Doxorubicin Hydrochloride: Package Insert and Label Information (Page 4 of 5)

14.1 Adjuvant Breast Cancer

15 REFERENCES

  1. “Hazardous Drugs”. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16 HOW SUPPLIED/STORAGE AND HANDLING

Doxorubicin Hydrochloride Injection, USP is supplied in flip-top vials, as a clear, red solution containing doxorubicin hydrochloride USP, 2 mg/mL in the following package strengths:

Single-Dose Vials

NDC 45963-733-55: 10 mg/5 mL (2 mg/mL)

NDC 45963-733-57: 20 mg/10 mL (2 mg/mL)

NDC 45963-733-68: 50 mg/25 mL (2 mg/mL)

Multiple-Dose Vial

NDC 45963-733-60: 200 mg/100 mL (2 mg/mL)

For the single dose vials: Store under refrigeration between 2° to 8°C (36° to 46°F).

Protect from light. Retain in carton until time of use. Discard unused portion.

For the multiple-dose vial: Store under refrigeration between 2° to 8°C (36° to 46°F).

Protect from light. Retain in carton until contents are used.

Storage

Storage of Doxorubicin Hydrochloride Injection, USP under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

Handling and Disposal

Doxorubicin Hydrochloride Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Sterile, Nonpyrogenic, Preservative-free.

The vial stopper is not made with natural rubber latex.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Cardiomyopathy

Advise patients that Doxorubicin Hydrochloride Injection can cause irreversible myocardial damage and to contact a healthcare provider for symptoms of heart failure during or after treatment [see Warnings and Precautions (5.1)].

Secondary Malignancy

Advise patients of the increased risk of treatment-related leukemia [see Warnings and Precautions (5.2)].

Myelosuppression

Advise patients that Doxorubicin Hydrochloride Injection can reduce the absolute neutrophil count resulting in an increased risk of infection and to contact a healthcare provider for new onset fever or symptoms of infection [see Warnings and Precautions (5.4)].

Embryo-Fetal Toxicity

Advise pregnant women and females of reproductive potential of the potential risk to a fetus, and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 6 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3)].

Advise patients that Doxorubicin Hydrochloride Injection may induce chromosomal damage in sperm, which may lead to loss of fertility and offspring with birth defects. Advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection and for 3 months after treatment [see Warnings and Precautions (5.8), Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

Advise males with pregnant partners to use condoms during treatment with Doxorubicin Hydrochloride Injection for at least 10 days after the final dose [see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with Doxorubicin Hydrochloride Injection and for 10 days after the final dose [see Use in Specific Populations (8.2)].

Infertility

Advise females and males of the potential loss of fertility from Doxorubicin Hydrochloride Injection [see Use in Specific Populations (8.3)].

Gastrointestinal and Dermatologic Adverse Reactions

Advise patients that Doxorubicin Hydrochloride Injection can cause nausea, vomiting, diarrhea, mouth/oral pain and sores and to contact a healthcare provider should they develop any severe symptoms that prevent them from eating and drinking [see Adverse Reactions (6)]. Advise patients that Doxorubicin Hydrochloride Injection can cause alopecia [see Adverse Reactions (6.1)].

Administration

Advise patients that Doxorubicin Hydrochloride Injection can cause their urine to appear red for 1 to 2 days after administration.

Manufactured In Romania By:

Sindan Pharma SRL

Bucharest 1, Romania 011171

Manufactured For:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

Rev. C 1/2021

PATIENT INFORMATION

Doxorubicin Hydrochloride (dox” oh roo’ bi sin hye” droe klor’ ide) Injection

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

Doxorubicin Hydrochloride Injection may cause serious side effects including:

  • Heart muscle problems. Doxorubicin Hydrochloride Injection can cause heart muscle damage that may lead to heart failure. Heart failure means your heart does not pump blood well. Heart failure is irreversible in some cases and can lead to death. Heart failure can happen during your treatment with Doxorubicin Hydrochloride Injection or months to years after stopping treatment. Your risk of heart muscle damage increases with higher total amounts of Doxorubicin Hydrochloride Injection that you receive in your lifetime. Your risk of heart failure is higher if you:
    • 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 healthcare provider if you get any of these symptoms of heart failure during or after treatment with Doxorubicin Hydrochloride Injection:

  • extreme tiredness or weakness
  • fast heartbeat
  • shortness of breath
  • swelling of your feet and ankles

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

  • Heart rhythm problems. Doxorubicin Hydrochloride Injection can cause serious heart rhythm problems that may lead to death. This can happen during your infusion, within a few hours after your infusion or anytime during treatment with Doxorubicin Hydrochloride Injection. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast, irregular or slow, or you feel lightheaded, dizzy, short of breath, chest discomfort or you faint.
  • 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 Hydrochloride Injection. Talk with your healthcare provider about your risk of developing new cancers if you receive Doxorubicin Hydrochloride Injection.
  • Skin damage at or near the vein where doxorubicin hydrochloride is given. Doxorubicin Hydrochloride Injection can damage the skin if it leaks out of the vein and might cause blisters, skin sores or severe tissue damage, which may require skin grafts. Tell your healthcare provider if you get burning or stinging during your infusion.
  • Decreased blood cell counts. Doxorubicin Hydrochloride Injection can cause a decrease in neutrophils (a type of white blood cell 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 or death. Your healthcare provider will check your blood cell counts before each infusion and during treatment with Doxorubicin Hydrochloride Injection. Call your healthcare provider right away if you get a fever (temperature of 100.4°F or higher) or chills with shivering.

What is Doxorubicin Hydrochloride Injection?

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

Do not receive Doxorubicin Hydrochloride Injection if:

  • you have had a recent heart attack (within the past 4 to 6 weeks) 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 severe liver problems.
  • you have had a severe allergic reaction to Doxorubicin Hydrochloride Injection

    Before you receive Doxorubicin Hydrochloride Injection, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems including heart failure.
  • are currently receiving radiation therapy or plan to receive radiation to the chest.
  • have liver problems.
  • have had an allergic reaction to Doxorubicin Hydrochloride Injection.
  • are pregnant or plan to become pregnant. Doxorubicin Hydrochloride can harm your unborn baby. You should not become pregnant during treatment with Doxorubicin Hydrochloride Injection. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

    Females who are able to become pregnant:

    • Your healthcare provider will check to see if you are pregnant before you start treatment with Doxorubicin Hydrochloride Injection
    • You should use effective birth control (contraception) during treatment with Doxorubicin Hydrochloride Injection and for 6 months after treatment.

    Males:

    • Doxorubicin hydrochloride can affect your sperm and could cause birth defects.
    • If you have a female partner who can become pregnant, you should use effective birth control during treatment with Doxorubicin Hydrochloride Injection and for 3 months after treatment
    • If you have a pregnant partner, you should use condoms during treatment with Doxorubicin Hydrochloride Injection and for at least 10 days after the final dose
    • Talk to your healthcare provider about birth control methods that may be right for you
  • are breastfeeding or plan to breastfeed. Doxorubicin hydrochloride can pass into your breast milk. Do not breastfeed during treatment with doxorubicin hydrochloride and for 10 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive Doxorubicin Hydrochloride Injection?

  • Doxorubicin hydrochloride will be given to you into your vein through an intravenous (IV) line.
  • Your healthcare provider will do blood tests to check for side effects during treatment with Doxorubicin Hydrochloride Injection.
  • Your healthcare provider may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving Doxorubicin Hydrochloride Injection.

What are the possible side effects of Doxorubicin Hydrochloride Injection?

Doxorubicin Hydrochloride may cause serious side effects, including:

  • See “What is the most important information I should know about Doxorubicin Hydrochloride Injection?”

    The most common side effects of Doxorubicin Hydrochloride 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 Injection. This is normal. Tell your healthcare provider if it does not stop in a few days, or if you see what looks like blood or blood clots in your urine.
  • Call your healthcare provider if you have severe symptoms that prevent you from eating or drinking, such as:
    • nausea
    • vomiting
    • diarrhea
    • mouth pain or sores

Doxorubicin Hydrochloride may cause fertility problems in males. This could affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

Doxorubicin Hydrochloride may cause fertility problems in females. Your periods (menstrual cycle) may completely stop when you receive Doxorubicin Hydrochloride Injection. Your periods may or may not return following treatment. Early menopause has also happened. Talk to your healthcare provider if this is a concern for you.

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

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 Hydrochloride Injection.

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

You can ask your pharmacist or healthcare provider for information about Doxorubicin Hydrochloride Injection that is written for health professionals.

What are the ingredients in Doxorubicin Hydrochloride Injection?

Active ingredient: doxorubicin hydrochloride

Inactive ingredients: 0.9% sodium chloride, water for injection, and hydrochloric acid.

Manufactured In Romania By: Sindan Pharma SRL , Bucharest 1, Romania 011171

Manufactured For: Teva Pharmaceuticals USA, Inc. , Parsippany, NJ 07054 USA

For more information, call Teva Pharmaceuticals USA, Inc., at 1-888-838-2872.

This Patient Information has been approved by the U.S. Food and Drug Administration. Rev. C 1/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45963-733-55

Doxorubicin Hydrochloride Injection USP

10 mg/5 mL

(2 mg/mL)

For Intravenous Use Only

Sterile Isotonic Solution

Nonpyrogenic, Preservative-free.

Warning: Severe cellulitis vesication and tissue necrosis will occur if doxorubicin is extravasated during administration.

CAUTION: Cytotoxic Agent

Rx only

5 mL Single-Dose Vial

new
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45963-733-57

Doxorubicin Hydrochloride Injection USP

20 mg/10 mL

(2 mg/mL)

For Intravenous Use Only

Sterile Isotonic Solution

Nonpyrogenic, Preservative-free.

Warning: Severe cellulitis vesication and tissue necrosis will occur if doxorubicin is extravasated during administration.

CAUTION: Cytotoxic Agent

Rx only

10 mL Single-Dose Vial

new
(click image for full-size original)

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