Epogen for Anemia: Uses, Dosage, Side Effects, and Safety Measures

Epoetin alfa is an FDA-approved medicine to treat anemia associated with chemotherapy, chronic kidney disease (CKD), or zidovudine treatment in patients with HIV. While Epogen and Procrit share the same active ingredient (epoetin alfa), they are marketed for different uses: Epogen is primarily indicated for patients on dialysis, whereas Procrit is marketed for non-dialysis uses and oncology adjunctive care. Epogen was initially marketed by Amgen in 1989, while Procrit is distributed by Johnson & Johnson.

You can get Epogen as an injection under the skin or directly into your dialysis line. The dosage of Epogen may vary depending on your condition. Some common side effects of this drug include high blood pressure, fever, and muscle or joint pain. 

Read on to learn how Epogen works, when it is used, its dosage, and safety measures. 

FDA-Approved Uses

Epogen is approved by the FDA to treat anemia in patients if it is caused by:

• Chronic kidney disease (a patient who may or may not be on dialysis)
• Cancer chemotherapy that will be used for at least 2 months after starting Epogen
• An antiviral drug called zidovudine (AZT) used to treat HIV

Epogen may also be used to reduce the need for blood transfusion during certain types of surgeries, where a lot of blood loss is expected.

Boxed Warnings

Epogen may cause serious side effects that can lead to death. In some clinical studies involving patients with certain cancers, erythropoiesis-stimulating agents (ESAs) shortened overall survival and/or increased the risk of tumor progression or recurrence. 

Moreover, people taking Epogen may experience serious cardiovascular and thromboembolic events, including heart attack, stroke, and blood clots. In patients with chronic kidney disease, targeting hemoglobin levels above 11 g/dl with ESAs has been associated with an increased risk of death and serious cardiovascular reactions. 

Therefore, it is highly recommended to discuss the risks and benefits of Epogen with your healthcare provider. 

Mechanism of Action

Epogen is the man-made version of human erythropoietin (EPO). EPO is a protein that is naturally produced by your kidneys that stimulates the bone marrow to produce more red blood cells (RBCs). When you have chronic kidney disease or certain other medical conditions, your body may not produce enough red blood cells, which can lead to anemia.

Epoetin alfa, the active substance of Epogen, mimics the function of natural erythropoietin (EPO) protein and causes the bone marrow to produce more red blood cells. This helps treat anemia and improves oxygen delivery in the body. 

Epogen: Drug Form

Epogen is available as a sterile liquid solution in single-dose and multiple-dose vials. The single-dose vials are available in strengths of 2,000, 3,000, 4,000, and 10,000 units/ml, while the multiple-dose vials are available as 20,000 units/2 ml (10,000 units/ml) and 20,000 units/ml.

Note: Units/ml tells you how much epoetin alfa is present in 1 ml of solution. For example, 2,000 units/ml means 1 ml of Epogen contains 2,000 units of epoetin alfa. 

Dosage and Administration

Epogen is administered either under the skin (subcutaneously) or into a vein (intravenously). The Epogen dosage is adjusted based on the patient’s condition, hemoglobin level, response to treatment, and other clinical factors. Below are general FDA-labeled starting regimens for Epogen based on the condition being treated:

1. Dosage for Chronic Kidney Disease (CKD) 

The initial recommended dose of Epogen is 50–100 units/kg, given three times per week, either intravenously or subcutaneously. For patients with CKD on hemodialysis, the intravenous route is recommended. 

2. Dosage for Zidovudine-Treated Patients with HIV Infection

The recommended starting dose of Epogen in patients treated with zidovudine is 100 units/kg, which is given as an intravenous or subcutaneous injection three times per week. 

3. Dosage for Chemotherapy-Related Anemia

The starting dose of Epogen for adults is 150 units/kg subcutaneously three times per week or 40,000 units once a week by subcutaneous injection until completion of a chemotherapy course. 

For pediatric patients (5 to 18 years), a dose of 600 units/kg of Epogen is given intravenously once a week until completion of a chemotherapy course.

4. Dosage for Patients Undergoing Surgery

If a patient is undergoing a surgical procedure, they may receive a dose of 300 units/kg daily for 10 days before surgery, on the day of surgery, and for 4 days afterward. 

Alternatively, a dose of 600 units/kg once weekly for 3 weeks before surgery and on the day of surgery may be given, depending on the patient’s condition.

Who Should Not Take Epogen? 

You should not take Epogen if you: 

• Have uncontrolled high blood pressure.
• Have developed pure red cell aplasia (PRCA) after treatment with Epogen or other erythropoietin protein medicines.
• Have had a serious allergic reaction to Epogen.

Side Effects

Epogen may cause some common side effects, as well as potentially serious side effects depending on the condition being treated. 

Common Side Effects

Common side effects vary depending on the condition being treated. Reported adverse reactions include: 

• Joint, muscle, or bone pain 
• Fever, chills, cough 
• Rash
• Nausea, vomiting
• Soreness of mouth
• Itching
• Headache
• Dizziness
• Blood vessel blockage
• Respiratory infection
• High blood sugar 
• Low white blood cells
• Weight decrease 
• Low potassium levels in the blood 
• Trouble sleeping (insomnia)
• Depressed mood
• Difficulty swallowing 
• Muscle spasm 
• Redness and pain at the Epogen injection site

Serious Side Effects 

• Heart attack 
• Stroke 
• Heart failure 
• Blood clots (thrombosis) 
• Severe hypertension 
• Seizures 
• Serious allergic reactions 
• Severe skin reactions 
• Pure red cell aplasia (PRCA), a rare condition in which the bone marrow stops producing red blood cells

Safety Measures

To ensure Epogen is safe for you, tell your healthcare provider if you:

• Have heart disease. 
• Have high blood pressure. 
• Have had a seizure (convulsion) or stroke. 
• Receive dialysis treatment. 
• Are pregnant or plan to become pregnant. It is not known if Epogen may harm your unborn baby. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you. 
• Are breastfeeding or plan to breastfeed. It is not known if Epogen passes into breast milk.
• Are taking any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Epogen: Estimated Cost

Epogen can be expensive, as the price varies by strength and quantity. Since Epogen is a branded drug, patients who find it difficult to afford may consider Retacrit (epoetin alfa-epbx) as an alternative. 

Retacrit is an FDA-approved biosimilar of Epogen and was approved on May 15, 2018. Biosimilars are highly similar to an FDA-approved reference product, with no clinically meaningful differences in safety, purity, or potency, and may be available at a lower cost. The table below compares the costs of Epogen and Retacrit:

Talk to your healthcare provider before switching to a biosimilar such as Retacrit. If cost is a concern, contact us to explore financial or copay assistance for Epogen.