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DOXORUBICIN HYDROCHLORIDE injection, 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. Active Ingredient:
  5. Inactive Ingredients For Doxorubicin Hydrochloride Injection:
  6. Revised: 10/2017document Id:
  7. Do Not Receive Doxorubicin If:
  8. Before You Receive Doxorubicin, Tell Your Doctor If You:
  9. How Will I Receive Doxorubicin?
  10. Inform Patients Of The Following:
  11. Patient Information
  12. Tell Your Doctor If You Get Any Of These Symptoms Of Heart Problems:
  13. What Is Doxorubicin?
  14. Do Not Receive Doxorubicin If:
  15. Before You Receive Doxorubicin, Tell Your Doctor If You:
  16. What Should I Avoid While Taking Doxorubicin?
  17. Doxorubicin Can Cause Serious Side Effects Including:
  18. Revised: 2/2017document Id:

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
  • 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.

  • 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.

Active Ingredient: 

doxorubicin hydrochloride

Inactive Ingredients For Doxorubicin Hydrochloride Injection: 

0.9% sodium chloride, USP, water for injection, USP q.s., and hydrochloric acid, USP.

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

Athenex

Mfd. for Athenex
Schaumburg, IL 60173 (USA)
Made in India
2017 Athenex.

September 2017

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 70860-208-05

Doxorubicin HCl Injection, USP

10 mg per 5 mL (2 mg per mL)

Rx only

For Intravenous Use Only

5 mL Single-Dose Vial

Discard unused portion

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Carton

NDC 70860-208-05

Doxorubicin HCl Injection, USP

10 mg per 5 mL (2 mg per mL)

Rx only

For Intravenous Use Only

5 mL Single-Dose Vial

Discard unused portion

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 70860-208-25

Doxorubicin HCl Injection, USP

50 mg per 25 mL (2 mg per mL)

Rx only

For Intravenous Use Only

25 mL Single-Dose Vial

Discard unused portion

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Carton

NDC 70860-208-25

Doxorubicin HCl Injection, USP

50 mg per 25 mL (2 mg per mL)

Rx only

For Intravenous Use Only

25 mL Single-Dose Vial

Discard unused portion

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Carton

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Vial Label

NDC 70860-208-51

Doxorubicin HCl Injection, USP

200 mg per 100 mL (2 mg per mL)

Rx only

For Intravenous Use Only

100 mL Multi-Dose Vial

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Vial Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL Carton

NDC 70860-208-51

Doxorubicin HCl Injection, USP

200 mg per 100 mL (2 mg per mL)

Rx only

For Intravenous Use Only

100 mL Multi-Dose Vial

Caution: Cytotoxic Agent

PACKAGE LABEL     PRINCIPAL DISPLAY PANEL     Carton
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70860-208
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
doxorubicin hydrochloride(UNII: 82F2G7BL4E) (doxorubicin - UNII:80168379AG)doxorubicin hydrochloride2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
sodium chloride(UNII: 451W47IQ8X)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70860-208-051 in 1 CARTON10/20/2017
15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:70860-208-251 in 1 CARTON10/20/2017
225 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
3NDC:70860-208-511 in 1 CARTON10/20/2017
3100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20982510/20/2017
Labeler -Athenex Pharmaceutical Division, LLC. (080318964)

Revised: 10/2017document Id: 

93ce419e-e621-46a8-9e35-b818a569a18aSet id: 8fa04d6d-ac9f-437a-9891-fed0d90a789dVersion: 1Effective Time: 20171020Athenex Pharmaceutical Division, LLC.

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.

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 (5.8andUse 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.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

PREMIERPro Logo

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

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

LAB-0702-2.0

Patient Information 

Doxorubicin
(dakse-RU-besen)
Hydrochloride Injection, USP

Read this Patient information before you start receiving doxorubicin and before each infusion. This information leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

Tell Your Doctor If You Get Any Of These Symptoms Of Heart Problems: 

shortness of breath

cough

swelling of your feet and ankles

fast heartbeat

Your doctor should do tests to check your heart before, during, and after your treatment with doxorubicin.

Secondary cancers.Some people who have received doxorubicin have developed acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS). Your chance of developing a secondary cancer is higher if you receive doxorubicin along with other anti-cancer medicines or with radiation therapy.

Decreased blood cell counts.Doxorubicin can cause a severe decrease in neutrophils (a type of white blood cells important in fighting in bacterial infections), red blood cells (blood cells that carry oxygen to the tissues), and platelets (important for clotting and to control bleeding).Your doctor will check your blood cell count during your treatment with doxorubicin and after you have stopped your treatment.

What Is Doxorubicin? 

Doxorubicin is a prescription anti-cancer 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: 

your blood cell counts are too low: platelets (which help your blood to clot), red blood cells (which help to carry iron and oxygen throughout your body), and white blood cells (which help to fight infection)

you have a severe liver problem

you have had a recent heart attack or have severe heart problems

you have had previous treatment with doxorubicin or certain other anticancer medicines and received the maximum dose allowed

you are allergic to certain other anti-cancer medicines, doxorubicin hydrochloride, or any other ingredient in Doxorubicin Hydrochloride Injection, USP.

Before You Receive Doxorubicin, Tell Your Doctor If You: 

have heart problems

have had radiation treatment or currently receiving radiation therapy

are over the age of 50

have liver problems

plan to receive any vaccines. Talk to your doctor about which vaccines are safe for you to receive during your treatment with doxorubicin.

Your doctor will prescribe doxorubicin in an amount that is right for you.

Doxorubicin will be given to you by intravenous (IV) infusion into your vein.

Your doctor will do regular blood tests to check for side effects of doxorubicin.

Before receiving doxorubicin you may receive other medicines to prevent or treat side effects.

Caregivers of children receiving doxorubicin should take precautions (such as wearing latex gloves) to prevent contact with the patient s urine and other body fluids for at least 5 days after each treatment.

What Should I Avoid While Taking Doxorubicin? 

Avoid receiving live vaccines during treatment with doxorubicin. Talk to your doctor to find out which vaccines are safe for you while receiving doxorubicin.

Doxorubicin Can Cause Serious Side Effects Including: 

Active ingredient: Doxorubicin hydrochloride

Inactive ingredient: sodium chloride 0.9%, water for injection, hydrochloric acid and/or sodium hydroxide.

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

logo

www.fresenius-kabi.us

45771E
Revised: August 2016

PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 5 mL Single Dose Vial Label

DOXOrubicin HydrochlorideInjection, USP

10 mg per 5 mL
(2 mg per mL)

For intravenous use only.
Preservative free.

5 mLSingle Dose Vial Rx only


vial


PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 5 mL Single Dose Vial Carton Panel

DOXOrubicin HydrochlorideInjection, USP
10 mg per 5 mL
(2 mg per mL)

For intravenous use only.

Preservative free.
Rx only
5 mL
Single Dose Vial



pbox


PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 100 mL Multiple Dose Vial Label

DOXOrubicin HydrochlorideInjection, USP

200 mg per 100 mL
(2 mg per mL)

For intravenous use only.

Preservative free.

100 mL
Multiple Dose Vial Rx only

vial



PACKAGE LABEL - PRINCIPAL DISPLAY - Doxorubicin 100 mL Multiple Dose Vial Carton Panel

DOXOrubicin HydrochlorideInjection, USP

200 mg per 100 mL
(2 mg per mL)

For intravenous use only.
Preservative free.

Rx only
100 mL
Multiple Dose Vial

pbox
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-883
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXORUBICIN HYDROCHLORIDE(UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)DOXORUBICIN HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-883-051 in 1 CARTON04/14/2000
15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2NDC:63323-883-101 in 1 CARTON04/14/2000
210 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
3NDC:63323-883-301 in 1 CARTON04/14/2000
325 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06327704/14/2000
DOXORUBICIN HYDROCHLORIDE
doxorubicin hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-101
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXORUBICIN HYDROCHLORIDE(UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)DOXORUBICIN HYDROCHLORIDE2 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-101-611 in 1 CARTON06/14/2000
1100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06327706/14/2000
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC023648251MANUFACTURE(63323-101, 63323-883)

Revised: 2/2017document Id: 

f48b1ac2-923f-4825-9c44-02df9253cf96Set id: e0349f98-42fa-4003-b6d8-a1db1401b0efVersion: 3Effective Time: 20170227Fresenius Kabi USA, LLC



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