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Additional Quantities of DOXIL® (doxorubicin HCl liposome injection) Now Available in the U.S.

(12/10/2014)

We are pleased to release additional supplies of DOXIL (doxorubicin HCl liposome injection) under U.S. Food and Drug Administration (FDA) regulatory discretion. You can read more information in our letter to U.S. healthcare providers here.

Ensuring availability of DOXIL for physicians and their patients remains our urgent priority. Following this latest lot release, we are working to restore full supply through a manufacturing agreement with an alternate supplier. We are committed to continuing to work closely with the FDA and are fully committed to providing a consistent supply of DOXIL for the long-term.

If you are a patient with medical questions related to DOXIL, please contact Janssen Medical Information at 1 (800) JANSSEN (1-800-526-7736) or speak to your physician.

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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.

Very rare cases of oral cancer have been reported in people who had taken DOXIL® more than one year or who had taken a total dose greater than 720 mg/m2. The oral cancer was diagnosed during treatment and up to 6 years after the last dose. Your doctor will examine you at regular times for the signs and symptoms of oral cancer.

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 full Product Information for more details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

©Janssen Products, LP 2013

INDICATIONS

DOXIL® is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.

DOXIL® in combination with bortezomib is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

DOXIL® is administered intravenously by your healthcare professional.


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Last Updated: December 2th, 2014

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