Procrit 40,000 U/ml 1ml Sd 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
Erythropoiesis-stimulating agent (ESA)
Pharmacologic Class
Recombinant human erythropoietin
Pregnancy 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. It's like a natural hormone your kidneys produce. It's used to treat anemia (low red blood cell count) caused by kidney disease, chemotherapy for cancer, or certain other conditions. It helps reduce the need for blood transfusions.
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.
Self-Administration
If you are giving yourself the injection, your doctor or nurse will instruct you on the proper technique. It is essential to follow their guidance to ensure safe and effective use.
Important Handling 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 is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.
Avoid injecting 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 and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the 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 with the medication. If you miss a dose, contact your doctor for guidance on what to do next.
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.
Self-Administration
If you are giving yourself the injection, your doctor or nurse will instruct you on the proper technique. It is essential to follow their guidance to ensure safe and effective use.
Important Handling 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 is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.
Avoid injecting 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 and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the 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 with the medication. If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- It is very important to take iron supplements as prescribed by your doctor, as iron is needed for epoetin alfa to work effectively.
- Monitor your blood pressure regularly at home as instructed by your doctor, and report any significant changes.
- Maintain a healthy diet as advised by your healthcare provider.
- Do not stop taking this medication without consulting your doctor, even if you feel better.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and route of administration (IV or SC). For CKD anemia (non-dialysis): 0.45 mcg/kg (equivalent to 200 U/kg) IV or SC once weekly. For CKD anemia (dialysis): 50-100 U/kg IV or SC 3 times per week. For chemotherapy-induced anemia: 150 U/kg SC 3 times per week or 40,000 U SC weekly. The 40,000 U/ml vial is typically used for weekly or less frequent dosing.
Condition-Specific Dosing:
CKD Anemia (non-dialysis):
0.45 mcg/kg (approx 200 U/kg) IV or SC once weekly, or 40,000 U SC every 2 weeks, or 80,000 U SC every 4 weeks. Titrate to maintain Hb 10-11 g/dL.
CKD Anemia (dialysis):
50-100 U/kg IV or SC 3 times per week. Titrate to maintain Hb 10-11 g/dL.
Chemotherapy-Induced Anemia:
150 U/kg SC 3 times per week or 40,000 U SC weekly. Discontinue if no response after 8 weeks or if chemotherapy is completed. Do not exceed Hb 10 g/dL.
Zidovudine-induced Anemia in HIV:
100 U/kg IV or SC 3 times per week for 8 weeks. If response is inadequate, increase to 150 U/kg 3 times per week.
Reduction of Allogeneic RBC Transfusions in Surgery:
300 U/kg/day SC for 10 days before surgery, on the day of surgery, and for 4 days after surgery; OR 600 U/kg SC once weekly (3, 2, and 1 week before surgery) plus on the day of surgery.
Pediatric Dosing
Neonatal:
Not established for routine use. Limited data for anemia of prematurity (250 U/kg SC 3 times weekly).
Infant:
Not established for routine use. For CKD anemia: 50 U/kg IV or SC 3 times per week.
Child:
For CKD anemia: 50 U/kg IV or SC 3 times per week. Titrate to maintain Hb 10-11 g/dL.
Adolescent:
For CKD anemia: 50 U/kg IV or SC 3 times per week. Titrate to maintain Hb 10-11 g/dL. For chemotherapy-induced anemia: 150 U/kg SC 3 times per week or 40,000 U SC weekly.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment needed, as it is indicated for anemia associated with CKD.
Moderate:
No specific dose adjustment needed, as it is indicated for anemia associated with CKD.
Severe:
No specific dose adjustment needed, as it is indicated for anemia associated with CKD.
Dialysis:
Administered IV or SC. Dosing is typically 3 times per week for dialysis patients. Monitor hemoglobin and iron status closely.
Hepatic Impairment:
Mild:
No specific dose adjustment provided in labeling.
Moderate:
No specific dose adjustment provided in labeling.
Severe:
No specific dose adjustment provided in labeling.
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, stimulating their proliferation and differentiation into mature red blood cells. It also induces the release of reticulocytes from the bone marrow.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30-40% (subcutaneous), 100% (intravenous)
Tmax:
5-24 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 4-10 L (similar to plasma volume)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
4-13 hours (IV), 18-24 hours (SC)
Clearance:
Approximately 12-50 mL/hr/kg (IV)
ExcretionRoute:
Primarily non-renal catabolism; a small amount excreted unchanged in urine.
Unchanged:
<10% (urine)
Pharmacodynamics
OnsetOfAction:
Increased reticulocyte count within 7-10 days; significant increase in hemoglobin typically within 2-6 weeks.
PeakEffect:
Hemoglobin levels peak after several weeks of consistent dosing.
DurationOfAction:
Effects on erythropoiesis persist for several days after discontinuation due to the half-life and maturation of red blood cells.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, myocardial infarction, stroke, venous thromboembolism, and tumor progression or recurrence. Use the lowest effective dose to reduce the need for red blood cell transfusions. For patients with chronic kidney disease (CKD), target hemoglobin should not exceed 11 g/dL. For patients with cancer, ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. ESAs are not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue ESAs once chemotherapy is completed.
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 or seek immediate 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 or 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, significant 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 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 immediately, 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 a leg or arm, or difficulty speaking or swallowing.
In rare cases, a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems and even death. Seek medical help right away if you notice: red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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.
Difficulty sleeping.
* Signs of a common cold.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 or seek immediate 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 or 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, significant 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 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 immediately, 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 a leg or arm, or difficulty speaking or swallowing.
In rare cases, a severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, which can cause serious health problems and even death. Seek medical help right away if you notice: red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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.
Difficulty sleeping.
* Signs of a common cold.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 severe headache, confusion, vision changes (signs of high blood pressure)
- Chest pain, shortness of breath, sudden numbness or weakness on one side of the body, trouble speaking (signs of heart attack or stroke)
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Unusual tiredness, dizziness, or pale skin that suddenly worsens (signs of pure red cell aplasia)
- Signs of an allergic reaction: rash, itching, hives, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing.
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, including allergies to this medication, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you are currently experiencing active bleeding.
If you have low levels of vitamins or minerals.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia.
Additional Considerations for Multi-Dose Containers:
If you are pregnant or think you might be pregnant. This medication is not recommended during pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication and for 2 weeks after your last dose.
If the patient is a premature baby or newborn. This form of the medication is not suitable for premature babies or newborns.
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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs 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, including allergies to this medication, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you are currently experiencing active bleeding.
If you have low levels of vitamins or minerals.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia.
Additional Considerations for Multi-Dose Containers:
If you are pregnant or think you might be pregnant. This medication is not recommended during pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication and for 2 weeks after your last dose.
If the patient is a premature baby or newborn. This form of the medication is not suitable for premature babies or newborns.
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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs 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 this medication 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 may recommend regular blood tests to monitor your condition. It is vital to follow your doctor's instructions and discuss any concerns with them.
Dosage and Administration
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.
Risks and Abuse
This medication increases the production of red blood cells in the blood. However, misuse or abuse of this type of medication can lead to severe health problems, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult your doctor.
Specific Product Information
Multi-dose container: This product contains benzyl alcohol, which can cause serious side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. Whenever possible, avoid using products with benzyl alcohol in these age groups. If you have questions, consult your doctor.
Single-use vial: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential 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 this medication 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 may recommend regular blood tests to monitor your condition. It is vital to follow your doctor's instructions and discuss any concerns with them.
Dosage and Administration
To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.
Risks and Abuse
This medication increases the production of red blood cells in the blood. However, misuse or abuse of this type of medication can lead to severe health problems, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult your doctor.
Specific Product Information
Multi-dose container: This product contains benzyl alcohol, which can cause serious side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. Whenever possible, avoid using products with benzyl alcohol in these age groups. If you have questions, consult your doctor.
Single-use vial: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential 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
- Severe hypertension
- Increased risk of thromboembolic events (e.g., stroke, MI, DVT)
What to Do:
Seek immediate medical attention. Management typically involves phlebotomy to reduce hemoglobin and hematocrit, and supportive care for symptoms like hypertension. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Iron supplements (concurrent administration is often necessary but requires careful monitoring of iron stores)
- Other erythropoiesis-stimulating agents (risk of additive effects/overdose)
Monitoring
Baseline Monitoring
Hemoglobin (Hb)
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron status (TSAT, ferritin)
Rationale: Adequate iron stores are essential for optimal response to epoetin alfa. Iron deficiency will limit efficacy.
Timing: Prior to initiation of therapy.
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 rule out other causes of anemia and assess overall hematologic status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then every 2-4 weeks.
Target: 10-11 g/dL (do not exceed 11 g/dL for CKD patients, 10 g/dL for CIA patients).
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or approaches target, reduce dose. If Hb exceeds target, interrupt or reduce dose. If Hb does not increase after 4-8 weeks, consider increasing dose or investigating other causes of anemia.
Blood Pressure (BP)
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, maintain within patient's target range.
Action Threshold: If BP increases significantly, manage hypertension aggressively. May require dose reduction or discontinuation of epoetin alfa.
Iron status (TSAT, ferritin)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: TSAT >20%, Ferritin >100 ng/mL (CKD patients often require higher targets: TSAT >20%, Ferritin >200 ng/mL).
Action Threshold: If iron stores are low, initiate or increase iron supplementation (oral or IV).
Symptom Monitoring
- Symptoms of hypertension (headache, blurred vision, dizziness)
- Symptoms of thromboembolic events (chest pain, shortness of breath, sudden numbness/weakness, swelling/pain in leg)
- Symptoms of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
- Symptoms of pure red cell aplasia (sudden worsening of anemia, fatigue, pallor)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited data, theoretical risk of adverse developmental outcomes.
Second Trimester:
Limited data, theoretical risk of adverse developmental outcomes.
Third Trimester:
Limited data, theoretical risk of adverse developmental outcomes.
Lactation
L3 (Moderately Safe). Epoetin alfa is a large protein and is unlikely to pass into breast milk in significant amounts. However, caution should be exercised. Consider the benefits of breastfeeding versus the potential risks.
Infant Risk:
Low risk of adverse effects on the infant due to poor oral absorption of large proteins.
Pediatric Use
Approved for anemia associated with CKD and chemotherapy-induced anemia in pediatric patients. Dosing is weight-based. Close monitoring of hemoglobin and blood pressure is crucial. Safety and efficacy in neonates and infants for conditions other than CKD are not fully established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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 assess iron status (TSAT and ferritin) before and during epoetin alfa therapy; iron supplementation is almost always required for optimal response.
- The goal of therapy is to achieve and maintain a hemoglobin level sufficient to avoid transfusions, not to normalize hemoglobin levels, due to increased risks at higher Hb levels.
- Monitor blood pressure closely, especially during the initial phase of therapy, as hypertension is a common side effect.
- Patients with cancer should only receive epoetin alfa if they are receiving myelosuppressive chemotherapy and the goal is palliation, not cure, due to risks of tumor progression.
- Pure Red Cell Aplasia (PRCA) is a rare but serious adverse event associated with anti-erythropoietin antibody formation; if suspected, discontinue epoetin alfa and investigate.
- The 40,000 U/ml concentration is typically used for less frequent dosing regimens (e.g., weekly or every 2-4 weeks) in appropriate indications.
Alternative Therapies
- Darbepoetin alfa (Aranesp) - longer-acting ESA
- Methoxy polyethylene glycol-epoetin beta (Mircera) - even longer-acting ESA
- Blood transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
- Iron supplementation (often used adjunctively, not as a sole alternative for severe anemia)
Cost & Coverage
Average Cost:
Varies widely, typically several hundred to over a thousand USD per vial depending on concentration and quantity. per 1ml vial
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to strict criteria and step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides important information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.