Important Updates on DOXIL® Supply Shortage
IMPORTANT PRESCRIBING INFORMATION—Availability of DOXIL® 50 mg in 30-mL vials—October 26, 2015.
for consumer information and additional updates on DOXIL® supply.
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.
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.
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 such as a new onset fever or symptoms of infection. Your doctor will monitor your blood laboratory results.
Hand-Foot Syndrome may occur while taking DOXIL®. This may lead to tingling or burning, redness,flaking, bothersome swelling, small blisters, or small sores on palms of hands or soles of feet. In certain cases, this reaction can be more severe leading to serious infections, interfering with walking and other daily activities.
Cases of oral cancer have been reported in people who had taken DOXIL® for more than one year. 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.
If you are pregnant, planning to become pregnant, or nursing, inform your doctor. DOXIL® can cause fetal harm. Nursing should be discontinued during treatment with DOXIL®. Females and males of reproductive potential should use effective contraception during and for 6 months following treatment with DOXIL®. DOXIL® may cause temporary or permanent infertility.
The most common side effects reported in at least 20% of patients treated with DOXIL® during clinical studies were: weakness, tiredness, fever, nausea, stomatitis (painful redness, swelling, or sores in the mouth), vomiting, diarrhea, constipation, loss of appetite, hand-foot syndrome, rash, low white blood cell count, low platelet count, and anemia. Tell your doctor if you experience these or other side effects.
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.
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.
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.
DOXIL® (doxorubicin HCl liposome injection) is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy.
DOXIL® is indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy.
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.
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