ADRIAMYCIN PFS SIDE EFFECTS
- Generic Name: doxorubicin hydrochloride
- Brand Name: Adriamycin PFS
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 .