Generic Name: doxorubicin liposomal (DOX-oh-ROO-bi-sin)
Brand Name: Doxil
Doxil is for intravenous (IV) use only and should only be given under the supervision of a doctor experienced in the use of cancer chemotherapy agents. If Doxil accidentally leaks into surrounding tissue, the skin and/or muscle may be severely damaged. Notify your doctor immediately if redness, pain, or swelling at or around the injection site occurs.
Doxil may cause severe and possibly life-threatening heart problems (eg, heart failure). These problems may occur during therapy or sometimes months to years after receiving Doxil. In some cases, heart problems are irreversible. The risk may be increased if you are using certain medicines that may affect heart function (eg, trastuzumab), or have a history of heart problems, radiation treatment to the chest area, or previous therapy with other anthracyclines (eg, epirubicin). The risk of developing heart problems varies depending on your dose and condition, although it can occur at any dose whether or not you are at risk. Notify your doctor right away if you develop cough; fast, slow, or irregular heartbeat; shortness of breath; sudden, unexplained weight gain; or swelling of the hands, ankles, or feet.
Serious and sometimes life-threatening, infusion-related reactions have occurred with the use of Doxil. Contact your doctor right away if you experience back pain, chills, fainting, flushing, headache, severe dizziness or light-headedness, shortness of breath, swelling of the face, or tightness in the chest or throat.
Another type of cancer (acute myelogenous leukemia [AML]) and a certain blood problem (myelodysplastic syndrome [MDS]) have been reported in patients treated with anthracyclines, including Doxil. The risk varies depending on your dose, and other medicines and/or radiation therapy. Discuss any questions or concerns with your doctor.
Doxil may cause bone marrow suppression. Notify your doctor immediately if you develop easy bruising or bleeding, unusual tiredness or weakness, or signs of an infection (eg, fever, chills, persistent sore throat).
Tell your doctor if you have liver problems because your dose will have to be decreased. Your doctor will closely monitor you while you are using Doxil.
Doxil is used for:
Treating advanced ovarian cancer and AIDS-related Kaposi sarcoma in certain patients. It is also used with another medicine to treat a type of bone marrow cancer (multiple myeloma) in certain patients.
Doxil is an antineoplastic antibiotic. It works by killing cancer cells.
Do NOT use Doxil if:
- you are allergic to any ingredient in Doxil or to similar medicines (eg, epirubicin)
- you have certain bone marrow problems (eg, low blood platelet levels, low red blood cell levels, low white blood cell levels)
- you have taken or will be taking palifermin within 24 hours before or after using Doxil
Contact your doctor or health care provider right away if any of these apply to you.
Before using Doxil:
Some medical conditions may interact with Doxil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have swelling or soreness of the mouth or tongue, blood vessel disease, an infection, or liver problems
- if you plan to receive any vaccines
- if you are older than 50 years old
- if you have a history of heart problems, mouth cancer, or radiation treatment (or are currently receiving radiation treatment), or if you have previously received Doxil or similar medicines (eg, epirubicin, daunorubicin)
- if you are taking medicines that may affect heart function (eg, calcium channel blockers, trastuzumab). Ask your doctor if you are unsure if any of your medicines may affect heart function
Some MEDICINES MAY INTERACT with Doxil. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Calcium channel blockers (eg, diltiazem, verapamil), cyclophosphamide, or trastuzumab because the risk of heart problems (eg, heart failure) may be increased
- Cyclosporine, cytarabine, paclitaxel, progesterone, or streptozocin because they may increase the risk of Doxil's side effects
- Phenobarbital because it may decrease Doxil's effectiveness
- Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Doxil
- Palifermin because if mouth or tongue sores develop, they may be more severe or last longer
- Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Doxil
- Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of Doxil's side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver
This may not be a complete list of all interactions that may occur. Ask your health care provider if Doxil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Doxil:
Use Doxil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Doxil is usually given as an injection at your doctor's office, hospital, or clinic. Ask your doctor any questions that you may have about Doxil.
- Do not use Doxil if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Drinking extra fluids while you are taking Doxil is recommended. Check with your doctor for instructions.
- Your doctor may prescribe another medicine to lessen nausea and vomiting that can occur when taking Doxil. Discuss any questions with your doctor.
- If you spill Doxil on your skin, wash it off right away with soap and water.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Doxil, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Doxil.
Important safety information:
- Doxil may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Doxil may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Doxil. Talk with your doctor before you receive any vaccine.
- Doxil may cause the urine to turn red. This is harmless and usually goes away 1 to 2 days after receiving a dose of Doxil.
- Doxil may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Doxil. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Doxil may cause cancer of the mouth. The risk is greater in those patients who take Doxil for more than a year. Your doctor will check your mouth while you use Doxil. Tell your doctor right away if you have mouth pain, sores, or ulcers.
- Lab tests, including liver function, complete blood cell counts, blood uric acid and electrolyte levels, and heart function, may be performed while you use Doxil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Tell your doctor or dentist that you take Doxil before you receive any medical or dental care, emergency care, or surgery.
- Doxil should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- Caution is advised when using Doxil in CHILDREN; they may be more sensitive to its effects.
- Doxil may damage sperm. Use effective birth control methods (eg, condoms) while using Doxil. Discuss any questions or concerns with your doctor.
- PREGNANCY and BREAST-FEEDING: Doxil has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you are able to become pregnant, talk with your doctor about using an effective form of birth control. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Doxil while you are pregnant. It is not known if Doxil is found in breast milk. Do not breast-feed while taking Doxil.
Possible side effects of Doxil:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; hair loss; indigestion; loss of appetite; nausea; tiredness; weakness; weight changes.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); absence of menstrual cycle or menstrual changes; back pain; black, tarry stools; bluish skin or nails; calf or leg pain, swelling, redness, or tenderness; chest pain; dizziness or light-headedness; fainting; fast, slow, or irregular heartbeat; flushing; headache; loose or bloody stools; pain, redness, burning, stinging, swelling, or open sores at the injection site; rectal bleeding or irritation; redness or discharge of the eyes; redness, pain, swelling, peeling, tingling, or blistering of the palms of the hands and the soles of the feet; severe or persistent nausea; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; swelling or soreness of the mouth or tongue; symptoms of dehydration (eg, dry mouth or eyes, decreased urination, fast heartbeat, sluggishness, unusual thirst); symptoms of infection (eg, fever, chills, cough, sore throat, burning or painful urination); unusual bruising or bleeding; unusual tiredness or weakness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Doxil:
Doxil is usually handled and stored by a health care provider. If you are using Doxil at home, store Doxil as directed by your pharmacist or health care provider. Keep Doxil out of the reach of children and away from pets.
- If you have any questions about Doxil, please talk with your doctor, pharmacist, or other health care provider.
- Doxil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Doxil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Doxil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Doxil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Doxil.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.