Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated Mantle Cell Lymphoma who are unsuitable for haematopoietic stem cell transplantation

INN:

Subtype:

Mantle Cell Lymphoma (MCL)

License:

EMA

Class:

PI

Newly Diagnosed

SmPC: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000539/WC500048471.pdf

1. Approved Labelling

Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for hematopoietic stem cell transplantation. 

2. Treatment Regimen

Treatment must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Velcade must be reconstituted by a healthcare professional.
Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone
Velcade 1 mg powder for solution for injection is administered via intravenous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11, followed by a 10-day rest period on days 12-21. This 3-week period is considered a treatment cycle. Six Velcade cycles are recommended, although, for patients with a response first documented at cycle 6, two additional Velcade cycles may be given. At least 72 hours should elapse between consecutive doses of Velcade.
The following medicinal products are administered on day 1 of each Velcade 3-week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each Velcade treatment cycle.
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma prior to initiating a new cycle of therapy:

  • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
  • Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
  • Hemoglobin ≥ 8 g/dL
  • Non-hematological toxicities should have resolved to Grade 1 or baseline.


Velcade treatment must be withheld at the onset of any ≥ Grade 3 Velcade-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 hematological toxicities.
Granulocyte colony stimulating factors may be administered for ha=ematologic toxicity according to local standard practice. Prophylactic use of granulocyte colony stimulating factors should be considered incase of repeated delays in cycle administration. Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
In addition, when Velcade is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.

3. AE/Warnings

Please see section 4.4 of the SmPC  

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