated mature B-cell lymphoma or acute leukaemia, 6 months and older
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| COPDAM1 and COPDAM2 induction | |||
| Rituximab | 375 mg/m² | IV | Day −2 and day 1 of each cycle |
| CYM/CYVE 1 and 2 consolidation | |||
| Rituximab | 375 mg/m² | IV | Day 1 |
Start the first infusion at 0.5 mg/kg/h (maximum 50) and later infusions at 1 mg/kg/h (maximum 50), and increase by the same amount every 30 minutes to a maximum of 400 mg/h [1].
Subcutaneous form (Rituxan Hycela)
Follicular lymphoma, DLBCL and CLL — only after at least one full IV doseCycle length: As per regimen
Follicular lymphoma, DLBCL and CLL — only after at least one full IV dose
Before prescribing: Prescribing notes| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Follicular and DLBCL | |||
| Rituximab + hyaluronidase | 1400 mg / 23,400 units (11.7 mL) | Subcutaneous in the abdomen, about 5 minutes | As for the IV form schedule |
| CLL | |||
| Rituximab + hyaluronidase | 1600 mg / 26,800 units (13.4 mL) | Subcutaneous in the abdomen, about 7 minutes | Day 1 of cycles 2 to 6 |
Premedicate with paracetamol and an antihistamine (and consider a glucocorticoid); observe for 15 minutes after the injection [7].
Before prescribing, check each dose against the drug label, laboratory tests and the patient’s condition.
Side effects
The most common side effects:
- A reaction during the infusion, especially the first one: fever, chills, itching, nausea, headache or low blood pressure; this is why the first infusion is slow and medicines are given beforehand [1].
- Tiredness and weakness, infections, night sweats and skin rash [1].
- Low white blood cells, seen on blood tests [1].
For physicians
The most common side effects (≥ 25%) in the NHL trials were infusion reactions, fever, lymphopenia, chills, infection and weakness, and in CLL infusion reactions and neutropenia [1]. Infusion reactions are most frequent with the first infusion (77%) and less frequent with later ones; they usually occur 30 to 120 minutes after the start and resolve with slowing or interrupting the infusion and supportive care [1]. The table below shows the side effects of single-agent rituximab in 356 patients with relapsed low-grade or follicular lymphoma [1].
| Side effect | All grades | Grade 3 and 4 |
|---|---|---|
| Fever | 53% | 1% |
| Low lymphocytes | 48% | 40% |
| Chills | 33% | 3% |
| Infection | 31% | 4% |
| Weakness | 26% | 1% |
| Nausea | 23% | 1% |
| Headache | 19% | 1% |
| Night sweats | 15% | 1% |
| Skin rash / itching | 15% / 14% | 1% / 1% |
| Low neutrophils | 14% | 6% |
| Angioedema (swelling under the skin) | 11% | 1% |
| Low blood pressure | 10% | 1% |
In CLL (CLL Study 2), infusion reactions of any severity occurred in 59% of patients receiving R-FC; in CLL Study 1, grade 3–4 neutropenia was reported in 30% of R-FC patients vs 19% of FC patients [1].
Serious side effects
These side effects are less common but serious; if you notice any sign of them, tell your team early:
- A severe reaction during the infusion: shortness of breath, swelling of the face or throat, chest pain or dizziness; tell the nurse straight away [1].
- Hepatitis B coming back: a hepatitis test is needed before starting; report yellowing of the skin or severe tiredness for up to 2 years after treatment [1].
- Severe skin reactions: blisters, mouth sores or widespread peeling [1].
- Serious infection, and rarely a brain infection: confusion, problems with balance or vision, or new weakness [1].
- Heart and kidney problems, and severe abdominal pain [1].
For physicians
Rituximab has a boxed warning for four adverse reactions [1]:
- Fatal infusion reactions: deaths have occurred within 24 hours of the infusion, and about 80% of fatal reactions occurred with the first infusion. These reactions can include urticaria, hypotension, angioedema, hypoxia, bronchospasm, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation and shock [1].
- Severe mucocutaneous reactions: such as paraneoplastic pemphigus, Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN), sometimes fatal and even from the first day [1].
- Hepatitis B virus reactivation: sometimes leading to fulminant hepatitis, liver failure and death, even in people who are HBsAg-negative and anti-HBc-positive. It has been reported up to 24 months after the end of treatment [1].
- Progressive multifocal leukoencephalopathy (PML): a brain infection caused by the JC virus that can be fatal; most cases were diagnosed within 12 months of the last infusion [1].
Other important warnings: tumour lysis syndrome (12 to 24 hours after the first infusion, especially with ≥ 25,000 circulating malignant cells per cubic millimetre or a high tumour burden), serious infections (bacterial, fungal and viral, sometimes with prolonged hypogammaglobulinaemia), cardiac adverse reactions (arrhythmia, myocardial infarction), kidney toxicity and bowel obstruction or perforation [1].
When should I call my doctor?
During or after the infusion, tell the staff or your doctor straight away if you have these symptoms [1]:
- Hives, itching, swelling of the lips, tongue, throat or face; sudden cough, shortness of breath or wheezing
- Weakness, dizziness or feeling faint, palpitations or chest pain
- Painful sores in the mouth or on the skin, blisters, peeling skin or pus-filled spots
- Fever, chills, cold or flu symptoms, burning when passing urine, or a painful red sore (signs of infection)
- Increasing tiredness or yellowing of the skin and eyes (possible hepatitis)
- Confusion, loss of balance, difficulty walking or speaking, weakness on one side of the body or vision problems (possible PML)
- Nausea, vomiting, diarrhoea and lethargy after the first infusion (possible tumour lysis syndrome)
- Severe abdominal pain or repeated vomiting
Interactions, pregnancy and precautions
- Hepatitis B screening: before starting treatment, all patients should be tested for HBsAg and anti-HBc. If there is evidence of current or past infection, a liver specialist should advise on monitoring and antiviral treatment, and monitoring continues for several months after treatment ends [1].
- Vaccines: live vaccines are not recommended before or during treatment. If possible, complete vaccinations before starting and have non-live vaccines at least 4 weeks before a course of treatment [1].
- Interactions: no formal drug interaction studies have been done; combination with cisplatin has been associated with kidney damage and is not an approved regimen [1].
- Pregnancy and breastfeeding: rituximab can lower B lymphocytes in a newborn baby. Women who could become pregnant should use effective contraception during treatment and for 12 months after the last dose, and should not breastfeed for 6 months after the last dose [1].
- Heart or lung disease: tell your doctor if you have a history of arrhythmia, angina or lung disease; heart monitoring during the infusion may be needed [1].
Frequently asked questions
Is rituximab chemotherapy?
Why does the first infusion take so long?
Why do I need a hepatitis B test before treatment?
Rituximab can reactivate dormant hepatitis B virus, which may lead to liver failure; testing before treatment makes prevention possible [1].
Can I have vaccines during treatment?
Live vaccines are not recommended. Non-live vaccines are best given at least 4 weeks before a course of treatment starts; plan this with your doctor [1].
Is there still a risk of infection after treatment ends?
Yes. Serious infections can happen during and after treatment, and in some patients antibody levels stay low for a long time [1]. Tell your doctor about any sign of infection.
Scientific evidence
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Key studies
3 itemsiwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL
Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
Related cancer types
Treatment regimens (physicians)
References
7 referencesShow all references, 5 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1
- 2
- 3
- 4
- 5
- 6Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
- 7RITUXAN HYCELA (rituximab and hyaluronidase human) injection, for subcutaneous use: Prescribing Information
This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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