Procrit (epoetin alfa)
Last reviewed · Source: First Databank (FDB) drug data
Overview
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.
Generic name: epoetin alfa
Pronunciation: (e-POE-tin AL-fa)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Procrit
Indications
The following indications are listed for Procrit:
- 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
Also known as: 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.
Dosing
No dosing information is available for this tab.
Administer epoetin alfa products by IV or subcutaneous injection. In patients undergoing hemodialysis, the manufacturers recommend that epoetin alfa products be given IV rather than subcutaneously because of reports of pure red cell aplasia (PRCA) associated with the latter route of administration.
Do not shake or freeze vials of epoetin alfa product, and discard if subjected to these conditions.
Inspect visually the contents of vials of epoetin alfa product for discoloration and/or particulate matter prior to administration whenever solution and container permit; if either is present, discard the solution.
For IV or subcutaneous use, withdraw the appropriate dose of the epoetin alfa product from the vial into the syringe for administration; once the dose has been withdrawn from the vial, administer promptly.
Do not mix epoetin alfa products with other drug solutions in general. However, the manufacturers of Epogen(R) and Procrit(R) state that the preservative-free formulation from single-use vials may be admixed in equal parts (in a 1:1 ratio) in a syringe with bacteriostatic 0.9% sodium chloride injection (preserved with benzyl alcohol) at the time of administration.
Discard unused portions of epoetin alfa product from single-dose preservative-free vials. Any unused portion of epoetin alfa product from multi-dose vials can be stored, protected from light, between 2-8degreesC for 21 days after initial entry. Because of the risks associated with benzyl alcohol, do not use epoetin alfa product that has been admixed with injection solutions containing benzyl alcohol in neonates, infants, and pregnant and nursing women.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
Interactions between epoetin alfa and other drugs have not been fully evaluated.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Uncontrolled hypertension.
*Pure red cell aplasia (PRCA) following treatment with epoetin alfa products or other erythropoietin proteins.
*History of a serious allergic reaction to epoetin alfa products.
*Use of epoetin alfa products from multi-dose vials containing benzyl alcohol in women who are pregnant or breastfeeding, neonates, and infants.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Patients with CKD (>=5%): hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.
Patients with HIV infection treated with zidovudine (>=5%): pyrexia, cough, rash, and injection site irritation.
Patients with cancer receiving chemotherapy (>=5%): nausea, vomiting, myalgia, arthralgia, stomatitis, cough, weight decrease, leukopenia, bone pain, rash, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis.
Surgical patients (>=5%): nausea, vomiting, pruritus, headache, injection site pain, chills, deep vein thrombosis, cough, and hypertension.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
The safety and efficacy of epoetin alfa products for the treatment of anemia associated with CKD, regardless of dialysis status, in pediatric patients younger than 1 month of age have not been established. In children at least 1 month of age with CKD, the pattern of most adverse events was similar to that found in adults. There does not appear to be a difference in safety profiles in pediatric patients with CKD requiring dialysis and not requiring dialysis.
The safety and efficacy of epoetin alfa products have not been established in pediatric patients who are younger than 5 years of age with cancer and receiving chemotherapy. In pediatric patients with cancer who are at least 5 years of age, the pattern of most adverse events was similar to that found in adults.
The safety and efficacy of epoetin alfa products have not been established in pediatric patients who are younger than 8 months of age with HIV infection receiving zidovudine.
Because of a potential risk of neurologic and other toxicity in neonates and infants exposed to benzyl alcohol, epoetin alfa products from multidose vials (with benzyl alcohol preservative) or from single-dose vials admixed with bacteriostatic saline containing benzyl alcohol should not be used in these populations. When epoetin alfa products are needed for neonates or infants, use of a benzyl alcohol-free formulation is recommended.
Although there are no adequate and controlled studies to date of epoetin alfa product use during pregnancy, the drug has been used in a limited number of pregnant women with anemia alone or anemia associated with severe renal disease and hematologic disorders. Adverse pregnancy outcomes, including prenatal complications (i.e., polyhydramnios, intrauterine growth restriction) have been reported. The manufacturers state that due to the limited number of exposed pregnancies and the presence of multiple confounding factors (e.g., concomitant medications or other maternal conditions), such data cannot be used to reliably estimate the frequency or absence of adverse pregnancy outcomes. Epoetin alfa products should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
Because of a potential risk of neurologic and other toxicity (e.g., gasping syndrome) in neonates exposed to benzyl alcohol, epoetin alfa product from multidose vials (with benzyl alcohol preservative) or from single-dose vials admixed with bacteriostatic saline containing benzyl alcohol should not be used in pregnant women. When therapy is needed during pregnancy or nursing, use of a benzyl alcohol-free formulation is recommended.
It is not known whether epoetin alfa is distributed into human milk. The effects of the drug on breast-fed infants or on the production of milk are unknown. Because of the potential for adverse reactions to epoetin alfa in breast-fed infants, caution is advised in women who breast-feed while receiving the drug.
Because of a potential risk of neurologic and other toxicity in neonates exposed to benzyl alcohol, epoetin alfa from multidose vials (with benzyl alcohol preservative) or from single-dose vials admixed with bacteriostatic saline containing benzyl alcohol should not be used in nursing women. The manufacturer advises women not to breastfeed for at least 2 weeks after the last dose of epoetin alfa product from a multidose vial. When therapy is needed for women who are nursing, use of a benzyl alcohol-free formulation is recommended.
In geriatric patients with anemia due to CKD, individualized dosing is recommended to maintain target hemoglobin concentrations.
The manufacturers of epoetin alfa products do not make specific dosage recommendations for geriatric patients with anemia and HIV infection treated with zidovudine.
In geriatric patients with chemotherapy-induced anemia and those undergoing elective surgery, dosage requirements appear to be similar to those in younger adults.
While safety and efficacy of epoetin alfa products have not been established specifically in geriatric patients, a large proportion of patients treated with the drug for anemia associated with CKD have been 65 years of age or older. In geriatric patients with anemia associated with CKD, no overall differences in safety and efficacy have been observed relative to younger adults.
In geriatric patients with anemia due to concomitant chemotherapy or in those undergoing elective surgery, no overall differences in safety and efficacy of epoetin alfa products have been observed relative to younger adults; dosing requirements generally were similar between geriatric patients and younger adults for each indication.
Data are insufficient in patients 65 years of age and older who have HIV infection and are treated with zidovudine to determine whether they respond differently than younger adults to epoetin alfa products.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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