this product is only for intravenous administration, and intrathecal injection can cause death. it is contraindicated in patients who are allergic to bortezomib, boron or mannitol.
untreated multiple myeloma patients
this product is administered as a 3 to 5 second bolus intravenous injection when combined with oral melphalan and oral prednisone. each cycle of treatment is 6 weeks (as shown in table 1) for a total of 9 cycles. this product is administered twice a week (days 1, 4, 8, 11, 22, 25, 29 and 32) during the first to fourth cycles. this product is administered once a week (days 1, 8, 22 and 29) during the 5th to 9th cycles. at least 72 hours should elapse between consecutive doses of bortezomib.
recurrent multiple myeloma patients and recurrent mantle cell lymphoma patients
bortezomib (1.3 mg/m2/dose) is administered twice weekly for 2 weeks (days 1, 4, 8, and 11) followed by a 10-day rest period (days 12-21). 3 weeks is a cycle of treatment and at least 72 hours should elapse between consecutive doses of bortezomib. for extended therapy of more than 8 cycles, this product may be administered on the standard schedule or, for relapsed multiple myeloma, on a maintenance schedule of once weekly for 4 weeks (days 1, 8, 15, and 22) followed by a 13-day rest period (days 23 to 35).
dose modifications and restart treatment
bortezomib therapy should be withheld at the onset of any grade 3 non-hematological or grade 4 hematological toxicities excluding neuropathy as discussed below. once the symptoms of the toxicity have resolved, bortezomib therapy may be reinitiated at a 25% reduced dose (1.3 mg/m2/dose reduced to 1 mg/m2/dose; 1 mg/m2/dose reduced to 0.7 mg/m2/dose).
if the patient has neuropathic pain or peripheral sensory neuropathy associated with the treatment of this product, it is recommended to use the modified dose recommended in the following tablet. the attending physician should select the appropriate dose adjustment plan according to the actual condition of the patient. there are reports of interruption or discontinuation of treatment due to severe autonomic neuropathy. patients with pre-existing severe neuropathy should be treated with bortezomib only after careful risk-benefit assessment
patents with hepatic impairment
patients with mild hepatic impairment do not need to adjust the starting dose and should be treated at the recommended dose. the initial dose of this product should be reduced to 0.7 mg/m2 in patients with moderate and severe hepatic impairment. the subsequent treatment dose is increased to 1.0 mg/m2 or further reduced to 0.5 mg/m2 depending on the patient's first cycle tolerance.
patients with renal impairment
the pharmacokinetics of this product is not affected by the degree of renal impairment. therefore, dosing adjustments of this product are not necessary for patients with renal insufficiency. since dialysis will reduce the concentration of this product, it should be administered after the dialysis procedure.
this product should be completely dissolved in saline and then injected through a central venous catheter or peripheral vein within 3 to 5 seconds, followed by a 0.9% sodium chloride solution for injection.
note: please refer to the product manual for details.