Adriamycin

Name: Adriamycin

What is the most important information I should know about Adriamycin (doxorubicin)?

You should not use this medicine if you have an untreated or uncontrolled infection, severe liver disease, severe heart problems, or if you have recently had a heart attack.

Doxorubicin can weaken your immune system. Your blood may need to be tested often. Tell your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, body aches).

Doxorubicin may cause dangerous effects on your heart. Call your doctor at once if you have fast heartbeats, shortness of breath (even with mild exertion), or swelling in your ankles or feet.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Adriamycin (doxorubicin) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Call your doctor at once if you have:

  • pain, blisters, or skin sores where the injection was given;

  • missed menstrual periods;

  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • low white blood cell counts--fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing; or

  • signs of heart problems--fast heartbeats, shortness of breath (even with mild exertion), swelling in your ankles or feet.

Doxorubicin may cause your urine to turn a reddish-orange color. This side effect by itself is usually not harmful. However, call your doctor if you also have upper stomach pain, clay-colored stools, or jaundice (yellowing of your skin or the whites of your eyes).

Common side effects may include:

  • nausea, vomiting; or

  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Proper Use of Adriamycin

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.

The medicine is usually given once every 21 to 28 days. You may also receive other medicines to help prevent nausea and vomiting.

Doxorubicin is sometimes given together with certain other medicines. If you are receiving a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your doctor to help you plan a way to take them at the right times.

While you are using this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine should come with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

What do I need to tell my doctor BEFORE I take Adriamycin?

  • If you have an allergy to doxorubicin or any other part of Adriamycin.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Anemia, heart problems, liver disease, a low platelet count, or a low white blood cell count.
  • If you have had a recent heart attack.
  • If you have had daunorubicin, doxorubicin, epirubicin, idarubicin, or mitoxantrone before, talk with your doctor.
  • If you are taking any of these drugs: Phenobarbital, phenytoin, St. John's wort, or verapamil.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Adriamycin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Adriamycin?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • To help with mouth sores, use a soft toothbrush or cotton swabs and rinse the mouth. Do not use mouth rinses that have alcohol in them.
  • Use care to keep body fluids from coming in contact with family members or caregivers. Wash soiled clothing right away and use gloves when touching body fluids for at least 5 days after each treatment.
  • Talk with your doctor before getting any vaccines. Use with Adriamycin may either raise the chance of an infection or make the vaccine not work as well.
  • You will need to have heart function tests while taking this medicine. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you have had or will be having radiation treatment, talk with your doctor. Worse side effects from radiation treatment have happened with Adriamycin.
  • Use with care in children. Talk with the doctor.
  • This medicine may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 6 months after care ends. Use birth control that you can trust.
  • This medicine may cause menstrual periods to stop in females who can get pregnant. This may affect being able to have children. It is not known if this will go back to normal. Talk with the doctor.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.
  • Use birth control that you can trust to prevent pregnancy while taking Adriamycin and for 6 months after stopping this medicine.
  • If you or your sex partner gets pregnant while taking Adriamycin (doxorubicin (conventional)) or within 6 months after stopping this medicine, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Indications and Usage for Adriamycin

Adjuvant Breast Cancer

Adriamycin (DOXOrubicin HCl) Injection, USP and Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer [see Clinical Studies (14.1)].

Other Cancers

Doxorubicin is indicated for the treatment of

  • acute lymphoblastic leukemia
  • acute myeloblastic leukemia
  • Hodgkin lymphoma
  • non-Hodgkin lymphoma (NHL)
  • metastatic breast cancer
  • metastatic Wilms’ tumor
  • metastatic neuroblastoma
  • metastatic soft tissue sarcoma
  • metastatic bone sarcoma
  • metastatic ovarian carcinoma

Dosage Forms and Strengths

Adriamycin (DOXOrubicin HCl) Injection, USP: Vials contain 10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL, 150 mg/75 mL, and 200 mg/100 mL doxorubicin hydrochloride as a clear red solution.

Contraindications

Doxorubicin is contraindicated in patients with:

  • Severe myocardial insufficiency [see Warnings and Precautions (5.1)]
  • Recent (occurring within the past 4 to 6 weeks) myocardial infarction [see Warnings and Precautions (5.1)]
  • Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4)]
  • Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5)]
  • Severe hypersensitivity reaction to doxorubicin including anaphylaxis [see Adverse Reactions (6.2)]

In Summary

Common side effects of Adriamycin include: severe nausea and vomiting, nausea and vomiting, and alopecia. See below for a comprehensive list of adverse effects.

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