ADRIAMYCIN PFS SIDE EFFECTS

  • Generic Name: doxorubicin hydrochloride
  • Brand Name: Adriamycin PFS
Last updated on MDtodate: 10/03/2022

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling.

  • Cardiomyopathy and Arrhythmias.
  • Secondary Malignancies.
  • Extravasation and Tissue Necrosis.
  • Severe Myelosuppression.
  • Tumor Lysis Syndrome.
  • Radiation Sensitization and Radiation Recall.

Clinical Trial Experience In Breast Cancer

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety data below were collected from 1492 women who received doxorubicin at a dose of 60 mg/m² and cyclophosphamide at a dose of 600 mg/m² (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer. The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 1. No treatment-related deaths were reported in patients on either arm of the study.

Table 1: Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes

Adverse reactions, % of patients AC*
N=1492
Conventional CMF
N=739
Leukopenia
Grade 3 (1,000 to 1,999 /mm³) 3.4 9.4
Grade 4 (<1000 /mm³) 0.3 0.3
Thrombocytopenia
Grade 3 (25,000 to 49,999 /mm³) 0 0
Grade 4 (<25,000 /mm³) 0.1 3 0
Shock, sepsis 2 1
Systemic infection 2 1
Vomiting
Vomiting <12 hours 34 25
Vomiting >12 hours 37 12
Intractable 5 2
Alopecia 92 71
Cardiac dysfunction
Asymptomatic 0.2 0.1
Transient 0.1 0
Symptomatic 0.1 0
* 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

 

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of doxorubicin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac – cardiogenic shock

Cutaneous – Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia

Gastrointestinal – Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa

Hypersensitivity – Anaphylaxis

Laboratory Abnormalities –Increased alanine aminotransferase, increased aspartate aminotransferase

Neurological – Peripheral sensory and motor neuropathy, seizures, coma

Ocular – Conjunctivitis, keratitis, lacrimation

Vascular – Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism

Other – Malaise/asthenia, fever, chills, weight gain

 

SRC: NLM .