Registered South Africa · SAHPRA

ACCORD EPIRUBICIN 50

EPIRUBICNIN HYDROCHLORIDE

42/26/0900

What it does

Epirubicin is a chemotherapy medication used to treat certain types of cancer.

Commonly used for: breast cancer, bladder cancer, stomach cancer

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
42/26/0900
Registration date
2011/05/08
Expiry date
-
Status
Registered
Active ingredient
EPIRUBICNIN HYDROCHLORIDE
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Accord Healthcare (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:11:33 · updated 2026-10-21 04:00:08

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About this medicine

Epirubicin is a chemotherapy medication used to treat certain types of cancer.

What it treats

  • breast cancer
  • bladder cancer
  • stomach cancer

How it works

Epirubicin works by stopping the growth of cancer cells in the body.

Who it's for

Epirubicin is prescribed for patients diagnosed with specific cancers as part of their treatment plan.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: epirubicnin

Epirubicin is an anthracycline antibiotic used primarily in the treatment of various cancers, including breast cancer and other solid tumors. It functions by inhibiting DNA synthesis and interfering with the replication of cancer cells, thereby exerting cytotoxic effects. Epirubicin is a semisynthetic derivative of doxorubicin, designed to enhance the therapeutic index and reduce the risk of certain side effects.

Indications

  • Breast cancer
  • Gastric cancer
  • Lung cancer
  • Ovarian cancer
  • Soft tissue sarcomas
  • Bladder cancer

Dosage

Children: Refer to the BNF for Children for pediatric dosing guidelines.

Adults: Refer to the BNF for specific dosing based on cancer type and treatment regimen.

Mechanism of action

Epirubicin intercalates into DNA, disrupting the structure and function of the DNA molecule. This action inhibits the enzyme topoisomerase II, which is crucial for DNA replication. By preventing the proper unwinding of DNA, epirubicin induces double-strand breaks and ultimately leads to cell death, particularly in rapidly dividing cancer cells.

Pharmacodynamics

The pharmacodynamics of epirubicin involve its ability to induce apoptosis in malignant cells. The drug's action is concentration-dependent, and its effectiveness can be influenced by the cell cycle phase, with the most significant effects occurring during the S and G2 phases. Epirubicin also has immunosuppressive properties, which can affect the response to cancer therapy and the patient’s overall immune status.

Pharmacokinetics

Epirubicin is administered intravenously and has a volume of distribution of approximately 50 L/m². It is metabolized primarily in the liver, undergoing extensive hepatic metabolism, with its active metabolites contributing to its overall antitumor activity. The elimination half-life is approximately 30 to 36 hours, and it is primarily excreted in urine as metabolites. Renal impairment may affect the clearance of the drug, necessitating dose adjustments in patients with compromised renal function.

Contra-indications

  • Hypersensitivity to epirubicin or any of its components
  • Severe myelosuppression
  • Active infections
  • Pregnancy
  • Severe liver impairment

Adverse effects

  • Nausea and vomiting
  • Myelosuppression
  • Cardiotoxicity
  • Alopecia
  • Mucositis
  • Extravasation reactions
  • Diarrhea
  • Fatigue

Interactions

  • CYP3A4 inhibitors and inducers may affect epirubicin metabolism
  • Other cardiotoxic agents may increase the risk of cardiac side effects
  • Live vaccines can pose a risk in patients receiving immunosuppressive chemotherapy

Precautions

  • Monitor cardiac function due to potential cardiotoxicity
  • Use caution in patients with pre-existing liver disease
  • Regular blood counts are necessary to monitor for myelosuppression
  • Avoid live vaccines during treatment

Pregnancy

Epirubicin is contraindicated in pregnancy due to potential teratogenic effects.

Breast-feeding

Breastfeeding is not recommended during treatment with epirubicin due to potential excretion in breast milk.

Storage

Store in a cool, dry place away from light. Protect from freezing.

Formulations

  • Injection solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.