Buy Truxima (rituximab)

What is Truxima (rituximab)?

Truxima (rituximab) is a CD20-directed monoclonal antibody indicated for the treatment of patients with follicular lymphoma and diffuse large B-cell Non-Hodgkin’s Lymphoma (NHL)^[1,2]; chronic lymphocytic leukemia (CLL)^[2]; severe active rheumatoid arthritis^[2] and granulomatosis with polyangiitis and microscopic polyangiitis^[2].

Truxima is the first rituximab biosimilar approved in the United States and the European Union that can be used alone or in combination with other therapies for the treatment of approved indications^[3].

How does Truxima (rituximab) work?

The active ingredient in Truxima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the CD20-protein present on the surface of B-cells.

B-cells, also known as B-lymphocytes, are cells of the immune system that protect the body against attacks from external agents, like toxins, viruses, or cancerous cells^[1,2,4].

Deficiencies in the immune system caused by B-cell dysfunctions can result in many different diseases like CLL or NHL (where B-lymphocytes have become cancerous), rheumatoid arthritis (where B-lymphocytes are involved in joint inflammation), and GPA and MPA (where B-cells are thought to attack the blood vessels and cause inflammation)^[1,2,4].

By attaching to CD20, rituximab causes the death of B-lymphocytes. In this way, it stops the B-cells from causing these types of diseases^[1,2,4].

Where has Truxima (rituximab) been approved?

Truxima (rituximab) was approved by:

• Food and Drug Administration (FDA), USA: November 28, 2018, for the treatment of adult patients with^[1]:
  • relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL;
  • previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy;
  • non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

• European Medical Agency (EMA), European Union: February 16, 2018, for the treatment of patients with^[2]:
  • Non-Hodgkin lymphoma: It is indicated for previously untreated patients with stage 3 and 4 follicular lymphoma in combination with chemotherapy; as a maintenance therapy for follicular lymphoma patients responding to induction therapy; as monotherapy for chemotherapy-resistant patients with stage 3 and 4 follicular lymphoma; or in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy for patients with CD20 positive diffuse large B-cell NHL.
  • Chronic lymphocytic leukemia (CLL): In combination with chemotherapy, it is indicated for previously untreated relapsed or refractory patients with CLL.
  • Rheumatoid arthritis: In combination with methotrexate, it is indicated for adult patients with severe active rheumatoid arthritis who haven’t responded or are intolerant to other disease modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
  • Granulomatosis with polyangiitis and microscopic polyangiitis: In combination with glucocorticoids, it is indicated for the induction of remission in adult patients with severe and active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

• Therapeutic Goods Administration (TGA), Australia: February 16, 2018, for the treatment of patients with^[5]:
  • Non-Hodgkin lymphoma
  • Chronic lymphocytic leukemia (CLL)
  • Rheumatoid arthritis
  • Granulomatosis with polyangiitis.

• Health Canada, December 11, 2019, for the treatment of patients with^[6]:
  • Non-Hodgkin lymphoma
  • Chronic lymphocytic leukemia (CLL)
  • Rheumatoid arthritis.

• Medsafe, New Zealand, August 15, 2019, for the treatment of patients with^[7]:
  • Non-Hodgkin lymphoma.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Truxima (rituximab) taken?

The recommended therapy varies for the different indications and depends on whether Truxma (rituximab) is used alone or in combination with other therapeutics. Complete information about Truxma (rituximab) dosage and administration, for some of the countries of approval, can be found in the official prescribing information listed in our resources section^[1,2].

Note: Please consult with your treating doctor for personalised dosing.

Are there any known side effects or adverse reactions of Truxima (rituximab)?

Common adverse reactions

The most common adverse reactions listed in the prescribing information include^[1,2]:

• fever
• infusion reactions
• blood and lymphatic system disorders
• chills
• asthenia (lack of energy)
• headache
• infections.

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include^[1,2]:

• progressive multifocal leukoencephalopathy
• cytokine release
• tumour lysis syndrome
• angina pectoris
• cardiac arrhythmias
• severe skin reactions.

Use in specific populations

Truxima (rituximab) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1,2].

References

1. Summary of Product Characteristics [FDA]: Truxima (rituximab)[PDF] Teva Pharmaceuticals, November 2018
2. Summary of Product Characteristics [EMA]: Truxima (rituximab)[PDF] Celltrion Healthcare Hungary Kft., March 2017
3. Celltiron Press Release: Celltrion and Teva Announce FDA Approval of TRUXIMA® (rituximab-abbs), a Biosimilar to RITUXAN®, for Three Non-Hodgkin’s Lymphoma Indications, Date: 29/11/2018, cited on 11/12/2018
4. British Society for Immunology, B-cell mediated disease, cited on 12/12/2018
5. Public summary [TGA]: Truxima (rituximab)[PDF] Celltrion Healthcare, November 2019
6. Product monograph [Health Canada]: Truxima (rituximab)[PDF] Celltrion Healthcare, December 2019
7. Product detail [Medsafe]: Truxima (rituximab)
   Celltrion Healthcare, August 2019