Retacrit 4000unit Inj, 1ml

Epoetin alfa-epbx is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It interacts with the erythropoietin receptor on progenitor cells in the bone marrow to stimulate red blood cell production and differentiation.

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, 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 arm or leg.
Difficulty walking.
Dizziness or fainting.
Excessive sweating.
Seizures.
Extreme fatigue or weakness.
Pale skin.
Depression.

Blood Clots and Severe Skin Reactions

If you experience any of the following symptoms, seek medical help immediately:

Signs of 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.
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes. This condition can cause severe health problems and may be life-threatening.

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.

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 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.

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 issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

Important Information About Your Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Monitoring Your Health

You will need to have your blood pressure checked regularly, as directed by your doctor, because this medication can cause high blood pressure. Additionally, your doctor will instruct you on when to have blood work done to monitor your health.

Special Considerations

If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products contain phenylalanine.

Safe Use of Your Medication

Do not exceed 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 than the prescribed dose, contact your doctor immediately.

Understanding the Effects of Your Medication

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

Multi-Dose Container Precautions

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.

Single-Dose Container Precautions

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

• Symptoms of anemia (fatigue, pallor, shortness of breath)
• Symptoms of hypertension (headache, dizziness, blurred vision)
• Symptoms of thrombotic events (chest pain, shortness of breath, sudden weakness or numbness on one side of the body, vision changes, pain/swelling in a limb)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

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.

Considered compatible with breastfeeding (L2). Epoetin alfa is a large protein and is poorly excreted into milk. It is also inactivated in the infant's gastrointestinal tract. No adverse effects have been reported in breastfed infants.

Dosing is established for pediatric patients with CKD-associated anemia. Safety and efficacy for other indications (e.g., chemotherapy-induced anemia) have not been established in pediatric patients.

No specific dose adjustment is required based on age alone. However, older patients may have an increased risk of cardiovascular events and should be monitored closely for hypertension and thrombotic complications.

• Iron supplementation is almost always required for optimal response to epoetin alfa-epbx, as iron deficiency is a common cause of resistance.
• Do not shake the vial or syringe; shaking can denature the glycoprotein, rendering it inactive.
• Target hemoglobin levels should be individualized and generally kept at the lowest level sufficient to avoid transfusions, typically not exceeding 11 g/dL, due to the increased risk of serious adverse cardiovascular events and stroke.
• Monitor blood pressure closely, as hypertension is a common and potentially serious side effect.
• Educate patients on the signs and symptoms of thrombotic events (e.g., DVT, PE, stroke, MI) and to seek immediate medical attention if they occur.
• Retacrit is a biosimilar to Epogen/Procrit, meaning it is highly similar to and has no clinically meaningful differences from the reference product.

• Other Erythropoiesis-Stimulating Agents (ESAs) such as darbepoetin alfa (Aranesp) or methoxy polyethylene glycol-epoetin beta (Mircera)
• Blood transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
• Iron supplementation (oral or intravenous)
• Treatment of underlying cause of anemia (e.g., nutritional deficiencies, bleeding, inflammatory conditions)

If your symptoms or health issues persist or worsen, it's 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. 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 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.