Procrit 10,000 U/ml 1ml Sd Vial

Manufacturer JANSSEN Active Ingredient Epoetin Alfa Vials(e POE e tin AL fa) Pronunciation e POE e tin AL fa
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.
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Drug Class
Hematopoietic agent
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Pharmacologic Class
Erythropoiesis-stimulating protein
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Pregnancy Category
Category C
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FDA Approved
Jun 1989
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Epoetin alfa is a medicine that helps your body make more red blood cells. It's like a natural substance your kidneys make, called erythropoietin. When you have certain conditions like kidney disease or cancer and are undergoing chemotherapy, your body might not make enough red blood cells, leading to anemia. This medicine helps to correct that, reducing the need for blood transfusions.
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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

For information on storing and disposing of this medication, refer to the specific product instructions.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Maintain adequate iron intake as prescribed by your doctor (often requires iron supplements).
  • Monitor blood pressure regularly at home as instructed.
  • Report any new or worsening symptoms immediately to your healthcare provider.
  • Do not shake the vial, as this can damage the medicine.
  • Store in the refrigerator, do not freeze.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. For CKD anemia (non-dialysis): Initial 0.45 mcg/kg (equivalent to 100 U/kg) IV or SC 3 times/week. For CKD anemia (dialysis): Initial 50-100 U/kg IV or SC 3 times/week. For chemotherapy-induced anemia: Initial 150 U/kg SC 3 times/week or 40,000 U SC once weekly.
Dose Range: 50 - 60000 mg

Condition-Specific Dosing:

CKD_Anemia_NonDialysis: Initial 0.45 mcg/kg (approx 100 U/kg) IV or SC 3 times/week. Titrate to maintain hemoglobin between 10-11 g/dL.
CKD_Anemia_Dialysis: Initial 50-100 U/kg IV or SC 3 times/week. Titrate to maintain hemoglobin between 10-11 g/dL.
Chemotherapy_Induced_Anemia: Initial 150 U/kg SC 3 times/week or 40,000 U SC once weekly. Titrate to maintain hemoglobin between 10-11 g/dL. Discontinue if no response after 8 weeks.
Zidovudine_Treated_HIV_Anemia: Initial 100 U/kg IV or SC 3 times/week. Titrate based on response and hemoglobin levels.
Reduction_Allogeneic_RBC_Transfusions_Surgery: 300 U/kg/day SC for 10 days before surgery, on day of surgery, and for 4 days after surgery; OR 600 U/kg SC once weekly (21, 14, and 7 days before surgery) and on day of surgery.
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Pediatric Dosing

Neonatal: Not established for routine use; limited data for specific conditions.
Infant: Not established for routine use; limited data for specific conditions.
Child: CKD anemia: Initial 50 U/kg IV or SC 3 times/week. Titrate to maintain hemoglobin between 10-11 g/dL.
Adolescent: CKD anemia: Initial 50 U/kg IV or SC 3 times/week. Titrate to maintain hemoglobin between 10-11 g/dL.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required; dose based on hemoglobin response.
Moderate: No specific dose adjustment required; dose based on hemoglobin response.
Severe: No specific dose adjustment required; dose based on hemoglobin response. Patients on dialysis are a primary indication.
Dialysis: Primary indication for use. Dosing is typically 50-100 U/kg IV or SC 3 times/week, adjusted to maintain target hemoglobin.

Hepatic Impairment:

Mild: No specific dose adjustment recommended.
Moderate: No specific dose adjustment recommended.
Severe: No specific dose adjustment recommended.

Pharmacology

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Mechanism of Action

Epoetin alfa is a recombinant human erythropoietin, a glycoprotein that stimulates erythropoiesis. It binds to erythropoietin receptors on the surface of erythroid progenitor cells in the bone marrow, stimulating their proliferation, differentiation, and maturation into red blood cells. It also promotes the release of reticulocytes from the bone marrow.
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Pharmacokinetics

Absorption:

Bioavailability: IV: 100%; SC: Approximately 30-40% (variable)
Tmax: IV: End of infusion; SC: 5-24 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: IV: 4-13 hours; SC: 13-24 hours (due to slow absorption)
Clearance: Approximately 12-30 mL/min/kg (variable)
ExcretionRoute: Primarily non-renal catabolism
Unchanged: Minimal renal excretion of unchanged drug
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Pharmacodynamics

OnsetOfAction: Reticulocytosis within 2-5 days; significant increase in hemoglobin typically within 2-6 weeks.
PeakEffect: Peak hemoglobin effect typically observed after several weeks of consistent dosing.
DurationOfAction: Effects persist for several days after discontinuation, related to half-life and red blood cell lifespan.

Safety & Warnings

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BLACK BOX WARNING

Increased risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, 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 are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue ESAs once chemotherapy is completed. For patients undergoing surgery, ESAs are not indicated for patients who are able to donate autologous blood. For patients with cancer, ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies.
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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, 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 skin on an arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Extreme fatigue or weakness
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.
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Seek Immediate Medical Attention If You Experience:

  • Sudden chest pain or shortness of breath
  • Pain, swelling, warmth, or redness in an arm or leg (signs of blood clot)
  • Sudden numbness or weakness, especially on one side of the body
  • Sudden severe headache, confusion, or problems with vision, speech, or balance (signs of stroke)
  • Unusual tiredness or weakness, pale skin (signs of worsening anemia or PRCA)
  • Severe headache, dizziness, or blurred vision (signs of high blood pressure)
  • Rash, hives, itching, swelling of face/lips/tongue, difficulty breathing (signs of allergic reaction)
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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 before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you have 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.

Additionally, if you are using a multi-dose container, tell your doctor:

If you are pregnant or think you may 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.

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. They will help you determine if it is safe to take this medication with your other drugs and health problems. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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. Adhere to your doctor's instructions for monitoring your blood pressure. Additionally, your doctor will require you to undergo regular blood tests to ensure safe treatment. It is vital to follow your doctor's guidance on testing and discuss any concerns with them.

Dosage and Administration

Do not exceed the dosage prescribed by your doctor, as this may increase the risk of severe side effects. If you accidentally take more than the recommended dose, contact your doctor immediately.

Risks and Abuse

This medication increases red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to severe health complications, including stroke, heart attack, and blood clots. If you have any questions or concerns, consult your doctor.

Specific Product Warnings

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.
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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)

What to Do:

Seek immediate medical attention. Management typically involves phlebotomy to reduce red blood cell mass and supportive care. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Thalidomide (increased risk of VTE when used with ESAs in multiple myeloma patients - contraindicated in this setting)
  • Lenalidomide (increased risk of VTE when used with ESAs in multiple myeloma patients - contraindicated in this setting)
  • Pomalidomide (increased risk of VTE when used with ESAs in multiple myeloma patients - contraindicated in this setting)

Monitoring

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Baseline Monitoring

Complete Blood Count (CBC) with differential

Rationale: To establish baseline hemoglobin, hematocrit, red blood cell indices, and rule out other causes of anemia.

Timing: Prior to initiation of therapy

Serum Ferritin

Rationale: To assess iron stores, as adequate iron is essential for optimal response.

Timing: Prior to initiation of therapy

Transferrin Saturation (TSAT)

Rationale: To assess iron availability for erythropoiesis.

Timing: Prior to initiation of therapy

Blood Pressure

Rationale: To establish baseline and identify pre-existing hypertension, which can be exacerbated by epoetin alfa.

Timing: Prior to initiation of therapy

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Routine Monitoring

Hemoglobin (Hb)

Frequency: Weekly or bi-weekly initially, then every 2-4 weeks once stable.

Target: Generally 10-11 g/dL (avoid exceeding 11 g/dL in CKD patients and 10 g/dL in cancer patients due to increased risks).

Action Threshold: If Hb increases by >1 g/dL in any 2-week period or approaches target, consider dose reduction. If Hb exceeds target, hold dose until Hb falls below target, then restart at a reduced dose.

Iron Studies (Ferritin, TSAT)

Frequency: Monthly or every 3 months, or as clinically indicated.

Target: Ferritin >100 ng/mL (CKD) or >30 ng/mL (non-CKD); TSAT >20%.

Action Threshold: If iron deficiency is present, initiate or increase iron supplementation.

Blood Pressure

Frequency: Regularly, especially during the initial phase of therapy.

Target: Individualized, maintain within patient's target range.

Action Threshold: If significant increase in blood pressure or new onset hypertension, manage with antihypertensive therapy or consider dose adjustment/discontinuation of epoetin alfa.

Platelet Count

Frequency: Periodically, especially during the first 8 weeks.

Target: Normal range.

Action Threshold: Monitor for thrombocytosis, which can occur.

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Symptom Monitoring

  • Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness on one side of body, vision changes, severe headache)
  • Signs and symptoms of hypertension (e.g., headache, dizziness, blurred vision)
  • Signs and symptoms of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Signs and symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
  • Signs and symptoms of tumor progression (in cancer patients)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for adverse developmental effects observed in animal studies.
Second Trimester: Potential for adverse developmental effects observed in animal studies.
Third Trimester: Potential for adverse developmental effects observed in animal studies.
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Lactation

L3 (Moderately safe). It is unknown whether epoetin alfa is excreted in human milk. Due to its large protein nature, transfer into breast milk is likely low, and oral absorption by the infant is unlikely. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for epoetin alfa and any potential adverse effects on the breastfed infant.

Infant Risk: Low risk of adverse effects to the infant, but monitor for any unusual symptoms.
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Pediatric Use

Dosing is established for pediatric patients with chronic kidney disease anemia. Safety and efficacy in other pediatric indications are not fully established. Close monitoring of hemoglobin and blood pressure is crucial.

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Geriatric Use

No specific dose adjustment is required based on age alone. However, elderly patients may be at increased risk for cardiovascular events (e.g., hypertension, thrombosis) and should be monitored closely. Use the lowest effective dose.

Clinical Information

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Clinical Pearls

  • Adequate iron stores are critical for optimal response to epoetin alfa. Iron supplementation is often required.
  • Do not shake the vial; shaking can denature the glycoprotein, rendering it inactive.
  • Administer via subcutaneous (SC) or intravenous (IV) injection. The SC route is generally preferred for non-dialysis patients due to convenience.
  • Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges, as higher hemoglobin levels are associated with increased risks of cardiovascular events and mortality.
  • Patients should be well-hydrated to minimize the risk of thrombotic events.
  • Pure Red Cell Aplasia (PRCA) with neutralizing antibodies to erythropoietin has been reported, primarily with subcutaneous administration in CKD patients. If PRCA is suspected, discontinue epoetin alfa and evaluate for anti-erythropoietin antibodies.
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Alternative Therapies

  • Darbepoetin alfa (Aranesp) - another ESA with a longer half-life, allowing less frequent dosing.
  • Methoxy polyethylene glycol-epoetin beta (Mircera) - another ESA with a very long half-life, allowing monthly dosing.
  • Iron supplementation (oral or intravenous) - often used in conjunction with ESAs or as primary treatment for iron deficiency anemia.
  • Blood transfusions - for acute, severe anemia requiring rapid correction.
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Cost & Coverage

Average Cost: Varies significantly by strength and quantity (e.g., 10,000 U/mL 1mL vial can range from $100-$300+ per vial) per vial
Generic Available: Yes
Insurance Coverage: Tier 3 or 4 (Specialty drug), often requires prior authorization and may have quantity limits. Coverage varies widely by insurance plan.
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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 provides crucial information for patients. Please read this guide carefully and review it again each time 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.