Retacrit 3000unit Inj, 1ml

Epoetin alfa-epbx is a biosimilar to epoetin alfa, which is a recombinant human erythropoietin. It stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It interacts with erythropoietin receptors on the surface of erythroid progenitor cells, stimulating their proliferation and differentiation into mature red blood cells. This process leads to an increase in red blood cell mass, hemoglobin levels, and hematocrit.

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, difficulty 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

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. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, 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
* Signs of a common cold

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 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.

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.

Monitoring and Precautions

Regular blood pressure checks are crucial while taking this drug, as it may cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure. Additionally, have your blood work checked as directed by your doctor, and discuss any concerns with them.

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

Dosage and Administration

Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount may increase the risk of severe side effects. If you accidentally take more than the prescribed dose, contact your doctor immediately.

Risks and Abuse

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

Special Considerations

Multi-dose container: This product contains benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur, especially when combined with other medications containing benzyl alcohol. If you have questions, consult your doctor.
Single-dose container: If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of this medication to both you and your baby.

• Signs and symptoms of hypertension (headache, blurred vision, dizziness)
• Signs and symptoms of thrombotic events (chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness)
• Signs and symptoms of allergic reactions (rash, itching, hives, swelling, difficulty breathing)
• Signs and symptoms of pure red cell aplasia (sudden worsening of anemia, fatigue, pallor)
• Signs and symptoms of tumor progression or recurrence (in cancer patients)

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.

L3 (Moderate risk). It is unknown whether epoetin alfa-epbx is excreted in human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Retacrit and any potential adverse effects on the breastfed infant from Retacrit or from the underlying maternal condition.

Safety and efficacy have been established for certain indications (e.g., anemia associated with CKD in pediatric patients 1 month to 16 years of age, and chemotherapy-induced anemia in pediatric patients 5 to 18 years of age). Dosing is weight-based and requires careful titration. The lowest effective dose should be used.

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 individualized, and monitoring for adverse events (especially cardiovascular) is important.

• Retacrit is a biosimilar to Epogen/Procrit. It is not an interchangeable biological product, meaning a pharmacist cannot substitute it without prescriber approval.
• Always ensure adequate iron stores (ferritin >100 ng/mL, TSAT >20%) before and during ESA therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
• The goal of ESA therapy is to avoid transfusions, not to normalize hemoglobin levels, due to increased risks associated with higher hemoglobin targets.
• Closely monitor blood pressure, 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 and the importance of immediate reporting.
• In cancer patients, ESAs should only be used for chemotherapy-induced anemia when the anticipated outcome is not cure, and only to avoid red blood cell transfusions. Discontinue when chemotherapy is completed.

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

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 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 amount consumed, and the time it occurred.