Bortezomib For Injection

Fecha: 2021-03-03 19:17:03 -0500


website: http://www.sundentpharm.com/oncology/bortezomib-for-injection.html

Bortezomib for injection Description A white or similar white mass or powder. ? Indications Multiple Myeloma (bortezomib) is indicated for the treatment of patients with multiple myeloma. Mantle Cell Lymphoma bortezomib is indicated for the treatment of patients with mantle cell lymphoma. ? 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. ? Side Effect? >10% 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 ? Contraindications Hypersensitivity to any component or boron or mannitol; intrathecal administration ? Precautions Fatal events with inadvertent intrathecal administration reported Syncope history Dehydration Use caution in hepatic impairment (reduce starting dose); monitor hepatic enzymes during treatment Diabetes mellitus Heart disease 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 . Pharmacology Mechanism of Action Reversible inhibitor of chymotrypsin-like activity at the 26-S proteasome, which in turn causes cell cycle arrest and apoptosis Absorption Pleak plasma level: 509 ng/mL Distribution Protein bound: 83% Vd: 498-1884 L/m2 Metabolism Hepatic P450 enzyme CYP3A4 (major); also CYP1A2, 2C9, 2C19, 2D6 (minor) Enzymes inhibited: CYP2C19 Elimination Half-Life: 9-15 hr (single dose IV); 40-193 (multiple 1 mg/m2 doseing); 76-108 hr (multiple 1.3 mg/m2 dosing) Related Keywords: China bortezomib for Injection manufacturer,China bortezomib for Injection suppliers,bortezomib for Injection from China professional pharmaceutical factory,Oncology Drugs , Oncology Nursing Drug , Oncology And Supplementary Drug , Oncology Drugs Manufacturers , Oncology Drugs Suppliers , China Oncology Drugs , Bortezomib for Injection





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