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What to expect during therapy with DOXIL® for progressed or recurrent ovarian cancer

If you or a loved one will be treated with DOXIL®, you can prepare for the months ahead. Small lifestyle changes may help you manage your treatment experience with DOXIL®.

Chemotherapy infusion with DOXIL®

DOXIL® is administered as an intravenous (IV) infusion into your vein by your healthcare provider.

  • The recommended dosing schedule for DOXIL® for progressed or recurrent ovarian cancer is once every 28 days until the cancer worsens or the side effects become intolerable
  • Your infusion may take 60 minutes or longer
  • Your healthcare provider may adjust or stop your dose based on infusion-related reactions or side effects that could occur
  • Alert a healthcare professional immediately if DOXIL® gets on your skin during your infusion or if you feel a burning or stinging sensation during your infusion

Cardiac adverse reactions

Serious and possibly permanent heart-related side effects that may damage the heart and 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 before, during, and after your treatment with DOXIL®

Infusion-related reactions

Your healthcare provider will administer the drug slowly and increase the rate as tolerated while monitoring you in order to treat any adverse reactions that may occur.

Serious, life-threatening, and fatal infusion reactions have been reported for patients receiving DOXIL®. Let your healthcare provider know immediately if you develop any of these symptoms.

If you do have an infusion-related reaction:

Your healthcare provider will temporarily stop the infusion to control the symptoms and resume treatment at a reduced rate. Treatment with DOXIL® will be stopped for serious or life-threatening infusion-related reactions.

Symptoms of infusion-related reactions include:

  • Flushing
  • Shortness of breath
  • Facial swelling
  • Headache
  • Chills
  • Chest pain
  • Back pain
  • Tightness in the chest and throat
  • Fever
  • Increased heart rate
  • Itching
  • Rash
  • Skin discoloration
  • Fainting
  • Wheezing
  • Low blood pressure
  • Breathing problems
  • Flushing
  • Shortness of breath
  • Facial swelling
  • Headache
  • Chills
  • Chest pain
  • Back pain
  • Tightness in the chest and throat
  • Fever
  • Increased heart rate
  • Itching
  • Rash
  • Skin discoloration
  • Fainting
  • Wheezing
  • Low blood pressure
  • Breathing problems

In clinical studies:

About 1 in 10 patients (11%) experienced some type of reaction during drug administration, some of which may have required dose interruption. The majority of reactions occurred during the first treatment.

Side effects

The most common adverse reactions (>20%) observed with DOXIL® are asthenia, fatigue, fever, nausea, stomatitis, vomiting, diarrhea, constipation, anorexia, hand-foot syndrome, rash and neutropenia, thrombocytopenia, and anemia.

The side effects management tips include interactions, what you can do to help manage side effects, and possible infusion reactions. Speak to your team of healthcare professionals about any side effects you may be experiencing on DOXIL®.

Please tell your doctor and team of healthcare professionals if:

  • You develop any symptoms of heart failure
  • Your urine and other body fluids become reddish-orange or change color
  • You have any oral discomfort that may be indicative of secondary oral cancer
  • You are pregnant, planning to become pregnant, or nursing; or
  • You have any history of allergic reactions to doxorubicin HCl, or to any other medications or substances

For more information and tips about:

Hand-Foot Syndrome (HFS)
HFS can include tingling or burning, redness, flaking, swelling, and blisters or sores on hands or soles of feet. Simple changes in daily activities may help manage HFS.
Mouth pain (stomatitis)
Stomatitis is painful redness, swelling, or sores in the mouth. Recognize and help control symptoms with attention to oral care and diet.
Low white blood cell counts
White blood cells help protect against infection. Understand how to avoid the risk of infection.
Low platelet counts
Platelets help your blood form clots and stop bleeding. Learn important tips to help avoid bleeding and bruising.
Low red blood cell counts (anemia)
Low red blood cell counts can lead to anemia, which can make you feel tired and fatigued. Understand why you may feel tired and try to plan ahead.
Nausea and vomiting
Certain eating habits may help you reduce or avoid symptoms.

DOXIL® and STEALTH® are registered trademarks of ALZA Corporation.

  

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.

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.

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.

INDICATIONS

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.

Click here to read Full Prescribing Information for DOXIL®, including BOXED WARNINGS, and discuss any questions you have with your doctor.

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.

030068-150417

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.

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.

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.

INDICATIONS

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.

Click here to read Full Prescribing Information for DOXIL®, including BOXED WARNINGS, and discuss any questions you have with your doctor.

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.

030068-150417

INDICATIONS

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.

Click here to read Full Prescribing Information for DOXIL®, including BOXED WARNINGS, and discuss any questions you have with your doctor.

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.

030068-150417