Procrit 2,000 U/ml 1ml Sd Vial

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, differentiation, and maturation into red blood cells. It also induces the release of reticulocytes from the bone marrow.

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 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 immediately, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, 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 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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, 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
* Common cold symptoms

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.

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 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.

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 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.

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 may require regular blood tests to ensure safe treatment. It is vital to follow your doctor's guidance 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. However, 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. It is essential to discuss the benefits and risks of this medication to both you and your baby.

• Iron supplements (oral or IV): Essential for optimal response to epoetin alfa. Iron deficiency will blunt response.
• Other myelosuppressive agents: May reduce erythroid response.

• Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness)
• Signs and symptoms of allergic reactions (e.g., rash, itching, hives, swelling, difficulty breathing)
• Symptoms of worsening hypertension (e.g., severe headache, blurred vision, seizures)
• Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening anemia, fatigue, pallor)
• Signs of tumor progression/recurrence (in cancer patients)

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. Endogenous erythropoietin levels increase during pregnancy.

Epoetin alfa is excreted in human milk. However, due to the large molecular weight, oral absorption by the infant is unlikely. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.

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

No specific dose adjustment is required based on age alone. However, elderly patients may be at increased risk for cardiovascular events and thrombotic complications. Monitor hemoglobin and blood pressure closely.

• Always ensure adequate iron stores (ferritin and TSAT) before and during epoetin alfa therapy; iron supplementation is often necessary for optimal response.
• Do not exceed target hemoglobin levels (e.g., 10-11 g/dL) as higher levels are associated with increased risks of cardiovascular events, stroke, and mortality.
• Monitor hemoglobin levels frequently (weekly/bi-weekly initially) and adjust dose to avoid rapid increases or exceeding target range.
• Educate patients on the importance of blood pressure monitoring and reporting any signs of thrombosis or severe headache.
• Pure Red Cell Aplasia (PRCA) is a rare but serious complication, characterized by sudden worsening anemia and absence of erythroid precursors in the bone marrow, often associated with anti-erythropoietin antibodies. Discontinue epoetin alfa if PRCA is suspected.
• Procrit (epoetin alfa) vials are single-dose and preservative-free. Do not re-enter the vial. Discard any unused portion.

• Darbepoetin alfa (Aranesp): Longer-acting ESA, allowing for less frequent dosing.
• Methoxy PEG-epoetin beta (Mircera): Another longer-acting ESA.
• Iron supplementation (oral or intravenous): Often used in conjunction with ESAs or as primary treatment for iron deficiency anemia.
• Blood transfusions: Used for acute, severe anemia requiring rapid correction, but carry their own risks.

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 valuable resource for patients. 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, we encourage you to discuss them 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.