Doxil contains the active ingredient doxorubicin hydrochloride, which is an anthracycline topoisomerase inhibitor. It is formulated as a pegylated liposome for intravenous injection, available in dosage strengths of 20 mg and 50 mg per vial. Key inactive ingredients include cholesterol, fully hydrogenated soy phosphatidylcholine, and MPEG-DSPE. Doxil is intended for intravenous use with doxorubicin hydrochloride encapsulated in liposomes to facilitate delivery.

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication 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?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It 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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Infusion reactions—chest pain, shortness of breath or trouble breathing, feeling faint or lightheaded
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Redness, swelling, and blistering of the skin over hands and feet
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Diarrhea
• Loss of appetite
• Nausea
• Pain, redness, or swelling with sores inside the mouth or throat
• Red urine
• Unusual weakness or fatigue

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.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood disorder
• Heart disease
• Infection especially a viral infection, such as chickenpox, cold sores, herpes
• Liver disease
• Recent or ongoing radiation
• An unusual or allergic reaction to doxorubicin, soybeans, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Zidovudine

This medication may also interact with the following:

• Medications to increase blood counts, such as filgrastim, pegfilgrastim, sargramostim
• Vaccines

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 medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication 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 care team tells you to stop.

Your urine may turn orange-red for a few days after your dose. This is not blood. If your urine is dark or brown, call your care team.

In some cases, you may be given additional medications to help with side effects. Follow all directions for their use.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 6 months after the last dose. Contraception is recommended while taking this medication and for 6 months after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom while taking this medication and for 6 months after the last dose.

Do not breastfeed while taking this medication.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What are the most serious risks of this medication?

This medicine causes damage to the heart. Heart damage can occur during treatment or many years after treatment is done. Your healthcare provider will closely monitor your heart.

Serious side effects can occur during the infusion of this treatment. Your care team will watch you closely.