Rituxem 500mg/50ml Injection (Rituximab)
Prescription RequiredManufactured By
Emcure
Pack Of
1
Salt Composition
Rituximab
Storage
Refrigerate 2°C–8°C; protect from light; do not freeze
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Overview
Rituxem 500mg/50ml Injection contains rituximab, a chimeric monoclonal antibody targeting the CD20 antigen on B lymphocytes. By depleting CD20-positive B cells, rituximab 500mg/50ml Injection treats several B-cell cancers and autoimmune diseases. It is used in non-Hodgkin lymphomas, chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis/microscopic polyangiitis and pemphigus vulgaris under major reference labels. The 500 mg/50 mL vial is a supply presentation; dosing varies by indication and may be based on body-surface area or fixed doses.
Quick Product Facts
| Field | Publication wording |
|---|---|
| Brand | Rituxem 500mg/50ml Injection |
| Molecule / Combination | Rituximab |
| Strength / Composition | 500 mg/50 mL |
| Dosage form | IV infusion |
| Manufacturer / Marketer | Emcure Pharmaceuticals Ltd |
| Pack / Presentation | 1 vial |
| Storage | Refrigerate 2°C–8°C; protect from light; do not freeze. |
| Prescription | Prescription |
| Publication status | Medical-review sign-off required |
Uses and Indications
In oncology, rituximab 500mg/50ml Injection is combined with chemotherapy in CD20-positive B-cell lymphomas such as diffuse large B-cell lymphoma and follicular lymphoma and with systemic therapy in CLL. In autoimmune disease it is used after or with disease-specific therapy, including rheumatoid arthritis after inadequate TNF-inhibitor response, GPA/MPA and pemphigus vulgaris. Screening for hepatitis B is mandatory before treatment because rituximab Injection can cause severe or fatal HBV reactivation.
How Rituxem 500mg/50ml Injection Works
Rituximab 500mg/50ml Injection binds CD20 on pre-B and mature B lymphocytes and triggers complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity and apoptosis, leading to prolonged B-cell depletion.
Clinical Evidence for Rituxem 500mg/50ml Injection
GELA DLBCL trial: Adding rituximab to CHOP improved survival in older patients with diffuse large B-cell lymphoma and established R-CHOP.
PRIMA: Rituximab 500mg/50ml Injection maintenance prolonged progression-free survival in selected follicular lymphoma patients after induction.
RA trials: Rituximab Injection plus methotrexate improved outcomes in TNF-inhibitor-inadequate-response RA.
Side Effects
Side Effects of Rituxem 500mg/50ml Injection
Common or Clinically Frequent Side Effects
- ● Infusion fever/chills
- ● Nausea
- ● Fatigue
- ● Headache
- ● Infections
- ● Low blood counts
Serious Side Effects
- ● Severe/fatal infusion reaction
- ● HBV reactivation
- ● Progressive multifocal leukoencephalopathy (PML)
- ● Tumour lysis syndrome
- ● Severe mucocutaneous reactions
- ● Serious infection/cytopenias
Critical Safety Warning
HBV AND INFUSION WARNING: screen all patients for HBsAg and anti-HBc before rituximab 500mg/50ml Injection. HBV reactivation can be fatal and may require antiviral prophylaxis. Severe infusion reactions usually occur during the first infusion and require close monitoring and premedication.
Rituxem 500mg/50ml Injection Dosage and How To Take It
Clinical context | Typical labelled / protocol guidance |
Lymphoma common regimen | 375 mg/m² IV per protocol; schedule varies by disease and chemotherapy combination. |
CLL classic regimen | 375 mg/m² first cycle then 500 mg/m² on later cycles in classic combinations. |
Rheumatoid arthritis | Two 1,000 mg IV infusions separated by 2 weeks in the reference regimen. |
GPA/MPA/pemphigus | Disease-specific fixed or mg/m² regimens apply. |
Important: Dose and regimen must be prescribed by the treating specialist. Tablet/vial strength is not necessarily the patient dose. Do not start, stop, split, combine or substitute treatment based on website information.
Rituxem 500mg/50ml Injection Missed Dose
If an infusion is missed, contact the treating unit. Do not simply shift the schedule because timing relative to chemotherapy or autoimmune-disease induction matters.
Safety Advice for Rituxem 500mg/50ml Injection
| Category | Status | Guidance |
|---|---|---|
| HBV | Mandatory screening | Consider antiviral prophylaxis and monitor during/after therapy. |
| Infusion | Premedicate/monitor | Antipyretic and antihistamine are standard; steroid use depends on indication. |
| Vaccines | Plan before treatment | B-cell depletion reduces vaccine responses; avoid live vaccines. |
| Pregnancy | Specialist guided | Can deplete fetal/neonatal B cells. |
| Driving | Caution | Infusion reactions/dizziness may impair driving. |
Monitoring During Rituxem 500mg/50ml Injection Treatment
● HBsAg and anti-HBc before therapy
● CBC
● Infusion vital signs
● Infection signs
● Immunoglobulins in recurrent-infection risk
● Disease-specific response
Rituxem 500mg/50ml Injection Fact Box
| Parameter | Verified / publication wording |
|---|---|
| Brand | Rituxem 500mg/50ml Injection |
| Generic / Combination | Rituximab |
| Strength | 500 mg/50 mL |
| Form | IV infusion |
| Manufacturer / Marketer | Emcure Pharmaceuticals Ltd |
| Pack | 1 vial |
| Storage | Refrigerate 2°C–8°C; protect from light; do not freeze. |
| Major safety theme | HBV AND INFUSION WARNING |
| Prescription | Yes |
Rituxem 500mg/50ml Injection Drug Interactions
| Drug / Class | Risk | What To Do |
|---|---|---|
| Live vaccines | Reduced response/infection risk | Avoid during significant B-cell depletion. |
| Other immunosuppressants | Additive infection risk | Coordinate prophylaxis and monitoring. |
| Antihypertensives | Infusion hypotension may be worsened | Some protocols consider withholding before infusion. |
FAQs About Rituxem 500mg/50ml Injection
Does one 500 mg vial equal one dose?
Not necessarily. Many oncology doses are calculated in mg/m².
Why is hepatitis B testing mandatory?
Rituximab 500mg/50ml can reactivate latent HBV, sometimes fatally.
Why are premedicines given?
They reduce infusion reactions such as fever and chills.
What is PML?
A rare, often fatal JC-virus brain infection reported with profound immunosuppression.
Can vaccines be given during Rituxem therapy?
Vaccine response may be poor and live vaccines are generally avoided; plan timing with the specialist.
How long does B-cell depletion last?
Often months, which is why infection/vaccine planning extends beyond the last infusion.
Can rituximab 500mg/50ml Injection treat autoimmune disease?
Yes, selected diseases including RA, GPA/MPA and pemphigus vulgaris.
Who markets Rituxem 500mg/50ml Injection?
It is possible to verify the availability of Rituxem injection by contacting any licensed pharmacy or reputable online pharmacy. Current stock and prescription fulfillment can be confirmed by visiting their website.
References
1. Current rituximab 500mg/50ml Injection prescribing information (Rituxan/MabThera reference). https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf
2. Coiffier B, et al. R-CHOP in DLBCL. New England Journal of Medicine.https://www.nejm.org/doi/full/10.1056/NEJMoa011795
3. Salles G, et al. PRIMA. Lancet. https://pubmed.ncbi.nlm.nih.gov/21176949/
4. Current oncology/rheumatology/vasculitis guidelines. Https://rheumatology.org/vasculitis-guideline
5. National Library of medicine. Rituximab.https://www.ncbi.nlm.nih.gov/books/NBK564374
Marketer Details
Emcure
Author Details
Written By:
Nonish Sharma
I am a medical content writer with a strong academic background in life sciences, holding an M.Sc. in Biotechnology... Read More
Reviewed By:
Vaibhav Shakya
Dr. Vaibhav Shakya, MD, is a Medical reviewer and medicine expert at Globans Pharma, with more than 9 years of experienc... Read More
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