RETACRIT™ (Epoetin Alfa-Epbx) Injection

RETACRIT™

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Important Safety Information

RETACRIT™ (epoetin alfa-epbx) injection is used to treat patients with anemia due to chronic kidney disease (CKD).

RETACRIT™ is an FDA-approved erythropoiesis-stimulating agent (ESA) used to treat the same conditions as Epogen®/Procrit® (epoetin alfa). It is considered a biosimilar of epoetin alfa, meaning that there are no clinically meaningful differences between the biosimilar and its reference product.

What is the most important information I should know about RETACRIT™?

Erythropoiesis-stimulating agents (ESAs) increase the risk of the following:

  • Death
  • Heart Attack
  • Stroke
  • Venous thromboembolism
  • Thrombosis of vascular access

In controlled trials involving patients with chronic kidney disease (CKD), patients experienced a greater risk of death, severe cardiovascular reactions, and stroke when the ESA was used to target hemoglobin levels above 11 g/dL. No trial has yet shown an ESA dosage or dosing strategy that decreases these risks.

In clinical trials involving patients with breast, head and neck, lymphoid, non-small cell lung, and cervical cancers, ESAs shortened overall survival and increased the risk of tumor recurrence or progression. In cancer contexts, ESAs should only be used to treat anemia from myelosuppressive chemotherapy in cases when the anticipated outcome is not cure, and treatments should be discontinued at the end of the patient’s chemotherapy course.

In perisurgical use, DVT prophylaxis is recommended due to the increased risk of deep venous thrombosis (DVT)

To reduce the likelihood of these risks, use the lowest dosage needed to reduce the need for red blood cell (RBC) transfusions.

Side Effects of RETACRIT™

Side effects of RETACRIT™ include but are not limited to:

  • Hypertension (high blood pressure)
  • Seizures
  • Joint and muscle pain
  • Fever, dizziness, and cough
  • Nausea, vomiting, and chills
  • Increased mortality in cancer patients
  • Serious allergic reactions

For a complete listing of side effects, adverse effects, and contraindications of RETACRIT™, view the complete documentation on FDA’s website.

If you experience these or any other adverse reactions to RETACRIT™ injection, contact a medical professional for further consultation, and — in severe cases — seek emergency medical help. To report side effects of RETACRIT™ not listed in the official documentation, contact the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

RETACRIT™ is indicated for the treatment of anemia due to: chronic kidney disease (CKD), to decrease the need for red blood cell (RBC) transfusion. It is also indicated for reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

Please refer to the full prescribing information.