Doxorubicin Intravenous

In the U.S.

• Adriamycin

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

It is very important that your doctor check your progress at regular visits to make sure that doxorubicin is working properly. Blood tests may be needed to check for unwanted effects.

Using doxorubicin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep you or your partner from getting pregnant during therapy and for 6 months after the last dose of doxorubicin. If you think you have become pregnant while using the medicine, tell your doctor right away.

doxorubicin may cause irreversible heart muscle damage, leading to heart failure. This is more likely to occur if you have other heart problems, have had or currently receiving radiation therapy to your chest, or have received other cancer medicines. Tell your doctor right away if you have chest pain, decreased urine output, irregular heartbeat, trouble breathing, rapid weight gain, or swelling of your hands, ankles, or feet.

doxorubicin may increase risk of new cancers, such as acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Talk to your doctor if you have concerns about this risk.

If doxorubicin accidentally seeps out of the vein into which it is injected, it may damage some tissues and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

While you are being treated with doxorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Doxorubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine, since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Doxorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

doxorubicin may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.

doxorubicin may decrease the amount of sperm made and affect a man's ability to father a child. It may also cause premature menopause in women. Talk with your doctor before you use doxorubicin if you plan to have children.

Doxorubicin causes your urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Nausea, vomiting, diarrhea, 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.

Doxorubicin may give a reddish color to your urine, tears, and sweat. This effect may start in the first hours after treatment and may last up to several days. 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 after treatment has ended.

Nail changes (including fungal infections in the nail beds) may rarely occur.

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.

Tell your doctor right away if you have any serious side effects, including: cough/hoarseness, persistent diarrhea, redness/flushing of face, eye redness/itching, unusual tiredness, joint pain, pain in the lower back/side/stomach/abdomen, painful/difficult urination, stopped/missed menstrual periods, black/tarry stools, bloody mucus or discharge in stools, fast/irregular heartbeat, shortness of breath, dizziness, swelling of ankles/feet, decreased urination.

Painful 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 you have any very serious side effects, including: 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. Also, doxorubicin may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you have skin redness, pain, tenderness, swelling, peeling, blisters, or if you get sunburned. Your doctor may prescribe medication to help your skin heal faster and reduce the swelling.

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

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.

See also Side Effects section.

Before using doxorubicin, tell your doctor or pharmacist if you are allergic to it; 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: a current infection, low blood cell counts (e.g., anemia, neutropenia, thrombocytopenia), gout, heart problems (e.g., recent heart attack, heart failure, irregular heartbeat), a history of receiving any anthracycline-type drug (e.g., doxorubicin, idarubicin, daunorubicin, mitoxantrone), kidney problems, liver disease, severe mouth sores (stomatitis), radiation treatment (especially to the chest area).

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 when using this drug in children because they may be more sensitive to the effects of the drug, especially to radiation recall in the lungs, heart problems, or another cancer later on in life. Doxorubicin, in combination with other chemotherapies, may also slow the growth of children before puberty.

This medication may lower sperm count or may cause abnormal sperm to form, possibly causing infertility or birth defects. Consult your doctor for more details.

This medication can affect menstruation in females and cause premature menopause. Consult your doctor or pharmacist for details.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is recommended that men and women use effective forms of birth control (e.g., condoms and birth control pills) while being treated with this medication and for 6 months after stopping the medication. Consult your doctor for more details and to discuss reliable forms of birth control.

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.

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 taking doxorubicin. It may decrease doxorubicin's effects. Consult your doctor or pharmacist for more details.