Epoetin Alfa

Epoetin Alfa
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Black Box Warning

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete Boxed Warning. Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5.1). No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1). Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (Table 2, 5.3). Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Epogen to patients with cancer (5.2). Use the lowest dose to avoid RBC transfusions (2.4). Use ESAs only for anemia from myelosuppressive chemotherapy (1.5). ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5). Discontinue following the completion of a chemotherapy course (2.4). Perisurgery: Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended (5.1).

Overview

Epoetin Alfa is a Erythropoiesis-stimulating Agent that is FDA approved for the treatment of Anemia Due to Chronic Kidney Disease, Anemia Due to Zidovudine in HIV-infected Patients， Anemia Due to Chemotherapy in Patients With Cancer， Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Edema，Injection site irritation, Injection site pain, Pruritus, Rash，Nausea, Vomiting，Arthralgia, Myalgia, Spasm, Muscle，Dizziness, Headache, Insomnia，Cough, Upper respiratory infection，Fever.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Evaluation of Iron Stores and Nutritional Factors

• Evaluate the iron status in all patients before and during treatment and maintain iron repletion. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) before initiating Epogen.

Patients with Chronic Kidney Disease

• In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Individualize dosing and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions. Physicians and patients should weigh the possible benefits of decreasing transfusions against the increased risks of death and other serious cardiovascular adverse events.

• For all patients with CKD

• When initiating or adjusting therapy, monitor hemoglobin levels at least weekly until stable, then monitor at least monthly. When adjusting therapy consider hemoglobin rate of rise, rate of decline, ESA responsiveness and hemoglobin variability. A single hemoglobin excursion may not require a dosing change.

Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments.

• If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Epogen by 25% or more as needed to reduce rapid responses.
• For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
• For patients who do not respond adequately over a 12-week escalation period, increasing the Epogen dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Epogen if responsiveness does not improve.

• For patients with CKD on dialysis

• Initiate Epogen treatment when the hemoglobin level is less than 10 g/dL.

• If the hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt the dose of Epogen.
• The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously. For pediatric patients, a starting dose of 50 Units/kg 3 times weekly intravenously or subcutaneously is recommended. The intravenous route is recommended for patients on hemodialysis.

• For patients with CKD not on dialysis

• Consider initiating Epogen treatment only when the hemoglobin level is less than 10 g/dL and the following considerations apply:

• The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion and,
• Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal

• If the hemoglobin level exceeds 10 g/dL, reduce or interrupt the dose of Epogen, and use the lowest dose of Epogen sufficient to reduce the need for RBC transfusions.
• The recommended starting dose for adult patients is 50 to 100 Units/kg 3 times weekly intravenously or subcutaneously.

When treating patients who have chronic kidney disease and cancer, physicians should refer to Warnings and Precautions. Refer patients who self-administer Epogen to the Instructions for Use.

Zidovudine-treated HIV-infected Patients

• Starting Dose

• The recommended starting dose in adults is 100 Units/kg as an intravenous or subcutaneous injection 3 times per week.

• Dose Adjustment

• If hemoglobin does not increase after 8 weeks of therapy, increase Epogen dose by approximately

50 to 100 Units/kg at 4- to 8-week intervals until hemoglobin reaches a level needed to avoid RBC transfusions or 300 Units/kg.

• Withhold Epogen if hemoglobin exceeds 12 g/dL. Resume therapy at a dose 25% below the previous dose when hemoglobin declines to less than 11 g/dL.
• Discontinue Epogen if an increase in hemoglobin is not achieved at a dose of 300 Units/kg for 8 weeks.

• Patients on Cancer Chemotherapy

• Initiate Epogen in patients on cancer chemotherapy only if the hemoglobin is less than 10 g/dL, and if there is a minimum of two additional months of planned chemotherapy.
• Use the lowest dose of Epogen necessary to avoid RBC transfusions.

• Recommended Starting Dose

• Adults:

• 150 Units/kg subcutaneously 3 times per week until completion of a chemotherapy course or
• 40,000 Units subcutaneously weekly until completion of a chemotherapy course.

• Pediatric Patients (5 to 18 years):

• 600 Units/kg intravenously weekly until completion of a chemotherapy course.

• Dose Reduction

• Reduce dose by 25% if:

• Hemoglobin increases greater than 1 g/dL in any 2-week period or
• Hemoglobin reaches a level needed to avoid RBC transfusion.

• Withhold dose if hemoglobin exceeds a level needed to avoid RBC transfusion. Reinitiate at a dose 25% below the previous dose when hemoglobin approaches a level where RBC transfusions may be required.

• Dose Increase

• After the initial 4 weeks of Epogen therapy, if hemoglobin increases by less than 1 g/dL and remains below 10 g/dL, increase dose to:

• 300 Units/kg three times per week in adults or
• 60,000 Units weekly in adults
• 900 Units/kg (maximum 60,000 Units) weekly in children

After 8 weeks of therapy, if there is no response as measured by hemoglobin levels or if RBC transfusions are still required, discontinue Epogen.

Surgery Patients

• The recommended Epogen regimens are:

• 300 Units/kg per day subcutaneously for 15 days total: administered daily for 10 days before surgery, on the day of surgery, and for 4 days after surgery.
• 600 Units/kg subcutaneously in 4 doses administered 21, 14, and 7 days before surgery and on the day of surgery.

• Deep venous thrombosis prophylaxis is recommended during Epogen therapy.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epoetin Alfa in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epoetin Alfa in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Epoetin Alfa FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Epoetin Alfa in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Epoetin Alfa in pediatric patients.

Contraindications

There is limited information regarding Epoetin Alfa Contraindications in the drug label.

Warnings

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE See full prescribing information for complete Boxed Warning. Chronic Kidney Disease: In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL (5.1). No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. Use the lowest Epogen dose sufficient to reduce the need for red blood cell (RBC) transfusions (5.1). Cancer: ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers (Table 2, 5.3). Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Epogen to patients with cancer (5.2). Use the lowest dose to avoid RBC transfusions (2.4). Use ESAs only for anemia from myelosuppressive chemotherapy (1.5). ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure (1.5). Discontinue following the completion of a chemotherapy course (2.4). Perisurgery: Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended (5.1).

There is limited information regarding Epoetin Alfa Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Epoetin Alfa Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Epoetin Alfa Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Epoetin Alfa Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Epoetin Alfa in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Epoetin Alfa in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Epoetin Alfa during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Epoetin Alfa in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Epoetin Alfa in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Epoetin Alfa in geriatric settings.

Gender

There is no FDA guidance on the use of Epoetin Alfa with respect to specific gender populations.

Race

There is no FDA guidance on the use of Epoetin Alfa with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Epoetin Alfa in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Epoetin Alfa in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Epoetin Alfa in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Epoetin Alfa in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Epoetin Alfa Administration in the drug label.

Monitoring

There is limited information regarding Epoetin Alfa Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Epoetin Alfa and IV administrations.

Overdosage

There is limited information regarding Epoetin Alfa overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Epoetin Alfa Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Epoetin Alfa Mechanism of Action in the drug label.

Structure

There is limited information regarding Epoetin Alfa Structure in the drug label.

Pharmacodynamics

There is limited information regarding Epoetin Alfa Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Epoetin Alfa Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Epoetin Alfa Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Epoetin Alfa Clinical Studies in the drug label.

How Supplied

There is limited information regarding Epoetin Alfa How Supplied in the drug label.

Storage

There is limited information regarding Epoetin Alfa Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Epoetin Alfa Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Epoetin Alfa interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Epoetin Alfa Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Epoetin Alfa Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.