Doxorubicin Hydrochloride (Page 6 of 7)

15 REFERENCES

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

16 HOW SUPPLIED/STORAGE AND HANDLING

DOXOrubicin HCI Injection, USP is supplied in single-dose, flip-top vials, as a red-orange solution containing Doxorubicin Hydrochloride, USP 2 mg/mL in the following package strengths:

NDC 0143-9084-01: 10 mg in 5 mL; individually boxed.

NDC 0143-9085-01: 20 mg in 10 mL; individually boxed.

NDC 0143-9086-01: 50 mg in 25 mL; individually boxed.

Store refrigerated, 2° to 8°C (36° to 46°F).

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

DOXOrubicin HCI Injection, USP is supplied in a sterile, multiple dose, flip-top vial, as a red-orange solution containing Doxorubicin Hydrochloride, USP 2 mg/mL in the following package strength:

NDC 0143-9087-01: 200 mg in 100 mL; individually boxed.

Store refrigerated, 2° to 8°C (36° to 46°F).

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

Storage of vials of DOXOrubicin HCl Injection, USP following reconstitution 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

Handle and dispose of DOXOrubicin HCl Injection, USP consistent with recommendations for the handling and disposal of hazardous drugs.1

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information).

Inform patients of the following:

  • Doxorubicin can cause irreversible myocardial damage. Advise patients to contact a healthcare provider for symptoms of heart failure during or after treatment with doxorubicin [see Warnings and Precautions (5.1)].
  • There is an increased risk of treatment-related leukemia from doxorubicin [see Warnings and Precautions (5.2)].
  • Doxorubicin 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 [see Warnings and Precautions (5.4)].
  • Doxorubicin can cause fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with doxorubicin 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 [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].
  • Doxorubicin 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 [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6 )].
  • Doxorubicin can cause premature menopause in females and loss of fertility in males [see Use in Specific Populations (8.6 )].
  • Discontinue nursing while receiving doxorubicin [see Use in Specific Populations (8.3)].
  • Doxorubicin 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 [see Adverse Reactions (6)].
  • Doxorubicin causes alopecia [see Adverse Reactions (6.1)].
  • Doxorubicin can cause their urine to appear red for 1 to 2 days after administration.

Manufactured by:

THYMOORGAN PHARMAZIE GmbH

Schiffgraben 23, 38690 Goslar, Germany

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Revised March 2021

127.207.042/00

Patient Information

DOXORUBICIN (dok-suhroo -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
  • fast heartbeat weakness
  • 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.

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:

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

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 1-800-877-845-0689.

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.

Manufactured by:

THYMOORGAN PHARMAZIE GmbH,

Schiffgraben 23, 38690 Goslar, Germany

Distributed by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Revised March 2021

127.207.042/00

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