Retacrit 10,000unt Inj, 1ml
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor.If you will be having surgery, talk with your doctor. You may need to take another drug to keep you from getting blood clots while you get this drug. @ COMMON USES: It is used to treat anemia.It is used to help lower the need for blood transfusions for certain surgeries.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Erythropoiesis-stimulating agent (ESA)
Pharmacologic Class
Recombinant human erythropoietin
Pregnancy Category
Not available
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retacrit is a medicine that helps your body make more red blood cells. It's like a natural hormone your kidneys make. It's used to treat anemia (low red blood cell count) caused by kidney disease, chemotherapy for cancer, or HIV medication. It helps reduce the need for blood transfusions.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Continuing Your Treatment
Continue using this medication as directed by your doctor or healthcare provider, even if you start to feel better. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before administering the injection, wash your hands thoroughly. Do not shake the medication, and do not use it if it has been shaken. Check the solution for any visible particles, cloudiness, or color changes, and do not use it if you notice any of these issues. Additionally, avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Used Needles and Supplies
After use, dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storage and Disposal
For information on storing and disposing of this medication, refer to the specific product instructions.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Continuing Your Treatment
Continue using this medication as directed by your doctor or healthcare provider, even if you start to feel better. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
Before administering the injection, wash your hands thoroughly. Do not shake the medication, and do not use it if it has been shaken. Check the solution for any visible particles, cloudiness, or color changes, and do not use it if you notice any of these issues. Additionally, avoid injecting into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Used Needles and Supplies
After use, dispose of needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for proper disposal. If you have any questions or concerns, consult with your doctor or pharmacist.
Storage and Disposal
For information on storing and disposing of this medication, refer to the specific product instructions.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Take Retacrit exactly as prescribed by your doctor. Do not change your dose or stop taking it without consulting your doctor.
- Keep all appointments for blood tests and blood pressure checks. These are very important to ensure the medicine is working safely.
- Maintain adequate iron intake as advised by your doctor, as iron is crucial for Retacrit to work effectively. This may involve iron supplements.
- Report any new or worsening symptoms immediately, especially signs of blood clots (e.g., chest pain, shortness of breath, swelling/pain in legs, sudden weakness or numbness) or uncontrolled high blood pressure (e.g., severe headache, blurred vision).
- Do not shake the vial, as this can damage the medicine.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response. Doses are typically administered 1-3 times per week via IV or SC injection.
Condition-Specific Dosing:
Anemia of Chronic Kidney Disease (CKD):
Initial: 0.45 mcg/kg (equivalent to 40 units/kg) IV or SC 3 times per week, or 1.2 mcg/kg (equivalent to 100 units/kg) IV or SC once weekly. Titrate to maintain hemoglobin levels between 10-11 g/dL.
Chemotherapy-Induced Anemia:
Initial: 150 mcg/kg (equivalent to 12,000 units/kg) SC 3 times per week, or 40,000 units SC once weekly. Titrate to maintain hemoglobin levels between 10-11 g/dL.
Zidovudine-Induced Anemia in HIV-infected Patients:
Initial: 100 units/kg IV or SC 3 times per week. Titrate based on hemoglobin response and zidovudine dose.
Reduction of Allogeneic Red Blood Cell Transfusions in Surgery Patients:
300 units/kg/day SC for 10 days (5 days pre-surgery, day of surgery, and 4 days post-surgery) OR 600 units/kg SC once weekly for 4 weeks (3 weeks pre-surgery and on the day of surgery).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing for anemia of CKD: Initial 50 units/kg IV or SC 3 times per week. Titrate to maintain hemoglobin levels between 10-12 g/dL.
Adolescent:
Dosing for anemia of CKD: Initial 50 units/kg IV or SC 3 times per week. Titrate to maintain hemoglobin levels between 10-12 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment; used to treat anemia associated with CKD.
Moderate:
No specific adjustment; used to treat anemia associated with CKD.
Severe:
No specific adjustment; used to treat anemia associated with CKD.
Dialysis:
Dosing may be IV for patients on hemodialysis. Hemoglobin and iron status should be closely monitored.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Epoetin alfa-epbx is a biosimilar to epoetin alfa, which is a recombinant human erythropoietin. It stimulates erythropoiesis by binding to the erythropoietin receptor on erythroid progenitor cells, promoting their proliferation and differentiation into mature red blood cells. It mimics the action of endogenous erythropoietin, a glycoprotein hormone primarily produced by the kidneys in response to hypoxia.
Pharmacokinetics
Absorption:
Bioavailability:
SC: Approximately 30-40%
Tmax:
SC: 5-24 hours; IV: End of infusion
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not extensively studied, but generally distributes within the plasma volume.
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
IV: 4-13 hours (in CKD patients); SC: 13-28 hours
Clearance:
Varies based on route and patient population.
ExcretionRoute:
Primarily catabolism; minimal renal excretion of unchanged drug.
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Increased reticulocyte count typically within 7-10 days.
PeakEffect:
Hemoglobin levels begin to rise within 2-6 weeks, with peak effect varying based on dosing regimen.
DurationOfAction:
Effects on erythropoiesis persist for several days after discontinuation due to the half-life and maturation of red blood cells.
Safety & Warnings
BLACK BOX WARNING
ESAs increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence. To decrease these risks, use the lowest effective dose to avoid red blood cell transfusions. For patients with chronic kidney disease (CKD), the target hemoglobin should not exceed 11 g/dL. For cancer patients, ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue Retacrit when the chemotherapy course is completed. For perioperative patients, deep venous thrombosis (DVT) prophylaxis is recommended.
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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 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
Difficulty sleeping
* Common cold symptoms
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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 medical attention right away:
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 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
Difficulty sleeping
* Common cold symptoms
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Sudden chest pain or shortness of breath
- Pain, swelling, warmth, or redness in an arm or leg (signs of a blood clot)
- Sudden numbness or weakness, especially on one side of the body
- Sudden severe headache, confusion, or problems with vision, speech, or balance (signs of stroke)
- Uncontrolled high blood pressure (e.g., severe headache, blurred vision, dizziness)
- Seizures
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, 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:
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 is not suitable for 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 treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, 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:
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 is not suitable for 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 treatments and health issues. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
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), a condition where your body cannot break down the amino acid phenylalanine, you should discuss this with your doctor. Some formulations of this medication contain phenylalanine.
Safe Use of Your Medication
To minimize the risk of severe side effects, do not take more of this medication than prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.
Potential Risks and Abuse
This medication can increase the production of red blood cells in your body. 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, especially when combined with other medications containing benzyl alcohol. If you have questions, consult your doctor.
Single-Dose Container Considerations
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.
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), a condition where your body cannot break down the amino acid phenylalanine, you should discuss this with your doctor. Some formulations of this medication contain phenylalanine.
Safe Use of Your Medication
To minimize the risk of severe side effects, do not take more of this medication than prescribed by your doctor. If you accidentally take more than the recommended dose, contact your doctor immediately.
Potential Risks and Abuse
This medication can increase the production of red blood cells in your body. 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, especially when combined with other medications containing benzyl alcohol. If you have questions, consult your doctor.
Single-Dose Container Considerations
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.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count)
- Increased blood viscosity
- Increased risk of thrombotic events (e.g., stroke, MI, DVT)
What to Do:
There is no specific antidote. Management is supportive, including phlebotomy if polycythemia is severe. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Thalidomide
- Lenalidomide
- Pomalidomide
Monitoring
Baseline Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Prior to initiation of therapy.
Iron Status (TSAT and Ferritin)
Rationale: Adequate iron stores are essential for optimal erythropoietic response. Iron deficiency will limit response.
Timing: Prior to and during therapy.
Blood Pressure (BP)
Rationale: Epoetin alfa can cause or exacerbate hypertension.
Timing: Prior to initiation and regularly during therapy.
Complete Blood Count (CBC) with differential and platelet count
Rationale: To assess overall hematologic status and rule out other causes of anemia.
Timing: Prior to initiation.
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then monthly.
Target: 10-11 g/dL (CKD, Chemo-induced); 10-12 g/dL (Pediatric CKD). Avoid exceeding 11 g/dL in CKD patients and 10 g/dL in cancer patients.
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target range, reduce dose or interrupt therapy. If Hb does not increase by 1 g/dL after 4 weeks of therapy, consider increasing dose.
Blood Pressure (BP)
Frequency: Regularly, especially during the initial phase of therapy.
Target: Individualized, maintain within patient's target range.
Action Threshold: If BP significantly increases or becomes difficult to control, consider dose reduction or discontinuation.
Iron Status (TSAT and Ferritin)
Frequency: Monthly or every 3 months, or as clinically indicated.
Target: TSAT >20%, Ferritin >100 ng/mL (CKD); TSAT >20%, Ferritin >100 ng/mL (Chemo-induced).
Action Threshold: If iron stores are low, initiate or increase iron supplementation.
Signs/Symptoms of Thrombotic Events
Frequency: Ongoing clinical assessment.
Target: N/A
Action Threshold: Prompt evaluation and management if symptoms occur.
Symptom Monitoring
- Headache
- Fatigue
- Dizziness
- Shortness of breath
- Chest pain
- Swelling in legs/arms
- Sudden numbness or weakness (especially on one side of the body)
- Vision changes
- Speech difficulties
- Severe headache
- Seizures
- Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
Special Patient Groups
Pregnancy
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. Retacrit contains benzyl alcohol, which can cross the placenta and may cause serious adverse reactions and death in neonates and low birth weight infants.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental outcomes not fully established.
Second Trimester:
Potential for adverse developmental outcomes not fully established.
Third Trimester:
Benzyl alcohol content may be harmful to the fetus, especially in late pregnancy.
Lactation
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. Benzyl alcohol is present in multi-dose vials and should be avoided in nursing mothers.
Infant Risk:
L3 - Moderate risk. Potential for adverse effects from benzyl alcohol in multi-dose vials. Monitor for adverse effects in breastfed infant.
Pediatric Use
Safety and efficacy have been established in pediatric patients with CKD. Dosing is weight-based. Multi-dose vials contain benzyl alcohol and are contraindicated in neonates and infants due to the risk of serious adverse reactions, including fatal 'gasping syndrome'. Use single-dose vials for pediatric patients.
Geriatric Use
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 cautious, starting at the lower end of the dosing range.
Clinical Information
Clinical Pearls
- Retacrit is a biosimilar to Epogen/Procrit. It is not an interchangeable biological product at this time, meaning pharmacists cannot substitute it without prescriber approval.
- Always assess iron status (TSAT and ferritin) before and during Retacrit therapy. Iron deficiency is the most common cause of blunted response to ESAs.
- The primary goal of ESA therapy is to avoid red blood cell transfusions, not to achieve normal hemoglobin levels. Higher hemoglobin levels (above 11 g/dL) are associated with increased risks of serious adverse cardiovascular events and mortality.
- Closely monitor blood pressure, especially during the initial phase of therapy, as hypertension is a common adverse effect.
- Patients should be educated on the signs and symptoms of thrombotic events (e.g., DVT, PE, stroke, MI) and instructed to seek immediate medical attention if they occur.
- Multi-dose vials contain benzyl alcohol and should not be used in neonates, infants, pregnant women, or nursing mothers due to the risk of serious adverse events.
Alternative Therapies
- Other Erythropoiesis-Stimulating Agents (ESAs): Epoetin alfa (Epogen, Procrit), Darbepoetin alfa (Aranesp), Methoxy polyethylene glycol-epoetin beta (Mircera)
- Iron supplementation (oral or IV)
- Blood transfusions (for acute, severe anemia or when ESA therapy is ineffective/contraindicated)
Cost & Coverage
Average Cost:
Varies widely by dose and formulation. For 10,000 units/mL, typically $100-$300 per single-use vial. per single-use vial
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, 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. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.