Doxorubicin Hydrochloride

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 6/3/2022
Doxorubicin Hydrochloride Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Doxorubicin Hydrochloride?

Doxorubicin Hydrochloride is a cytotoxic, anthracycline, topoisomerase II inhibitor indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer. Doxorubicin hydrochloride is also indicated for the treatment of certain metastatic disease, leukemia, and lymphoma.  Doxorubicin hydrochloride is available in generic form.

What Are Side Effects of Doxorubicin Hydrochloride?

Common side effects of doxorubicin hydrochloride include:

Dosage for Doxorubicin Hydrochloride

The recommended dose of doxorubicin HCl is 60 mg/m administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles. The recommended dose of doxorubicin HCl for metastatic disease, leukemia, or lymphoma when used as a single agent is 60 to 75 mg/m intravenously every 21 days.

What Drugs, Substances, or Supplements Interact with Doxorubicin Hydrochloride?

Doxorubicin hydrochloride may interact with verapamil, phenobarbital, phenytoin, St. John's Wort, trastuzumab, paclitaxel, dexrazoxane, and 6-mercaptopurine. Tell your doctor all medications and supplements you use.

Doxorubicin Hydrochloride During Pregnancy and Breastfeeding

Doxorubicin hydrochloride is not recommended for use during pregnancy; it may harm a fetus. Doxorubicin hydrochloride may pass into breast milk. Breastfeeding while receiving doxorubicin hydrochloride is not recommended.

Additional Information

Our Doxorubicin hydrochloride Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Doxorubicin Hydrochloride Professional Information

SIDE EFFECTS

Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. Other reactions reported are:

Cardiotoxicity

(See WARNINGS).

Cutaneous

Reversible complete alopecia occurs in most cases. Hyperpigmentation of nailbeds and dermal creases, primarily in pediatric patients, and onycholysis have been reported in a few cases. Radiation recall reaction has occurred with doxorubicin administration. Rash, itching, or photosensitivity may occur.

Gastrointestinal

Acute nausea and vomiting occurs frequently and may be severe. This may be alleviated by antiemetic therapy. Mucositis (stomatitis and esophagitis) may occur within 5 to 10 days of beginning therapy, and most patients recover from this adverse event within another 5 to 10 days. The effect may be severe leading to ulceration and represents a site of origin for severe infections. The dosage regimen consisting of administration of doxorubicin on three successive days results in greater incidence and severity of mucositis. Ulceration and necrosis of the colon, especially the cecum, may occur leading to bleeding or severe infections which can be fatal. This reaction has been reported in patients with acute non-lymphocytic leukemia treated with a 3-day course of doxorubicin combined with cytarabine. Anorexia, abdominal pain, dehydration, diarrhea, and hyperpigmentation of the oral mucosa have been occasionally reported.

Hematologic

(See WARNINGS).

Hypersensitivity

Fever, chills and urticaria have been reported occasionally. Anaphylaxis may occur. A case of apparent cross sensitivity to lincomycin has been reported.

Neurological

Peripheral neurotoxicity in the form of local-regional sensory and/or motor disturbances have been reported in patients treated intra-arterially with doxorubicin, mostly in combination with cisplatin. Animal studies have demonstrated seizures and coma in rodents and dogs treated with intra-carotid doxorubicin. Seizures and coma have been reported in patients treated with doxorubicin in combination with cisplatin or vincristine.

Ocular

Conjunctivitis, keratitis, and lacrimation occur rarely.

Other

Malaise/asthenia have been reported.

Adverse Reactions In Patients With Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy

Safety data were collected from approximately 2,300 women who participated in a randomized, open-label trial (NSABP B-15) evaluating the use of AC versus CMF in the treatment of early breast cancer involving axillary lymph nodes. In the safety analysis, the follow-up data from all patients receiving AC were combined (N=1,492 evaluable patients) and compared with data from patients receiving conventional CMF (i.e., oral cyclophosphamide; N=739 evaluable patients). The most relevant adverse events reported in this study are provided in Table 2.

Table 2. Relevant Adverse Events in Patients with Early Breast Cancer Involving Axillary Lymph Nodes

AC*Conventional CMF
N=1,492N=739
Treatment administration
  Mean number of cycles3.85.5
  Total cycles5,6764,068
Adverse events, % of patients
Leukopenia
  Grade 3 (1,000 to 1,999 /mm3 )3.49.4
  Grade 4 (<1000/mm3 )0.30.3
Thrombocytopenia
  Grade 3 (25,000 to 49,999 /mm3 )00.3
  Grade 4 (<25,000 /mm3 )0.10
Shock, sepsis1.50.9
Systemic infection2.41.2
Nausea and vomiting
  Nausea only15.542.8
  Vomiting ≤ 12 hours34.425.2
  Vomiting >12 hours36.812
  Intractable4.71.6
Alopecia92.471.4
  Partial22.956.3
  Complete69.515.1
Weight loss
  5 to 10%6.25.7
  >10%2.42.8
Weight gain
  5 to 10%10.627.9
  >10%3.814.3
Cardiac function
  Asymptomatic0.20.1
  Transient0.10
  Symptomatic0.10
Treatment-related death00
*Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF

Read the entire FDA prescribing information for Doxorubicin Hydrochloride (Doxorubicin Hydrochloride Injection)

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© Doxorubicin Hydrochloride Patient Information is supplied by Cerner Multum, Inc. and Doxorubicin Hydrochloride Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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