Bortezomib for injection

Bortezomib. Chemical name: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinecarboxyl)amino]propyl]amino]butyl]boric acid. Molecular formula: C19H25BN4O4. Molecular weight: 384.24. Excipients: mannitol, nitrogen.

This product is white or off-white lump or powder.

Myeloma: This product can be used in combination with melphalan and prednisone (MP regimen) for the treatment of patients with multiple myeloma who have not been treated before and are not suitable for high-dose chemotherapy and bone marrow transplantation; or it can be used alone to treat patients with multiple myeloma who have relapsed after at least one or more treatments. Mantle cell lymphoma: This product can be used to treat patients with relapsed or refractory mantle cell lymphoma who have received at least one treatment before using this product. The safety and efficacy data for this indication come from a foreign single-arm Phase II clinical study of mantle cell lymphoma that relapsed after previous treatment, and there is a lack of clinical research data for the Chinese population.

This product is only for intravenous administration. Intrathecal injection can cause death. This product is administered intravenously within 3 to 5 seconds in patients with untreated multiple myeloma in combination with oral mefa and oral prednisone. Each course of treatment is 6 weeks (as shown in Table 1), for a total of 9 courses. In the 1st to 4th courses, this product is administered twice a week (on the 1st, 4th, 8th, 11th, 22nd, 25th, 29th and 32nd days). In the 5th to 9th courses, this product is administered once a week (on the 1st, 8th, 22nd and 29th days). There should be at least 72 hours between the two doses. Dose adjustment of this product in combination with melphalan and prednisone Before starting any course of this product in combination with melphalan and prednisone, patients should meet the following conditions: Platelet count should be ≥70×10^9/L, ANC should be ≥1.0×10^9/L Non-hematological toxicity should be reduced to grade 1 or baseline level Patients with relapsed multiple myeloma and relapsed mantle cell lymphoma Recommended dose for monotherapy The recommended dose of this product is a single injection of 1.3 mg/m2, twice a week, for 2 consecutive weeks (i.e., injection on days 1, 4, 8 and 11), followed by a 10-day break (i.e., from day 12 to day 21). 3 weeks is a course of treatment, with at least 72 hours between two doses. For maintenance treatment of more than 8 courses, it can be administered according to the standard regimen, or it can be administered once a week for 4 consecutive weeks (days 1, 8, 15 and 22), followed by a 13-day rest period (days 23 to 35). Dose adjustment and restarting treatment When any grade 3 non-hematological toxicity or any grade 4 hematological toxicity (excluding neuropathy discussed below) occurs, treatment with this product should be suspended. Once the toxic symptoms are relieved, treatment with this product can be restarted with a 25% dose reduction (e.g., 1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2). If the patient develops neuralgia or peripheral sensory neuropathy related to treatment with this product, it is recommended to treat with the dose adjustment recommended in the table below. The attending physician should choose the appropriate dose adjustment plan based on the patient's actual condition. If the patient suffers from severe neuropathy, this product should only be used after weighing the pros and cons. Patients with liver impairment Patients with mild liver function impairment do not need to adjust the starting dose and should be treated at the recommended dose. The starting dose of this product for patients with moderate to severe liver function impairment should be reduced to 0.7 mg/m2. Based on the patient's tolerance in the first cycle, the subsequent treatment dose is increased to 1.0 mg/m2 or further reduced to 0.5 mg/m2. Patients with renal impairment The pharmacokinetics of this product are not affected by the degree of renal impairment, so the dosage of this product does not need to be adjusted in patients with renal impairment. Since dialysis will reduce the concentration of this product, this product should be given after dialysis. Administration method This product must be completely dissolved in normal saline and injected through a central venous catheter or peripheral vein within 3 to 5 seconds, followed by flushing with 0.9% sodium chloride solution for injection.

Protect from light and store at a temperature not exceeding 30°C

3.5 mg

24 months

Nanjing Chia Tai-tianqing Pharmaceutical Co., Ltd.

• Founded in:

  2001-08-31

• Address:

  No. 9 Huiou Road, Nanjing Economic and Technological Development Zone

• Tax NO.:

  91320100730586189T

• Registered Funds:

  336.031726 yuan

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