Doxil Vial

GENERIC NAME(S): Doxorubicin, Peg-Liposomal

OTHER NAME(S): Doxil Solution

WARNINGS:

Liposomal doxorubicin may cause heart problems, including possibly fatal heart failure. Heart problems may occur during liposomal doxorubicin therapy or months to years after receiving this medication. Your risk of developing heart problems depends on your dose, medical history (including previous heart disease, radiation therapy in the chest area), and previous use of this and other drugs (including daunorubicin and cyclophosphamide). Children are at higher risk and should be monitored later in life for delayed heart problems. See also Side Effects section.

While this drug is first being given into your vein, this medication may cause severe (rarely fatal) reactions, including allergic reactions. Tell your doctor right away if you experience flushing, trouble breathing, swelling of the face, tightness in the chest/throat, chills, back pain, severe dizziness, or fast heartbeat. See also Side Effects section.

Your doctor will closely monitor you while you are being treated with this medication.

Different types of this medication work in different ways. Do not switch types of this medication without your doctor's permission.

Who should not take Doxil Vial?

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Uses

Uses

Liposomal doxorubicin is an anthracycline-type chemotherapy drug that is used to treat certain types of cancer (e.g., ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma). It works by slowing or stopping cancer cell growth.

How to use Doxil Vial

This medication is given by injection into a vein over 30-60 minutes or longer by a health care professional. The dosage is based on your medical condition, body size, and response to therapy. Notify your doctor right away if redness, pain, or swelling occur at or near the injection site.

If this medication touches your skin, immediately and completely wash skin with soap and water. If this medication gets in your eye, open the eyelids and flush with plenty of water for 15 minutes. Seek immediate medical attention.

Family members and caregivers should take precautions (e.g., wear gloves) to prevent contact with the patient's urine or other body fluid for at least 5 days after treatment. Consult your pharmacist.

Side Effects

Side Effects

See also Warning section.

Body aches/pains, headache, nausea, vomiting, constipation, diarrhea, stomach upset, and loss of appetite may occur. Nausea and vomiting can be severe. In some cases, drug therapy may be needed to prevent or relieve nausea and vomiting. Not eating before your treatment may help relieve vomiting. Changes in diet and lifestyle, such as eating several small meals and limiting activity, may help lessen some of these effects. If any of these effects continue or worsen, notify your doctor or pharmacist.

This medication may give a reddish-orange color to your urine, tears, and sweat. This is a normal effect of the drug and should not be mistaken for blood in your urine.

Temporary hair loss may occur. Normal hair growth should return several months after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). Notify your doctor promptly if you experience swelling, pain, redness, dryness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, long walks). Wear loose clothing. Depending on how severe your hand-foot syndrome is, your doctor may give you something to reduce the symptoms, or decrease or delay your next dose of liposomal doxorubicin.

Tell your doctor right away if you have any serious side effects, including: symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), drowsiness, trouble sleeping, mental/mood changes (e.g., anxiety, confusion, depression), cough/hoarseness, redness/pain/swelling of arms/legs, eye redness/itching, painful/difficult urination, stomach/abdominal pain, yellowing of the skin/eyes, dark urine, black/tarry stools, bloody mucus or discharge in stools, vision changes (e.g., blindness), fast/irregular heartbeat.

This medication may cause certain severe (rarely fatal) blood disorders (bone marrow suppression leading to low red blood cells/white blood cells /platelets). This can lower your body's ability to fight infection and stop bleeding. Tell your doctor right away if you develop any signs of infection (e.g., fever, chills, persistent sore throat), unusual tiredness, or easy bleeding/bruising.)

Painful swelling or sores on the lips, mouth and throat may occur. To decrease the risk, limit hot foods and drinks, brush your teeth carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water.

Get medical help right away if this rare but very serious side effect occurs: chest pain.

Within days to weeks after doxorubicin treatment, a serious skin reaction that looks likes a severe sunburn (radiation recall) may develop on any area of skin that has been previously treated with radiation. Tell your doctor right away if you develop skin redness, pain, tenderness, swelling, peeling, or blisters. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling. Sunlight may worsen any skin reactions that may occur while you are using this drug. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

In children, radiation recall may occur in the lungs. Tell the doctor right away if you notice wheezing or trouble breathing in the child.

Very rarely, people with cancer who are treated with this type of medication have developed other cancers (such as secondary leukemia, oral cancer). Your risk is greater if you have received this medication long-term (more than 1 year), or with certain types of chemotherapy or radiation treatment. Consult your doctor for more details.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using liposomal doxorubicin, tell your doctor or pharmacist if you are allergic to it; or to doxorubicin; or to other drugs containing polyethylene glycol; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood cell counts (e.g., anemia, neutropenia, thrombocytopenia), gout, heart problems, a history of receiving any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), infection, liver problems, radiation treatment (especially to the chest area), kidney problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.

To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lower the risk of bleeding gums.

Wash your hands well to prevent the spread of infections.

Caution is advised if using liposomal doxorubicin in children because they may be more sensitive to its effects, especially on the heart.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor will give you a pregnancy test before starting treatment. You should not become pregnant while using liposomal doxorubicin. Liposomal doxorubicin may harm an unborn baby. Women and men should ask about reliable forms of birth control to use during treatment with this medication and for 6 months after stopping treatment. If you or your female partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: digoxin, progesterone, streptozocin, stavudine, trastuzumab, zidovudine.

Other medications can affect the removal of doxorubicin from your body, which may affect how doxorubicin works. Examples include azole antifungals (such as ketoconazole), calcium channel blockers (e.g., verapamil, nifedipine), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital, primidone), among others.

Avoid eating foods or products containing turmeric (curcumin) while being treated with liposomal doxorubicin. It may decrease this medication's effects. Consult your doctor or pharmacist for more details.

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: unexplained bleeding.

Notes

Laboratory and/or medical tests (e.g., complete blood counts, heart studies, liver function tests) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details. Keep all your medical and laboratory appointments.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised August 2019. Copyright(c) 2019 First Databank, Inc.

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Doxil 2 mg/mL intravenous suspension
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Doxil 2 mg/mL intravenous suspension

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Doxil 2 mg/mL intravenous suspension
Doxil 2 mg/mL intravenous suspension

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This medicine is a red, translucent, vial
Doxil 2 mg/mL intravenous suspension
Doxil 2 mg/mL intravenous suspension

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This medicine is a red, translucent, vial

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.