Formulary
Rituximab: Indications, Dosing, Side Effects and Interactions
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
MedNext Academy | 5 min read
Rituximab: Indications, Dosing, Side Effects and Interactions
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
Drug action
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
Indications and dose
**Rheumatoid arthritis (under expert supervision)**
- **Adult** (By Intravenous Infusion): 1 g, then 1 g after 2 weeks, consult product literature for information on retreatment.
**Granulomatosis with polyangiitis and microscopic polyangiitis (under expert supervision)**
- **Adult** (By Intravenous Infusion): (consult product literature).
**Non-Hodgkin's lymphoma (specialist use only),Chronic lymphocytic leukaemia (specialist use only)**
- **Adult** (By Intravenous Infusion): Specialist indication - access specialist resources for dosing information.
**Non-Hodgkin's lymphoma (specialist use only)**
- **Adult** (By Subcutaneous Injection): Specialist indication - access specialist resources for dosing information.
**Pemphigus vulgaris (under expert supervision)**
- **Adult** (By Intravenous Infusion): 1 g, then 1 g after 2 weeks; maintenance 0.5 g, at months 12 and 18, and then every 6 months thereafter if needed, consult product literature for the treatment of relapse.
**Severe cases of resistant immune modulated disease [including idiopathic thrombocytopenia purpura, haemolytic anaemia, and systemic lupus erythematosus] (under expert supervision) for rituximab**
- **Child** (By intravenous infusion): Patients should receive premedication before each dose (consult product literature for details) (consult local protocol).
**Post-transplantation lymphoproliferative disease (specialist use only), Non-Hodgkin's lymphoma (specialist use only), Hodgkin's lymphoma (specialist use only) for rituximab**
- **Child** (By intravenous infusion): Specialist indication - access specialist resources for dosing information.
Cautions
General cautions: History of cardiovascular disease (exacerbation of angina, arrhythmia, and heart failure have been reported); patients receiving cardiotoxic chemotherapy (exacerbation of angina, arrhythmia, and heart failure have been reported); pre-medication recommended to minimise adverse reactions (consult product literature); predisposition to infection; transient hypotension occurs frequently during infusion (anti-hypertensives may need to be withheld for 12 hours before infusion) Specific cautions: When used for Granulomatosis with polyangiitis and microscopic polyangiitis Pneumocystis jirovecii pneumonia-consult product literature for prophylaxis requirements When used for Pemphigus vulgaris Pneumocystis jirovecii pneumonia-consult product literature for prophylaxis requirements Cautions, further information For full details on cautions, consult product literature or local treatment protocol. Hepatitis B infection and reactivation Hepatitis B infection and reactivation (including fatal cases) have been reported in patients taking rituximab . Manufacturer advises patients with positive hepatitis B serology should be referred to a liver specialist for monitoring and initiation of antiviral therapy before treatment initiation; treatment should not be initiated in patients with evidence of current hepatitis B infection until the infection has been adequately treated. Manufacturer also advises patients should be closely monitored for clinical and laboratory signs of active hepatitis B infection (consult product literature).
Contraindications
General contra-indications: Severe infection Specific contra-indications: When used for Granulomatosis with polyangiitis and microscopic polyangiitis Severe heart failure; severe, uncontrolled heart disease When used for Pemphigus vulgaris Severe heart failure; severe, uncontrolled heart disease When used for Rheumatoid arthritis Severe heart failure; severe, uncontrolled heart disease Contra-indications, further information For full details on contraindications, consult product literature.
Side effects
For all anti-lymphocyte monoclonal antibodies Common or very common Anaemia; anaphylactic reaction; arthralgia; conjunctivitis; cough; hypersensitivity (discontinue permanently); increased risk of infection; infusion related reaction; neutropenia; pain in extremity; thrombocytopenia; vomiting Uncommon Haemolytic anaemia Side-effects, further information Infusion-related side-effects In rare cases infusion reactions may be fatal. Infusion-related side-effects occur predominantly during the first infusion. Patients should receive premedication before administration of anti-lymphocyte monoclonal antibodies to reduce these effects-consult product literature for details of individual regimens. The infusion may have to be stopped temporarily and the infusion-related effects treated-consult product literature for appropriate management. Cytokine release syndrome Fatalities following severe cytokine release syndrome (characterised by severe dyspnoea) and associated with features of tumour lysis syndrome have occurred after infusions of anti-lymphocyte monoclonal antibodies. Patients with a high tumour burden as well as those with pulmonary insufficiency or infiltration are at increased risk and should be monitored very closely (and a slower rate of infusion considered). Progressive Multifocal Leukoencephalopathy (PML) If suspected, treatment should be suspended until PML has been excluded. If a patient develops an opportunistic infection or PML, anti-lymphocyte monoclonal antibodies should be permanently discontinued. Side-effects For rituximab Common or very common Alopecia; angioedema; anxiety; appetite decreased; arrhythmias; asthenia; bone marrow disorders; bursitis; cancer pain; cardiac disorder; chest pain; chills; constipation; depression; diarrhoea; dizziness; dysphagia; dyspnoea; ear pain; electrolyte imbalance; fever; gastrointestinal discomfort; gastrointestinal disorders; headaches; hepatitis B; hypercholesterolaemia; hyperglycaemia; hypertension; hypotension; insomnia; lacrimation disorder; leucopenia; malaise; multi organ failure; muscle complaints; muscle tone increased; myocardial infarction; nausea; nerve disorders; oedema; oral disorders; osteoarthritis; pain; respiratory disorders; sensation abnormal; sepsis; skin reactions; sweat changes; throat irritation; tinnitus; vasodilation; weight decreased Uncommon Asthma; coagulation disorder; heart failure; hypoxia; ischaemic heart disease; lymphadenopathy; taste altered Rare or very rare Cytokine release syndrome; facial paralysis; hepatitis B reactivation; interstitial lung disease; progressive multifocal leukoencephalopathy (PML); renal failure; Stevens-Johnson syndrome (discontinue); toxic epidermal necrolysis; tumour lysis syndrome; vasculitis; vision disorders Frequency not known Epistaxis; hearing loss; hypogammaglobulinaemia; infective thrombosis; influenza like illness; irritability; muscle weakness; nasal congestion; posterior reversible encephalopathy syndrome (PRES); psychiatric disorder; seizure; skin papilloma; tremor Side-effects, further information Associated with infections, sometimes severe, including tuberculosis, septicaemia, and hepatitis B reactivation. Progressive multifocal leucoencephalopathy has been reported in association with rituximab; patients should be monitored for cognitive, neurological, or psychiatric signs and symptoms. If progressive multifocal leucoencephalopathy is suspected, suspend treatment until it has been excluded.
Interactions
**Other interactions (6):**
- Currently, there are limited data on possible drug interactions with rituximab.
- In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine or cyclophosphamide.
- In addition, there was no apparent effect of fludarabine and cyclophosphamide on the pharmacokinetics of rituximab.
- Co-administration with methotrexate had no effect on the pharmacokinetics of rituximab in rheumatoid arthritis patients.
- In patients with rheumatoid arthritis, 283 patients received subsequent therapy with a biologic DMARD following rituximab.
- In these patients the rate of clinically relevant infection while on rituximab was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
Pregnancy
Avoid unless potential benefit to mother outweighs risk of B-lymphocyte depletion in fetus.
Breast feeding
Avoid breast-feeding during and for 12 months after treatment.
Medicinal forms
Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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