Bortezomib

DEA Class; Rx

Common Brand Names; Velcade

• Antineoplastics, Proteasome Inhibitors

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

Hypersensitivity to any component or boron or mannitol; intrathecal administration

• 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%)

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

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

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.

Bortezomib 

injection, lyophilized powder for reconstitution

• 3.5mg/vial