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DOXORUBICIN HYDROCHLORIDE injection, powder, lyophilized, for solution

  1. Doxorubicin May Cause Serious Side Effects Including:
  2. Tell Your Doctor If You Get Any Of These Symptoms Of Heart Failure During Or After Treatment With Doxorubicin:
  3. What Is Doxorubicin?
  4. Do Not Receive Doxorubicin If:
  5. Before You Receive Doxorubicin, Tell Your Doctor If You:
  6. How Will I Receive Doxorubicin?
  7. What Are The Possible Side Effects Of Doxorubicin?
  8. Active Ingredient:
  9. Inactive Ingredients For Doxorubicin Hydrochloride For Injection:
  10. Manufactured For:

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
fast heartbeat
swelling of your feet and ankles
shortness of breath

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.

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

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:

Active Ingredient: 

Doxorubicin hydrochloride, USP

Inactive Ingredients For Doxorubicin Hydrochloride For Injection: 

Lactose Monohydrate

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

Manufactured For: 

Mylan Institutional LLC

Rockford, IL 61103 U.S.A.

Made in India

JULY 2016

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