Procrit 3,000 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, 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 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, 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 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 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 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 are 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. Do not use this medication if you are pregnant.
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.

Other Important Interactions:

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking (including prescription, over-the-counter, natural products, and vitamins) and any health problems you have. This will help ensure it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

Important Information About This Medication

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.

Monitoring and Precautions

Regular blood pressure checks are crucial while taking this medication, as it can 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 your safety while taking this medication. It is vital to follow your doctor's guidance on these tests and to 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 Associated with Increased Red Blood Cell Count

This medication increases the production of red blood cells in the blood. 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.

Special Considerations for Multi-Dose Containers

This medication contains benzyl alcohol. In newborns and infants, benzyl alcohol can cause serious side effects, especially when combined with other medications containing benzyl alcohol. Whenever possible, avoid using products with benzyl alcohol in these age groups. If you have questions, discuss them with 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.

• Iron supplements (may be needed to support erythropoiesis, not an interaction but a co-requirement)
• Other hematopoietic growth factors (e.g., G-CSF, GM-CSF - generally not used concurrently unless specific clinical need)

• Signs of thrombosis (e.g., chest pain, shortness of breath, sudden numbness or weakness, vision changes, severe headache, swelling/pain in leg)
• Signs of uncontrolled hypertension (e.g., severe headache, blurred vision, dizziness)
• Signs of allergic reaction (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Symptoms of pure red cell aplasia (PRCA) such as sudden worsening of anemia (rare, but serious)

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 decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother.

Approved for anemia associated with CKD in pediatric patients. Dosing is weight-based. Safety and efficacy in other indications (e.g., CIA, HIV-induced anemia) are not fully established for all pediatric age groups.

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 crucial.

• Always assess and replete iron stores before and during epoetin alfa therapy, as iron deficiency is the most common cause of resistance to ESAs.
• Do not shake the vial; shaking can denature the glycoprotein and render it inactive.
• Administer subcutaneously for most indications, as it allows for less frequent dosing and is generally preferred for patient convenience. IV administration is typically used for hemodialysis patients.
• Target hemoglobin should generally not exceed 11 g/dL due to increased risks of serious cardiovascular events, stroke, and mortality.
• Monitor blood pressure closely, as hypertension is a common side effect and may require aggressive management.
• Educate patients on the signs and symptoms of blood clots and uncontrolled hypertension, and to seek immediate medical attention if they occur.
• Pure Red Cell Aplasia (PRCA) is a rare but serious adverse event associated with anti-erythropoietin antibody formation; investigate sudden loss of response.

• Darbepoetin alfa (Aranesp) - longer-acting ESA
• Methoxy polyethylene glycol-epoetin beta (Mircera) - even longer-acting ESA
• Iron supplementation (oral or IV) - essential co-therapy for anemia
• Blood transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)

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 receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the overdose, including the medication taken, the quantity, and the time it occurred.