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Special Myeloma Minute on FDA Approved Data for VELCADE®, including long-term survival data
01.19.12
 
Welcome to the IMF's Myeloma Minute
News about myeloma treatment, research, support and the myeloma community from the International Myeloma Foundation.

SPECIAL MINUTE ON FDA APPROVED DATA FOR VELCADE®
including long-term survival data
 
 
VELCADE(R) (bortezomib) for injection: New FDA Approved Data
At 5 years, patients initially treated with VELCADE® (bortezomib) plus melphalan/prednisone (MP) achieved a significant survival advantage compared to patients treated with MP alone.
Millennium: The Takeda Oncology Company is pleased to announce that the US Food and Drug Administration (FDA) has approved updated information about VELCADE. These updates include long-term survival data from a clinical trial.
   
 
VELCADE plus MP significantly improved survival.
The 5-year follow-up to this clinical trial showed that patients initially treated with VELCADE plus MP lived significantly longer (56.4 months) than patients treated with MP alone (43.1 months) — a greater than 13-month survival advantage.
 
 
Learn more about this update
VELCADE was approved by the FDA for the initial treatment of patients with multiple myeloma (a cancer of the plasma cells) based on a large clinical trial including patients from the US as well as across the globe. A clinical trial is a study that helps doctors determine how safe and effective a treatment is. VELCADE was studied in combination with two other drugs called melphalan and prednisone. In the study, VELCADE was evaluated in combination with melphalan and prednisone versus melphalan and prednisone alone. The 682 patients in the study had not been previously treated and were also not eligible candidates for stem cell transplantation.
Important Safety Information for VELCADE
Who Should Not Receive VELCADE?
Before you receive treatment with VELCADE, tell your doctor about all of your medical conditions. You should not receive VELCADE if you are:
allergic to bortezomib, boron or mannitol
pregnant or plan to become pregnant
breastfeeding. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.
The effects of VELCADE in children have not been evaluated.
How is VELCADE administered?
VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. It is administered as an injection into your vein (IV) by a health care professional.
What are the Possible Side Effects of VELCADE?
VELCADE can cause serious side effects including:
Neutropenia (low levels of neutrophils, a type of white blood cell) and Thrombocytopenia (low levels of platelets). VELCADE can cause low levels of white blood cells (infection fighting cells) and/or platelets (clot-forming cells). You will have regular blood tests to check your cell counts during your treatment with VELCADE. If the number of these cells is very low, your doctor may change the dose and/or schedule of VELCADE. If your white blood cells become low, you can be at higher risk for infections. Tell your doctor if you develop a fever or believe you have an infection. If platelets become very low, there is an increased risk of bleeding. Your doctor may recommend a platelet transfusion. There have been cases of bleeding in the stomach, bowels and brain during treatment with VELCADE.
Gastrointestinal problems. VELCADE treatment can cause nausea, vomiting, diarrhea, and constipation. If your symptoms are severe, your doctor may recommend IV fluids and/or medications.
Peripheral neuropathy. VELCADE can cause damage to the nerves, a condition called peripheral neuropathy. You may feel muscle weakness, tingling, burning, pain, and loss of feeling in your hands and feet, any of which can be severe. Tell your doctor if you notice any of these symptoms. Your doctor may change the dose and/or schedule of VELCADE or stop it altogether.
Low blood pressure. VELCADE can cause a drop in blood pressure. Tell your doctor if you have low blood pressure, feel dizzy or feel as though you might faint. If you are taking drugs that lower blood pressure, your medications might need to be adjusted. If you are not drinking enough liquids, your doctor may need to administer IV fluids.
Heart problems. VELCADE treatment can cause or worsen heart rhythm problems and heart failure. Your doctor may closely monitor you if you have, or are at risk for, heart disease. Tell your doctor if you experience chest pressure or pain, palpitations, swelling of your ankles or feet, or shortness of breath.
Lung disorders. There have been reports of lung disorders in patients receiving VELCADE. Some of these events have been fatal. Tell your doctor if you experience any cough, shortness of breath, wheezing or difficulty breathing.
Liver disease. If you have liver problems, it can be harder for your body to get rid of VELCADE. VELCADE has caused sudden liver failure in patients who were taking many medications or had other serious medical conditions. Symptoms of liver problems include a yellow discoloration of the eyes and skin (jaundice) and changes in liver enzymes measured in blood tests. Your doctor will closely monitor you if you have liver disease. In patients with moderate or severe liver disease, VELCADE should be started at a lower dose. Additional dose adjustments may be made based on your tolerance of the drug.
Tumor Lysis Syndrome (TLS). TLS can occur with cancer treatments and your doctor will be monitoring blood and urine for any signs of this syndrome. If you develop TLS, your doctor will take appropriate steps to treat it.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). There have been reports of a rare, reversible condition involving the brain called RPLS in patients treated with VELCADE. Patients with RPLS can have seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems. VELCADE treatment should be stopped in cases of RPLS.
The most common side effects seen in patients receiving VELCADE include: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (high temperature), diarrhea, anemia, leukopenia (low levels of white blood cells), decreased appetite, fatigue, constipation, vomiting, dehydration, dyspnea (difficulty breathing), cough, asthenia (low energy), insomnia (trouble sleeping), peripheral edema (swelling of the limbs), and headache.
What other information should you discuss with your doctor?
You should also tell your doctor if you:
have kidney disease. If you are on dialysis, your doctor will administer VELCADE after the dialysis procedure.
are taking medication for diabetes. VELCADE can affect your blood glucose levels. Your doctor may require close monitoring of your blood glucose levels and change the dose of your diabetes medicine while you are being treated with VELCADE.
have liver disease.
are using medicines like ketoconazole (an anti-fungal) and ritonavir (an anti-viral), which will require close monitoring during treatment with VELCADE.
are using any other medications (including over the counter drugs), herbal or dietary supplements, or holistic treatments.
develop a rash of any type while receiving VELCADE.
The side effects of VELCADE may impair your ability to drive or operate machinery.
These are not all of the possible side effects with VELCADE. It is important to always contact your doctor if you experience any side effects while on VELCADE. If you have any questions about VELCADE, contact your doctor.
Please click here for the full prescribing information for VELCADE including warnings and precautions.
Millennium logo
VELCADE, MILLENNIUM and Millennium M logo are registered trademarks of Millennium Pharmaceuticals, Inc.
Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc. Cambridge, MA 02139
Copyright © 2011, Millennium Pharmaceuticals, Inc.
All rights reserved.    Printed in USA    V-11-0282a    01/12



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Copyright 2011. International Myeloma Foundation. All Rights Reserved.
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