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Doxorubicin Hydrochloride Solution for injection

It is used to treat many kinds of cancer like Hodgkin's disease, leukemia, non-Hodgkin's lymphoma, n... more

Generic Name: DOXOrubicin  |  Brand Name: Adriamycin

Brand Names: Adriamycin, Adriamycin RDF

There is an FDA Alert for this drug. Click here to view it.

    Extravasation
  • Severe local tissue necrosis if extravasation occurs. Do not administer IM or sub-Q.

    Myocardial Toxicity
  • Possible cardiotoxicity and potentially fatal CHF during or months to years after therapy; risk of developing CHF increases rapidly with increasing total cumulative dosages >450 mg/m2. Toxicity may occur at lower cumulative dosages whether or not risk factors are present. (See Cardiotoxicity under Cautions.)
  • Probability of developing impaired myocardial function based on combined index of signs, symptoms, and decline in LVEF is estimated to be 1–2, 3–5, 5–8, or 6–20% at total cumulative dosage of 300, 400, 450, or 500 mg/m2, respectively.
  • Risk factors (active or dormant cardiovascular disease, doxorubicin exposure at an early or advanced age, prior or concomitant mediastinal/pericardial irradiation, previous therapy with other anthracyclines or anthracenediones, concomitant use of other cardiotoxic agents) may increase risk of cardiotoxicity.
  • Pediatric patients are at increased risk for developing delayed cardiotoxicity.
  • Experience with liposomal doxorubicin at high cumulative dosages is too limited to have established effects on the myocardium; assume myocardial toxicity is similar to that of conventional doxorubicin formulations. Administer to patients with history of cardiovascular disease only when benefits outweigh risk.

    Secondary Acute Myelogenous Leukemia (AML)
  • Possible secondary AML in patients treated with anthracyclines, including doxorubicin; occurrence of refractory secondary leukemia is more common when such drugs are given in combination with other DNA-damaging antineoplastics, after extensive exposure to cytotoxic agents, or when anthracyline dosages have been escalated. (See Mutagenicity and Carcinogenicity under Cautions.)
  • Pediatric patients are at risk of developing secondary AML.

    Infusion-related Effects
  • Infusion-related reactions (e.g., flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness of chest or throat, hypotension) reported in patients receiving liposomal doxorubicin. Reactions generally resolve within several hours to a day once infusion terminated; may resolve in some patients with slowing of infusion rate.
  • Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions reported; appropriate therapy and emergency equipment should be available for immediate use.
  • Administer liposomal doxorubicin at initial rate of 1 mg/minute to minimize risk of infusion reactions.

    Myelosuppression
  • Severe myelosuppression may occur. (See Hematologic Effects under Cautions.)

    Hepatic Impairment
  • Reduce dosage in patients with hepatic impairment. (See Special Populations under Dosage and Administration and also see Hepatic Impairment under Cautions.)

    Accidental Substitution
  • Accidental substitution of liposomal doxorubicin for conventional doxorubicin has resulted in severe adverse effects; do not substitute for conventional doxorubicin on a mg-per-mg basis.

    Experience of Supervising Clinician
  • Administer only under the supervision of qualified clinician experienced in the use of cancer chemotherapeutic agents.

What is this medicine?

DOXORUBICIN (dox oh ROO bi sin) is a chemotherapy drug. It is used to treat many kinds of cancer like Hodgkin's disease, leukemia, non-Hodgkin's lymphoma, neuroblastoma, sarcoma, and Wilms' tumor. It is also used to treat bladder cancer, breast cancer, lung cancer, ovarian cancer, stomach cancer, and thyroid cancer.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • blood disorders
  • heart disease, recent heart attack
  • infection (especially a virus infection such as chickenpox, cold sores, or herpes)
  • irregular heartbeat
  • liver disease
  • recent or ongoing radiation therapy
  • an unusual or allergic reaction to doxorubicin, other chemotherapy agents, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • cisapride
  • droperidol
  • halofantrine
  • pimozide
  • zidovudine

This medicine may also interact with the following medications:

  • chloroquine
  • chlorpromazine
  • clarithromycin
  • cyclophosphamide
  • cyclosporine
  • erythromycin
  • medicines for depression, anxiety, or psychotic disturbances
  • medicines for irregular heart beat like amiodarone, bepridil, dofetilide, encainide, flecainide, propafenone, quinidine
  • medicines for seizures like ethotoin, fosphenytoin, phenytoin
  • medicines for nausea, vomiting like dolasetron, ondansetron, palonosetron
  • medicines to increase blood counts like filgrastim, pegfilgrastim, sargramostim
  • methadone
  • methotrexate
  • pentamidine
  • progesterone
  • vaccines
  • verapamil

Talk to your doctor or health care professional before taking any of these medicines:

  • acetaminophen
  • aspirin
  • ibuprofen
  • ketoprofen
  • naproxen

What should I watch for while using this medicine?

Your condition will be monitored carefully while you are receiving this medicine. You will need important blood work done while you are taking this medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

Your urine may turn red for a few days after your dose. This is not blood. If your urine is dark or brown, call your doctor.

In some cases, you may be given additional medicines to help with side effects. Follow all directions for their use.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Be careful brushing and flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medicine.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Men and women of childbearing age should use effective birth control methods while using taking this medicine. Do not become pregnant while taking this medicine. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

Do not let others touch your urine or other body fluids for 5 days after each treatment with this medicine. Caregivers should wear latex gloves to avoid touching body fluids during this time.


Last Updated: April 07, 2009
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