Bortezomib for injection
A white or similar white mass or powder.
Product Name：Bortezomib for injection
Nombre del Producto: Bortezomib para inyección
Standard: State Standard
Dosage and administration
The recommended starting dose of bortezomib is 1.3 mg/m² . bortezomib may be administered intravenously at a concentration of 1 mg/mL, or subcutaneously at a concentration of 2.5 mg/mL.
bortezomib retreatment may be considered for patients with multiple myeloma who had previously responded to treatment with bortezomib and who have relapsed at least 6 months after completing prior bortezomib treatment. Treatment may be started at the last tolerated dose.
When administered intravenously, bortezomib is administered as a 3 to 5 second bolus intravenous injection. bortezomib is for intravenous or subcutaneous use only. bortezomib should not be administered by any other route.
Asthenia (61-65%),Nausea (61-65%),Diarrhea (51-55%),Anorexia (41-45%),Constipation (41-45%),Thrombocytopenia (41-45%),Peripheral neuropathy (IV: 16-41%; SC: 6-24%),Pyrexia (36-40%),Vomiting (36-40%),Anemia (31-35%),Arthralgia (26-30%),Headache (26-30%),Insomnia (26-30%),Limb pain (26-30%),Dizziness (21-25%),Dyspnea (21-25%),Edema (21-25%),Neutropenia (21-25%),Paresthesia (21-25%),Rash (21-25%),Cough (15-20%),Dehydration (15-20%),URI (15-20%),Rigors, grade 4 toxicity (10-15%)
Frequency Not Defined
Hypotension,Anxiety,Pain,Pruritis,Abdominal pain,Dyspepsia,Back pain,Bone pain,Myalgia,Muscle spasms,Herpes zoster,Pneumonia,Blurred vision
Hypersensitivity to any component or boron or mannitol; intrathecal administration
Fatal events with inadvertent intrathecal administration reported
Use caution in hepatic impairment (reduce starting dose); monitor hepatic enzymes during treatment
High tumor load (risk of tumor lysis syndrome)
Acute respiratory syndromes have occurred; monitor closely for new or worsening symptoms
Risks of: CHF; severe lung disease (eg, ARDS, pneumonitis)
Closely monitor patients with high tumor burden
Acute diffuse infiltrative pulmonary disease, PRES (formerly RPLS)
Monitor complete blood counts regularly throughout treatment
Hypotension (antihypertensive dosages may need modification)
Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement
Consider MRI imaging for onset of visual or neurological symptoms; discontinue therapy if suspected
Worsening of and development of cardiac failure reported; closely monitor patients with existing heart disease or risk factors for heart disease
Women should avoid becoming pregnant while on therapy; advise pregnant women of potential embryo-fetal harm
Associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle
Mechanism of Action
Reversible inhibitor of chymotrypsin-like activity at the 26-S proteasome, which in turn causes cell cycle arrest and apoptosis
Pleak plasma level: 509 ng/mL
Protein bound: 83%
Vd: 498-1884 L/m²
Hepatic P450 enzyme CYP3A4 (major); also CYP1A2, 2C9, 2C19, 2D6 (minor)
Enzymes inhibited: CYP2C19
Half-Life: 9-15 hr (single dose IV); 40-193 (multiple 1 mg/m² doseing); 76-108 hr (multiple 1.3 mg/m² dosing)
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