Formulation and specifications: Injection: 1mg, 3.5mg
Indications:
1. Adult patients with relapsed or refractory condylomatous lymphoma or previously untreated condylomatous lymphoma who are unsuitable for hematopoietic stem cell shadrops.
2. Primary and relapsed refractory multiple myeloma.
Key Points for Rational Use: 1.
1. Antiviral prophylaxis should be considered to reduce the risk of herpes zoster reactivation in patients treated with this product.
2. This product contains mannitol, and a history of allergy and prior medical history needs to be asked when patients try the drug for the first time to be alert for tumor lysis syndrome in patients with high tumor load.
3. Careful calculation of dosing volume is required.
4. The drug is cytotoxic, and gloves and protective gear are needed to avoid direct skin contact during preparation.
5. No dose reduction is required for use in patients with renal impairment, and patients on dialysis should be administered after dialysis.
6. Adverse reactions include neurological symptoms (including intestinal obstruction), viral activation, hematological myelosuppression, etc. Rarely, acute lung injury and pancreatitis may also occur.
7. Combination of potent CYP3A4 inhibitors is not recommended. If the combination of drugs cannot be avoided, close monitoring of toxic reactions should be performed.
8. Bortezomib subcutaneously has the same efficacy as intravenous infusion and has a lower incidence of neuropathy.
9. Multiple myeloma requires one of the following indications for treatment: abnormal renal function, elevated blood calcium, anemia and bone destruction, serum free light chain ratio greater than 100, clonal plasma cells in bone marrow greater than 60%, and MRI confirmation of 2 or more bone disruptions before treatment is required. Treatment of smoldering multiple myeloma that does not meet these criteria is not currently recommended, including treatment with bortezomib.
※10. Bortezomib for primary treatment of condylomatous lymphoma (FDA approved, based on LYM-3002 study).
*11. Walden’s macroglobulinemia (FDA approved).
※12. Other rare plasma cell diseases such as light chain amyloidosis, POEMS (phase I-II data only), MGRS (monoclonal immunoglobulinemia of undetermined significance with kidney damage, phase I-II data only) and other treatments.