VELCADE^® (bortezomib) for Injection Patient Profiles

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Indication: VELCADE^® (bortezomib) for Injection is indicated for the treatment of multiple myeloma patients who have received at least 1 prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

What precautions should I take during treatment?

Precautions: Risks include new or worsening peripheral neuropathy which may be severe, hypotension (observed throughout therapy), cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Patients should be monitored for symptoms of peripheral neuropathy including neuropathic pain; patients experiencing new or worsening peripheral neuropathy may require changes in dose and schedule. Improvement or resolution of peripheral neuropathy was reported in 51% of patients with greater than or equal to grade 2 peripheral neuropathy following dose adjustment in the phase 3 study and in 73% of patients in phase 2 studies who discontinued due to grade 2 neuropathy or had greater than or equal to grade 3 neuropathy. Caution should be used when treating patients with a history of syncope, patients receiving medications known to be associated with hypotension, and patients who are dehydrated. Acute development or exacerbation of congestive heart failure, and /or new onset of decreased left ventricular ejection fraction has been reported including reports in patients with few or no risk factors for decreased left ventricular ejection fraction. Patients with risk factors for, or existing heart disease, should be closely monitored. There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome (ARDS) in patients receiving VELCADE. Some of these events have been fatal. A higher proportion of these events has been reported in Japan. In the event of new or worsening pulmonary symptoms, a prompt diagnostic evaluation should be performed and patients treated appropriately. Complete blood counts should be frequently monitored during treatment. Platelet and neutrophil counts should be monitored prior to each dose. Platelets and neutrophils were lowest at day 11 of each cycle and typically recovered to baseline by the next cycle. Treatment should be held for platelet counts less than 25,000/µL and reinitiated at a reduced dose; transfusions may be considered. There was no evidence of cumulative thrombocytopenia or neutropenia. The mean platelet nadir was approximately 40% of baseline; platelet counts improved toward baseline between cycles, during the rest period. 4% of patients in phase 2 trials discontinued treatment due to thrombocytopenia. Gastrointestinal and intracerebral hemorrhage have been reported. The incidence of febrile neutropenia was less than1% in both the phase 3 and 2 trials. Patients with high tumor burden should be monitored closely and appropriate precautions taken to prevent tumor lysis syndrome. Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Other reported hepatic events include increases in liver enzymes, hyperbilirubinemia, and hepatitis which may be reversible upon discontinuation of VELCADE. There is limited rechallenge information in these patients.

Patients with renal or hepatic impairment should be closely monitored for toxicities. Patients who are concomitantly receiving drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for toxicities or reduced efficacy. In patients concomitantly receiving oral hypoglycemics, close monitoring of blood glucose levels and adjustment of antidiabetic medications may be required.

Please discuss the patient information with your patients. Since VELCADE may cause fatigue, dizziness, syncope, hypotension, patients should be advised not to drive or operate machinery if they experience these symptoms. Patients should be advised regarding appropriate measures to avoid dehydration. Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness, or fainting spells.

Pregnancy Category D: Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.

Safety Data: In 331 patients in a phase 3 study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), paresthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). 14% of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia (4%), and vomiting (3%).

For full Prescribing Information click here. (pdf) (74KB)

For further information about VELCADE^® (bortezomib) for Injection, call 1-866-VELCADE (U.S. clinicians only).

American Cancer Society
http://www.cancer.org/
Clinical Trials Service 800-303-5691

International Myeloma Foundation
http://www.myeloma.org/

Multiple Myeloma Research Foundation
http://www.multiplemyeloma.org/

National Cancer Institute
http://www.nci.nih.gov