Blitzima (Rituximab)
Monoclonal antibody biosimilar for lymphoma, leukaemia, rheumatoid arthritis, and vasculitis
Quick Facts About Blitzima
Key Takeaways About Blitzima
- Proven biosimilar: Blitzima is a biosimilar of MabThera/Rituxan (rituximab), approved by the EMA with equivalent efficacy and safety demonstrated through comprehensive comparability studies
- Broad indications: Used for non-Hodgkin lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and ANCA-associated vasculitis, making it one of the most versatile oncology-rheumatology medicines
- Infusion reactions are common: Most patients experience infusion-related reactions during the first infusion; premedication with corticosteroid, antihistamine, and paracetamol is mandatory
- Hepatitis B screening required: All patients must be screened for hepatitis B before starting treatment due to the risk of viral reactivation, which can be fatal
- B-cell depletion persists: Rituximab depletes B lymphocytes for months after treatment ends, affecting immune function and vaccine responses during this period
What Is Blitzima and What Is It Used For?
Blitzima is a biosimilar medicine containing rituximab, a monoclonal antibody that targets and destroys B lymphocytes by binding to the CD20 protein on their surface. It is used to treat certain types of blood cancer (non-Hodgkin lymphoma and chronic lymphocytic leukaemia), severe rheumatoid arthritis, and rare inflammatory blood vessel diseases (granulomatosis with polyangiitis and microscopic polyangiitis).
Blitzima belongs to a class of medicines known as monoclonal antibodies, which are laboratory-made proteins designed to recognise and attach to specific targets on cells. The active substance in Blitzima is rituximab, a chimeric (part mouse, part human) monoclonal antibody that specifically targets a protein called CD20. This protein is found on the surface of B lymphocytes, a type of white blood cell that plays a central role in the immune system and is involved in several serious diseases.
As a biosimilar medicine, Blitzima is highly similar to its reference product, MabThera (known as Rituxan in the United States), which was first approved in the European Union in 1998. The European Medicines Agency (EMA) approved Blitzima after extensive analytical, non-clinical, and clinical comparability studies demonstrated that it has no clinically meaningful differences from MabThera in terms of quality, safety, and efficacy. This means that patients receiving Blitzima can expect the same therapeutic benefits as those receiving the reference product.
Rituximab has revolutionised the treatment of B-cell malignancies since its introduction. According to the World Health Organization, rituximab is included on the WHO Model List of Essential Medicines, recognising its critical importance in healthcare systems worldwide. The development of biosimilar versions like Blitzima has increased access to this vital treatment and contributed to healthcare system sustainability by offering more affordable alternatives.
Approved Indications
Blitzima is approved for several different medical conditions, reflecting the diverse roles that B lymphocytes play in disease:
- Non-Hodgkin lymphoma (NHL): Treatment of previously untreated patients with stage III–IV follicular lymphoma in combination with chemotherapy. Maintenance therapy for follicular lymphoma responding to induction therapy. Treatment of CD20-positive diffuse large B-cell lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
- Chronic lymphocytic leukaemia (CLL): Treatment of previously untreated and relapsed/refractory CLL in combination with chemotherapy.
- Rheumatoid arthritis (RA): Treatment of severe active rheumatoid arthritis in adults in combination with methotrexate, when response to disease-modifying antirheumatic drugs (DMARDs) including TNF inhibitors has been inadequate.
- Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA): Treatment of adults with severe, active GPA (Wegener’s granulomatosis) and MPA in combination with glucocorticoids.
How Blitzima Works
The mechanism of action of rituximab involves targeting the CD20 antigen, which is expressed on the surface of pre-B lymphocytes and mature B lymphocytes. Importantly, CD20 is not found on haematopoietic stem cells, pro-B cells, normal plasma cells, or other healthy tissues, which allows rituximab to specifically target B cells while preserving the ability of the immune system to recover.
When rituximab binds to CD20 on a B lymphocyte, it triggers cell destruction through three complementary mechanisms. Complement-dependent cytotoxicity (CDC) involves the activation of the complement cascade, a series of proteins in the blood that punch holes in the cell membrane, causing the B cell to lyse. Antibody-dependent cellular cytotoxicity (ADCC) recruits natural killer cells and other immune effector cells to attack and destroy the targeted B cell. Finally, rituximab can directly trigger apoptosis (programmed cell death) in the B lymphocyte.
In oncology indications, the depletion of malignant B cells directly reduces the tumour burden. In autoimmune conditions like rheumatoid arthritis and vasculitis, the destruction of B cells reduces the production of autoantibodies and inflammatory mediators that drive tissue damage. The clinical effect may take several weeks to become apparent as the B-cell population is gradually depleted, and benefits can persist for months as B cells slowly repopulate.
A biosimilar is not a generic medicine. Biological medicines like rituximab are complex proteins produced by living cells, making exact copies impossible. Instead, biosimilars are developed to be highly similar to the reference product with no clinically meaningful differences. The EMA requires extensive comparability studies covering structural and functional analysis, non-clinical testing, and clinical trials before approving a biosimilar.
What Should You Know Before Taking Blitzima?
Before receiving Blitzima, your doctor will perform a thorough medical assessment including hepatitis B screening, cardiac evaluation, and blood counts. You must not receive Blitzima if you have active severe infections, are severely immunocompromised, or have severe heart failure. Special precautions apply to elderly patients, those with history of cardiac disease, and women of childbearing potential.
Blitzima is a potent immunosuppressive medicine that requires careful patient evaluation before treatment can begin. Your healthcare team will conduct comprehensive screening tests and assessments to ensure that the benefits of treatment outweigh the potential risks in your individual case. Understanding these considerations is essential for ensuring your safety throughout the treatment course.
Contraindications
You must not receive Blitzima if:
- You are hypersensitive (allergic) to rituximab, murine (mouse) proteins, or any of the other ingredients in Blitzima
- You have an active, severe infection at the time of planned infusion
- You are in a severely immunocompromised state (very weakened immune system)
- You have severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease — this applies specifically to the rheumatoid arthritis and vasculitis indications
Warnings and Precautions
Your doctor should be informed about your complete medical history before starting Blitzima. Several conditions require special attention and careful risk-benefit assessment:
Infusion-related reactions: These are the most common adverse events with rituximab and can range from mild symptoms like fever, chills, and rigors to severe, potentially life-threatening reactions including bronchospasm, hypotension, angioedema, and anaphylaxis. The first infusion carries the highest risk, with reactions occurring in approximately 77% of patients in clinical trials. Premedication with an analgesic/antipyretic (e.g. paracetamol), an antihistamine, and a corticosteroid is mandatory before each infusion. The infusion must be administered slowly with the first dose, and full resuscitation facilities must be immediately available.
Hepatitis B reactivation: Fatal hepatitis B reactivation has been reported in patients receiving rituximab, including those with resolved hepatitis B infection (HBsAg-negative, anti-HBc-positive). All patients must be screened for hepatitis B virus (HBV) before initiating treatment. HBV carriers and patients with a history of hepatitis B should be closely monitored for signs of active HBV infection during and for several months after therapy. If HBV reactivation occurs, Blitzima and any concomitant chemotherapy must be stopped immediately and appropriate antiviral therapy initiated.
Progressive multifocal leukoencephalopathy (PML): Very rare cases of PML, a serious and usually fatal brain infection caused by the JC virus, have been reported in patients treated with rituximab. PML should be considered in any patient with new or worsening neurological symptoms. If PML is suspected, treatment must be withheld until PML has been excluded.
Infections: Rituximab causes B-cell depletion and may be associated with decreased immunoglobulin levels. Patients may be at increased risk of infections, including serious bacterial, viral, and fungal infections. Treatment should not be initiated in patients with active infections, and caution is needed in patients with a history of recurrent or chronic infections.
Cardiovascular events: Angina pectoris, cardiac arrhythmias, and heart failure have been reported during rituximab infusions. Patients with a history of cardiac disease should be monitored closely. Infusions should be discontinued in patients who develop serious cardiac symptoms.
Pregnancy and Breastfeeding
Rituximab crosses the placental barrier and has been shown to cause B-cell depletion in the foetus. Blitzima should not be used during pregnancy unless the potential benefit outweighs the potential risk to the foetus. Women of childbearing potential must use effective contraception during treatment and for 12 months after the last dose of Blitzima.
It is not known whether rituximab is excreted in human breast milk. However, since maternal IgG is excreted in breast milk, and rituximab has been detected in milk of lactating animals, women should be advised not to breastfeed during Blitzima treatment and for 6 months after the last dose.
Blitzima must only be administered under the close supervision of an experienced physician in a setting where full resuscitation facilities are immediately available. Severe infusion-related reactions with fatal outcome have been reported. Patients must be closely monitored throughout each infusion and for at least one hour afterwards.
How Does Blitzima Interact with Other Drugs?
Blitzima can interact with live vaccines (contraindicated), other immunosuppressive medicines (increased infection risk), cisplatin (increased renal toxicity), and TNF-alpha inhibitors (additive immunosuppression). The blood pressure-lowering effects of antihypertensives may be enhanced during infusion. Always inform your doctor about all medicines you are taking.
Drug interactions with rituximab are an important consideration because of its potent immunosuppressive effects. The depletion of B lymphocytes affects the immune system broadly, and combining rituximab with other medicines that also suppress immune function can significantly increase the risk of serious infections. Your healthcare team will carefully review all your current medications before starting treatment.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Live vaccines (e.g. MMR, yellow fever, varicella) | Impaired immune response; risk of vaccine-strain infection due to B-cell depletion | Contraindicated during treatment and until B-cell recovery. Complete vaccinations at least 4 weeks before starting Blitzima. |
| Cisplatin | Rituximab is not compatible with cisplatin; increased renal toxicity observed | Avoid concurrent administration. Allow adequate washout period. |
| TNF-alpha inhibitors (e.g. adalimumab, infliximab, etanercept) | Additive immunosuppression with significantly increased risk of serious infections | Avoid concurrent use. If switching, monitor closely for infections during transition. |
| Other immunosuppressants (e.g. azathioprine, ciclosporin, mycophenolate) | Increased risk of immunosuppression and opportunistic infections | Use with caution. Monitor blood counts and immunoglobulin levels regularly. |
Minor Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Antihypertensives (e.g. ACE inhibitors, beta-blockers) | Enhanced blood pressure reduction during rituximab infusion due to cytokine release | Consider withholding antihypertensives 12 hours before infusion. Monitor blood pressure closely. |
| Inactivated vaccines (e.g. influenza, pneumococcal) | Reduced immune response to vaccination due to B-cell depletion | May still be given but with potentially reduced efficacy. Ideally vaccinate before treatment or after B-cell recovery. |
| Anticoagulants (e.g. warfarin) | Rituximab-induced thrombocytopenia may increase bleeding risk in anticoagulated patients | Monitor platelet counts and coagulation parameters regularly. |
Limited formal drug interaction studies have been conducted with rituximab. However, the pharmacokinetic data available suggest that rituximab clearance is not significantly affected by co-administered chemotherapy agents (such as CHOP or CVP regimens). When rituximab is combined with chemotherapy, the toxicities of each individual agent may be additive. Your doctor will monitor your blood counts and organ function carefully throughout treatment.
What Is the Correct Dosage of Blitzima?
The dosage of Blitzima depends on the condition being treated and the patient's body surface area. For most oncology indications, the standard dose is 375 mg/m² given as an intravenous infusion. For rheumatoid arthritis, the dose is a fixed 1,000 mg per infusion. Treatment is always administered in hospital under specialist supervision.
Blitzima dosing varies significantly depending on the medical indication, whether it is being given as initial treatment or maintenance therapy, and the specific chemotherapy regimen it is combined with. All doses are administered as intravenous infusions that must be prepared by a qualified healthcare professional and given in a clinical setting equipped for the management of severe infusion reactions. The dosing information below provides a general overview; your doctor will determine the exact dose and schedule appropriate for your individual situation.
Adults
Non-Hodgkin Lymphoma
Induction therapy: 375 mg/m² body surface area per cycle, given on Day 1 of each chemotherapy cycle for up to 8 cycles. The specific regimen depends on the type of lymphoma (e.g. R-CHOP, R-CVP, R-bendamustine).
Maintenance therapy (follicular lymphoma): 375 mg/m² body surface area once every 2 months (starting 2 months after the last induction dose) until disease progression or for a maximum of 2 years.
Chronic Lymphocytic Leukaemia (CLL)
Cycle 1: 375 mg/m² body surface area on Day 0, followed by chemotherapy (fludarabine/cyclophosphamide) on Days 1–3.
Cycles 2–6: 500 mg/m² body surface area on Day 1 of each 28-day cycle, followed by chemotherapy.
Rheumatoid Arthritis
One course: Two infusions of 1,000 mg each, given 2 weeks apart. Each infusion is preceded by 100 mg intravenous methylprednisolone 30 minutes before rituximab to reduce infusion reactions.
Re-treatment: A further course may be given after at least 24 weeks based on clinical response. Continuing to receive methotrexate concurrently is recommended.
GPA and MPA (Vasculitis)
Induction: 375 mg/m² body surface area once weekly for 4 consecutive weeks (4 infusions total), given in combination with intravenous methylprednisolone pulses followed by oral glucocorticoids.
Children
Blitzima is not indicated for use in children and adolescents below 18 years of age for most approved indications. The safety and efficacy of rituximab in paediatric patients has not been established for the conditions covered by Blitzima’s marketing authorisation. Rituximab may be used in paediatric patients for certain off-label indications at specialist centres, but this falls outside the scope of Blitzima’s approved prescribing information.
Elderly
No dose adjustment is required for patients aged 65 years and older. Clinical trials have included elderly patients, and no overall differences in efficacy or safety were observed compared with younger patients. However, elderly patients may have a higher risk of infections and should be monitored carefully. As with all patients, the infusion rate should be adjusted according to tolerability.
Infusion Rate Guidelines
| Infusion | Starting Rate | Escalation | Maximum Rate |
|---|---|---|---|
| First infusion | 50 mg/hour | Increase by 50 mg/hour every 30 minutes if tolerated | 400 mg/hour |
| Subsequent infusions | 100 mg/hour | Increase by 100 mg/hour every 30 minutes if tolerated | 400 mg/hour |
Missed Dose
If a scheduled infusion of Blitzima is missed, contact your healthcare team as soon as possible to arrange a new appointment. Treatment schedules vary depending on the indication, and your doctor will advise on the appropriate timing for the delayed infusion. Do not attempt to make up for a missed dose by doubling the next dose. In chemotherapy combination regimens, the timing of rituximab administration may need to be adjusted in relation to the chemotherapy schedule.
Overdose
There is limited experience with doses higher than the approved dosage in clinical trials. In the event of an overdose, the infusion should be stopped immediately and the patient closely monitored. Signs and symptoms of overdose may include exaggerated infusion-related reactions, more profound B-cell depletion, and increased susceptibility to infections. There is no specific antidote for rituximab overdose. Treatment is supportive, with monitoring of blood counts, immunoglobulin levels, and infection surveillance.
Before each Blitzima infusion, patients must receive premedication consisting of an antipyretic/analgesic (e.g. paracetamol), an antihistamine (e.g. diphenhydramine), and — for rheumatoid arthritis — an intravenous corticosteroid (methylprednisolone 100 mg). For oncology indications, a corticosteroid component of the chemotherapy regimen may serve this purpose. This premedication significantly reduces the incidence and severity of infusion-related reactions.
What Are the Side Effects of Blitzima?
The most common side effects of Blitzima are infusion-related reactions (fever, chills, rigors), infections (upper respiratory tract infections, urinary tract infections), and blood count abnormalities (neutropenia, leukopenia). Serious but less common side effects include severe infusion reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation, and cardiac events.
Like all medicines, Blitzima can cause side effects, although not everybody gets them. The side effect profile of rituximab is well established from over two decades of clinical experience with the reference product. The type and frequency of side effects may vary depending on the indication being treated and whether rituximab is combined with chemotherapy or other immunosuppressive agents.
Infusion-related reactions are the most frequently reported adverse events and are most likely to occur during or shortly after the first infusion. With proper premedication and gradual infusion rate escalation, the majority of these reactions are mild to moderate in severity. Serious side effects, while uncommon, can be life-threatening and require immediate medical attention.
Very Common
- Infusion-related reactions (fever, chills, rigors)
- Infections (bacterial, viral infections including upper respiratory tract infections)
- Neutropenia (low white blood cell count)
- Leukopenia (reduced white blood cells)
- Nausea
- Headache
- Pruritus (itching), rash
- Alopecia (hair thinning/loss)
- Night sweats
- Decreased immunoglobulin levels (IgG, IgM)
Common
- Thrombocytopenia (low platelet count)
- Anaemia
- Urinary tract infections
- Bronchitis, sinusitis
- Peripheral neuropathy, paraesthesia (tingling)
- Dizziness
- Anxiety, insomnia
- Bronchospasm, nasal congestion, rhinitis
- Dyspepsia, diarrhoea, abdominal pain
- Urticaria (hives)
- Myalgia (muscle pain), arthralgia (joint pain)
- Peripheral oedema
- Elevated lactate dehydrogenase (LDH)
Uncommon
- Severe infections (sepsis, pneumonia, herpes zoster)
- Tumour lysis syndrome
- Serum sickness-like reactions
- Pulmonary infiltrates, pneumonitis
- Coagulation disorders
- Atrial fibrillation, tachycardia
- Myocardial infarction
- Stevens-Johnson syndrome
Rare
- Progressive multifocal leukoencephalopathy (PML)
- Hepatitis B reactivation
- Anaphylaxis
- Posterior reversible encephalopathy syndrome (PRES)
- Toxic epidermal necrolysis
- Late-onset neutropenia (occurring months after treatment)
- Bowel obstruction/perforation
- Severe cardiac failure
Managing Infusion-Related Reactions
Infusion-related reactions are the hallmark side effect of rituximab therapy and deserve special attention. These reactions occur because rituximab triggers the rapid lysis of B cells, releasing cytokines and other inflammatory mediators into the bloodstream. The first infusion carries the highest risk because the patient typically has the largest B-cell population at that point.
Mild to moderate infusion reactions (fever, chills, nausea, headache, throat irritation) can usually be managed by temporarily slowing or pausing the infusion, with resumption at a reduced rate once symptoms resolve. Severe reactions (severe bronchospasm, hypotension, angioedema) require immediate interruption of the infusion and administration of emergency treatment including adrenaline (epinephrine), corticosteroids, bronchodilators, and intravenous fluids as clinically indicated.
With each subsequent infusion, the risk and severity of infusion reactions typically decrease significantly. Most patients who tolerate the first and second infusions well will have minimal or no reactions with subsequent doses.
Contact your healthcare team or seek emergency medical attention immediately if you experience: severe difficulty breathing or wheezing, chest pain or tightness, significant swelling of the face, lips, or tongue, severe dizziness or fainting, high fever with shaking chills, severe rash or skin blistering, or any new neurological symptoms such as confusion, vision changes, or difficulty walking (may suggest PML).
How Should You Store Blitzima?
Blitzima concentrate must be stored at 2°C to 8°C (in a refrigerator), protected from light, and must not be frozen. Once diluted for infusion, the solution should be used immediately or within 30 hours if stored at 2°C to 8°C followed by up to 12 hours at room temperature. Patients do not typically store this medicine at home as it is administered in hospital settings.
Blitzima is a biological medicine that requires careful storage to maintain its potency and safety. Because it is administered as an intravenous infusion in clinical settings, the storage and handling of Blitzima are primarily the responsibility of pharmacy and nursing staff at the treating hospital or infusion centre. However, understanding the storage requirements is important for overall awareness of the medicine.
The unopened vials of Blitzima concentrate for solution for infusion must be stored in a refrigerator at 2°C to 8°C. The vials should be kept in the outer carton to protect the contents from light. Blitzima must not be frozen, as freezing can damage the protein structure of the monoclonal antibody and render it ineffective or potentially harmful. Do not use Blitzima if the solution appears cloudy, contains particles, or has changed colour.
After dilution with sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) solution for infusion, the prepared infusion solution has a chemical and physical in-use stability of 30 hours at 2°C to 8°C and subsequently 12 hours at room temperature (not exceeding 25°C). From a microbiological standpoint, the prepared infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
As with all medicines, Blitzima should be kept out of the sight and reach of children. Do not use Blitzima after the expiry date stated on the vial label and carton. The expiry date refers to the last day of that month. Any unused product or waste material should be disposed of in accordance with local institutional requirements for biological waste.
What Does Blitzima Contain?
Each 10 mL vial of Blitzima contains 100 mg rituximab as the active ingredient, formulated in sodium citrate, polysorbate 80, sodium chloride, and water for injections. The solution is a clear to slightly opalescent, colourless to pale yellow liquid with a pH of approximately 6.5.
Understanding the composition of Blitzima is important for identifying potential allergens and understanding the pharmaceutical formulation. Blitzima is supplied as a sterile, preservative-free concentrate for solution for infusion that must be diluted before administration.
Active Ingredient
Each 10 mL vial contains 100 mg rituximab (10 mg/mL). Rituximab is a chimeric murine/human monoclonal antibody produced by mammalian cell (Chinese Hamster Ovary) culture using recombinant DNA technology. It is a glycosylated immunoglobulin with a molecular weight of approximately 145 kDa, consisting of human IgG1 constant regions and murine light-chain and heavy-chain variable region sequences specific for the CD20 antigen.
Inactive Ingredients (Excipients)
- Sodium citrate dihydrate — buffer to maintain pH stability
- Polysorbate 80 — surfactant to prevent protein aggregation
- Sodium chloride — tonicity agent for isotonicity
- Water for injections — solvent
Blitzima does not contain any preservatives. The pH of the solution is approximately 6.5. The concentrate should appear as a clear to slightly opalescent, colourless to pale yellow liquid. Do not use if the solution is discoloured or contains visible particulate matter.
Patients with known allergies to any of these excipients should inform their healthcare provider before receiving Blitzima. Of particular note, polysorbate 80 is a common excipient in biological medicines and can rarely cause hypersensitivity reactions in sensitive individuals.
Frequently Asked Questions About Blitzima
Blitzima is a biosimilar medicine containing rituximab, a monoclonal antibody that targets CD20 protein on B lymphocytes. It is used to treat non-Hodgkin lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (in combination with methotrexate), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA). It works by depleting B cells involved in disease through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and direct apoptosis.
Blitzima is a biosimilar of the reference medicine MabThera (known as Rituxan in the US). Biosimilar means it contains the same active substance (rituximab) and has been shown through extensive studies to be highly similar to the reference medicine with no clinically meaningful differences in efficacy, safety, or quality. Blitzima was approved by the EMA after comprehensive comparability studies including analytical, non-clinical, and clinical evaluations.
The most serious side effects include severe infusion-related reactions (which can be life-threatening), progressive multifocal leukoencephalopathy (PML, a rare brain infection), hepatitis B reactivation, severe infections including sepsis, and cardiac events such as heart failure and myocardial infarction. Most infusion reactions occur during the first infusion and can be managed by slowing or stopping the infusion and administering supportive treatment. PML, though very rare, is usually fatal and requires immediate investigation of any new neurological symptoms.
Blitzima is given as an intravenous (IV) infusion in a hospital or clinic setting under the supervision of an experienced physician. The first infusion is typically started at 50 mg/hour and gradually increased to a maximum of 400 mg/hour if tolerated, which may take several hours. If the first infusion is well tolerated, subsequent infusions may be started at 100 mg/hour. Patients receive premedication with paracetamol, antihistamine, and corticosteroid before each infusion to minimise infusion-related reactions.
Live vaccines should not be given during Blitzima treatment or while B cells are depleted, as the immune response may be impaired and there is a risk of infection from the vaccine strain. Inactivated vaccines can be given but may produce a reduced response. It is recommended to complete any necessary vaccinations at least 4 weeks before starting Blitzima treatment. Your doctor will advise on the appropriate timing for vaccinations after treatment has ended, which typically requires waiting until B-cell counts have recovered.
Treatment duration depends on the condition being treated. For non-Hodgkin lymphoma, rituximab is typically given in cycles combined with chemotherapy, often over 6–8 cycles, sometimes followed by maintenance therapy for up to 2 years. For chronic lymphocytic leukaemia, treatment usually consists of 6 cycles. For rheumatoid arthritis, a course consists of two infusions given 2 weeks apart, which may be repeated based on clinical response. For vasculitis, the induction regimen is 4 weekly infusions. Your doctor will determine the appropriate treatment schedule based on your response.
References
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- European Medicines Agency (EMA). Assessment report: Blitzima. Committee for Medicinal Products for Human Use (CHMP). EMA/524528/2017.
- World Health Organization. WHO Model List of Essential Medicines – 23rd List (2023). World Health Organization. Geneva: WHO; 2023.
- Salles G, Barrett M, Foà R, et al. Rituximab in B-Cell Hematologic Malignancies: A Review of 20 Years of Clinical Experience. Adv Ther. 2017;34(10):2232–2273. doi:10.1007/s12325-017-0612-x
- Cohen SB, Emery P, Greenwald MW, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006;54(9):2793–2806.
- Stone JH, Merkel PA, Spiera R, et al. Rituximab versus cyclophosphamide for ANCA-associated vasculitis. N Engl J Med. 2010;363(3):221–232. doi:10.1056/NEJMoa0909905
- Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346(4):235–242.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: B-Cell Lymphomas. Version 1.2026.
- Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82(1):3–18.
- British National Formulary (BNF). Rituximab. National Institute for Health and Care Excellence (NICE). Last updated 2025.
Editorial Team
This article was written and medically reviewed by the iMedic Medical Editorial Team, comprising board-certified specialists in hematology-oncology, rheumatology, clinical pharmacology, and immunology.
iMedic Medical Writers with expertise in oncology, haematology, rheumatology, and clinical pharmacology. All content follows the GRADE evidence framework and international reporting standards.
Reviewed by the iMedic Medical Review Board — an independent panel of specialist physicians who verify medical accuracy, clinical relevance, and adherence to current EMA, FDA, NCCN, and EULAR guidelines.
Our editorial process follows strict evidence-based methodology. All medical claims are supported by peer-reviewed research, international guidelines, and regulatory documents. We maintain complete independence from pharmaceutical companies with no commercial funding.