3 months to expiry Ghana · FDA Ghana

RETACRIT 4000 IU/0.4ML SOLUTION FOR INJECTION (EPOETIN ALFA-EPBX)

EPOETIN ALFA-EPBX

FDA/BS/251-07008 EPOETIN ALFA-EPBX 4000 IU/0.4ML

What it does

Epoetin is a medicine that helps to increase the number of red blood cells in the body.

Commonly used for: anemia (low red blood cell count), chronic kidney disease, certain cancers

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Registration & product details

Registration no.
FDA/BS/251-07008
Registration date
2025-07-09
Expiry date
2026-08-01
Status
3 months to expiry
Active ingredient
EPOETIN ALFA-EPBX
Dosage form
EPOETIN ALFA-EPBX
Strength
4000 IU/0.4ML
Pack size
-
Therapeutic class
-
RxNorm RxCUI
105694
Manufacturer / MAH
Hospira
Country of origin
CROATIA
Manufacturer location
Žmaučeva ul. 13A, 10291, Drenje Brdovečko, Croatia

Source: Food and Drugs Authority · fetched 2026-04-18 08:48:29 · updated 2026-07-31 04:00:09

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Epoetin is a medicine that helps to increase the number of red blood cells in the body.

What it treats

  • anemia (low red blood cell count)
  • chronic kidney disease
  • certain cancers

How it works

Epoetin stimulates the bone marrow to produce more red blood cells, which helps improve oxygen delivery in the body.

Who it's for

This medicine is for people with conditions that cause low red blood cell counts, such as kidney problems or specific types of cancer.

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

Clinical monograph: epoetin

Epoetin is a recombinant form of human erythropoietin, a glycoprotein hormone that stimulates the production of red blood cells (RBCs) in the bone marrow. It is primarily indicated for the treatment of anemia, particularly in patients with chronic kidney disease, cancer-related anemia, or those undergoing certain medical treatments that may lead to reduced erythropoiesis. Epoetin helps to improve hemoglobin levels, reduce the need for blood transfusions, and enhance the quality of life for patients with anemia.

Indications

  • Anemia of chronic kidney disease
  • Anemia associated with cancer chemotherapy
  • Anemia in patients undergoing major surgery
  • Anemia in patients with HIV receiving zidovudine

Dosage

Children: Refer to the BNF for Children for specific pediatric dosing information.

Adults: Refer to the BNF for specific dosing guidelines based on the condition being treated.

Mechanism of action

Epoetin binds to the erythropoietin receptor on erythroid progenitor cells in the bone marrow, promoting their differentiation and proliferation. This action stimulates erythropoiesis, leading to increased production of RBCs. Additionally, it enhances the survival of erythroid progenitor cells and promotes the release of reticulocytes into the bloodstream, ultimately leading to an increase in hemoglobin levels.

Pharmacodynamics

Epoetin exhibits dose-dependent effects on erythropoiesis. Its activity results in increased hemoglobin concentration and hematocrit levels. The onset of action is generally observed within a few days, with peak effects typically seen within 1 to 2 weeks of administration. Long-term use may lead to increased RBC mass and improved oxygen delivery to tissues.

Pharmacokinetics

Epoetin is administered via subcutaneous or intravenous routes. It has a half-life of approximately 4 to 13 hours, depending on the formulation and route of administration. The drug is primarily eliminated through the kidneys, with a significant portion undergoing metabolic degradation. The pharmacokinetics may be influenced by factors such as renal function and patient-specific characteristics.

Contra-indications

  • Uncontrolled hypertension
  • Pure red cell aplasia
  • Hypersensitivity to epoetin or any of its components

Adverse effects

  • Hypertension
  • Headache
  • Fatigue
  • Nausea
  • Diarrhea
  • Injection site reactions
  • Thrombotic events (e.g., stroke, myocardial infarction)

Interactions

  • Antihypertensive agents may require dose adjustments due to the potential for increased blood pressure
  • Iron supplements may be used concurrently; ensure adequate iron stores for optimal erythropoiesis

Precautions

  • Monitor hemoglobin levels regularly to avoid excessive increases
  • Use with caution in patients with a history of cardiovascular disease
  • Assess iron status before and during treatment

Pregnancy

Epoetin may be used during pregnancy if the benefits outweigh the risks, as it is classified as category C.

Breast-feeding

Epoetin is excreted in breast milk; caution is advised when administered to nursing mothers.

Storage

Store in the refrigerator (2°C to 8°C), do not freeze. Keep protected from light.

Formulations

  • Epoetin alfa injectable solution
  • Epoetin beta injectable 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.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.