What does epoetin alfa do. The Remarkable Epoetin Alfa: Revolutionizing Anemia Treatment
What does epoetin alfa do? How does it work? Discover the fascinating details about this groundbreaking erythropoiesis-stimulating agent and its impact on anemia treatment.
Epoetin Alfa: A Powerful Weapon Against Anemia
Epoetin alfa, marketed as Procrit and Epogen, is a highly effective Erythropoiesis-Stimulating Agent (ESA) that has revolutionized the treatment of anemia. This drug, developed by Amgen, Inc., works like the human protein erythropoietin, which stimulates the bone marrow to produce more red blood cells. By increasing the production of these vital cells, epoetin alfa can effectively treat anemia resulting from various medical conditions, including chronic kidney disease, chemotherapy, and certain treatments for Human Immunodeficiency Virus (HIV).
Overcoming the Risks: FDA’s REMS Evaluation
In 2017, the FDA conducted a thorough evaluation of the Risk Evaluation and Mitigation Strategy (REMS) for epoetin alfa and darbepoetin alfa, another ESA. The assessment revealed that the prescribers’ knowledge of the risks associated with these drugs, such as decreased survival and increased risk of tumor progression or recurrence in cancer patients, was acceptable. Additionally, the data showed that the prescribing of ESAs was consistent with the intended use as a treatment alternative to red blood cell transfusion for anemia related to myelosuppressive chemotherapy.
Regulatory Actions and Evolving Guidelines
The FDA’s evaluation took into account the multiple regulatory actions it had taken, including labeling changes, as well as the National Coverage Determination (NCD) made by the Center for Medicare and Medicaid Services (CMS) in 2007 to limit the coverage of ESAs for non-renal disease indications. These actions, alongside the implementation of the ESA REMS in 2011, led to significant changes in the utilization of ESAs, such as a decrease in the proportion of patients receiving chemotherapy using ESAs and an increase in the proportion of patients initiating ESAs at a hemoglobin level below 10 g/L.
Risks and Benefits: Empowering Informed Decisions
While the REMS is no longer deemed necessary to ensure the benefits of epoetin alfa and darbepoetin alfa outweigh the risks, the serious risks associated with these drugs remain. The prescribing information continues to highlight the increased risk of tumor progression or recurrence, as well as the potential for adverse events like death, myocardial infarction, stroke, and thromboembolism. Healthcare providers are encouraged to carefully discuss the risks and benefits with each patient before initiating treatment with these ESAs.
Evolving Regulatory Landscape and Clinical Guidelines
The FDA’s decision to release the REMS requirements for epoetin alfa and darbepoetin alfa was influenced by the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) clinical guidelines, which provide evidence-based recommendations for the standard of care in clinical oncology. These guidelines, along with the CMS NCD, support the appropriate use of ESAs as a treatment alternative to red blood cell transfusion for anemia associated with myelosuppressive chemotherapy.
Harnessing the Power of Erythropoiesis-Stimulating Agents
Epoetin alfa and darbepoetin alfa, as Erythropoiesis-Stimulating Agents, have played a pivotal role in the treatment of anemia. By stimulating the production of red blood cells, these drugs have become invaluable tools in the management of various medical conditions, offering patients an alternative to blood transfusions. The FDA’s decision to release the REMS requirements, coupled with the evolving clinical guidelines, demonstrates the ongoing effort to ensure the optimal and safe use of these remarkable pharmacological agents.
Reporting Adverse Reactions and Quality Issues
Healthcare providers and patients are encouraged to report any adverse reactions or quality problems experienced with the use of epoetin alfa (Procrit/Epogen) or darbepoetin alfa (Aranesp) to the FDA’s MedWatch Adverse Event Reporting program. This helps the regulatory authorities to monitor the safety and effectiveness of these drugs, ensuring their continued safe use in the treatment of anemia.
Information on Erythropoiesis-Stimulating Agents (ESA) Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
Epoetin alfa and darbepoetin alfa are Erythropoiesis-Stimulating Agents (ESAs), approved for the treatment of anemia (low red blood cells) resulting from chronic kidney disease, chemotherapy, certain treatments for Human Immunodeficiency Virus (HIV), and also to reduce the number of blood transfusions during and after certain major surgeries. ESAs work like the human protein erythropoietin, which stimulates bone marrow to make red blood cells.Epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen, Inc.
In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS), which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh its risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer.
The FDA made this determination based on an evaluation of the results of the REMS Assessments submitted by Amgen, Inc., and additional FDA analyses to understand the impact of the various regulatory and other actions on the use of ESAs.
The REMS Assessment showed that:
- The results from surveyed prescribers demonstrate acceptable knowledge of the product risks of decreased survival and/or the increased risk of tumor progression or recurrence and the need to counsel patients about these risks.
- The drug utilization data indicates appropriate prescribing of ESAs consistent with the intended use as a treatment alternative to RBC transfusion for anemia associated with myelosuppressive chemotherapy
The FDA conducted an evaluation of the impact of multiple actions, including the ESA REMS, on the utilization of the ESAs using sponsor-submitted data from outpatient oncology practices between 2006 and 2014. During 2004-2009, the FDA took multiple regulatory actions, including labeling changes.
In 2007, the Center for Medicare and Medicaid Services (CMS) made a National Coverage Determination (NCD) to limit coverage of ESAs for non-renal disease indications. These actions coincided with:
- A decrease in the proportion of patients receiving chemotherapy using ESAs
- An increase in the proportion of patients receiving chemotherapy who initiate ESAs at a hemoglobin level <10g l,=””>
- An increase in the proportion of patients who initiate ESAs at a dosage consistent with product prescribing information.
Full implementation of the ESA REMS in 2011 had minimal impact on trends in these three ESA utilization metrics beyond the changes observed after the CMS coverage determination and multiple other FDA regulatory actions.
This information led the FDA to conclude it is no longer necessary to require the certification of prescribers and hospitals that prescribe and/or dispense ESAs to patients with cancer in order to ensure the benefits outweigh the risks.
The FDA has released the REMS requirements for the ESA products, Epogen/Procrit and Aranesp, and the risks can be communicated by the current product prescribing information. The appropriate use of ESAs is supported by the CMS NCD, the American Society of Clinical Oncology (ASCO) and American Society of Hematology (ASH) clinical guidelines which are evidence-based guidelines intended to provide a basis for the standard of care in clinical oncology.
While the REMS is no longer necessary to ensure the benefits outweigh the risks, the serious risks of shortened overall survival and/or increased risk of tumor progression or recurrence associated with these drugs remain. The prescribing information continues to note an increased risk of tumor progression or recurrence, as well as death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access. Health care providers are encouraged to discuss the risks and benefits of using ESAs with each patient before initiating use.
More information on:
- Aranesp (darbepoetin alfa)
- Epogen/Procrit (epoetin alfa )
Adverse reactions or quality problems experienced with the use of these Products may be reported to the FDA’s MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.
History of REMS for ESAs
MORE INFO
In 2008, FDA determined a REMS was necessary for Epogen/Procrit and Aranesp to ensure their benefits for use as a treatment alternative to RBC transfusion for anemia associated with myelosuppressive chemotherapy outweigh their risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer. This determination was made after data accumulated from numerous randomized clinical trials indicating an increase in tumor progression and shortened survival in patients with certain types of cancer. The risks were particularly concerning because of the extensive use of these products in cancer patients for uses that extended beyond the treatment of anemia due to myelosuppressive chemotherapy .
The results of these trials prompted labeling changes that included a boxed warning and limitations of use. The results were also the topic of discussion at several FDA Oncologic Drugs Advisory Committee meetings. The FDA regulatory actions for ESA prescribing primarily occurred in the years 2004 through 2009. In 2007, the Centers for Medicare & Medicaid Services (CMS) made a National Coverage Determination (NCD) to limit coverage of the ESAs to patients with cancer whose hemoglobin level is less than 10 mg/dL, in addition to other safe use conditions.
The ESA REMS for Epogen/Procrit and Aranesp, approved in February 2010, jointly fall under a common implementation program, the ESA Apprise Oncology Program. The ESA REMS consisted of a Medication Guide, communication plan, elements to assure safe use, implementation system, and a timetable for submission of assessments of the REMS. The REMS required that healthcare providers that prescribe, or prescribe and dispense, ESAs for patients with cancer, become certified.
It also required hospitals that dispense ESAs to patients with cancer, to become certified. Finally, the REMS required a Patient and Healthcare Provider Acknowledgement Form be completed for each patient with cancer before the new ESA treatment course to ensure patients were counseled about the benefits and risks of these products. The ESA REMS was fully implemented in 2011.
Labeling and Regulatory History from Drugs@FDA
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Postmarket Safety History
MORE INFO
- FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease [ARCHIVED] 6/24/2011
- FDA Drug Safety Podcast for Healthcare Professionals: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease [ARCHIVED] 6/27/2011
- Enforcement Discretion Letter Regarding Aranesp Medication Guide (PDF – 33KB) [ARCHIVED] 6/2/2011
- Enforcement Discretion Letter Regarding Epogen/Procrit Medication Guide (PDF – 33KB) [ARCHIVED] 6/2/2011
- Aranesp Risk Evaluation and Mitigation Strategy (REMS) (PDF – 28MB) [ARCHIVED]
- Epogen/Procrit Risk Evaluation and Mitigation Strategy (REMS) (PDF – 27.
9MB) [ARCHIVED] - FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related Anemia [ARCHIVED] 2/16/2010
- FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp [ARCHIVED] 2/16/2010
- Historical Information on Erythropoiesis Stimulating Agents (ESA) (marketed as Procrit, Epogen, and Aranesp) [ARCHIVED]
- Questions and Answers on Medication Guides for Erythropoiesis-Stimulating Agents (ESAs) [ARCHIVED]
- Follow Up to the January 3, 2008 Communication About an Ongoing Safety Review Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp) 10/1/2008 [ARCHIVED]
- Early Communication about an Ongoing Safety Review of Epoetin Alfa [ARCHIVED] 9/26/2008
- CMS Decision Memo for Erythropoiesis Stimulating Agents (ESAs) for non-renal disease indications 7/30/2007
9MB) [ARCHIVED]
| Injection, solution | Intravenous | 1000 UI/0. 5ML |
| Injection, solution | Intravenous | 10000 UI/1.0ML |
| Injection, solution | Intravenous | 3000 UI/0.3ML |
| Injection, solution | Intravenous | 4000 UI/0.4ML |
| Injection, solution | Intravenous | 5000 UI/0.5ML |
| Injection, solution | Intravenous | 6000 UI/0.6ML |
| Injection, solution | Intravenous | 8000 UI/0.8ML |
| Solution | Intravenous | 1000 UI/0.5ML |
| Solution | Intravenous | 2000 UI/1.0ML |
| Solution | Intravenous | 3000 UI/0.3ML |
| Injection, solution | Parenteral | 10000 I.E./1ML |
| Injection, solution | Parenteral | 1000 I.E./0.5ML |
| Injection, solution | Parenteral | 2000 I.E./1ML |
| Injection, solution | Parenteral | 3000 I.E./0.3ML |
| Injection, solution | Parenteral | 4000 I. E./0.4ML |
| Injection, solution | Parenteral | 5000 I.E./0.5ML |
| Injection, solution | Parenteral | 6000 I.E./0.6ML |
| Injection, solution | Parenteral | 8000 I.E./0.8ML |
| Injection, solution | 4000 IU/ml | |
| Injection, solution | Intravenous | 20000 UI/0.5ML |
| Injection, solution | Intravenous | 30000 UI/0.75ML |
| Injection, solution | Intravenous | 40000 UI/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 10000 IU/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 2000 IU/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 20000 IU/0.5ML |
| Injection, solution | Intravenous; Subcutaneous | 3000 IU/0.5ML |
| Injection, solution | Intravenous; Subcutaneous | 3000 IU/3. 0ML |
| Injection, solution | Intravenous; Subcutaneous | 30000 IU/0.75ML |
| Injection, solution | Intravenous; Subcutaneous | 40000 IU/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 40000 IU/1ML |
| Injection, solution | Subcutaneous | 7000 UI/0.7ML |
| Injection, solution | Subcutaneous | 9000 UI/0.9ML |
| Solution | Intravenous; Parenteral | 1000 UI/0.5ML |
| Solution | Intravenous; Parenteral | 10000 UI/1ML |
| Solution | Intravenous; Parenteral | 2000 UI/1ML |
| Solution | Intravenous; Parenteral | 20000 UI/0.5ML |
| Solution | Intravenous; Parenteral | 3000 UI/0.3ML |
| Solution | Intravenous; Parenteral | 30000 UI/0.75ML |
| Solution | Intravenous; Parenteral | 4000 UI/0. 4ML |
| Solution | Intravenous; Parenteral | 40000 UI/1ML |
| Solution | Intravenous; Parenteral | 5000 UI/0.5ML |
| Solution | Intravenous; Parenteral | 6000 UI/0.6ML |
| Solution | Intravenous; Parenteral | 7000 UI/0.7ML |
| Solution | Intravenous; Parenteral | 8000 UI/0.8ML |
| Solution | Intravenous; Parenteral | 9000 UI/0.9ML |
| Injection, solution | Parenteral | 10.000 I.E./1ML |
| Injection, solution | Intravenous; Subcutaneous | 10000 iu/1ml |
| Solution | Intravenous; Subcutaneous | |
| Injection, solution | Parenteral | 2.000 I.E./1.0ML |
| Injection, solution | Parenteral | 2.000 I.E./1ML |
| Injection, solution | Parenteral | 2.000 IE/1ML |
| Injection, solution | Intravenous; Subcutaneous | 2000 iu/1ml |
| Injection, solution | Parenteral | 2000 IE/1ML |
| Injection, solution | Parenteral | 3. 000 I.E./0.3ML |
| Injection, solution | Parenteral | 3000 IE/0.3ML |
| Injection, solution | Parenteral | 4.000 I.E./0.4ML |
| Injection, solution | Parenteral | 40.000 I.E./1ML |
| Injection, solution | Parenteral | 40.000 IE/1ML |
| Injection, solution | Parenteral | 40000 I.E./1ML |
| Injection, solution | Parenteral | 5.000 I.E./0.5ML |
| Injection, solution | Parenteral | 6.000 I.E./0.6ML |
| Injection, solution | Parenteral | 8.000 I.E./0.8ML |
| Injection, solution | Intravenous | 2000 iu/0.2ml |
| Injection, solution | Intravenous | 3000 iu/0.3ml |
| Injection, solution | Intravenous | 4000 iu/0.4ml |
| Injection, solution | 10000 iu/1ml | |
| Solution | Intravenous; Subcutaneous | 10000 IU/ml |
| Solution | Intravenous; Subcutaneous | 2000 IU/0. 6ml |
| Injection, solution | 3333 iu/1ml | |
| Injection, solution | 40000 iu/1ml | |
| Solution | Intravenous; Subcutaneous | 4000 IU/0.4ml |
| Injection | Intravenous | 10000 iu/1.0ml |
| Injection | Intravenous | 1000 iu/0.3ml |
| Injection | Intravenous | 2000 iu/0.6ml |
| Injection | Intravenous | 3000 iu/0.9ml |
| Injection | Intravenous | 4000 iu/0.4ml |
| Injection | Intravenous | 5000 iu/0.5ml |
| Injection | Intravenous | 6000 iu/0.6ml |
| Injection | Intravenous | 8000 iu/0.8ml |
| Injection, solution | Parenteral | 10000 IE |
| Injection, solution | Parenteral | 1000 IE |
| Injection, solution | Parenteral | 20000 IE |
| Injection, solution | Parenteral | 2000 IE |
| Injection, solution | Parenteral | 30000 IE |
| Injection, solution | Parenteral | 3000 IE |
| Injection, solution | Parenteral | 40000 IE |
| Injection, solution | Parenteral | 4000 IE |
| Injection, solution | Parenteral | 5000 IE |
| Injection, solution | Parenteral | 6000 IE |
| Injection, solution | Parenteral | 8000 IE |
| Solution | Intravenous; Subcutaneous | 10000 [iU]/1mL |
| Solution | Intravenous; Subcutaneous | 2000 [iU]/1mL |
| Solution | Intravenous; Subcutaneous | 20000 [iU]/1mL |
| Solution | Intravenous; Subcutaneous | 3000 [iU]/1mL |
| Solution | Intravenous; Subcutaneous | 4000 [iU]/1mL |
| Solution | Intravenous; Subcutaneous | 40000 1/1mL |
| Injection, solution | Intravenous | 2000 iu/ml |
| Injection, solution | Intravenous | 4000 iu/ml |
| Injection, solution | Intravenous; Parenteral | 10000 UI/1. 0ML |
| Injection, solution | Intravenous; Parenteral | 20000 UI/1.0ML |
| Injection, solution | Intravenous; Parenteral | 30000 UI/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 20000 IU/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 30000 IU/1.0ML |
| Injection, solution | Intravenous; Subcutaneous | 4000 IU/0.5ML |
| Injection, solution | Parenteral | 1000 IE/0.5ML |
| Injection, solution | Parenteral | 1.0 ML |
| Injection, solution | Parenteral | 10000 IE/1.0ML |
| Injection, solution | Parenteral | 2000 IE/0.5ML |
| Injection, solution | Parenteral | 1 ML |
| Injection, solution | Parenteral | 20000 IE/1.0ML |
| Injection, solution | Parenteral | 20000 IE/1ML |
| Injection, solution | Parenteral | 30. 000 IE/1.0ML |
| Injection, solution | Parenteral | 3000 IE/0.5ML |
| Injection, solution | Parenteral | 30000 IE/1.0ML |
| Injection, solution | Parenteral | 30000 IE/1ML |
| Injection, solution | Parenteral | 4000 IE/0.5ML |
| Injection, solution | Parenteral | 0.5 ML |
| Injection | Intravenous; Subcutaneous | 10000 iu/1.0ml |
| Solution | 4000 iu/0.4ml | |
| Injection | 10000 IU | |
| Injection | 2000 IU/0.5ml | |
| Injection | 4000 IU | |
| Injection, solution | ||
| Injection, solution | Intravenous; Subcutaneous | |
| Injection, powder, lyophilized, for solution | Intravenous; Subcutaneous | 1000 IU |
| Injection, solution | 30000 UI/0.75ML | |
| Injection, solution | 40000 UI | |
| Injection, solution | 40000 UI/ML | |
| Injection, solution | Intravenous; Subcutaneous | 1000 IU/0. 5ml |
| Injection, solution | Intravenous; Subcutaneous | 10000 IU/ml |
| Injection, solution | Intravenous; Subcutaneous | 2000 IU/ml |
| Injection, solution | Intravenous; Subcutaneous | 2000 IU/0.5ml |
| Injection, solution | Intravenous; Subcutaneous | 3000 IU/0.3ml |
| Injection, solution | Intravenous; Subcutaneous | 4000 IU/ml |
| Injection, solution | Intravenous; Subcutaneous | 4000 IU/0.4ml |
| Injection, solution | Intravenous; Subcutaneous | 500 IU/0.25ml |
| Injection, solution | Intravenous; Subcutaneous | 5000 IU/0.5ml |
| Injection, solution | Intravenous; Subcutaneous | 6000 IU/0.6ml |
| Injection, solution | Intravenous; Subcutaneous | 7000 IU/0.7ml |
| Injection, solution | Intravenous; Subcutaneous | 8000 IU/0. 8ml |
| Injection, solution | Intravenous; Subcutaneous | 9000 IU/0.9ml |
| Injection, solution | Parenteral | 40000 IU/ML |
| Solution | 2000 iu/0.5ml | |
| Solution | 40000 IU/1ml | |
| Injection | Subcutaneous | 10000 iu/ml |
| Injection | Subcutaneous | 2000 iu/0.5ml |
| Injection | Intravenous; Subcutaneous | 3000 iu/0.3ml |
| Injection | Subcutaneous | 4000 iu/0.4ml |
| Injection | Intravenous; Subcutaneous | 40000 iu/ml |
| Injection | Intravenous; Subcutaneous | 6000 iu/0.6ml |
| Injection | Intravenous; Subcutaneous | 10000 IU/ML |
| Injection | Intravenous; Subcutaneous | 2000 IU/0.5ml |
| Injection | Intravenous; Subcutaneous | 4000 IU/0.4ml |
| Solution | Intravenous; Subcutaneous | 20000 unit / 0. 5 mL |
| Solution | Intravenous; Subcutaneous | 30000 unit / 0.75 mL |
| Solution | Intravenous; Subcutaneous | 10000 unit / mL |
| Solution | Intravenous; Subcutaneous | 1000 unit / 0.5 mL |
| Solution | Intravenous; Subcutaneous | 20000 unit / mL |
| Solution | Intravenous; Subcutaneous | 2000 unit / 0.5 mL |
| Solution | Intravenous; Subcutaneous | 2000 unit / mL |
| Solution | Intravenous; Subcutaneous | 3000 unit / 0.3 mL |
| Solution | Intravenous; Subcutaneous | 40000 unit / mL |
| Solution | Intravenous; Subcutaneous | 4000 unit / 0.4 mL |
| Solution | Intravenous; Subcutaneous | 4000 unit / mL |
| Solution | Intravenous; Subcutaneous | 5000 unit / 0.5 mL |
| Solution | Intravenous; Subcutaneous | 6000 unit / 0. 6 mL |
| Solution | Intravenous; Subcutaneous | 8000 unit / 0.8 mL |
| Solution | Intravenous; Subcutaneous | 10000 IU |
| Solution | Intravenous; Subcutaneous | 2000 IU |
| Solution | Intravenous; Subcutaneous | 40000 IU |
| Solution | Intravenous; Subcutaneous | 4000 IU |
| Injection, powder, lyophilized, for solution | Intravenous; Subcutaneous | 4000 IU |
| Solution | Parenteral | 2000 IU |
| Injection | Parenteral | |
| Injection, solution | Parenteral | 1000 IU |
| Injection, solution | Parenteral | 10000 IU |
| Injection, solution | Parenteral | 2000 IU |
| Injection, solution | Parenteral | 20000 I.E./0.5ML |
| Injection, solution | Parenteral | 3000 IU |
| Injection, solution | Parenteral | 30000 I. E./0.75ML |
| Injection, solution | Parenteral | 4000 IU |
| Injection, solution | Parenteral | 40000 I.E./ML |
| Injection, solution | Parenteral | 5000 IU |
| Injection, solution | Parenteral | 6000 IU |
| Injection, solution | Parenteral | 8000 IU |
| Injection | Intravenous | |
| Solution | 4000 iu/1ml | |
| Injection, powder, lyophilized, for solution | Intravenous; Subcutaneous | 2000 IU |
| Injection, solution | 1000 IU/0.25ml | |
| Injection, powder, for solution | 1000 IU | |
| Injection, powder, for solution | 10000 IU | |
| Injection, powder, for solution | 2000 IU | |
| Injection, powder, for solution | 3000 IU | |
| Injection, powder, for solution | Intravenous; Subcutaneous | 50000 IU |
| Injection, solution | Intravenous; Parenteral | 1000 IU/0. 3ML |
| Injection, solution | Intravenous; Parenteral | 10000 IU/0.6ML |
| Injection, solution | Intravenous; Parenteral | 10000 IU |
| Injection, solution | Intravenous; Parenteral | 2000 IU/0.3ML |
| Injection, solution | Intravenous; Parenteral | 20000 IU/0.6ML |
| Injection, solution | Intravenous; Parenteral | 3000 IU/0.3ML |
| Injection, solution | Intravenous; Parenteral | 4000 IU/0.3ML |
| Injection, solution | Intravenous; Parenteral | 500 IU/0.3ML |
| Injection, solution | Intravenous; Parenteral | 5000 IU/0.3ML |
| Injection, solution | Intravenous; Parenteral | 6000 IU/0.3ML |
| Injection, solution | Intravenous; Parenteral; Subcutaneous | 2000 IU/0.3ML |
| Injection, solution | Intravenous; Subcutaneous | 10000 IU |
| Injection, solution | Intravenous; Subcutaneous | 2000 IU |
| Injection, solution | Intravenous; Subcutaneous | 20000 IU |
| Injection, solution | Intravenous; Subcutaneous | 3000 IU |
| Injection, solution | Intravenous; Subcutaneous | 30000 IU |
| Injection, solution | Intravenous; Subcutaneous | 4000 IU |
| Injection, solution | Intravenous; Subcutaneous | 500 IU |
| Injection, solution | Intravenous; Subcutaneous | 5000 IU |
| Injection, solution | Intravenous; Subcutaneous | 6000 IU |
| Injection, solution | Parenteral; Subcutaneous | 4000 IU |
| Injection, solution | Parenteral; Subcutaneous | 6000 IU |
| Powder | Intravenous | 1000 UI |
| Powder | Intravenous | 10000 UI |
| Powder | Intravenous | 2000 UI |
| Powder | Intravenous | 500 UI |
| Powder | Intravenous | 5000 UI |
| Powder | Parenteral | 100000 IU/ml |
| Powder | Parenteral | 50000 IU/ml |
| Powder | Subcutaneous | 10000 UI |
| Powder | Subcutaneous | 20000 UI |
| Injection, solution | Parenteral | 10. 000 I.E. |
| Injection, solution | Intravenous; Subcutaneous | 10000 iu/0.6ml |
| Injection, solution | Parenteral | 10000 IU/0.6ml |
| Injection, solution | Intravenous; Subcutaneous | 2000 iu/0.3ml |
| Injection, solution | Intravenous; Subcutaneous | 20000 iu/0.6ml |
| Injection, solution | Parenteral | 2000 IU/0.3ml |
| Injection, solution | Parenteral | 3000 IU/0.3ml |
| Injection, solution | Parenteral | 4000 IU/0.3ml |
| Injection, solution | Parenteral | 5000 IU/0.3ml |
| Injection, solution | Intravenous; Subcutaneous | 5000 iu/0.3ml |
| Injection, solution | Parenteral | 500 IU/0.3ml |
| Injection, solution | Parenteral | 6000 IU/0.3ml |
| Injection, solution | Intravenous; Subcutaneous | 10000 [iU]/1mL |
| Injection, solution | Intravenous; Subcutaneous | 2000 [iU]/1mL |
| Injection, solution | Intravenous; Subcutaneous | 20000 [iU]/1mL |
| Injection, solution | Intravenous; Subcutaneous | 3000 [iU]/1mL |
| Injection, solution | Intravenous; Subcutaneous | 4000 [iU]/1mL |
| Injection, solution | Intravenous; Subcutaneous | 40000 [iU]/1mL |
| Injection | 2000 IU | |
| Injection | 5000 IU | |
| Injection, solution | 2000 IU/0. 3ml | |
| Injection, solution | 3000 IU/0.3ml | |
| Injection, solution | 5000 IU/0.3ml | |
| Injection | Intravenous; Subcutaneous | 10000 iu/0.6ml |
| Injection | Intravenous; Subcutaneous | 2000 iu/0.3ml |
| Injection, solution | Intravenous; Subcutaneous | 30000 IU/0.6ml |
| Injection | Intravenous; Subcutaneous | 4000 iu/0.3ml |
| Injection | Intravenous; Subcutaneous | |
| Solution | Parenteral | 1000 IU |
| Solution | Intravenous; Subcutaneous | 500 IU |
| Solution | Intravenous; Subcutaneous | 5000 IU |
| Solution | 3000 IU/0.3ml | |
| Solution | Intravenous; Subcutaneous | 30000 IU |
| Injection | ||
| Injection | 10000 IU/ml | |
| Injection | 2000 IU/ml | |
| Injection | 3000 IU/ml | |
| Injection | 4000 IU/ml | |
| Injection, solution | Intravenous; Parenteral | 1000 UI/0. 3ML |
| Injection, solution | Intravenous; Parenteral | 10000 IU/1.0ML |
| Injection, solution | Intravenous; Parenteral | 2000 IU/0.6ML |
| Injection, solution | Intravenous; Parenteral | 2000 UI/0.6ML |
| Injection, solution | Intravenous; Parenteral | 20000 IU/0.5ML |
| Injection, solution | Intravenous; Parenteral | 20000 UI/0.5ML |
| Injection, solution | Intravenous; Parenteral | 3000 UI/0.9ML |
| Injection, solution | Intravenous; Parenteral | 3000 IU/0.9ML |
| Injection, solution | Intravenous; Parenteral | 30000 IU/0.75ML |
| Injection, solution | Intravenous; Parenteral | 30000 UI/0.75ML |
| Injection, solution | Intravenous; Parenteral | 4000 IU/0.4ML |
| Injection, solution | Intravenous; Parenteral | 4000 UI/0. 4ML |
| Injection, solution | Intravenous; Parenteral | 40000 IU/1.0ML |
| Injection, solution | Intravenous; Parenteral | 40000 UI/1.0ML |
| Injection, solution | Intravenous; Parenteral | 5000 IU/0.5ML |
| Injection, solution | Intravenous; Parenteral | 5000 UI/0.5ML |
| Injection, solution | Intravenous; Parenteral | 6000 UI/0.6ML |
| Injection, solution | Intravenous; Parenteral | 6000 IU/0.6ML |
| Injection, solution | Intravenous; Parenteral | 8000 IU/0.8ML |
| Injection, solution | Intravenous; Parenteral | 8000 UI/0.8ML |
| Injection, solution | Intravenous; Subcutaneous | 1000 IU/0.3ML |
| Injection, solution | Intravenous; Subcutaneous | 2000 IU/0.6ML |
| Injection, solution | Intravenous; Subcutaneous | 3000 IU/0. 9ML |
| Injection, solution | Parenteral | 10.000 I.E./1.0ML |
| Injection, solution | Parenteral | 10000 I.E./1.0ML |
| Injection, solution | Parenteral | 1000 I.E./0.3ML |
| Injection, solution | Parenteral | 1000 IE/0.3ML |
| Injection, solution | Parenteral | 2.000 I.E./0.6ML |
| Injection, solution | Parenteral | 2000 I.E./0.6ML |
| Injection, solution | Parenteral | 20000 IE/0.5ML |
| Injection, solution | Parenteral | 2000 IE/0.6ML |
| Injection, solution | Parenteral | 3.000 I.E./0.9ML |
| Injection, solution | Parenteral | 30.000 IE/0.75ML |
| Injection, solution | Parenteral | 3000 I.E./0.9ML |
| Injection, solution | Parenteral | 30000 IE/0.75ML |
| Injection, solution | Parenteral | 3000 IE/0. 9ML |
| Injection, solution | Parenteral | 4.000 IE/0.4ML |
| Injection, solution | Parenteral | 40.000 I.E./1.0ML |
| Injection, solution | Parenteral | 40000 I.E./1.0ML |
| Injection, solution | Parenteral | 40000 IE/1.0ML |
| Injection, solution | Parenteral | 4000 IE/0.4ML |
| Injection, solution | Parenteral | 5000 IE/0.5ML |
| Injection, solution | Parenteral | 6.000 IE/0.6ML |
| Injection, solution | Parenteral | 6000 IE/0.6ML |
| Injection, solution | Parenteral | 8000 IE/0.8ML |
| Injection, solution | 4000 IU/1ml | |
| Solution | 10000 IU/0.6ml | |
| Solution | 2000 IU/0.3ml | |
| Solution | 30000 IU/0.6ml | |
| Solution | 5000 IU/0.3ml | |
| Injection, solution | 2000 iu/0. 5ml | |
| Solution | 10000 iu/1ml | |
| Solution | 2000 iu/1ml | |
| Injection, solution | 4000 iu/0.4ml | |
| Injection, solution | 5000 IU/0.5ml | |
| Injection, powder, for solution | 4000 IU |
Relative safety and efficacy of various drugs – epoetins in the treatment of anemia in people with chronic kidney disease
This translation is out of date. Please click here for the latest English version of this review.
Several drugs are available to treat anemia in people with chronic kidney disease, but it is not yet clear whether these drugs are similar or different in their ability to reduce anemia symptoms such as fatigue and shortness of breath, and whether they are equally safe given the risk the occurrence of a stroke or heart attack during their use. This is due to the lack of studies comparing the effects of one drug directly with another.
We found 56 studies involving 15596 people who evaluated the safety and ability of these drugs to improve well-being, kidney function, and survival in patients with kidney disease. Our last literature search was conducted in February 2014.
We have some confidence that the four drugs (epoetin alfa, epoetin beta, darbepoetin beta, and methoxy polyethylene glycol-epoetin beta) are better than placebo injections in preventing the need for blood transfusions (blood transfusions) in patients. We are less confident that biosimilars (biosimilars) are better than placebo in helping patients avoid blood transfusions.
All erythropoiesis-stimulating drugs can cause an increase in blood [blood] pressure, but we cannot be absolutely sure that biosimilars (biosimilars) have an effect on blood pressure. We cannot be sure of other important effects of these drugs – we are not sure if these drugs are similar or different in their effect on the chances of death, heart attack or stroke; the risk of a blood clot (blood clot) in a fistula or vascular catheter needed for dialysis; or the chances of needing dialysis in people with milder kidney disease.
We are not sure if different medicines are better than others in their effect on symptoms [symptom reduction] such as fatigue or shortness of breath, as available scientific studies generally do not measure/evaluate these aspects of treatment well.
In general, it is not known whether different medicines are safer or better at treating symptoms of anemia in people with kidney disease. It is likely that most, if not all, drugs prevent patients from needing transfusions [blood transfusions]. The decision to select a drug to treat anemia in a patient with kidney disease can be made between patients and healthcare professionals based on shared/shared preferences, how often the drug should be taken, and considering drug costs and availability.
Translation notes:
Translation: Baiysbekov Kairat Baiysbekovich. Editing: Yudina Ekaterina Viktorovna. Russian translation project coordination: Kazan Federal University. For questions related to this translation, please contact us at: lezign@gmail.
com
EPOETIN-ALFA INDUCED PARTIAL RED CELL APPLASIA. CLINICAL CASE
Clinical case
Likunov Evgeny Borisovich
Mordovian State University N.P. Ogaryova
Autoimmune depressions of the red bone marrow germ PKKA occur as a result of suppression of the production of own erythrocytes, which occurs due to the suppression of erythropoiesis by immune mechanisms during the interaction of antibodies with bone marrow erythrocytes [1].
An interesting fact of the development of epoetin-induced PPKA in a sick child of 8 years old with a diagnosis of chronic renal failure, who received epoetin alfa Eprex as a treatment for anemia, is described.
Clinically and laboratory this condition is manifested by normochromic anemia (Hb – 50 g/l, E – 1.2, reticulocytes 0.5%). inhibition of erythroid growth. In the blood serum, a sharp increase in the level of iron up to 80 μmol / l with the development of hemosiderosis of the liver and lungs according to ultrasound and puncture biopsy.
The development of PPCA was preceded by 6 months of administration of recombinant erythropoietin alfa Eprex, subcutaneously at a dose of 50 IU/kg/week. After discontinuation of the drug, treatment with cyclosporine A was carried out. Subsequently, the patient was prescribed Darbopoetin alfa (Aranesp), to which the patient responded without complications, while complete recovery of the erythroid germ in the bone marrow occurred within 1 year. Unfortunately, it was not possible to detect and evaluate the titer of antibodies to erythrocytes, erythrocytes and erythropoietin due to the lack of this research method.
There are no more than 506 case reports of epoetin-induced partial red cell aplasia worldwide [2]. At the same time, PCCA was diagnosed in 208 cases in patients with chronic renal failure.
The disease develops, as a rule, with the subcutaneous injection of a recombinant erythropoietin preparation. An interesting fact remains that PPCA did not develop during intravenous infusion of this drug [3].
At the same time, the majority of patients develop the following immunological phenomena: combinations of serum autoantibodies to both erythrokaryocytes, erythrocytes, and (anti-EPO) and rHuEPO [4] antibodies are formed, this leads to inhibition of the erythroid germ and the development of normochromic anemia with an increase in the level of the gland and the development organ hemosiderosis. The formed antibodies neutralize rHuEPO and also interact with endogenous erythropoietin, resulting in a sharp decrease in serum erythropoietin levels.
This phenomenon may be associated with differences in the molecular structure and glycosylation of exogenous types of erythropoietins compared to endogenous, further research is ongoing to study this rare but dangerous complication [5].
Literature
- Cazzola M. Erythropoietin therapy: need for rationality and active surveillance. Haematologica/Journal of haematology, 2003.
- Casadevall N, Nataf J, Viron B, Kolta A, Kiladjan J-J, Martin-Dupont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P.
