Active Ingredient: Bortezomib
Bortezomib 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.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
1.3 - 1.3 mg per m² of body surface area (BSA)
From 1.3 To 1.3 mg per m² of body surface area (BSA) once every 3 day(s)
Bortezomib 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous 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 bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given. At least 72 hours should elapse between consecutive doses of bortezomib.
The following medicinal products are administered on day 1 of each bortezomib 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 bortezomib treatment cycle.
Prior to initiating a new cycle of therapy:
Bortezomib treatment must be withheld at the onset of any ≥Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥Grade 3 haematological toxicities. For dose adjustments, the following table. Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice. Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration. Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma:
| Toxicity | Posology modification or delay |
|---|---|
| Haematological toxicity | |
| ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count <10,000 cells/μL | Bortezomib therapy should be withheld for up to 2 weeks until the patient has an ANC ≥750 cells/μL and a platelet count ≥25,000 cells/μL. - If, after bortezomib has been held, the toxicity does not resolve, as defined above, then bortezomib must be discontinued. - If toxicity resolves i.e. patient has an ANC ≥750 cells/μL and a platelet count ≥25,000 cells/μL, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m² to 1 mg/m², or from 1 mg/m² to 0.7 mg/m²). |
| If platelet counts <25,000 cells/μL or ANC <750 cells/μL on a bortezomib dosing day (other than Day 1 of each cycle). | Bortezomib therapy should be withheld. |
| Grade ≥ non-haematological toxicities considered to be related to bortezomib. | Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better. Then, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m² to 1 mg/m², or from 1 mg/m² to 0.7 mg/m²). For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify bortezomib. |
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