Erythropoietin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [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::
Perisurgery:
|
Overview
Erythropoietin is a glycoprotein hormone that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection, cough, rash, and injection site irritation, nausea, vomiting, myalgia, stomatitis, cough, weight decrease, leukopenia, bone pain, hyperglycemia, insomnia, headache, depression, dysphagia, hypokalemia, and thrombosis, pruritus, headache, injection site pain, chills and deep vein thrombosis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Anemia Due to Chronic Kidney Disease
PROCRIT is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and not on dialysis to decrease the need for red blood cell (RBC) transfusion.
- Dosing Information
- Dosage
Anemia Due to Zidovudine in HIV-infected Patients
PROCRIT is indicated for the treatment of anemia due to zidovudine administered at ≤ 4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of ≤ 500 mUnits/mL.
- Dosing Information
- Dosage
Anemia Due to Chemotherapy in Patients With Cancer
PROCRIT is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
- Dosing Information
- Dosage
Reduction of Allogeneic Red Blood Cell Transfusions in Patients Undergoing Elective, Noncardiac, Nonvascular Surgery
PROCRIT is indicated to reduce the need for allogeneic RBC transfusions among patients with perioperative hemoglobin > 10 to ≤ 13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery. PROCRIT is not indicated for patients who are willing to donate autologous blood pre-operatively.
- Dosing Information
- Dosage
Limitations of Use
- PROCRIT has not been shown to improve quality of life, fatigue, or patient well-being.
- PROCRIT is not indicated for use:
- In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy.
- In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
- In patients scheduled for surgery who are willing to donate autologous blood.
- In patients undergoing cardiac or vascular surgery.
- As a substitute for RBC transfusions in patients who require immediate correction of anemia.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Erythropoietin in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythropoietin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Erythropoietin in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Erythropoietin in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Erythropoietin in pediatric patients.
Contraindications
- Condition1
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::
Perisurgery:
|
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Erythropoietin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Erythropoietin in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Erythropoietin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Erythropoietin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Erythropoietin with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Erythropoietin with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Erythropoietin with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Erythropoietin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Erythropoietin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Erythropoietin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Erythropoietin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Erythropoietin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Erythropoietin in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Erythropoietin in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Erythropoietin in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Erythropoietin in the drug label.
Pharmacology
There is limited information regarding Erythropoietin Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Erythropoietin in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Erythropoietin in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Erythropoietin in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Erythropoietin in the drug label.
How Supplied
Storage
There is limited information regarding Erythropoietin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Erythropoietin in the drug label.
Precautions with Alcohol
- Alcohol-Erythropoietin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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