DOXORUBICIN HYDROCHLORIDE Injection, Solution [Pfizer Laboratories Div Pfizer Inc]

DOXORUBICIN (dok-suh-roo-buh-sin) HYDROCHLORIDE
Injection, for intravenous use

What is the most important information I should know about Doxorubicin?

Doxorubicin may cause serious side effects including:

• Heart failure. Doxorubicin may cause heart muscle damage that may lead to heart failure, which is a condition in which the heart does not pump well. Heart failure is irreversible in some cases and can lead to death. Heart failure can happen during your treatment with Doxorubicin or months to years after stopping treatment. Your risk of heart muscle damage increases with higher total amounts of doxorubicin hydrochloride that you receive in your lifetime. Your risk of heart failure is higher if you:
  • already have other heart problems
  • have had or are currently receiving radiation therapy to your chest
  • have had treatment with certain other anti-cancer medicines
  • take other medicines that can have severe side effects on your heart

  Tell your doctor if you get any of these symptoms of heart failure during or after treatment with Doxorubicin:

  extreme tiredness or weakness shortness of breath

  fast heartbeat swelling of your feet and ankles

  Your doctor will do tests to check the strength of your heart muscle before, during, and after your treatment with Doxorubicin.

• Risk of new cancers. You may have an increased risk of developing certain blood cancers called acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) after treatment with doxorubicin. Talk with your doctor about your risk of developing new cancers if you take Doxorubicin.
• Skin damage near the vein where Doxorubicin is given (Injection site reaction). Doxorubicin can damage the skin if it leaks out of the vein. Symptoms of infusion reaction include blisters and skin sores at injection site which may require skin grafts.
• Decreased blood cell counts. Doxorubicin can cause a decrease in neutrophils (a type of white blood cells important in fighting bacterial infections) and platelets (important for clotting and to control bleeding). This may lead to a serious infection, the need for blood transfusions, treatment in a hospital and death. Your doctor will check your blood cell count during your treatment with Doxorubicin and after you have stopped your treatment. Call your doctor right away if you get a fever (temperature of 100.4 F or greater) or chills with shivering.

What is Doxorubicin?

Doxorubicin is a prescription medicine used to treat certain types of cancers. Doxorubicin may be used alone or along with other anti-cancer medicines.

Who should not receive Doxorubicin?

Do not receive Doxorubicin if:

• you have had a recent heart attack or have severe heart problems
• your blood cell counts (platelets, red blood cells, and white blood cells) are very low because of prior chemotherapy
• you have a severe liver problem
• you have had a serious allergic reaction to doxorubicin hydrochloride

What should I tell my doctor before receiving Doxorubicin?

Before you receive Doxorubicin, tell your doctor if you:

• have heart problems including heart failure
• are currently receiving radiation therapy or plan to receive radiation to the chest
• have severe liver problems
• have had an allergic reaction to doxorubicin
• have any other medical conditions
• are pregnant or plan to become pregnant. Doxorubicin can harm your unborn baby. Women who are able to become pregnant and men who take Doxorubicin should use effective birth control (contraception) during treatment and for 6 months after treatment. Talk to your doctor about birth control methods. If you or your partner becomes pregnant, tell your doctor right away.
• are breastfeeding or plan to breast feed. Doxorubicin can pass into your breast milk and harm your baby. You and your doctor should decide if you will receive Doxorubicin or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Doxorubicin can interact with other medicines. Do not start any new medicine before you talk with the doctor that prescribed Doxorubicin.

Know the medicines you take. Keep a list to show your doctor and pharmacist each time you get a new medicine.

How will I receive Doxorubicin?

• Doxorubicin will be given to you into your vein.

What are the possible side effects of Doxorubicin?

Doxorubicin may cause serious side effects, including:

Doxorubicin may cause lower sperm counts and sperm problems in men.

This could affect your ability to father a child and cause birth defects. Talk to your healthcare provider if this is a concern for you. Talk to your healthcare provider about family planning options that might be right for you.

Irreversible amenorrhea or early menopause. Your periods (menstrual cycle) may completely stop when you receive Doxorubicin. Your periods may or may not return following treatment. Talk to your healthcare provider about family planning options that might be right for you.

The most common side effects of Doxorubicin include:

• Total hair loss (alopecia). Your hair may re-grow after your treatment.
• nausea
• vomiting

Other side effects:

• Red colored urine. You may have red colored urine for 1 to 2 days after your infusion of Doxorubicin. This is normal. Tell your doctor if it does not stop in a few days, or if you see what looks like blood or blood clots in your urine.
• Darkening of your nails or separation of your nails from your nail bed.
• Easy bruising or bleeding.
• Call your doctor if you have severe symptoms that prevent you from eating or drinking, such as:
  • nausea
  • vomiting
  • diarrhea
  • mouth sores

Tell your doctor or nurse if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Doxorubicin.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Doxorubicin.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

You can ask your pharmacist or doctor for information about Doxorubicin that is written for health professionals.

For more information, call 1-800-438-1985.

What are the ingredients of Doxorubicin?

Active ingredient: doxorubicin hydrochloride

Inactive ingredients for Doxorubicin Hydrochloride Injection: 0.9% sodium chloride, USP, water for injection, USP, and hydrochloric acid, USP.

This Patient Information has been approved by the U.S. Food and Drug Administration.

PREMIERPro™Rx is a trademark of Premier, Inc., used under license.

Distributed by
Pfizer Labs
Division of Pfizer, Inc.
New York, NY 10017

LAB-0703-1.0

11/2013

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DOXORUBICIN HYDROCHLORIDE Injection, Solution [Pfizer Laboratories Div Pfizer Inc]