Adriamycin

Name: Adriamycin

Manufacturer

  • Bedford Laboratories

  • Pharmacia, Inc.

Adriamycin Drug Class

Adriamycin is part of the drug class:

  • Anthracyclines and related substances

Adriamycin Usage

  • Your doctor will prescribe Adriamycin in an amount that is right for you.
  • Adriamycin 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 Adriamycin.
  • Before receiving Adriamycin you may receive other medicines to prevent or treat side effects.
  • Caregivers of children receiving Adriamycin 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.

Adriamycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common
  • Cough or hoarseness accompanied by fever or chills
  • darkening or redness of the skin (if you recently had radiation treatment)
  • fast or irregular heartbeat
  • fever or chills
  • joint pain
  • lower back or side pain accompanied by fever or chills
  • pain at the injection site
  • painful or difficult urination accompanied by fever or chills
  • red streaks along the injected vein
  • shortness of breath
  • stomach pain
  • swelling of the feet and lower legs
Rare
  • Black, tarry stools
  • blood in the urine
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Hair loss, thinning of hair
  • nausea and vomiting
  • sores in the mouth and on the lips
Less common
  • Darkening of the soles, palms, or nails
  • diarrhea

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Fast or irregular heartbeat
  • shortness of breath
  • swelling of the feet and lower legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Mouth irritation or mouth sores.
  • A burning, numbness, or tingling feeling that is not normal.
  • Seizures.
  • Chest pain.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Patients with cancer who take this medicine may be at a greater risk of getting a bad health problem called tumor lysis syndrome (TLS). Sometimes, this has been deadly. Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools, or not able to eat; or feel sluggish.

What are some other side effects of Adriamycin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Hair loss.
  • Change in nails.
  • Not hungry.
  • More thirst.
  • Weight gain or loss.
  • Belly pain.
  • Urine and other body fluids may change to an orange or red color. This is normal.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Overdosage

Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin (300 mg/m2) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis. The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose. A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin daily for 2 days (intended dose was 50 mg per day for 3 days). The patient developed severe mucositis on days 4-7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after overdose.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Doxorubicin treatment results in an increased risk of secondary malignancies based on postmarketing reports [see Warnings and Precautions (5.2) ]. Doxorubicin was mutagenic in the in vitro Ames assay, and clastogenic in multiple in vitro assays (CHO cell, V79 hamster cell, human lymphoblast, and SCE assays) and the in vivo mouse micronucleus assay.

Doxorubicin decreased fertility in female rats at the doses of 0.05 and 0.2 mg/kg/day (approximately 0.005 and 0.02 times the recommended human dose, based on body surface area)

A single intravenous dose of 0.1 mg/kg doxorubicin (approximately 0.01 times the recommended human dose based on body surface area) was toxic to male reproductive organs in animal studies, producing testicular atrophy, diffuse degeneration of the seminiferous tubules, and oligospermia/hypospermia in rats. Doxorubicin induces DNA damage in rabbit spermatozoa and dominant lethal mutations in mice.

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:

WEST-WARD PHARMACEUTICALS

Eatontown, NJ 07724 USA

Revised September 2015

127.207.004/01

Patient Information

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

For 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.

Inactive ingredients for Doxorubicin Hydrochloride For Injection: lactose and methylparaben

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:

WEST-WARD PHARMACEUTICALS

Eatontown, NJ 07724 USA

Revised September 2015

127.207.004/01

Package/Label Display Panel

 

Adriamycin 5 mL vial label

 

NDC 0143-9549-01

Rx only

Adriamycin (Doxorubicin HCl Injection, USP)

10 mg/5 mL (2 mg/mL)

FOR IV USE ONLY

STERILE ISOTONIC SOLUTION

5 mL SINGLE DOSE VIAL 

Doxorubicin Identification

Substance Name

Doxorubicin

CAS Registry Number

23214-92-8

Drug Class

Antineoplastic Agents

Antibiotics, Antineoplastic

Topoisomerase II Inhibitors

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