Severe local tissue necrosis if extravasation occurs. Do not administer IM or sub-Q.
Myocardial Toxicity
Possible cardiotoxicity and potentially fatal CHF during or months to years after therapy; risk of developing CHF increases rapidly with increasing total cumulative dosages >450 mg/m2. Toxicity may occur at lower cumulative dosages whether or not risk factors are present. (See Cardiotoxicity under Cautions.)
Probability of developing impaired myocardial function based on combined index of signs, symptoms, and decline in LVEF is estimated to be 1–2, 3–5, 5–8, or 6–20% at total cumulative dosage of 300, 400, 450, or 500 mg/m2, respectively.
Risk factors (active or dormant cardiovascular disease, doxorubicin exposure at an early or advanced age, prior or concomitant mediastinal/pericardial irradiation, previous therapy with other anthracyclines or anthracenediones, concomitant use of other cardiotoxic agents) may increase risk of cardiotoxicity.
Pediatric patients are at increased risk for developing delayed cardiotoxicity.
Experience with liposomal doxorubicin at high cumulative dosages is too limited to have established effects on the myocardium; assume myocardial toxicity is similar to that of conventional doxorubicin formulations. Administer to patients with history of cardiovascular disease only when benefits outweigh risk.
Secondary Acute Myelogenous Leukemia (AML)
Possible secondary AML in patients treated with anthracyclines, including doxorubicin; occurrence of refractory secondary leukemia is more common when such drugs are given in combination with other DNA-damaging antineoplastics, after extensive exposure to cytotoxic agents, or when anthracyline dosages have been escalated. (See Mutagenicity and Carcinogenicity under Cautions.)
Pediatric patients are at risk of developing secondary AML.
Infusion-related Effects
Infusion-related reactions (e.g., flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness of chest or throat, hypotension) reported in patients receiving liposomal doxorubicin. Reactions generally resolve within several hours to a day once infusion terminated; may resolve in some patients with slowing of infusion rate.
Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions reported; appropriate therapy and emergency equipment should be available for immediate use.
Administer liposomal doxorubicin at initial rate of 1 mg/minute to minimize risk of infusion reactions.
Myelosuppression
Severe myelosuppression may occur. (See Hematologic Effects under Cautions.)
Hepatic Impairment
Reduce dosage in patients with hepatic impairment. (See Special Populations under Dosage and Administration and also see Hepatic Impairment under Cautions.)
Accidental Substitution
Accidental substitution of liposomal doxorubicin for conventional doxorubicin has resulted in severe adverse effects; do not substitute for conventional doxorubicin on a mg-per-mg basis.
Experience of Supervising Clinician
Administer only under the supervision of qualified clinician experienced in the use of cancer chemotherapeutic agents.
This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.
This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.
Your urine may turn red for a few days after your dose. This is not blood. If your urine is dark or brown, call your doctor.
In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.
Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.
This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.
Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.
Men and women of childbearing age should use effective birth control methods while using taking this medicine. Do not become pregnant while taking this medicine. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.
Do not let others touch your urine or other body fluids for 5 days after each treatment with this medicine. Caregivers should wear latex gloves to avoid touching body fluids during this time.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.
signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
breathing problems
chest pain
fast, irregular heartbeat
mouth sores
nausea, vomiting
pain, swelling, redness at site where injected
pain, tingling, numbness in the hands or feet
swelling of ankles, feet, or hands
unusual bleeding or bruising
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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