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What is Multiple Myeloma? 5 Things You Need to Know

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(ARA) - Multiple myeloma (MM) is a relatively rare type of blood cancer that affects white blood cells. Approximately 20,000 patients are diagnosed with MM in the United States each year, including Geraldine Ferraro, the first female Vice Presidential candidate for a major US political party, and actor Roy Scheider, made famous for his role in Jaws.

MM accounts for 13% of all hematological, or blood, cancer cases. Below are five things you need to know about this disease.

1) The cause of MM is uncertain.

2) The most significant risk factor for MM is age. Ninety six percent of cases are diagnosed in people 45 years of age and older, and more than 63% are diagnosed in people older than 65 years.

3) MM occurs more frequently in men than women.

4) The incidence of MM in black populations is nearly twice as high compared to the white population. The lowest incidence of MM is found in people of Asian or Hispanic descent.

5) In its early stages, there are often no symptoms of MM.

While MM remains an incurable disease, the introduction of novel therapies in recent years including the introduction of VELCADE® (bortezomib), the first FDA approved proteasome inhibitor, have led to advances in treatment. VELCADE has been shown to significantly increase overall survival rates in MM patients when used in combination with other standard treatments. Recently published results from a large Phase 3 study that followed previously untreated patients for five years after initial treatment reported that VELCADE in combination with melphalan and prednisone, increased overall survival by 13 months compared to melphalan and prednisone alone (56.4 versus 43.1 months respectively).

VELCADE is approved for the treatment of MM, including previously untreated patients and those who have failed other therapies. With the recent approval of a new subcutaneous route of administration for VELCADE, patients and physicians now have additional treatment options.

In a clinical study in patients with relapsed MM, subcutaneous VELCADE demonstrated efficacy consistent with intravenous VELCADE in overall response rate, after four cycles (43 versus 42 percent). The overall safety profile was similar between the two arms, however, differences were observed in the incidence of peripheral neuropathy. In the subcutaneous arm 38 percent of patients experienced peripheral neuropathy of all grades, compared with 53 percent of patients in the intravenous arm.

To learn more about subcutaneous VELCADE, visit www.VELCADE.com.

Important Safety Information for VELCADE

What is VELCADE (bortezomib) used for?

VELCADE is approved for the treatment of patients with multiple myeloma (a cancer of the plasma cells). VELCADE is also approved for the treatment of patients with mantle cell lymphoma (a cancer of the lymph nodes) who have already received other treatments.

How is VELCADE administered?

VELCADE is prescribed by a physician experienced in the use of medications to treat cancer. It is administered by a healthcare professional as an injection into your vein (intravenously, or IV) or under your skin (subcutaneously). VELCADE must not be administered into your spinal fluid (intrathecally).

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.

What are the possible side effects of VELCADE?

VELCADE can cause serious side effects, including:

  • 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. If you have peripheral neuropathy before starting VELCADE, your doctor could consider giving you VELCADE subcutaneously.
  • 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. Treatment with VELCADE 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.
  • 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.
  • 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.
  • Tumor lysis syndrome (TLS). TLS can occur with cancer treatments, and your doctor will be monitoring your 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. Treatment with VELCADE should be stopped in cases of RPLS.

More than 30% of patients receiving VELCADE have experienced the following side effects: thrombocytopenia, neutropenia, nausea, peripheral neuropathy, neuralgia (nerve pain), pyrexia (fever), 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?

Women should avoid becoming pregnant or breastfeeding while being treated with VELCADE. Discuss with your doctor when it is safe to restart breastfeeding after finishing your treatment.

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 antifungal), ritonavir (an antiviral), and rifampin (an antibiotic), 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. St. John's Wort should be avoided.
  • 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.