Janssen Press Release information reposted with permission by PAF
Janssen Products Announces Important Updates on Restoring Supply of DOXIL® Following Recent Drug Shortage
On October 15, 2012, Janssen Products, LP announced that it has restored full access to DOXIL® (doxorubicin HCl liposome injection) supply for physicians and their patients in the United States. The company also has suspended its DOXIL® C.A.R.E.S. Physician Access Program.
For physicians, DOXIL® orders can be placed through normal distribution channels starting on October 22. For a list of approved distributors, visit www.jom.com/products.html and select DOXIL®. More details and direction for these physicians can be found in the Dear Healthcare Professional Letter on DOXIL.com.
Janssen said that the DOXIL® C.A.R.E.S. Physician Access Program has met its goal of helping to continue a patient’s course of therapy while DOXIL® was in short supply. The supply released on October 15 is the remainder of its physician access program reserve.
The company has communicated that this was the first step in a systematic approach to restore a reliable supply of DOXIL®. Janssen notes its efforts are on track to transition DOXIL® manufacturing to additional suppliers in the longer term.
Janssen commits to continuing to provide updates about its progress on all production solutions. For more information on the supply updates, visit DOXILSupply.com and follow
@supplyupdate on Twitter.
Please direct any questions about the DOXIL® C.A.R.E.S. Physician Access Program to 1-(866)-298-5774. For medical questions related to DOXIL® or to report product quality complaints and/or adverse events, please contact Janssen Medical Information at 1-(800)-JANSSEN (1-800-526-7736).
DOXIL® (doxorubicin HCl liposome injection) is used to treat patients with ovarian cancer that has progressed or recurred after platinum-based chemotherapy.
DOXIL® is used with VELCADE® (bortezomib) for Injection to treat patients with multiple myeloma who have received at least one prior therapy (other than VELCADE).
DOXIL® is administered intravenously by your healthcare professional.
IMPORTANT SAFETY INFORMATION
Serious and possibly permanent heart-related side effects that may lead to congestive heart failure can occur in patients treated with DOXIL®. Inform your doctor of any history of heart disease, radiation to your chest, or prior anticancer therapy. Your doctor will monitor your heart function.
Infusion reactions may also occur during administration. Be sure to tell your doctor if you have any symptoms during infusion, including: flushing, shortness of breath, facial swelling, headaches, chills, back pain, tightness in your chest or throat, dizziness, or lightheadedness. For most patients, these reactions have resolved within several hours to a day once the infusion is stopped, or for some patients with slowing of the infusion rate. However, in some cases, these reactions may be serious and sometimes life-threatening and may be fatal.
DOXIL® may severely reduce the number of blood cells (red blood cells, white blood cells, and cells that prevent bleeding called platelets) in your body that may potentially increase risk of infections, anemia, and bleeding. Speak to your doctor if you notice any changes in your health. Your doctor will monitor your blood laboratory results.
Talk to your doctor if you have a history of heart disease or liver disease, or have received prior radiation therapy and/or anticancer therapy.
If you are pregnant, planning to become pregnant, or nursing inform your doctor. Nursing should be discontinued during treatment with DOXIL®.
You should not take DOXIL® if you have a prior history of allergic reactions to doxorubicin or other ingredients found in the formulation. Please inform your doctor about your history of allergic reactions to medications or other substances.
The most common side effects reported in at least 20% of patients treated with DOXIL® during clinical studies were: weakness, fever, nausea, vomiting, stomatitis (painful redness, swelling, or sores in the mouth), diarrhea, and rash, loss of appetite, low white blood cell count, low platelet count, anemia, tiredness, and constipation. Hand-foot syndrome, which may lead to tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet, was reported as well. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.
In the treatment of multiple myeloma, nerve damage called peripheral neuropathy, which may lead to pain, numbness, burning sensation, tingling, and more serious symptoms, was reported in >40% of patients.
Be sure to tell your doctor immediately if you experience any of these or other symptoms.
DOXIL® may make the side effects of other anticancer therapies worse when used in combination.
Following administration, DOXIL® may turn urine and other bodily fluids a reddish-orange color. This is due to the color of DOXIL® and will go away as the drug leaves the body.
Your doctor may prescribe antinausea medications before or during your DOXIL® treatment.
Please talk to your doctor or nurse if you have any additional questions regarding DOXIL®.
For more information about DOXIL® therapy, please visit www.DOXIL.com.
Please see important Product Information by clicking here.
VELCADE is a registered trademark of Millennium Pharmaceuticals, Inc.
©Janssen Products, LP 2012 10/12 K08D121014
• Janssen Products Announces Important Updates on Restoring Supply of DOXIL® Following Recent Drug Shortage
• NPAF Addresses Drug Shortages