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DOXORUBICIN HYDROCHLORIDE- doxorubicin injection, powder, lyophilized, for solutionDOXORUBICIN HYDROCHLORIDE injection, powder, lyophilized, for solution


  1. Inform Patients Of The Following:
  2. Patient Information
  3. Hydrochloride For Injection May Cause Serious Side Effects Including:
  4. Tell Your Doctor If You Get Any Of These Symptoms Of Heart Failure During Or After Treatment With Doxorubicin Hydrochloride For Injection:
  5. Hydrochloride For Injection?
  6. Before You Receive Doxorubicin Hydrochloride For Injection, Tell Your Doctor If You:
  7. May Cause Serious Side Effects, Including:
  8. Include:
  9. Other Side Effects:
  10. Active Ingredient:
  11. Inactive Ingredients For Doxorubicin Hydrochloride For Injection:

Inform Patients Of The Following: 

  • Doxorubicin HCl can cause irreversible myocardial damage. Advise patients to contact a healthcare provider for symptoms of heart failure during or after treatment with doxorubicin HCl[seeWarnings and Precautions (5.1)].
  • There is an increased risk of treatment-related leukemia from doxorubicin HCl[seeWarnings and Precautions (5.2)].
  • Doxorubicin HCl can reduce the absolute neutrophil count resulting in an increased risk of infection. Advise patients to contact a healthcare provider for new onset fever or symptoms of infection[seeWarnings and Precautions (5.4)].
  • Doxorubicin HCl can cause fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with doxorubicin HCl and for 6 months after treatment, and to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with doxorubicin HCl[seeWarnings and Precautions (5.8)andUse in Specific Populations (8.6)].
  • Doxorubicin HCl may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise patients to use effective contraception during and for 6 months after treatment[seeWarnings and Precautions (5.8)andUse in Specific Populations (8.6)].
  • Doxorubicin HCl can cause premature menopause in females and loss of fertility in males[seeUse in Specific Populations (8.6)].
  • Discontinue nursing while receiving doxorubicin HCl[seeUse in Specific Populations (8.3)].
  • Doxorubicin HCl can cause nausea, vomiting, diarrhea, mouth/oral pain and sores. Advise patients to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking[seeAdverse Reactions (6)].
  • Doxorubicin HCl causes alopecia[seeAdverse Reactions (6.1)].
  • Doxorubicin HCl can cause their urine to appear red for 1 to 2 days after administration.

Manufactured by:
Amneal Oncology Pvt. Ltd.
Plot No S-3, S-4, S-5A,
TSIIC-SEZ Village-Polepally,
Mandal-Jadcherla, Mahaboobnagar,
Telangana 509301, INDIA

Distributed by:
Amneal Biosciences LLC
Bridgewater, NJ 08807

Rev. 02-2017-00



Patient Information 

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

What is the most important information I should know about Doxorubicin

Hydrochloride For Injection May Cause Serious Side Effects Including: 

  • Heart failure.Doxorubicin hydrochloride for injection 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 hydrochloride for injection 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 Hydrochloride For Injection: 

  • extreme tiredness or weakness
  • fast heartbeat
  • shortness of breath
  • 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 hydrochloride for injection.

  • 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 hydrochloride for injection.
  • Skin damage near the vein where Doxorubicinhydrochloride for injectionis given (Injection site reaction).Doxorubicin hydrochloride for injection 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 hydrochloride for injection 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 hydrochloride for injection 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

Hydrochloride For Injection? 

Do not receive DoxorubicinHydrochloride for Injectionif:

  • 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 Hydrochloride For Injection, 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 hydrochloride for injection can harm your unborn baby. Women who are able to become pregnant and men who take doxorubicin hydrochloride for injection 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 hydrochloride for injection 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 hydrochloride for injection can interact with other medicines. Do not start any new medicine before you talk with the doctor that prescribed doxorubicin hydrochloride for injection.

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

May Cause Serious Side Effects, Including: 

Doxorubicinhydrochloride for injectionmay 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 hydrochloride for injection. 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 DoxorubicinHydrochloride for Injection

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 hydrochloride for injection. This is normal. Tell your doctor if it does not stop in a few days, or if you

Active Ingredient: 

doxorubicin hydrochloride, USP

Inactive Ingredients For Doxorubicin Hydrochloride For Injection: 

lactose monohydrate, NF

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

Manufactured by:
Amneal Oncology Pvt. Ltd.
Plot No S-3, S-4, S-5A,
TSIIC-SEZ Village-Polepally,
Mandal-Jadcherla, Mahaboobnagar,
Telangana 509301, INDIA

Distributed by:
Amneal Biosciences LLC
Bridgewater, NJ 08807

Rev. 02-2017-00





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