Classes
DEA Class; Rx
Common Brand Names; Velcade
- Antineoplastics, Proteasome Inhibitors
Description
A proteasome inhibitor; administered intravenously or subcutaneously
Used for the treatment of multiple myeloma and mantle cell lymphoma
Patients with pre-existing severe neuropathy should receive bortezomib only after careful risk-benefit assessment
Indications
Indicated for treatment of patients with mantle cell lymphoma as first-line in previously untreated patients or those who have relapsed
Indicated for retreatment of adults with multiple myeloma who had previously responded to bortezomib and relapsed at least 6 months following completion of prior bortezomib treatment
Contraindications
Hypersensitivity to any component or boron or mannitol; intrathecal administration
Adverse Effects
- 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%)
Warnings
Cases, sometimes fatal, of thrombotic microangiopathy (eg, thrombotic thrombocytopenic purpura/hemolytic uremic syndrome [TTP/HUS]), have been reported in the postmarketing setting
Monitor for signs and symptoms of TTP/HUS; if diagnosis is suspected, stop treatment and evaluate; if diagnosis of TTP/HUS excluded, consider restarting therapy; safety of reinitiating therapy in patients previously experiencing TTP/HUS not known
Use caution in hepatic impairment (reduce starting dose); monitor hepatic enzymes during treatment High tumor load (risk of tumor lysis syndrome); closely monitor patients with high tumor burden
Posterior reversible encephalopathy syndrome, PRES (formerly RPLS); safety of reinitiating therapy in patients previously experiencing PRES is not known
Associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically resolves before initiation of the subsequent cycle; monitor CBCs regularly throughout treatment
Hypotension (postural, orthostatic, and hypotension NOS) observed throughout therapy; management of orthostatic/postural hypotension may include adjustment of antihypertensive medications, hydration, and administration of mineralocorticoids and/or sympathomimetics
Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement
Women should avoid becoming pregnant while on therapy; advise pregnant women of potential embryo-fetal harm (see Pregnancy)
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
Pregnancy and Lactation
Based on mechanism of action and findings in animals, therapy can cause fetal harm when administered to a pregnant woman
There are no data on presence of bortezomib or metabolites in human milk, the effects of the drug on the breast fed infant or on milk production
Maximum Dosage
1.3 mg/m2 per dose IV or subcutaneously; 1.6 mg/m2 per dose IV has also been studied.
1.3 mg/m2 per dose IV or subcutaneously; 1.6 mg/m2 per dose IV has also been studied.
Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
How supplied
Bortezomib
injection, lyophilized powder for reconstitution
- 3.5mg/vial
