Leaflet TRUXIMA 500mg concentrate for solution for infusion

Product code:
W63707001
Quantity:
1
Indicated for:
hematologic malignancies
Route of administration:
infusion
Substance:
rituximab (monoclonal antibody)
ATC
L01FA01 — Antineoplastic and immunomodulating agents | Monoclonal antibodies and antibody drug conjugates | Cd20 (clusters of differentiation 20) inhibitors

Precautions:

Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Immunosuppression / infection risk

This medicine may increase the risk of infections.

Additional monitoring

This medicine is subject to additional monitoring.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Rituximab is a monoclonal antibody used in the treatment of various autoimmune diseases and hematological cancers, such as non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. It works by targeting the CD20 protein expressed on the surface of B lymphocytes, leading to their destruction through immune mechanisms.

Rituximab is administered intravenously, usually in cycles, and is used either as monotherapy or in combination with other chemotherapeutic or immunosuppressive agents. It is indicated to reduce disease activity, prolong remission, and improve patients' quality of life.

Common side effects include infusion reactions, fever, chills, nausea, and fatigue. In rare cases, severe adverse reactions such as serious infections, reactivation of hepatitis B, or progressive multifocal leukoencephalopathy (PML) may occur. Careful monitoring of patients during and after administration is essential.

Rituximab is a valuable therapeutic option for patients with autoimmune diseases and hematological cancers, offering significant benefits in disease control and survival extension.

Official documents

Added to database:
08/03/2017
Source record updated:
29/09/2025

General data about TRUXIMA 500mg

Substance:
rituximab
Date of latest medicines list:
01-06-2026
Product code:
W63707001
Concentration:
500mg
Pharmaceutical form:
concentrate for solution for infusion
Quantity:
1
Product type:
Generic medicine
Price:
4039.00 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
BIOTEC SERVICES INTERNATIONAL LTD. - MAREA BRITANIE
Holder:
CELLTRION HEALTHCARE HUNGARY KFT. - UNGARIA
Number:
1167/2017/01
Shelf life:
3 years

Pharmaceutical forms available for rituximab

Concentrations available for rituximab

  • 100mg
  • 10mg/ml
  • 120mg/ml
  • 500mg

Compensation lists for TRUXIMA 500mg Celltrion

G17 (C1) - Major collagenosis (systemic lupus erythematosus, scleroderma)

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Copayment
3282.96 RON
Patient
756.04 RON

G27 (C1) - Pemphigus

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4039.00 RON
Copayment
3282.96 RON
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756.04 RON

G31B (C1) - Rheumatoid arthritis

Price
4039.00 RON
Copayment
3282.96 RON
Patient
756.04 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price
4039.00 RON
Copayment
3282.96 RON
Patient
756.04 RON

NHP 3 (C2) - NHP oncology

Price
4039.00 RON
Copayment
3282.96 RON
Patient
756.04 RON

NHP 9.1 (C2) - Spinal cord transplant

Price
4039.00 RON
Copayment
3282.96 RON
Patient
756.04 RON