Retacrit 10,000unt Inj, 2ml

Epoetin alfa-epbx is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It binds to erythropoietin receptors on erythroid progenitor cells, stimulating their proliferation and differentiation into mature red blood cells. This 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, 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
Difficulty sleeping
* Common cold symptoms

This list is not exhaustive, and you may experience other side effects. 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 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.

Additional Considerations for Multi-Dose Containers:

If you are pregnant or think you may 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 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 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 can increase 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 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)

• Iron supplements (may be needed for optimal response, but not an interaction)
• Blood pressure medications (monitor BP closely, as ESAs can cause hypertension)

• Signs and symptoms of thrombosis (e.g., chest pain, shortness of breath, pain/swelling in leg)
• Signs and symptoms of hypertension (e.g., headache, dizziness, blurred vision)
• Signs and symptoms of allergic reaction (e.g., rash, urticaria, dyspnea)
• Signs and symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
• Signs of tumor progression or recurrence (in cancer patients)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, and there are no adequate and well-controlled studies in pregnant women.

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 infant from Retacrit or from the underlying maternal condition.

Approved for anemia associated with CKD in pediatric patients aged 1 month to 16 years. Dosing is weight-based and individualized. Safety and efficacy in neonates and infants under 1 month have not been 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 cardiovascular events.

• Always ensure adequate iron stores (TSAT >20%, Ferritin >100 ng/mL for CKD) before and during ESA therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
• Do not shake the vial or syringe, as this can denature the glycoprotein and render it inactive.
• Administer subcutaneously for most indications to allow for less frequent dosing and potentially better patient convenience, though IV is also an option.
• Monitor hemoglobin levels closely and adjust dose to avoid exceeding target ranges, especially 11 g/dL in CKD patients, due to increased risk of serious adverse events.
• Educate patients on the signs and symptoms of blood clots and severe hypertension, and to seek immediate medical attention if they occur.
• Retacrit is a biosimilar to Epogen/Procrit; ensure proper prescribing and dispensing to avoid confusion.

• Darbepoetin alfa (Aranesp - longer-acting ESA)
• Methoxy polyethylene glycol-epoetin beta (Mircera - longer-acting ESA)
• Iron supplementation (oral or IV)
• Red blood cell transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
• Other agents for anemia depending on etiology (e.g., folic acid, vitamin B12 for deficiency anemias)

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 is a valuable resource that provides important information about your treatment. Please read this guide carefully and review it again each time you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the overdose, including the type and amount of medication taken, as well as the time it occurred.