Procrit 20,000 Units / 2ml Vial

Epoetin alfa is a recombinant human erythropoietin, a glycoprotein that stimulates erythropoiesis (red blood cell production). 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 mimics the action of endogenous erythropoietin, which is primarily produced by the kidneys in response to hypoxia.

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, 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 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 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
Difficulty speaking or swallowing

In rare cases, a severe skin reaction called Stevens-Johnson syndrome or toxic epidermal necrolysis may occur. Seek medical help right away 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 list is not exhaustive. If you have questions or concerns about side effects, 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.

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 should not be given to premature babies or newborns.

Interactions with Other Medications and Health Conditions:

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 determine if it is safe to take this medication with your other treatments. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 although it is thoroughly screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease. Discuss this with your doctor.

Monitor your blood pressure regularly, as prescribed by your doctor, because this medication can cause high blood pressure. Additionally, follow your doctor's instructions for having your blood work checked.

Adhere strictly to the dosage prescribed by your doctor. Taking more than the recommended dose can increase the risk of severe side effects. If you accidentally take more than the prescribed amount, contact your doctor immediately.

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

Special Considerations for Multi-Dose Containers

This medication contains benzyl alcohol. If possible, avoid using products that contain benzyl alcohol in newborns or infants, as certain doses of benzyl alcohol can cause serious side effects in these children, especially when combined with other medications containing benzyl alcohol. If you have questions, consult your doctor.

Special Considerations for Single-Use Vials

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• Thalidomide, Lenalidomide, Pomalidomide (increased risk of thrombotic events when used with ESAs in multiple myeloma patients)

• Symptoms of hypertension (headache, blurred vision, dizziness)
• Symptoms of thrombotic events (chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness)
• Symptoms of allergic reactions (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Symptoms of pure red cell aplasia (sudden worsening of anemia, fatigue, pallor)

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.

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 molecular weight is high, suggesting limited transfer into milk, but potential effects on the infant are unknown.

Approved for anemia associated with CKD in pediatric patients. Dosing is weight-based. Safety and efficacy in neonates and infants for other indications are not fully established.

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 for an elderly patient should be cautious, usually 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. Elderly patients may be at higher risk for cardiovascular events.

• Always ensure adequate iron stores (ferritin >100 ng/mL and TSAT >20%) before and during epoetin alfa therapy, as iron deficiency is the most common cause of resistance.
• Strictly adhere to hemoglobin targets (10-11 g/dL) and avoid exceeding 11 g/dL due to the black box warning regarding increased cardiovascular and thrombotic risks.
• Monitor blood pressure closely, especially during the initial phase of therapy, as hypertension is a common side effect and may require aggressive management.
• Educate patients on the signs and symptoms of thrombotic events (e.g., DVT, stroke, MI) and to seek immediate medical attention if they occur.
• 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 investigate for anti-erythropoietin antibodies.
• The 20,000 Units/2mL vial is a multi-dose vial, requiring careful handling and storage to maintain sterility and potency.

• 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 (oral or intravenous) - often used concomitantly with ESAs
• Other agents for anemia depending on etiology (e.g., folic acid, vitamin B12, immunosuppressants for aplastic anemia)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you refill your prescription. If you have any questions or concerns about this medication, don't hesitate to consult with 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 quantity, and the time it occurred.