Drug Notebook

FDA Alerts

    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.

Drug Info Tools
Pill Finder
Search by color, shape and markings. click here
Drug Interaction Checker
Check any 2 drugs for interactions. click here
Drug Compare
Compare any two drugs side by side. click here
Healthline Part D Plan Selector Medicare Part D
Medicare's drug plans are subsidized by the US federal government and offered through insurers.
Advertisement
Marketplace
Licensed from
DOXOrubicin
(dock sew RUE bih sin)

What is doxorubicin?
Doxorubicin is a cancer (antineoplastic) medication. Doxorubicin interferes with the growth of cancer cells and slows their growth and spread in the body. Doxorubicin is used to treat many types of cancer. Doxorubicin may also be used for purposes other than those listed in this medication guide.

Back to Top

What are the possible side effects of doxorubicin?

If you experience any of the following serious side effects from doxorubicin, contact your doctor immediately:

  • an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  • decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);

  • congestive heart failure (difficulty breathing, fluid retention, chest pain);

  • irregular heartbeats;

  • tissue or vein reactions near the site of administration;

  • liver damage (abdominal pain, yellowing of the skin or eyes);

  • severe nausea, vomiting, diarrhea, and loss of appetite;

  • inflamation and sores inside the mouth, throat, or intestines;

  • fever, chills, or other signs of infection;

  • numbness, tingling, or difficult movement of a body part;

  • seizures; or

  • increased levels of uric acid in the body (joint pain and stiffness).

Other, less serious side effects may be more likely to occur. Continue taking doxorubicin and talk to your doctor if you experience:

  • facial flushing during administration;

  • eye irritation or tearing;

  • darkening of the nail beds and skin folds;

  • temporary hair loss; or

  • red colored urine for 1 or 2 days following a dose.

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with doxorubicin.

Back to Top

How should I use doxorubicin?
Doxorubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents. Your doctor will determine the correct amount and frequency of treatment with doxorubicin depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule. Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with doxorubicin to monitor progress and side effects.

Back to Top

What is the most important information I should know about doxorubicin?
Doxorubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents. Serious side effects have been reported with the use of doxorubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with doxorubicin.

Back to Top

What happens if I miss a dose?
Contact your doctor if you miss a dose of doxorubicin.

Back to Top

What other drugs will affect doxorubicin?
Do not use doxorubicin without first talking to your doctor if you have had previous treatment with doxorubicin (Adriamycin, Rubex), doxorubicin liposomal (Doxil), daunorubicin (Cerubidine), daunorubicin liposomal (Daunoxome), idarubicin (Idamycin), or mitoxantrone (Novantrone). Because there is a maximum amount of these medications that should be administered to an individual, you may not be able to use doxorubicin. Before using doxorubicin, tell your doctor if you are taking any of the following medicines.

Back to Top

Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Doxorubicin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and teratogenicity. Although controlled data from human pregnancy studies are not available, several cases of birth defects have been associated with the use of doxorubicin. Some experts feel that the use of doxorubicin for the treatment of breast cancer during pregnancy improves the high postpartum maternal mortality rate and the chance of producing live births without excessive risk to the fetus or the mother, even if administered early in the course of pregnancy. Doxorubicin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Doxorubicin crosses the human placenta. Several cases of birth defects have been associated with the use of doxorubicin during pregnancy. These birth defects have included imperforate anus, rectovaginal fistula, brachycephaly, hypoplasia of the anterior cranial base and face, synostoses of cranial sutures, hypoplastic digits, and fetal maceration. Fetal death has been reported 36 hours after treatment with doxorubicin and other neoplastic agents. Doxorubicin may cause reversible testicular and ovarian dysfunction or menstrual abnormalities. Most men who have received doxorubicin regain spermatogenesis and sperm motility. Some women who were previously treated with doxorubicin have subsequently had normal pregnancies. Development of sterility may depend on the dose, duration of therapy, and the pretreatment state of gonadal function. Pregnancy outcome in women who received doxorubicin for malignancy in childhood has been reported to generally be favorable. Those with baseline left ventricular dysfunction should be considered at increased risk for worse pregnancy outcome and further deterioration in myocardial function. Peripartum heart failure has been reported years after doxorubicin therapy. Pregnancy, preeclampsia, anemia, or overhydration are possible precipitating factors in the emergence of heart failure in patients who have received doxorubicin. While there are no data regarding the handling of doxorubicin or other cytotoxic agents by women who are pregnant, attempting to conceive, or breast-feeding, some experts suggest the need for caution.

Doxorubicin is excreted into and accumulates in human milk. Side effects, including immune suppression, carcinogenesis, neutropenia, and unknown effects on growth are possible in nursing infants. The American Academy of Pediatrics considers the use of doxorubicin to be contraindicated during breast-feeding.

Peak milk concentrations of doxorubicin and its metabolite, doxorubicinol, averaged 128 and 111 ng/mL, respectively, 24 hours after a 70 mg/m2 IV dose was given to a 31 year old nursing woman. The milk to plasma concentration ratio at 24 hours was 4.43. Although doxorubicin concentrated into milk in this case, the absolute concentration of drug in the milk was only 0.24 mcg/mL. Although this amount appears negligible, experts consider the use of doxorubicin during breast-feeding to be contraindicated because of the known and suspected risks to the nursing infant.

Back to Top

Who should NOT use this medication?

  • Usual precautions and contraindications of doxorubicin apply to both conventional and PEG-stabilized liposomal formulations.

    Conventional Doxorubicin
  • Marked myelosuppression induced by previous treatment with other antineoplastic agents or radiation therapy.
  • Previous treatment with complete cumulative dosages of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenes.

    Liposomal Doxorubicin
  • Known hypersensitivity to conventional doxorubicin preparations or any ingredient in the liposomal formulation.
  • Nursing women.

Back to Top

What does my medication look like?
Doxorubicin is available with a prescription under the brand name Adriamycin PFS, Adriamycin RDF, and Rubex. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about this medication, especially if it is new to you.

Back to Top

What happens if I overdose?
If for any reason an overdose of doxorubicin is suspected, seek emergency medical attention or contact your healthcare provider immediately. Symptoms of a doxorubicin overdose tend to be similar to side effects caused by the medication, although often more severe.

Back to Top

What should I discuss with my healthcare provider before using doxorubicin?
Do not use doxorubicin without first talking to your doctor if you have kidney disease; liver disease; heart disease; poor bone marrow function; received radiation therapy that encompassed the heart; or previously received treatment with doxorubicin (Adriamycin, Rubex), doxorubicin liposomal (Doxil), daunorubicin (Cerubidine), daunorubicin liposomal (Daunoxome), idarubicin (Idamycin), or mitoxantrone (Novantrone). The use of doxorubicin may be dangerous if you have any of the conditions listed above.

Back to Top

Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

Back to Top

I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

Back to Top

Where can I get more information?
More Information

Back to Top

Back to Top