Procrit 20,000u/ml, 1ml Vial
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor.If you will be having surgery, talk with your doctor. You may need to take another drug to keep you from getting blood clots while you get this drug. @ COMMON USES: It is used to treat anemia.It is used to help lower the need for blood transfusions for certain surgeries.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hematopoietic Agent; Erythropoiesis-Stimulating Agent (ESA)
Pharmacologic Class
Recombinant Human Erythropoietin
Pregnancy Category
Category C
FDA Approved
Jun 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Epoetin alfa is a medicine that helps your body make more red blood cells. Red blood cells carry oxygen throughout your body. If you have too few red blood cells (anemia), you might feel tired, weak, or short of breath. This medicine works like a natural substance in your body called erythropoietin, which tells your bone marrow to produce more red blood cells. It's given as an injection under the skin or into a vein.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling better. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Important Administration Instructions
Do not shake the medication.
Do not use the medication if it has been shaken.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Used Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box.
Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
* Follow the storage instructions provided for all products.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling better. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Important Administration Instructions
Do not shake the medication.
Do not use the medication if it has been shaken.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Used Needles and Supplies
Dispose of used needles in a designated needle/sharp disposal box.
Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
* Follow the storage instructions provided for all products.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Adhere strictly to the prescribed dosing schedule and administration instructions.
- Do not shake the vial, as this can damage the protein.
- Store in the refrigerator (2°C to 8°C / 36°F to 46°F); do not freeze. Protect from light.
- Report any new or worsening symptoms, especially signs of blood clots or high blood pressure, to your doctor immediately.
- Maintain adequate iron intake, as iron is crucial for red blood cell production. Your doctor may prescribe iron supplements.
- Attend all scheduled blood tests and doctor appointments to monitor your hemoglobin levels, blood pressure, and iron stores.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication, route (IV/SC), and patient response. Dosing is individualized to achieve and maintain target hemoglobin levels (typically 10-11 g/dL).
Condition-Specific Dosing:
Anemia of Chronic Kidney Disease (CKD):
Initial: 50-100 units/kg IV or SC 3 times/week. Titrate to maintain Hb 10-11 g/dL. Max 300 units/kg 3 times/week.
Anemia due to Chemotherapy in Cancer Patients:
Initial: 150 units/kg SC 3 times/week OR 40,000 units SC once weekly. Titrate to maintain Hb 10-11 g/dL. Max 300 units/kg 3 times/week or 60,000 units SC weekly.
Anemia in Zidovudine-treated HIV-infected Patients:
Initial: 100 units/kg IV or SC 3 times/week. Titrate to maintain Hb 10-11 g/dL. Max 300 units/kg 3 times/week.
Reduction of Allogeneic Red Blood Cell Transfusions in Surgery Patients:
300 units/kg/day SC for 10 days before surgery, on the day of surgery, and for 4 days after surgery OR 600 units/kg SC once weekly (21, 14, and 7 days before surgery, and on the day of surgery).
Pediatric Dosing
Neonatal:
Not established for routine use; limited data for specific conditions (e.g., anemia of prematurity, but not FDA approved for this indication).
Infant:
Anemia of CKD (1 month to 18 years): Initial 50 units/kg IV or SC 3 times/week. Titrate to maintain Hb 10-11 g/dL.
Child:
Anemia of CKD (1 month to 18 years): Initial 50 units/kg IV or SC 3 times/week. Titrate to maintain Hb 10-11 g/dL. Chemotherapy-induced anemia (5-18 years): 150 units/kg SC 3 times/week or 40,000 units SC once weekly.
Adolescent:
Anemia of CKD (1 month to 18 years): Initial 50 units/kg IV or SC 3 times/week. Titrate to maintain Hb 10-11 g/dL. Chemotherapy-induced anemia (5-18 years): 150 units/kg SC 3 times/week or 40,000 units SC once weekly.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment beyond standard CKD dosing, as CKD is a primary indication.
Moderate:
No specific dose adjustment beyond standard CKD dosing, as CKD is a primary indication.
Severe:
No specific dose adjustment beyond standard CKD dosing, as CKD is a primary indication.
Dialysis:
Patients on dialysis are a primary population for epoetin alfa use. Dosing is typically IV for hemodialysis patients. No specific adjustment for dialysis itself, but dose is titrated based on Hb response.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution due to potential for altered drug disposition, though not primarily metabolized by the liver.
Pharmacology
Mechanism of Action
Epoetin alfa is a recombinant human erythropoietin, a glycoprotein that stimulates erythropoiesis (red blood cell production). It binds to erythropoietin receptors on erythroid progenitor cells in the bone marrow, stimulating their proliferation and differentiation into mature red blood cells. It also induces the release of reticulocytes from the bone marrow into the bloodstream.
Pharmacokinetics
Absorption:
Bioavailability:
Subcutaneous (SC): Approximately 30-40% (range 20-50%)
Tmax:
Subcutaneous (SC): 5-24 hours (mean 12-18 hours)
FoodEffect:
Not applicable (administered parenterally)
Distribution:
Vd:
Approximately 4-10 L (similar to plasma volume)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Intravenous (IV): 4-13 hours (in patients with CKD). Subcutaneous (SC): 18-48 hours (due to slower absorption).
Clearance:
Variable, depends on route and patient population. Primarily cleared by receptor-mediated uptake.
ExcretionRoute:
Primarily catabolized; minimal renal excretion of intact drug.
Unchanged:
Less than 10% (renal excretion of intact drug)
Pharmacodynamics
OnsetOfAction:
Increase in reticulocytes typically seen within 7-10 days.
PeakEffect:
Peak increase in hemoglobin typically observed within 2-6 weeks after initiation of therapy, depending on dose and frequency.
DurationOfAction:
Effects on erythropoiesis persist for several days after discontinuation, but hemoglobin levels will decline if underlying cause of anemia is not resolved or if therapy is stopped.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, myocardial infarction, stroke, venous thromboembolism (VTE), thrombosis of vascular access, and tumor progression/recurrence. Use the lowest effective dose to reduce the need for red blood cell transfusions. For patients with chronic kidney disease (CKD), the target hemoglobin should not exceed 11 g/dL. For cancer patients, ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue ESA use once chemotherapy course is completed. For patients undergoing surgery, ESAs are not indicated for patients who are able to donate autologous blood.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Rapid heartbeat
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
Cool or pale skin on an arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Depression
If you experience any of the following symptoms, call your doctor right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in an arm or leg
Difficulty speaking or swallowing
In rare cases, a severe skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. Seek immediate medical attention if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Irritation at the injection site
Fever or chills
Headache
Upset stomach or vomiting
Cough
Bone, joint, or muscle pain
Muscle spasms
Mouth irritation or mouth sores
Weight loss
Sleep disturbances
* Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat
Rapid heartbeat
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
Cool or pale skin on an arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Depression
If you experience any of the following symptoms, call your doctor right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in an arm or leg
Difficulty speaking or swallowing
In rare cases, a severe skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. Seek immediate medical attention if you notice:
Red, swollen, blistered, or peeling skin (with or without fever)
Red or irritated eyes
Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Irritation at the injection site
Fever or chills
Headache
Upset stomach or vomiting
Cough
Bone, joint, or muscle pain
Muscle spasms
Mouth irritation or mouth sores
Weight loss
Sleep disturbances
* Common cold symptoms
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden chest pain or shortness of breath
- Sudden numbness or weakness on one side of the body
- Sudden severe headache or confusion
- Problems with vision, speech, or balance
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Unusual tiredness or weakness, dizziness, pale skin (signs of worsening anemia or PRCA)
- Severe headache, blurred vision, or seizures (signs of very high blood pressure)
- Rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing (signs of allergic reaction)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
If you have high blood pressure, as this may affect your treatment.
If you are experiencing active bleeding, as this medication may not be suitable for you.
If you have low levels of vitamins or minerals, which could impact your treatment.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia, as this medication may not be appropriate for you.
Additional Considerations for Multi-Dose Containers:
If you are pregnant or think you might be pregnant, do not use this medication. Inform your doctor if you are pregnant or plan to become pregnant.
If you are breastfeeding, do not use this medication and wait for 2 weeks after your last dose before resuming breastfeeding.
If the patient is a premature baby or newborn, do not administer this form of the medication, as it is not suitable for them.
Other Important Interactions:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
If you have high blood pressure, as this may affect your treatment.
If you are experiencing active bleeding, as this medication may not be suitable for you.
If you have low levels of vitamins or minerals, which could impact your treatment.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia, as this medication may not be appropriate for you.
Additional Considerations for Multi-Dose Containers:
If you are pregnant or think you might be pregnant, do not use this medication. Inform your doctor if you are pregnant or plan to become pregnant.
If you are breastfeeding, do not use this medication and wait for 2 weeks after your last dose before resuming breastfeeding.
If the patient is a premature baby or newborn, do not administer this form of the medication, as it is not suitable for them.
Other Important Interactions:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is derived from human plasma, which is a component of blood, and may potentially contain viruses that can cause disease. Although the drug is thoroughly screened, tested, and treated to minimize the risk of infection, it is crucial to discuss this with your doctor.
Monitoring and Precautions
Regular blood pressure checks are necessary while taking this medication, as it may cause high blood pressure. Your doctor will advise you on the frequency of these checks. Additionally, your doctor will recommend regular blood tests to monitor your condition. It is vital to adhere to the dosage prescribed by your doctor, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more than the prescribed dose, contact your doctor immediately.
Risks and Abuse
This medication increases the production of red blood cells in the blood. However, it is essential to be aware that misuse or abuse of this type of drug can lead to severe health problems, including stroke, heart attack, and blood clots. If you have any questions or concerns, discuss them with your doctor.
Special Considerations
Multi-dose container: This medication contains benzyl alcohol, which can be harmful to newborns and infants. If possible, avoid using products containing benzyl alcohol in these age groups, as it can cause serious side effects, especially when combined with other medications containing benzyl alcohol. If you have questions, consult your doctor.
Single-use vial: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of this medication to both you and your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug is derived from human plasma, which is a component of blood, and may potentially contain viruses that can cause disease. Although the drug is thoroughly screened, tested, and treated to minimize the risk of infection, it is crucial to discuss this with your doctor.
Monitoring and Precautions
Regular blood pressure checks are necessary while taking this medication, as it may cause high blood pressure. Your doctor will advise you on the frequency of these checks. Additionally, your doctor will recommend regular blood tests to monitor your condition. It is vital to adhere to the dosage prescribed by your doctor, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more than the prescribed dose, contact your doctor immediately.
Risks and Abuse
This medication increases the production of red blood cells in the blood. However, it is essential to be aware that misuse or abuse of this type of drug can lead to severe health problems, including stroke, heart attack, and blood clots. If you have any questions or concerns, discuss them with your doctor.
Special Considerations
Multi-dose container: This medication contains benzyl alcohol, which can be harmful to newborns and infants. If possible, avoid using products containing benzyl alcohol in these age groups, as it can cause serious side effects, especially when combined with other medications containing benzyl alcohol. If you have questions, consult your doctor.
Single-use vial: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), leading to increased blood viscosity
- Increased risk of thrombotic events (e.g., stroke, heart attack, blood clots)
- Exacerbation of hypertension
What to Do:
In case of overdose, contact a poison control center or emergency medical services immediately. Treatment is supportive and may include phlebotomy (blood removal) to reduce hemoglobin and hematocrit levels, and management of hypertension or thrombotic events. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Cyclosporine: Epoetin alfa may decrease blood levels of cyclosporine. Monitor cyclosporine levels and adjust dose as needed.
- Thalidomide, Lenalidomide, Pomalidomide: Increased risk of VTE when used concurrently with ESAs in patients with multiple myeloma. Concomitant use is generally not recommended outside of clinical trials.
Monitoring
Baseline Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron Status (Serum Ferritin, Transferrin Saturation [TSAT])
Rationale: Adequate iron stores are essential for optimal erythropoiesis and response to epoetin alfa. Iron deficiency is a common cause of ESA hyporesponsiveness.
Timing: Prior to initiation of therapy and periodically during treatment.
Blood Pressure (BP)
Rationale: Epoetin alfa can cause or exacerbate hypertension.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC) with differential and platelet count
Rationale: To assess overall hematologic status and rule out other causes of anemia.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then monthly.
Target: 10-11 g/dL (do not exceed 11 g/dL in CKD patients or 10 g/dL in cancer patients).
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target range, reduce dose or interrupt therapy. If Hb does not increase by 1 g/dL after 4 weeks of therapy, consider dose increase or investigate other causes of anemia.
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly or bi-weekly initially, then monthly or as clinically indicated).
Target: Individualized, maintain within patient's target range.
Action Threshold: If significant increase in BP occurs, initiate or intensify antihypertensive therapy. If hypertension is difficult to control, reduce or withhold epoetin alfa.
Iron Status (Serum Ferritin, TSAT)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: Ferritin >100 ng/mL (CKD), TSAT >20% (CKD).
Action Threshold: If iron stores are low, initiate or increase iron supplementation. If iron deficiency persists, investigate malabsorption or blood loss.
Potassium
Frequency: Periodically, especially in CKD patients.
Target: Normal range.
Action Threshold: Monitor for hyperkalemia, which can occur with rapid increase in red cell mass.
Symptom Monitoring
- Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, pain/swelling in leg)
- Signs and symptoms of severe hypertension (e.g., severe headache, blurred vision, confusion, seizures)
- Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
- Signs of tumor progression or recurrence (in cancer patients)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Epoetin alfa has been shown to have adverse effects in animal reproduction studies.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects observed in animal studies at doses higher than human therapeutic doses.
Second Trimester:
Potential for adverse developmental effects observed in animal studies at doses higher than human therapeutic doses.
Third Trimester:
Potential for adverse developmental effects observed in animal studies at doses higher than human therapeutic doses.
Lactation
It is not known whether epoetin alfa is excreted in human milk. Caution should be exercised when epoetin alfa is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for epoetin alfa and any potential adverse effects on the breastfed infant from epoetin alfa or from the underlying maternal condition.
Infant Risk:
L3 (Moderate risk - no human data, animal data suggest low risk, or human data show minor non-serious adverse effects). Consider potential for adverse effects on the infant, such as altered erythropoiesis, though systemic absorption by the infant is unlikely due to the large protein nature of the drug.
Pediatric Use
Approved for anemia of CKD in pediatric patients (1 month to 18 years) and chemotherapy-induced anemia in pediatric cancer patients (5 to 18 years). Dosing is weight-based. Safety and efficacy in neonates and infants under 1 month for CKD, or under 5 years for chemotherapy-induced anemia, have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to cardiovascular events, including hypertension and thrombotic events. Dose selection should be cautious, generally starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (TSAT >20%, Ferritin >100 ng/mL) before and during epoetin alfa therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Do not shake the vial or syringe, as this can denature the glycoprotein and reduce its activity.
- Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges (e.g., 11 g/dL in CKD, 10 g/dL in cancer) due to increased risks of serious adverse events.
- Educate patients on the signs and symptoms of thrombotic events and severe hypertension, and instruct them to seek immediate medical attention if these occur.
- Pure Red Cell Aplasia (PRCA) with neutralizing antibodies to erythropoietin has been reported, primarily in CKD patients receiving subcutaneous epoetin alfa. If PRCA is suspected, discontinue epoetin alfa and investigate for anti-erythropoietin antibodies.
- Procrit is for single-dose use only; discard any unused portion. Do not re-enter the vial.
Alternative Therapies
- Darbepoetin alfa (Aranesp): A longer-acting erythropoiesis-stimulating agent (ESA) that can be administered less frequently (e.g., weekly or every 2-3 weeks).
- Methoxy polyethylene glycol-epoetin beta (Mircera): Another longer-acting ESA.
- Blood Transfusions: For acute, severe anemia requiring rapid correction, or when ESAs are contraindicated or ineffective.
- Iron Supplementation: Oral or intravenous iron to address iron deficiency, which is often co-existent with anemia requiring ESA therapy.
- Other Anemia Treatments: Depending on the underlying cause of anemia (e.g., vitamin B12/folate supplementation for megaloblastic anemia, immunosuppressants for aplastic anemia).
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to thousands of dollars per vial/dose depending on strength and quantity. per 1ml vial (20,000 units)
Generic Available:
Yes
Insurance Coverage:
Typically covered by most commercial and government insurance plans (Medicare Part B, Medicaid) but often requires prior authorization and adherence to specific criteria (e.g., hemoglobin levels, diagnosis). Tier 4 or Specialty Tier.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.