Precautions
Procrit ( epoetin alfa) is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.
What is Procrit used for?
Limitations of Use. Procrit has not been shown to improve quality of life, fatigue, or patient well-being. Procrit is not indicated for use: In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
What are the limitations of Procrit?
Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with PROCRIT®or other erythropoietin protein medicines. Have had a serious allergic reaction to PROCRIT® Do notgive PROCRIT®from multiple–dose vials to:
Do you have anemia after taking Procrit®?
In controlled clinical trials of patients with cancer, Procrit and other ESAs increased the risks for death and serious adverse cardiovascular reactions. These adverse reactions included myocardial infarction and stroke.
Is Procrit safe for patients with cancer?
What drugs are ESA?
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 ...
Is EPO and ESA the same?
Erythropoietin stimulating agents (ESAs) are recombinant versions of EPO produced pharmacologically. Examples of ESAs are epoetin, darbepoetin, and methoxy polyethylene glycol-epoetin beta. ESAs are generally indicated in conditions where there is impaired red blood cell production.
What is an ESA anemia?
Erythropoietin stimulating agents (also called ESA medicines) are used to treat anemia caused by chronic kidney disease or chemotherapy for cancer treatment. They may also be used to treat anemia caused by taking medicines for human immunodeficiency virus (HIV). Or they may be given for certain types of surgeries.
What is ESA in hematology?
A substance that stimulates the bone marrow to make more red blood cells. ESAs are used to treat anemia caused by chronic kidney failure, some anticancer drugs, and certain treatments for HIV.
Is Aranesp and Procrit the same?
The differences between the two drugs are not limited to molecular structure: While Procrit is measured in units per kilogram of the patient's weight, Aranesp is measured in micrograms per kg. There is currently no formula for direct comparison of dosages measured in units to those measured by weight.
When can you start ESA?
o Initiate ESA treatment when the hemoglobin level is less than 10 g/dL. o If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of ESA. When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly.
How long does PROCRIT take to work?
It usually takes 2 to 6 weeks before the number of red blood cells increases in your body. Individual results with PROCRIT® may vary. There are many different types of side effects that can occur with PROCRIT®.
Why is iron needed for ESA?
ESA treatment alone will rapidly deplete iron stores leading to functional iron deficiency and the production of iron-poor RBCs (iron-deficient erythropoiesis). In most cases, patients receiving erythropoietin therapy are unable to keep up with via oral iron, the demand for iron and intravenous iron is indicated.
What health problem is a possible side effect of erythropoiesis stimulating agent ESA therapy?
ESAs may cause some patients to develop blood clots, and serious heart problems such as a heart attack, heart failure or stroke.
How often should Procrit be given?
This medication is given as an injection under the skin or into a vein as directed by your doctor, usually 1 to 3 times a week. Patients getting this medication before surgery may have a special dosing schedule.
What drugs are erythropoiesis-stimulating agents?
Examples of erythropoiesis-stimulating agents are epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp). Also called ESA.
Is erythropoietin covered by Medicare?
Medicare contractors do make payment for dosage of EPO in excess of 500,000 IUs per month or dosage of Aranesp greater than 1500 mcg per month. If dosage exceeds these thresholds, Medicare contractors return the claim to the provider as a medically unbelievable error.
What type of drug is EPO?
EPO is part of a class of substances called Erythropoiesis-Stimulating Agents (ESAs). In a clinical setting, EPO is primarily used for kidney failure, chemotherapy, and other medical conditions involving red blood cell loss and anemia.
What is ESA in CKD?
Erythropoiesis-stimulating agents (ESAs) continue to have an important role in the treatment of anemia in patients with CKD. ESA use in this group of patients has been shown to raise hemoglobin (Hgb) levels, decrease blood transfusion requirements, and improve the quality of life and symptoms related to anemia.
What is the function of EPO?
Erythropoietin (Epo), which is produced by the kidney in the adult and by the liver in the fetus, increases red blood cells by supporting the survival of erythroid progenitor cells and stimulating their differentiation and proliferation via binding to Epo receptor (EpoR).
What are the side effects of EPO?
More commonBone or joint pain.general feeling of tiredness or weakness.heartburn or belching.itching or stinging at the injection site.loss of strength or energy.muscle aches or weakness.shivering.skin pain.More items...•
What is epoetin alfa used for?
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.
What is ESA REMS?
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.
When did the FDA change the labeling of ESAs?
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:
Is epogen a REMS?
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.
Is it necessary to use REMS?
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.
How long does it take for Procrit to increase hemoglobin?
Procrit increases the reticulocyte count within 10 days of initiation, followed by increases in the RBC count, hemoglobin, and hematocrit, usually within 2 to 6 weeks. The rate of hemoglobin increase varies among patients and is dependent upon the dose of Procrit administered. For correction of anemia in hemodialysis patients, a greater biologic response is not observed at doses exceeding 300 Units/kg 3 times weekly.
What is the target level of hemoglobin for ESA?
In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Procrit sufficient to reduce the need for RBC transfusions [see Warnings and Precautions (5.1)]. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse reactions [see Boxed Warning and Clinical Studies (14) ].
How many units of Procrit are in a vial?
2,000 Units/mL, 3,000 Units/mL, 4,000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL of Procrit as a clear and colorless liquid in single -dose vials
What is Procrit used for?
Procrit is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
How much does epoetin alfa weigh?
It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin.
What to do if you have low reticulocyte count?
If severe anemia and low reticulocyte count develop during treatment with Procrit, withhold Procrit and evaluate patients for neutralizing antibodies to erythropoietin. Contact Janssen Products, LP at 1-800-JANSSEN (1-800-526-7736) to perform assays for binding and neutralizing antibodies. Permanently discontinue Procrit in patients who develop PRCA following treatment with Procrit or other erythropoietin protein drugs. Do not switch patients to other ESAs.
What causes anemia before procrit?
Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Procrit. Following initiation of therapy and after each dose adjustment, monitor hemoglobin weekly until the hemoglobin level is stable and sufficient to minimize the need for RBC transfusion.
Why do you need to follow the labeled directions for initiation and dose selection of Epogen/Procrit?
Prescribers should continue to follow the labeled directions for initiation and dose selection of Epogen/Procrit in order to treat anemia associated with chemotherapy in patients with cancer
When was the ESA APPRISE program approved?
The REMS was approved in 2010. Under the REMS program, referred to as the ESA APPRISE Oncology Program, healthcare providers that prescribed and/or dispensed Aranesp to patients with cancer and hospitals that dispensed Aranesp to patients with cancer were required to enroll and become certified in the ESA REMS.
What are the risks of epogen/procrit?
Epogen/Procrit increases the risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access and tumor progession or recurrence. Epogen/Procrit can also lead to an increase in adverse cardiovascular events, hypertension, seizures, and severe anemia.
When did the FDA change the labeling of ESAs?
During 2004-2009, 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 the ESAs for on-renal disease indications. These actions coincided with:
Can you prescribe Epogen/Procrit?
Health care professionals who prescribe Epogen/Procrit for the treatment of anemia due to myelosuppressive chemotherapy will no longer be required to enroll and become certified in the ESA REMS to prescribe or dispense Aranesp.
When did the FDA stop epogen?
FDA announced on April 13, 2017 the elimination of the risk evaluation and mitigation strategy (REMS) for Epogen/Procrit (epoetin alfa).
Do ESA REMS require a patient acknowledgement form?
The ESA REMS also 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.
How does Procrit work?
PROCRIT®works like EPO — it causes your bone marrow to make more red blood cells. This, in turn, raises your level of hemoglobin, a protein found in red blood cells that carries oxygen to all parts of the body. Increasing your hemoglobin level may lessen the need for a blood transfusion. The rise in hemoglobin does not happen right away. It usually takes 2 to 6 weeks before the number of red blood cells goes up in your body. Not everyone will have the same results with PROCRIT®.
What is the purpose of Procrit?
PROCRIT®is a prescription medicine used to treat anemia. People with anemia have a lower–than–normal number of red blood cells (RBCs). PROCRIT®works like the human protein called erythropoietin to help your body make more RBCs. PROCRIT®is used to reduce or avoid the need for RBC transfusions.
What is the name of the disease that starts after a procritic?
Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with PROCRIT®or other erythropoietin protein medicines.
What to do if you take more than the prescribed dose of Procrit?
If you take more than the prescribed dose of PROCRIT®, call your healthcare provider right away .
What is the drug used to treat HIV?
A medicine called zidovudine (AZT) used to treat HIV infection. PROCRIT®may also be used to reduce the chance you will need red blood cell transfusions if you are scheduled for certain surgeries where a lot of blood loss is expected.
Can you have cancer and not receive chemo?
If you have cancer and you will not be receiving chemotherapy, that may cause anemia. If you have a cancer that has a high chance of being cured, talk to your healthcare provider about the kind of cancer you have. If your anemia caused by chemotherapy treatment can be managed by RBC transfusion. In place of emergency treatment for anemia (RBC ...
Can you get anemia from chemo?
If your anemia caused by chemotherapy treatment can be managed by RBC transfusion.
What is Procrit?
Procrit ( epoetin alfa) is a man-made form of a protein that helps your body produce red blood cells. This protein may be reduced when you have kidney failure or use certain medications. When fewer red blood cells are produced, you can develop a condition called anemia.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What other drugs will affect Procrit?
Other drugs may interact with epoetin alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
How to know if you have stopped taking epoetin alfa?
Call your pharmacist for new medicine. Do not shake a Procrit vial or you may ruin it. Call your doctor if you feel weak, tired, or light-headed. These may be signs that your body has stopped responding to epoetin alfa. You may need frequent medical tests to be sure this medicine is not causing harmful effects.
Why is Procrit used?
Procrit is used to treat anemia caused by chemotherapy or chronic kidney disease, or anemia caused by taking zidovudine to treat HIV (human immunodeficiency virus). Procrit is also used to reduce the need for red blood cell transfusions in people having certain types of surgery.
How to use Procrit?
Your doctor may occasionally change your dose. Use the medicine exactly as directed. Procrit is injected under the skin, or as an infusion into a vein.
What are the symptoms of a blood clot?
Call your doctor at once if you have signs of a blood clot: sudden numbness or weakness, problems with vision or speech, chest pain, trouble breathing, pain or cold feeling in an arm or leg.
What is the Schwartzberg LS?
Schwartzberg LS. A randomized comparison of every 2-week Darbepoetin alpha and epoetin alpha for the treatment of chemotherapy-induced anemia in patients with breast, lung, or gynecological cancer. Oncologist 2004;9 (6): 696-707.
What is CMS in healthcare?
The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare, Medicaid and the State Children's Health Insurance Programs, contracts with certain organizations to assist in the administration of the Medicare program. Medicare contractors are required to develop and disseminate Local Coverage Determinations (LCDs). CMS believes that the Internet is an effective method to share LCDs that Medicare contractors develop. While every effort has been made to provide accurate and complete information, CMS does not guarantee that there are no errors in the information displayed on this web site. THE UNITED STATES GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION, PRODUCT, OR PROCESSES DISCLOSED HEREIN. Neither the United States Government nor its employees represent that use of such information, product, or processes will not infringe on privately owned rights. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information, product, or process.
How long does ESA last?
ESA treatment duration for each course of chemotherapy includes the 8 weeks following the final dose of myelosuppressive chemotherapy in a chemotherapy regimen.
Does CMS have a CDT license?
Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.
Is CPT a year 2000?
CPT is provided “as is” without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon no upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.
Can you use CPT in Medicare?
You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.
What does "you" mean when acting on behalf of an organization?
If you are acting on behalf of an organization, you represent that you are authorized to act on behalf of such organization and that your acceptance of the terms of this agreement creates a legally enforceable obligation of the organization. As used herein, “you” and “your” refer to you and any organization on behalf of which you are acting.
What modifier is used for non-covered services?
Effective from April 1, 2010, non-covered services should be billed with modifier –GA, -GX, -GY, or –GZ, as appropriate.
What is the MEA02 on a CMS claim?
The specifics are mEA01=TR (for test results), MEA02=R1 (for hemoglobin) orR2 (for hematocrit), and MEA03= the test results.
What is the value code for hemoglobin?
For institutional claims the hemoglobin reading is reported with a value code 48 and a hematocrit reading is reported with the value code 49. Claims not reporting a value code 48 or 49 will be returned to the provider.
What is an ABN in Medicare?
An ABN may be used for services which are likely to be non-covered, whether for medical necessity or for other reasons. Refer to CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 30, for complete instructions.
Why do contractors need to specify revenue codes?
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.
Why do contractors specify bill types?
Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service . Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.
Why are ESAs not listed in the LCD?
Bill type codes for Home Health services are not listed in the LCD for Erythropoiesis Stimulating Agents (ESAs) because " drugs and biologicals are specifically excluded from coverage by the statute section 1861 (m) (5) of the Act .”
