Retacrit 2000unit Inj, 1ml

Epoetin alfa-epbx is a biosimilar to epoetin alfa, which is a recombinant human erythropoietin. Erythropoietin is a glycoprotein that stimulates erythropoiesis (red blood cell production). It is produced naturally by the kidneys in response to hypoxia and acts on erythroid progenitor cells in the bone marrow to stimulate their proliferation, differentiation, and maturation into red blood cells. Epoetin alfa-epbx binds to erythropoietin receptors on these cells, mimicking the action of endogenous erythropoietin.

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 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 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 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 a comprehensive list of all 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.

Additional Considerations for Multi-Dose Containers:

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.

Other Important Interactions:

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as 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 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 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. 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. Whenever 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.

• Iron supplements (may be needed for optimal response)
• Other erythropoiesis-stimulating agents (concurrent use not recommended)
• Immunosuppressants (may affect erythropoietic response, though not a direct interaction)

• Signs and symptoms of serious cardiovascular events (e.g., chest pain, shortness of breath, weakness, numbness, vision changes, slurred speech, severe headache)
• Signs and symptoms of hypertension (e.g., headache, dizziness, blurred vision)
• Signs and symptoms of allergic reactions (e.g., rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
• Signs and symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
• Signs and symptoms of tumor progression (in cancer patients)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown adverse effects at doses higher than human therapeutic doses.

It is unknown whether epoetin alfa-epbx is excreted in human milk. Caution should be exercised when administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Retacrit and any potential adverse effects on the breastfed child from Retacrit or from the underlying maternal condition.

Dosing is established for anemia of chronic kidney disease and anemia due to chemotherapy in pediatric patients. Safety and efficacy in neonates and infants for all indications are not fully established. Close monitoring of hemoglobin and blood pressure is crucial.

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 selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may be at increased risk for thrombotic events.

• Retacrit is a biosimilar to Epogen/Procrit. It is not interchangeable with other ESAs (e.g., darbepoetin alfa, methoxy polyethylene glycol-epoetin beta) or other epoetin alfa biosimilars without prescriber approval.
• Always ensure adequate iron stores before and during Retacrit therapy, as iron deficiency is the most common cause of resistance to ESAs.
• Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges, especially 11 g/dL, due to increased risks of cardiovascular events and mortality.
• Strict blood pressure control is essential, as hypertension is a common and potentially serious side effect.
• Patients should be educated on the signs and symptoms of serious adverse events, particularly thrombotic events, and instructed to seek immediate medical attention if they occur.
• Do not shake the vial or syringe, as this can denature the glycoprotein and render it inactive.

• Other Erythropoiesis-Stimulating Agents (ESAs): Darbepoetin alfa (Aranesp), Methoxy polyethylene glycol-epoetin beta (Mircera), Epoetin alfa (Epogen, Procrit, other biosimilars)
• Red Blood Cell Transfusions (for acute severe anemia or when ESAs are contraindicated/ineffective)
• Iron supplementation (oral or intravenous, often used adjunctively with ESAs)
• Correction of underlying causes of anemia (e.g., nutritional deficiencies, bleeding, inflammation)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, 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 safe use. It is important to read this guide carefully when you first receive your medication and again each time your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred. This information will help healthcare professionals provide you with the most appropriate care.