Procrit 10,000u/ml 2ml Mdv Vials

Epoetin alfa is a recombinant human erythropoietin, a glycoprotein that stimulates 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 into the bloodstream.

Urgent Side Effects: Seek Medical Help Immediately

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 medical attention right away:

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
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. 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 do not go away, 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, and you may experience other 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.

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 to ensure safe use. Do not 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 although it is screened, tested, and treated to minimize the risk of infection, there is still a possibility of transmitting viruses that can cause disease. Consult with your doctor to discuss this risk.

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 blood work checked to ensure your safety while taking this medication.

Adhere strictly 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 of this medication than directed, 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 with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. If you have questions, consult with your doctor.

Special Considerations for Single-Use Vials

If you are pregnant, plan 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 VTE when used with ESAs in multiple myeloma patients)

• Headache
• Fatigue
• Dizziness
• Shortness of breath
• Chest pain
• Swelling in legs/arms (signs of VTE)
• Sudden numbness or weakness (signs of stroke)
• Vision changes
• Severe headache (hypertensive crisis)
• Skin rash or itching (allergic reaction)

Category C. Use 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.

L3 - Moderately safe. It is unknown whether epoetin alfa is excreted in human milk. 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.

Approved for anemia of CKD in pediatric patients. Dosing is weight-based. Safety and efficacy in neonates for anemia of prematurity are not fully established for routine use. Close monitoring of hemoglobin and iron status is essential.

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 titration should be done carefully, and monitoring for cardiovascular events is important.

• 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.
• Do not shake the vial; shaking can denature the glycoprotein, rendering it inactive.
• Administer SC injections in the arm, thigh, or abdomen, rotating sites. IV administration is preferred for hemodialysis patients.
• The goal of therapy is to avoid transfusions, not to achieve normal hemoglobin levels. Higher Hb targets (>11 g/dL) are associated with increased risks.
• Monitor blood pressure closely, as hypertension is a common side effect and may require aggressive management.
• Pure red cell aplasia (PRCA) is a rare but serious adverse event, characterized by a sudden drop in Hb and reticulocytes, often associated with anti-erythropoietin antibodies. If suspected, discontinue epoetin alfa and investigate.
• Patients should be educated on the signs and symptoms of blood clots and stroke and instructed to seek immediate medical attention if they occur.

• Darbepoetin alfa (Aranesp) - longer-acting ESA, less frequent dosing.
• Methoxy polyethylene glycol-epoetin beta (Mircera) - even longer-acting ESA, once monthly dosing.
• Iron supplementation (oral or IV) - often used adjunctively.
• Red blood cell transfusions - for acute, severe anemia or when ESAs are contraindicated/ineffective.
• Other agents for specific anemia types (e.g., folic acid, vitamin B12 for deficiency anemias).

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. It is vital to 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 the 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.