PROCRIT (epoetin alfa)


Drug overview for PROCRIT (epoetin alfa):

Generic name: EPOETIN ALFA (e-POE-tin AL-fa)
Drug class: Erythropoiesis-Stimulating Agents
Therapeutic class: Hematological Agents

Epoetin alfa, a biosynthetic form of the glycoprotein hormone erythropoietin, is a hematopoietic agent that principally affects erythropoiesis. Epoetin alfa-epbx is biosimilar to epoetin alfa (Epogen(R); Procrit(R)). The FDA defines a biosimilar as a biological that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency.

The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies. Therefore, biosimilarity of 2 drugs may be established even when there are formulation or minor structural differences or minor differences in rates of adverse effects between the drugs as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological.

In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alternation or switch. Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. The currently available epoetin alfa biosimilar does not have interchangeable data at this time. In this monograph, unless otherwise stated, the term ''epoetin alfa products'' refers to epoetin alfa (the reference drug), epoetin alfa-epbx (the biosimilar), or both drugs.

Epoetin alfa and epoetin alfa-epbx have not been shown to improve quality of life, fatigue, or patient well-being.
DRUG IMAGES
  • PROCRIT 10,000 UNITS/ML VIAL
    PROCRIT 10,000 UNITS/ML VIAL
  • PROCRIT 3,000 UNITS/ML VIAL
    PROCRIT 3,000 UNITS/ML VIAL
  • PROCRIT 2,000 UNITS/ML VIAL
    PROCRIT 2,000 UNITS/ML VIAL
  • PROCRIT 4,000 UNITS/ML VIAL
    PROCRIT 4,000 UNITS/ML VIAL
  • PROCRIT 40,000 UNITS/ML VIAL
    PROCRIT 40,000 UNITS/ML VIAL
  • PROCRIT 20,000 UNITS/ML VIAL
    PROCRIT 20,000 UNITS/ML VIAL
The following indications for PROCRIT (epoetin alfa) have been approved by the FDA:

Indications:
Anemia due to chemotherapy and radiotherapy combination
Anemia in chronic kidney disease
Chemotherapy-induced anemia
Reduction of allogeneic blood transfusion in surgery
Zidovudine-induced anemia


Professional Synonyms:
Anemia co-occurrent and due to chronic kidney disease
Anemia due to chronic kidney disease
Anemia due to CKD
Anemia in CKD
AZT-induced anemia