Product Dossier
VELCADE
Product Dossier for VELCADE (bortezomib, Janssen-Cilag). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Janssen-Cilag
- Active ingredient: bortezomib
- Therapeutic area: Oncology
- Related brand: BORTEZOM
- Related brand: BORTEZOMIB-AFT
- Related brand: EUG-BORTEZOMIB
- Same area: TALZENNA
- Same area: ZARZIO
What it is
VELCADE (bortezomib) is an antineoplastic agent for intravenous injection (IV) or subcutaneous (SC) use only. Bortezomib is a modified dipeptidyl boronic acid. VELCADE is available in three strengths: 1 mg, 3.0 mg, and 3.5 mg powder for injection vials.
Approved indications
— Treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy, in combination with melphalan and prednisone. — Induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma, as part of combination therapy. — Treatment of multiple myeloma patients who have received at least one prior therapy and who have progressive disease. — Treatment of adult patients with previously untreated mantle cell lymphoma, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Dosing overview
VELCADE may be administered intravenously at a concentration of 1 mg/mL as a 3–5 second bolus injection or subcutaneously at a concentration of 2.5 mg/mL. For previously untreated transplant-eligible multiple myeloma in combination with thalidomide and dexamethasone, bortezomib is administered twice weekly at 1.3 mg/m² for three 3-week treatment cycles. For previously untreated transplant-eligible multiple myeloma in combination with dexamethasone alone, bortezomib is administered at 1.3 mg/m² for four 3-week treatment cycles. For previously untreated non-transplant-eligible multiple myeloma in combination with melphalan and prednisone, bortezomib is administered twice weekly for the first four 6-week cycles, then once weekly for cycles 5–9.
Key safety warnings
Intrathecal administration has resulted in death. VELCADE is for intravenous or subcutaneous use only.
Regulatory history
VELCADE bortezomib 3.5 mg powder for injection was first listed on the ARTG on 14 February 2006. The 1 mg strength was registered on 1 June 2009. An AusPAR was approved on 2 July 2012, authorising a major variation to allow subcutaneous administration in addition to intravenous administration. The 3.0 mg strength was registered on 17 November 2015. In March 2016, the PBAC recommended Authority Required Section 100 (Efficient Funding of Chemotherapy) listing of the 3 mg vial strength for all currently reimbursed multiple myeloma indications.