What is epoetin used for. Epoetin Alfa Injection: Uses, Risks, and Essential Information
What is epoetin alfa injection used for. How does epoetin alfa injection work. What are the potential risks and side effects of epoetin alfa injection. Who should use caution when taking epoetin alfa injection. How is epoetin alfa injection administered and monitored.
Understanding Epoetin Alfa Injection: An Overview
Epoetin alfa injection is a biologic medication derived from living organisms. It’s important to note that epoetin alfa-epbx injection is a biosimilar product, functioning similarly to epoetin alfa injection in the body. Throughout this article, we’ll refer to these medications collectively as “epoetin injection products.”
These medications are primarily used to treat anemia, a condition characterized by a low red blood cell count. They work by stimulating the production of red blood cells in the bone marrow, thereby increasing hemoglobin levels in the blood.
Key Points About Epoetin Injection Products:
- Biologic medications derived from living organisms
- Used to treat various types of anemia
- Stimulate red blood cell production
- Require careful dosage adjustment and monitoring
Medical Applications of Epoetin Injection Products
Epoetin injection products have several important medical applications. They are primarily prescribed to treat anemia associated with various conditions and treatments.
Common Uses of Epoetin Injection Products:
- Anemia in chronic kidney disease patients
- Anemia caused by chemotherapy in cancer patients
- Anemia in HIV patients undergoing zidovudine treatment
- Reducing the need for blood transfusions in surgical patients
Do epoetin injection products treat all types of anemia. No, these medications are specifically indicated for certain types of anemia, particularly those associated with chronic kidney disease, chemotherapy, and HIV treatment. They are not typically used for anemia caused by iron or vitamin deficiencies.
Risks and Safety Considerations of Epoetin Injection Products
While epoetin injection products can be beneficial for many patients, they also carry significant risks that require careful consideration and monitoring.
Increased Risk of Blood Clots
One of the primary concerns with epoetin injection products is the increased risk of blood clots. These clots can form in or move to the legs, lungs, or brain, potentially leading to serious complications.
Are certain patients at higher risk for blood clots when using epoetin injection products. Yes, patients with a history of heart disease, stroke, deep venous thrombosis (DVT), or pulmonary embolus (PE) are at increased risk. Additionally, patients undergoing surgery, especially coronary artery bypass graft (CABG) or orthopedic surgery, should exercise caution.
Cardiovascular Risks
Epoetin injection products can also increase the risk of serious cardiovascular events, particularly when used to raise hemoglobin levels to normal or near-normal levels.
What cardiovascular risks are associated with epoetin injection products. Patients may be at increased risk of stroke, heart attack, heart failure, and other serious or life-threatening heart problems. It’s crucial to monitor hemoglobin levels carefully and adjust dosages accordingly.
Special Considerations for Cancer Patients
Cancer patients using epoetin injection products require special attention due to potential risks observed in clinical studies.
Clinical studies have shown that cancer patients receiving epoetin alfa injection may experience faster tumor growth, earlier cancer recurrence, or more rapid cancer spread compared to those not receiving the medication. Additionally, some studies indicated that cancer patients receiving epoetin alfa injection had shorter survival times.
Guidelines for Cancer Patients:
- Epoetin injection products should only be used to treat chemotherapy-induced anemia when chemotherapy is expected to continue for at least 2 more months
- The lowest dose necessary to avoid blood transfusions should be used
- Treatment should be discontinued following the completion of chemotherapy
Administration and Dosage of Epoetin Injection Products
The administration and dosage of epoetin injection products require careful management and monitoring by healthcare professionals.
Administration Methods
How are epoetin injection products administered. These medications can be given in several ways:
- Intravenous injection (IV): Directly into a vein
- Subcutaneous injection: Under the skin
The method of administration may depend on the specific condition being treated and the patient’s individual circumstances.
Dosage Considerations
Dosage is highly individualized and depends on several factors, including:
- The patient’s weight
- The underlying cause of anemia
- The patient’s response to treatment
- Current hemoglobin levels
How often is the dosage adjusted. Healthcare providers will regularly monitor the patient’s hemoglobin levels and adjust the dosage as needed. The goal is to use the lowest dose necessary to reduce the need for blood transfusions while minimizing risks.
Monitoring and Follow-up Care
Regular monitoring is crucial for patients receiving epoetin injection products to ensure safety and efficacy.
Laboratory Tests
What tests are typically performed during treatment with epoetin injection products. Healthcare providers will order regular blood tests to monitor:
- Hemoglobin levels
- Red blood cell count
- Iron levels
These tests help determine the effectiveness of the treatment and guide any necessary dosage adjustments.
Follow-up Appointments
Regular follow-up appointments are essential for patients receiving epoetin injection products. During these appointments, healthcare providers will:
- Review laboratory test results
- Assess the patient’s response to treatment
- Monitor for any side effects or complications
- Make any necessary adjustments to the treatment plan
Potential Side Effects and Complications
While epoetin injection products can be beneficial, they may also cause various side effects and complications.
Common Side Effects
What are the most common side effects of epoetin injection products. Patients may experience:
- Headaches
- Joint pain
- Nausea
- Fever
- Fatigue
- Dizziness
Serious Complications
In addition to the risks of blood clots and cardiovascular events mentioned earlier, other serious complications may include:
- Severe allergic reactions
- High blood pressure
- Seizures
- Pure red cell aplasia (a rare condition where the body stops producing red blood cells)
When should patients seek immediate medical attention. Patients should contact their healthcare provider or seek emergency care if they experience:
- Chest pain or pressure
- Shortness of breath
- Sudden weakness or numbness, especially on one side of the body
- Sudden difficulty speaking or understanding speech
- Severe headache
- Swelling in the legs or arms
Patient Education and Self-Care
Proper patient education is crucial for the safe and effective use of epoetin injection products.
Understanding the Medication
Patients should be provided with comprehensive information about their medication, including:
- The purpose of the treatment
- Proper administration techniques (if self-administering)
- Potential side effects and when to seek medical attention
- The importance of regular monitoring and follow-up appointments
Lifestyle Considerations
What lifestyle factors should patients consider while using epoetin injection products. Patients should be advised to:
- Maintain a balanced diet rich in iron and other nutrients essential for red blood cell production
- Stay hydrated
- Exercise regularly, as recommended by their healthcare provider
- Avoid smoking and limit alcohol consumption
- Report any new medications or supplements to their healthcare provider, as these may interact with epoetin injection products
By following these guidelines and maintaining open communication with their healthcare team, patients can maximize the benefits of epoetin injection products while minimizing potential risks.
In conclusion, epoetin injection products are powerful medications that can significantly improve quality of life for patients with certain types of anemia. However, their use requires careful consideration, close monitoring, and a thorough understanding of both benefits and risks. As with any medical treatment, the decision to use epoetin injection products should be made in close consultation with a healthcare provider, taking into account the individual patient’s specific circumstances and medical history.
Epoetin Alfa, Injection: MedlinePlus Drug Information
pronounced as (e poe’ e tin)
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Epoetin alfa injection and epoetin alfa-epbx injection are biologic medications (medications made from living organisms). Biosimilar epoetin alfa-epbx injection is highly similar to epoetin alfa injection and works the same way as epoetin alfa injection in the body. Therefore, the term epoetin injection products will be used to represent these medications in this discussion.
All patients:
Using epoetin alfa injection products increases the risk that blood clots will form in or move to the legs, lungs, or brain. Tell your doctor if you have or have ever had heart disease, a stroke, deep venous thrombosis (DVT; blood clot in your leg), a pulmonary embolus (PE; blood clot in your lungs), or if you are going to have surgery. Before having any surgery, even dental surgery, tell your doctor or dentist that you are being treated with an epoetin alfa injection product, especially if you are having coronary artery bypass graft (CABG) surgery or orthopedic surgery. Your doctor may prescribe an anticoagulant (‘blood thinner’) to prevent clots from forming during surgery. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: pain, tenderness, redness, warmth, and/or swelling in the legs; coolness or paleness in an arm or leg; difficulty breathing or shortness of breath; chest pain; sudden trouble speaking or understanding speech; sudden confusion; sudden weakness or numbness of an arm or leg (especially on one side of the body) or of the face; sudden trouble walking, dizziness, or loss of balance or coordination; or fainting. If you are being treated with hemodialysis (treatment to remove waste from the blood when the kidneys are not working), a blood clot may form in your vascular access (place where the hemodialysis tubing connects to your body). Tell your doctor if your vascular access is not working as usual.
Your doctor will adjust your dose of an epoetin alfa injection product so that your hemoglobin level (amount of a protein found in red blood cells) is just high enough that you do not need a red blood cell transfusion (transfer of one person’s red blood cells to another person’s body to treat severe anemia). If you receive enough of an epoetin alfa product to increase your hemoglobin to a normal or near normal level, there is a greater risk that you will have a stroke or develop serious or life threatening heart problems including heart attack or heart failure. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: chest pain, squeezing pressure, or tightness; shortness of breath; nausea, lightheadedness, sweating, and other early signs of heart attack; discomfort or pain in the arms, shoulder, neck, jaw, or back; or swelling of the hands, feet, or ankles.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to epoetin alfa injection products. Your doctor may decrease your dose or tell you to stop using an epoetin alfa injection product for a period of time if the tests show that you are at high risk of experiencing serious side effects. Follow your doctor’s directions carefully.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with an epoetin alfa injection product and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
Talk to your doctor about the risks of using an epoetin alfa injection product.
Cancer patients:
In clinical studies, people with certain cancers who received epoetin alfa injection died sooner or experienced tumor growth, a return of their cancer, or cancer that spread sooner than people who did not receive the medication. You should only receive epoetin alfa injection products to treat anemia caused by chemotherapy if your chemotherapy is expected to continue for at least 2 months after you start your treatment with epoetin alfa injection and if there is not a high chance that your cancer will be cured. Treatment with epoetin alfa injection products should be stopped when your course of chemotherapy ends.
Surgical patients:
You may be given an epoetin alfa injection product to decrease the risk that you will develop anemia and require a blood transfusion as a result of blood loss during certain types of surgery. However, receiving an epoetin alfa injection product before and after surgery may increase the risk that you will develop a dangerous blood clot during or after surgery. Your doctor will probably prescribe medication to help prevent blood clots.
Epoetin alfa injection products are used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Epoetin alfa injection products are also used to treat anemia caused by chemotherapy in people with certain types of cancer or caused by zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a medication used to treat human immunodeficiency virus (HIV). Epoetin alfa injection products are also used before and after certain types of surgery to decrease the chance that blood transfusions (transfer of one person’s blood to another person’s body) will be needed because of blood loss during surgery. Epoetin alfa injection products should not be used to decrease the risk that transfusions will be needed in people who are having surgery on their hearts or blood vessels. Epoetin alfa injection products also should not be used to treat people who are able and willing to donate blood before surgery so that this blood can be replaced in their bodies during or after surgery. Epoetin alfa injection products cannot be used in place of a red blood cell transfusion to treat severe anemia and has not been shown to improve tiredness or poor well-being that may be caused by anemia.
Epoetin alfa products are in a class of medications called erythropoiesis-stimulating agents (ESAs). They work by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
Epoetin alfa injection products come as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected one to three times weekly. When epoetin alfa injection products are used to decrease the risk that blood transfusions will be required due to surgery, it is sometimes injected once daily for 10 days before surgery, on the day of surgery and for 4 days after surgery. Alternatively, epoetin alfa injection products are sometimes injected once weekly, beginning 3 weeks before surgery and on the day of surgery.
Your doctor will start you on a low dose of an epoetin alfa injection product and adjust your dose depending on your lab results and how you are feeling, usually not more than once every month. Your doctor may also tell you to stop using an epoetin alfa injection product for a time. Follow these instructions carefully.
Epoetin alfa injection products will help control your anemia only as long as you continue to use it. It may take 2–6 weeks or longer before you feel the full benefit of an epoetin alfa injection product. Do not stop using an epoetin alfa injection product without talking to your doctor.
Epoetin alfa injection products may be given by a doctor or nurse, or you may be told to inject the medication at home. If you will be injecting the medication at home, follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Use an epoetin alfa injection product exactly as directed. To help you remember to use an epoetin alfainjection product, mark a calendar to keep track of when you are to receive a dose. Do not use more or less of it or use it more often than prescribed by your doctor.
If you are using an epoetin alfa injection product at home, a healthcare provider will show you how to inject the medication. Be sure that you understand these directions. Before you use an epoetin alfaproduct for the first time, you and the person who will be giving the injections should read the manufacturer’s information for the patient that comes with it. Ask your healthcare provider if you have any questions about where on your body you should inject the medication, how to give the injection, what type of syringe to use, or how to dispose of used needles and syringes after you inject the medication. Always keep a spare syringe and needle on hand.
Do not shake an epoetin alfa injection product. If you shake the medication, it may look foamy and should not be used.
You can inject an epoetin alfa injection product just under the skin anywhere on the outer area of your upper arms, middle of the front thighs, stomach (except for a 2-inch [5-centimeter] area around the navel [belly button]), or outer area of the buttocks. Do not inject an epoetin alfa injection product into a spot that is tender, red, bruised, hard, or has scars or stretch marks. Choose a new spot each time you inject the medication, as directed by your doctor.
If you are being treated with dialysis (treatment to remove waste from the blood when the kidneys are not working), your doctor may tell you to inject the medication into your venous access port. Ask your doctor if you have any questions about how to inject your medication.
Always look at the solution before you inject it. Be sure that the vial is labeled with the correct name and strength of medication and an expiration date that has not passed. Also check that the solution is clear and colorless and does not contain lumps, flakes, or particles. If there are any problems with your medication, call your pharmacist and do not inject it.
This medication may be prescribed for other uses. Talk to your doctor about the risks of using this medication for your condition.
Before using an epoetin alfa injection product,
- tell your doctor and pharmacist if you are allergic to epoetin alfa, epoetin alfa-epbx, darbepoetin alfa (Aranesp), any other medications, or any of the ingredients in epoetin alfa injection products.
Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have had high blood pressure and if you have ever had pure red cell aplasia (PRCA; a type of severe anemia that may develop after treatment with an ESA such as darbepoetin alfa injection or epoetin alfa injection). Your doctor may tell you not to use an epoetin alfa injection product.
- tell your doctor if you have or have ever had seizures. If you are using an epoetin alfa injection product to treat anemia caused by chronic kidney disease, tell your doctor if you have or have ever had cancer.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.
If you become pregnant while using an epoetin alfa injection product, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using an epoetin alfa injection product.
Your doctor may prescribe a special diet to help control your blood pressure and to help increase your iron levels so that an epoetin alfa injection product can work as well as possible. Follow these directions carefully and ask your doctor or dietician if you have any questions.
Call your doctor to ask what to do if you miss a dose of an epoetin injection product. Do not use a double dose to make up for a missed one.
Epoetin alfa injection products may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- joint or muscle aches, pain, or soreness
- nausea
- vomiting
- weight loss
- sores in the mouth
- difficulty falling asleep or staying asleep
- depression
- muscle spasms
- runny nose, sneezing, and congestion
- fever, cough, or chills
- redness, swelling, pain, or itching at the injection spot
Some side effects can be serious.
If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- rash
- hives
- itching
- swelling of the face, throat, tongue, lips, or eyes
- skin blisters or peeling skin
- wheezing
- difficulty breathing or swallowing
- unusual tiredness
- lack of energy
- dizziness
- fainting
- seizures
Epoetin alfa injection products may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
Keep this medication in the container it came in to protect from light, tightly closed, and out of reach of children. Store epoetin alfa and epoetin alfa-epbx in the refrigerator, but do not freeze it. Dispose of any medication that has been frozen. Dispose of a multidose vial of epoetin alfa injection 21 days after you first use it.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
- fast or racing heart beat
- Epogen®(Epoetin Alpha)
- Eprex®(Epoetin Alpha)¶
- Procrit® (Epoetin Alpha)
- Retacrit®(Epoetin Alpha-epbx)
- EPO
- Erythropoietin Human Glycoform alpha (Recombinant)
- rHuEPO-alpha
¶ This branded product is no longer on the market. Generic alternatives may be available.
Last Revised – 09/15/2019
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Epoetin Alfa – StatPearls – NCBI Bookshelf
Continuing Education Activity
Epoetin alfa is a medication used in the management of anemia secondary to bone marrow failure. It is one of the erythropoiesis-stimulating classes of drugs. This activity outlines the indications, action, and contraindications of epoetin alfa. This activity will highlight the mechanism of action, adverse event profile, and other key factors (e.g., off-label uses, dosing, pharmacodynamics, pharmacokinetics, monitoring, relevant interactions) pertinent for members of the interprofessional team in the management of patients with anemia due to bone marrow failure and related conditions.
Objectives:
Describe the importance of epoetin alfa in patients with anemia due to chronic kidney disease and cancer therapy.
Summarize the risks associated with initiating epoetin alfa along with key patient counseling points to prevent thromboembolism and other side effects.
Explain the importance of monitoring in the patients who are on epoetin alfa.
Review the importance of collaboration and coordination among interprofessional team members, which can enhance patient care.
Access free multiple choice questions on this topic.
Indications
Epoetin alfa is 165 amino acid glycoprotein manufactured by recombinant DNA technology, which has similar biological effects as endogenous erythropoietin. Erythropoietin stimulates red blood cell production in-situ. It is a hormone produced in the kidney and augments the differentiation of erythroid progenitors in the bone marrow. Indications of epoetin are as below.
FDA Approved
[1]
[2]
[3]
[4]
Chronic kidney disease patients who are on dialysis and not on dialysis
The patient receiving myelosuppressive therapy for cancer
Anemia due to zidovudine in HIV-infected patient
Reduction of allogeneic blood transfusion requirement in the patient who undergoes elective, noncardiac, nonvascular surgery
NON-FDA Approved
[5]
[6]
[7]
[8]
[9]
[10]
Blood transfusion refusing patients like Jehovah’s Witnesses
Anemia during therapy for chronic hepatitis C
Myelodysplastic syndrome
Symptomatic management for anemia
Preterm anemia
Mechanism of Action
Epoetin alfa is recombinant human erythropoietin, which is nearly identical to the endogenous hormone erythropoietin (EPO). Erythropoietin occurs in the peritubular cells of the kidney. Anemia and hypoxia are sensed by these cells and lead to the rapid secretion of EPO, which acts on erythroid marrow. Hypoxia-inducible factor (HIF-1) is a (HIF-1 alpha and HIF-1 beta) transcription factor that boosts the expression of erythropoietin in the setting of hypoxia. During the state of hypoxia, the prolyl hydroxylase is inactive, allowing the accumulation of HIF-1 alpha and activating erythropoietin expression, which stimulates erythroid progenitors.
Erythropoietin binds to specific receptors (JAK-STAT-binding receptor) on the surface of its target cells. It subsequently alters the phosphorylation of intracellular proteins and activates transcription factors to regulate gene expression. The magnitude of increase in red blood cell concentration after administration of epoetin alfa is primarily dependant on the length of time this medication is maintained, not by its concentration level.
It induces erythropoiesis in a dose-dependent manner but does not affect the RBC lifespan, which results in:
Stimulates the proliferation of colony-forming cells of the erythroid series
Induces hemoglobin formation and erythroblast maturation
Releases reticulocytes in circulation, followed by a rise in hematocrit and hemoglobin levels.
[11]
A clinically significant increase in hemoglobin is usually not observed in less than two weeks because of the length required for the erythropoiesis process. The erythroid progenitors take several days to mature and undergo release into circulation.
Administration
Epoetin alfa is available in single-dose, preservative-free, or multi-dose, preserved vials.
This medication can be administered via the intravenous or subcutaneous route. Subcutaneous is the preferred route for administration except in patients with end-stage kidney disease on maintenance hemodialysis. In dialysis patients and neonates, the IV route is recommended.[12]
When injected intravenously, epoetin alfa clears from plasma with a half-life of 4 to 8 hours. However, the effect on bone marrow progenitors lasts much longer, and once-weekly dosing can be sufficient sometimes. Single vial dose is preservative-free, so, should be diluted in a syringe as a 1 to 1 dilution using normal saline in adults but do not dilute in neonates or infants. [13] Multiple-dose vials contain benzyl alcohol. Shaking of injection can denature the glycoprotein making the drug biologically inactive. This product should not be used if it is shaken or frozen.
Adverse Effects
Patients on erythropoietin therapy may develop absolute (decreased ferritin levels with low transferrin saturation) or functional iron deficiency (normal ferritin levels with low transferrin saturation). This deficiency results from an inability to move enough amount of iron rapidly from storage to support the enhanced erythropoiesis.
It increases the risk of serious cardiovascular events, vascular access thrombosis, stroke, myocardial infarction, venous thromboembolism in clinical studies when target Hb levels reach more than 11 g/dL or a rapid rise in hemoglobin over 1 g/dL over two weeks (U.S. Boxed Warning). Although epoetin alfa does not affect blood pressure directly, it may raise blood pressure in the early phase after administration when the hematocrit is increasing acutely. Therefore, clinicians should exercise care when using it in patients with uncontrolled hypertension. Additionally, patients may require dosage adjustments of antihypertensive therapy after initiating this medication.
Pure red cell aplasia may occur in patients treated with specific epoetin alfa formulations. In chronic renal failure patients, chances of hypertensive encephalopathy and seizures have increased, particularly those with a previous history of seizures. Headache, nausea, shortness of breath, edema, vomiting, tachycardia, diarrhea have also been noted. Injection site erythema and flu-like symptoms (like arthralgias and myalgias) can occur, which last for 2 to 4 hours.
Due to a sudden increase in hematocrit, blood viscosity, and peripheral vascular resistance, particularly dialysis patients, may require to adjust anticoagulation. Serious thromboembolic events like increased clot formation in atrioventricular (AV) shunts, migratory thrombophlebitis, microvascular thrombosis, thrombosis of major vessels like retinal, temporal, pulmonary, and renal vessels increases. The risk of thrombotic events is even higher in adults with ischemic heart disease or congestive heart failure. So, lower target hematocrit should be preferable in these patients. Some dosage forms may contain benzyl alcohol, which is associated with fatal toxicity “gasping syndrome” in neonates.[14]
Contraindications
Absolute contraindications:
Multiple dosage vials contain benzyl alcohol, so this formulation is contraindicated in neonates, infants, pregnant women, and breastfeeding women. (Single dosage vial which is preservative-free should be used)
Uncontrolled hypertension
Known hypersensitivity to mammalian cell-derived products
Known hypersensitivity to albumin
Pure red cell aplasia that begins after treatment
Absolute contraindications:
Due to the delayed onset of erythropoiesis, it is contraindicated for acute correction of severe anemia or emergency transfusion.
It should be used cautiously with patients who have a history of seizures
In patients with cancer receiving hormonal agents, biologic products, or radiotherapy
In patients undergoing cardiac or vascular surgery
In patients who receive myelosuppressive therapy when the anticipated outcome is curative
Monitoring
Serum ferritin and transferrin saturation require measurement before initiation of epoetin alfa. If the serum ferritin level is less than 100 ng/mL and/or serum transferrin saturation level is less than 20%, then supplemental iron should be started before the initiation of epoetin alfa treatment.
If Hb does not increase by greater than 1 gram per deciliter after four weeks of the treatment, increase the dose by 25%. In any consecutive two weeks, hemoglobin increases greater than1 grams per deciliter, then cut down the dose by 25%. If there is inadequate or no response over three months of an escalation period, the clinician should stop treatment.
Serious cardiovascular events such as myocardial infarction, stroke, venous thromboembolism, and mortality increase when the Hb level increases more than 11 grams per deciliter. Signs and symptoms of these side effects also require monitoring. To decrease the risk of thromboembolism, encourage the patient to quit smoking and alcohol drinking, regular exercising, and diet modification.
Complete blood count, serum iron profile with ferritin should be monitored while the patient is receiving treatment.
Consult with the cardiologist to monitor cardiac complications.
Consult with a nephrologist for further management with dialysis.
Consult with the oncologist for coordinating myelosuppressive therapy if the patient is on chemotherapy.
Consult with the neurologist for a patient with a history of seizure.
Toxicity
Epoetin alfa increases the risk of serious cardiovascular events once the target hemoglobin level is greater than 11 g/dL or a rapid rise in hemoglobin (greater than 1 g/dL over two weeks of the period).
Reports exist of erythema multiforme, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Immediately discontinuation of the treatment is needed.
Overdose of this medication is very rare — no antidote available at present.
One case report describes an overdose of erythropoietin that caused essential erythrocytosis with the central nervous system and peripheral ischemia. The patient had successful treatment with emergent erythropheresis.[15]
Enhancing Healthcare Team Outcomes
Management of epoetin alfa requires an interprofessional team that includes a nurse, laboratory technologists, pharmacists, and several physicians involving different subspecialties. Without proper management, the rapid overcorrection of anemia can lead to various morbidity and mortality. The management of anemia secondary to multiple underlying causes such as kidney disease, zidovudine toxicity, cancer does not stop after starting epoetin alpha. Once the patient begins to respond, one has to determine treatment duration and when to decrease/stop treatment to prevent complications. Nursing can administer the drug, help explain therapy to the patient, answer questions, provide monitoring, and report any changes in status to the clinicians or pharmacist. The pharmacist can verify dosing and ensure there are no potential drug-drug interactions. Only by working as an interprofessional team, the proper management of anemia with this medication is possible. [Level 5] The long-term outcomes suggest that epoetin alfa is effective and safe for maintaining hemoglobin.[16]
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References
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Fishbane S, Spinowitz BS, Wisemandle WA, Martin NE. Randomized Controlled Trial of Subcutaneous Epoetin Alfa-epbx Versus Epoetin Alfa in End-Stage Kidney Disease. Kidney Int Rep. 2019 Sep;4(9):1235-1247.
[PMC free article: PMC6734106] [PubMed: 31517143]
- 2.
Ikunaiye NY, Denue BA, Aina BA, Aderemi-Williams R, Rawizza HE. INCIDENCE OF ANAEMIA AMONG HIV-INFECTED PATIENTS TREATED WITH ZIDOVUDINE-CONTAINING ANTIRETROVIRAL THERAPY IN NORTHEASTERN NIGERIA. Ann Ib Postgrad Med. 2018 Dec;16(2):115-124. [PMC free article: PMC6580400] [PubMed: 31217768]
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Disclosure: Saumil Patel declares no relevant financial relationships with ineligible companies.
Disclosure: Jayesh Patel declares no relevant financial relationships with ineligible companies.
💊 The composition of the drug Epoetin beta ✅ The use of the drug Epoetin beta Keep for yourself Search for analogues Description of the active ingredients of the preparation Epoetin beta The scientific information provided is general and cannot be used to make decisions. Update date: 2021.05.11 Marketing authorization holder: NPO MICROGEN, JSC ATX code: B03XA (Other antianemic drugs) Active substance: Rec.INN registered by WHO Dosage forms
Release form, packaging and composition |
Solution for i.v. and s.c. epoetin beta | 500 IU |
1 ml (500 IU) – ampoules ( 5) – packs of cardboard.
1 ml (500 IU) – ampoules (10) – packs of cardboard.
Solution for IV and SC administration | 1 ml |
1 ml (2000 IU) – ampoules (5) – cardboard packs.
1 ml (2000 IU) – ampoules (10) – packs of cardboard.
1 ml (2000 IU) – syringes (1) – packs of cardboard.
1 ml (2000 IU) – syringes (5) – packs of cardboard.
1 ml (2000 IU) – syringes (6) – cardboard packs.
IV and SC solution | 1 ml | ||||||||||
epoetin beta | 3000 IU 00 IU) – ampoules (5) – packs of cardboard. 1 ml (3000 IU) – ampoules (10) – packs of cardboard.
1 ml (4000 IU) – ampoules ( 5) – packs of cardboard. Clinical and pharmacological group: Erythropoiesis stimulator Pharmacotherapeutic group: Hematopoiesis stimulant Pharmacological action Recombinant human erythropoietin (purified glycoprotein), consisting of 165 amino acids, which, as a mitogenic factor and differentiation hormone, promotes the formation of red blood cells from partially determined erythropoiesis progenitor cells. Epoetin beta after IV and SC administration increases the number of erythrocytes, reticulocytes and hemoglobin levels, as well as the rate of iron incorporation ( 59 Fe) into cells, specifically stimulates erythropoiesis without affecting leukopoiesis. No cytotoxic effect of epoetin beta on bone marrow or human skin cells has been identified. PharmacokineticsAfter s / c administration C max in plasma is achieved after 12-28 hours. V d is equal to the BCC or 2 times higher than it. T 1/2 in the final phase – 13-28 hours. After the on/in the introduction of T 1/2 active substance is 4-12 hours. after intravenous administration, and averages 13-28 hours. Indications of the active substances of the drug Epoetin beta Symptomatic anemia in chronic kidney disease in dialysis patients; symptomatic anemia of renal origin in patients not yet receiving dialysis; treatment of symptomatic anemia in adult patients with solid and hematological non-myeloid tumors receiving chemotherapy; prevention of anemia in premature newborns born with a body weight of 750-1500 g before the 34th week of pregnancy. Open list of ICD-10 codes
Dosage regimen The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. Doses, scheme and duration of treatment are set individually, depending on the severity of anemia, the severity of the patient’s condition, the nature of the disease, the age of the patient. Enter s / c and / in. Side effectsFrom the side of the cardiovascular system: arterial hypertension, hypertensive crisis, shunt thrombosis. From the side of the nervous system: encephalopathy (more often in hypertensive crises), headache, confusion. From the blood coagulation system: rarely – thrombocytosis, thrombotic complications. From the side of the hematopoietic system: partial red cell aplasia (RCCA). Allergic reactions: rarely – skin rash, itching, urticaria, anaphylactoid reactions. From the skin and subcutaneous tissues: Stevens-Johnson syndrome. From the side of laboratory parameters: decrease in plasma ferritin with a simultaneous increase in hemoglobin, increase in plasma potassium and phosphate levels. Other: influenza-like syndrome, local reactions. ContraindicationsHistory of hypersensitivity to epoetin beta; uncontrolled arterial hypertension; myocardial infarction or stroke within the previous month, unstable angina pectoris or an increased risk of deep vein thrombosis (with a history of venous thromboembolism) – when prescribed to increase the volume of donated blood for autohemotransfusion. With care Refractory anemia in the presence of blast-transformed cells, thrombocytosis, epilepsy and chronic liver failure. Body weight less than 50 kg to increase the volume of donor blood for subsequent autotransfusion. Use in pregnancy and lactation Use epoetin beta during pregnancy and lactation only if the expected benefit to the mother outweighs the potential risk to the fetus or child. No teratogenic effects were found in experimental studies . Use in hepatic dysfunctionUse with caution in chronic liver failure. Use in Impaired Renal FunctionUse with caution in patients with nephrosclerosis not receiving hemodialysis as renal function may deteriorate more rapidly. Use in childrenMay be used in children according to indications, in recommended doses and schedules according to age. In the treatment of anemia associated with chronic kidney disease, epoetin beta should not be given to children under 2 years of age. Special instructionsDuring therapy with epoetin beta, platelet, hematocrit and hemoglobin should be regularly monitored. Epoetin beta should be used with caution in refractory anemia in the presence of blast-transformed cells, epilepsy, thrombocytosis and chronic liver failure. Therapeutic efficacy of epoetin beta may decrease in iron, folic acid, vitamin B deficiency 12 . Iron deficiency should be ruled out prior to initiation of treatment with epoetin beta and throughout the duration of therapy. If necessary, additional iron therapy may be prescribed in accordance with clinical recommendations. The effectiveness of treatment decreases with iron deficiency in the body, with infectious and inflammatory diseases, hemolysis. The possibility of the influence of epoetin beta on the growth of certain types of tumors, especially malignant neoplasms of the bone marrow, cannot be completely excluded. While using epoetin beta, it is necessary to monitor the level of blood pressure, paying attention to the occurrence or increase of unusual headaches. This may require correction of ongoing therapy or the appointment of antihypertensive drugs. Use with caution in epilepsy, thrombocytosis, liver failure, vascular insufficiency, malignant neoplasms; in patients with nephrosclerosis not receiving hemodialysis, since a more rapid deterioration in kidney function is possible. The decision to use epoetin beta in patients with nephrosclerosis not receiving dialysis must be made on an individual basis, as the possibility of a more rapid deterioration in renal function cannot be completely ruled out. In most cases, simultaneously with an increase in hemoglobin, the concentration of ferritin in serum decreases. The level of ferritin must be determined during the entire course of treatment. If it is less than 100 ng/ml, iron replacement therapy is recommended. Patients who donate autologous blood and are in the pre- or post-operative period should also receive an additional adequate amount of iron until ferritin levels normalize. Drug interactionsCo-administration of drugs that affect hematopoiesis (eg iron supplements) may increase the stimulatory effect of epoetin beta. Epoetin beta must not be mixed with solutions of other drugs. Keep If you want to place a link to the description of this drug – use this code Epoetin beta . |
Epoetin beta
Some facts
The drug has an erythropoietic effect, which significantly accelerates the prevention of anemia and the recovery period. The tool is designed to eliminate the consequences of hematological diseases caused by oncological neoplasms. A powerful composition that works as a single agent and enhancer of complex therapy.
Pharmacological properties
Epoetin beta is a means of targeted action on reticulocytes and erythrocytes. With regular use, it increases the average level of hemoglobin. The main function is the activation of heme synthesis. Over time, stabilizes low hematocrit values. After treatment, noticeable changes occur in the fourth week.
The maximum bioavailability of the drug varies from 23 to 42% of the standard rate. The concentration of active substances is maintained for 12-28 hours. With intravenous administration – up to 12 hours. The action of the pharmacological properties of this remedy is necessarily taken into account at the consultation of the attending physician.
Composition and formulation
Epoetin beta is sold as a solution for internal administration (subcutaneous version, through vessels). Available in several formats, depending on the activity of the active ingredient. As a rule, these are 1 ml ampoules of 500 IU, 2000, 3000, 4000 IU.
Another form of release – ready-made syringes 2000 IU, 1 ml. The packaging is supplied with contour cells. The instruction is attached.
The active substance is recombinant human erythropoietin with different levels of activity. As auxiliary components, an albumin solution, sodium chloride, and prepared water for injection are used.
Indications for use
Epoetin beta is recommended for prevention, rehabilitation therapy for:
- anemia accompanying renal failure, relevant for patients on hemodialysis;
- anemia with oncological complications – voluminous tumors, neoplasms of various etiologies, including non-Hodgkin’s lymphoma, various stages of myeloma;
- constant but relative deficiency of erythropoietin, in endogenous form.
The indication is a very low concentration of a substance in the blood serum. Measurements are made relative to a certain degree of anemia.
The drug is used for prophylactic therapy in newborns, infants with a minimum body weight of 0.7 to 1.5 kg (figures are observed up to 34 weeks of pregnancy).
Method and features of use
Epoetin beta solution is prescribed based on the diagnosis and body weight. The standard value, with chronic renal failure, is no more than 20 IU per 1 kg of the patient’s body weight. Taken 3 times a week. A lighter version is possible – 10 IU 7 times a week. With low efficiency, the figure is increased to 40 IU, taken every four weeks. The following values are also practiced:
- for support – 30 IU;
- for premature newborns – 250 IU per 1 kg of weight;
- cancer patients (subcutaneous injection) – 450 IU for 5-7 doses. The maximum figure, without contraindications – 720 IU.
Particular care is taken during the prevention of nephrosclerosis, arterial hypertension, malignant neoplasms. In this case, daily or weekly monitoring by the attending physician is recommended, including diagnostics of the liver, general metabolism, and blood pressure.
The effect and compatibility with other drugs is fixed. Special attention is paid to the level of hematocrit, ferritin, platelets.
During the correction of the main course, the initial subcutaneous dose is prescribed, in volume – from 20 IU per 1 kg of weight. Intravenous therapy begins with 40 IU. The maximum value is adjusted to 80 IU. If the hematocrit growth rate is more than 1%, the amount of injection is reduced, not the amount.
Interaction with other drugs
Epoetin beta solution is compatible with other medicines. No pharmacological incompatibility was found. The level of myelotoxic effects does not increase, including reactions with fluorouracil, etoposide, cisplatin, and other cytostatics.
Side effects
Epoetin beta solution causes jumps in blood pressure, a significant increase, accompanied by hypertensive crises. Perhaps the manifestation of encephalopathy (accompanied by the effect of “confused consciousness”, severe headaches, disorders of motor, sensory systems).
In rare cases, specific allergic reactions may occur, including urticaria, rash, unusual flushing at the injection site. Uncontrolled dosage enhances the above effects. Obligatory consultation with the attending physician is necessary, observation in a hospital is desirable.
The drug causes standard complications, from the side of the heart, coronal arteries, blood vessels. Most often manifested as:
- arterial hypertension;
- thrombosis of foreign bodies, such as shunts. One of the reasons is incorrectly selected treatment, inadequate heparinization;
- thromboembolism (epoetin beta did not show a clear reaction or causal relationship with this phenomenon).
The course is selected exclusively with a full-time consultation with a doctor. With the above violations, symptomatic therapy is prescribed.
Contraindications
With prolonged use, a pronounced hypersensitivity to the active substance, unstable angina is possible. Serious complications arise after strokes, myocardial infarction, and other similar diseases.
Pregnancy
No actual experience with the use of the solution during the 1-3 trimesters of pregnancy has been reported. There are no data for the time of breastfeeding, lactation period. The remedy is prescribed only after analyzing the situation, when the dosage and method of administration do not exceed the potential risks.
How to store
According to the instructions for use, store the medicine in a dark place, protected from children, away from fluctuations in temperature and humidity.