Epogen (Epoetin-Alfa)
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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Product Details
Description
Epogen is a synthetic form of human erythropoietin (EPO). It operates by encouraging the bone marrow to increase the production of red blood cells, similar to the natural hormone EPO. Classified as an erythropoiesis-stimulating agent (ESA), this medication primarily treats anemia associated with chronic kidney failure and certain types of cancer chemotherapy. Epoetin alfa also helps to reduce the need for blood transfusions in these patients.
Fact Table
Formula
C809H1297N233O241S5
License
US FDA
Bioavailability
20-30% (subcutaneous)
Legal status
Prescription only (?)
Chemical Name
Recombinant Human Erythropoietin (rHuEPO)
Elimination half-life
4-13 hours (IV), 24 hours (subcutaneous)
Dosage (Strength)
2,000 to 40,000 IU/mL
Pregnancy
Consult a doctor (Category C)
Brands
Epogen, Procrit, Eprex
Protein binding
Low
PubChem CID
16132265
MedlinePlus
a696001
ChEBI
52615
ATC code
B03XA01
DrugBank
DB00016
KEGG
D02775
Routes of administration
Intravenous (IV), Subcutaneous
Directions
When using Epogen, it's important to follow instructions provided by a healthcare professional. Patients or their caregivers should only administer Epogen after they have been fully trained in the injection process. This medication is usually given as an injection either under the skin or into a vein, which healthcare providers may demonstrate initially. The standard dosage varies and is tailored to the patient's specific medical condition, body weight, and response to treatment. For those managing chronic renal failure, it may be administered three times weekly, whereas patients with HIV or those undergoing surgery have different dosing schedules.
Ingredients
Epogen contains the active ingredient Epoetin Alfa, a synthetic form of a naturally occurring human hormone known as erythropoietin. Inactive ingredients commonly found in Epogen include:
- Albumin (human)
- Sodium citrate
- Sodium chloride
- Citric acid
- Water for Injection
Contraindications
Avoid aking or using this medication if any of the following apply:
- Uncontrolled hypertension (high blood pressure)
- Pure red cell aplasia (PRCA) that begins after treatment with Epoetin Alfa or other erythropoietin proteins
- Known hypersensitivity to Epogen or any of its ingredients
- Use of the multiple-dose vials containing benzyl alcohol in neonates, infants, pregnant women, and lactating women
Cautions
- Before beginning treatment with Epogen, it's important to notify your healthcare professional regarding:
- All other medicines you are currently using
- Any pre-existing medical conditions
- Known allergies you have
- Your pregnancy status or intentions to conceive
- If you are nursing a baby
- There's an increased risk of heart-related issues like heart attacks, strokes, and blood clots when using Epogen, especially if it raises your hemoglobin level above 11 g/dL. This higher hemoglobin target hasn't shown additional benefits and could be particularly risky for those with existing heart diseases or a history of strokes.
- For patients with cancer, using Epogen injections might lead to a higher risk of death or the cancer getting worse or coming back.
- If you have high blood pressure, it should be well controlled before you start Epogen and during treatment.
- Patients with chronic kidney disease (CKD) who use Epogen have a higher risk of seizures. If you're at risk, you should be closely monitored for any changes in seizure frequency or warning signs.
- If you develop severe anemia and low reticulocyte counts while on Epogen, stop the medication and get checked for pure red cell aplasia (PRCA), a rare but serious condition.
- If you have a serious allergic reaction to Epogen, stop using it immediately and seek medical attention.
- In case of severe skin reactions, discontinuation of Epogen is advised.
Side Effects
Epogen is associated with various side effects. In patients with CKD, common effects include high blood pressure, muscle spasm, fever, and dizziness. HIV-infected patients on Zidovudine may experience fever, cough, and rash. Cancer patients undergoing chemotherapy often report nausea, vomiting, muscle aches, and bone pain. Surgery patients might encounter nausea, vomiting, headache, and blood clots.
Epogen carries significant risks, especially when targeting high hemoglobin levels in CKD patients, which can lead to severe heart problems and stroke. In cancer patients, it may shorten survival and increase tumor progression. Surgery patients have an elevated risk of deep venous thrombosis. It's important to use the lowest effective dose and seek immediate medical attention if serious side effects occur.
References:
- Epogen (Epoetin-Alfa) Product Monograph. Thousand Oaks, CA: Amgen, Inc.; 2018.
- Epogen (Epoetin-Alfa) Drug Label Information. Thousand Oaks, CA: Amgen, Inc.; 2018.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 11526
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