万珂（硼替佐米）Bortezomib

【Function and Indications】
This product is used to treat patients with multiple myeloma.

【Model and Specification】
Powder injection 3.5mg

【Usage and Dosage】
This product must be completely dissolved with 3.5ml of normal saline and injected intravenously through the catheter within 3-5 seconds, followed by flushing with 0.9% sodium chloride solution for injection.

Adults
Recommended dose
The recommended dose of this product is a single injection of 1.3 mg/㎡, twice a week, for 2 consecutive weeks (i.e., injection on the 1st, 4th, 7th and 11th days) and then stopped for 10 days (i.e., from the 12th to the 21st day). 3 weeks is a course of treatment, and the two doses are at least 72 hours apart.
In clinical studies, patients who were confirmed to be completely effective received another 2 cycles of bortezomib injection. It is recommended that effective patients receive 8 cycles of bortezomib injection.
Dose adjustment and restart of treatment
When grade 3 non-hematological or any grade 4 hematological toxicity (excluding neuropathy discussed below) occurs, treatment with this product should be suspended. Once the toxicity symptoms are relieved, the treatment of this product can be restarted with a 25% dose reduction (for example: 1.3mg/㎡ reduced to 1.0mg/㎡; 1.0mg/㎡ reduced to 0.7mg/㎡).

[Clinical study]
This patient received at least two treatments before using this product, and the disease was still progressing during the most recent treatment.
The effectiveness of this product is based on its efficacy. There are no clinical controlled trials to prove its clinical benefits, such as improved survival.
In vitro experiments have shown that bortezomib is cytotoxic to various types of cancer cells. In vivo experiments in preclinical tumor models have shown that bortezomib can delay tumor growth, including multiple myeloma.

[Precautions]
Please use under the guidance of a doctor. This product is an anti-tumor drug. Be careful when preparing it and wear gloves to prevent skin contact.

[Adverse Reactions and Contraindications] In two clinical studies, 228 patients with multiple myeloma received this product at a dose of 1.3 mg/m2, injected twice a week, and stopped for 10 days after 2 consecutive weeks of injection (i.e. 21 days for 1 course of treatment), and continued for up to 8 courses. The most common adverse events were weakness (including fatigue, discomfort and weakness) (65%), nausea (64%), diarrhea (51%), decreased appetite (including anorexia) (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (including peripheral sensory neuropathy and exacerbation of peripheral neuropathy) (37%), fever (36%), vomiting (36%) and anemia (32%). 14% of patients had at least one grade 4 adverse reaction, the most common adverse reactions were thrombocytopenia (3%) and neutropenia (3%). [Contraindications] It is contraindicated for patients who are allergic to bortezomib, boron or mannitol. [Use in Pregnant Women] Unknown. 【Children’s Use】
Unknown.

【Drug Interactions】
Unknown.

【Storage】
Store at room temperature away from light.

【Manufacturer】
Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceuticals, Japan.