Epogen

Last updated on RxList: 5/13/2019
Epogen Side Effects Center

Last reviewed on RxList 5/13/2019

Epogen (epoetin alfa) is a man-made form of a protein that helps your body produce red blood cells used to treat anemia (a lack of red blood cells in the body). Common side effects of Epogen include:

  • headache,
  • body aches,
  • diarrhea,
  • cold symptoms (stuffy nose, sneezing, sore throat, cough),
  • joint pain,
  • bone pain,
  • muscle pain or spasms,
  • dizziness,
  • depression,
  • weight loss,
  • sleep problems (insomnia),
  • nausea,
  • vomiting,
  • trouble swallowing, or
  • injection site reactions (pain, tenderness, or irritation).

Epogen may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. Rarely, Epogen may suddenly stop working well after a period of time because your body may make antibodies that make it work less well, and a very serious anemia can result. Tell your doctor if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).

Dosing of Epogen depends on the patient's condition and body weight. Other drugs may interact with Epogen. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Epogen should be used only when prescribed. In some women of child-bearing age, menstrual periods have resumed with Epogen treatment. Therefore, it may be possible to become pregnant while using this medication. Discuss the need for birth control with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Epogen (epoetin alfa) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Get emergency medical help if you have signs of an allergic reaction (hives, sweating, rapid pulse, wheezing, trouble breathing, severe dizziness or fainting, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Epoetin alfa can cause serious side effects, including heart attack or stroke. Seek emergency medical help if you have:

  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • signs of a blood clot--pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Call your doctor at once if you have:

  • unusual tiredness;
  • a seizure (convulsions);
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
  • increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Common side effects may include:

  • fever, chills, cough, feeling short of breath;
  • low potassium, low white blood cells;
  • blood vessel blockage;
  • high blood sugar;
  • joint pain, bone pain, muscle pain or spasm;
  • itching or rash;
  • mouth pain, trouble swallowing;
  • nausea, vomiting;
  • headache, dizziness;
  • trouble sleeping;
  • depressed mood;
  • weight loss; or
  • pain or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Epogen (Epoetin Alfa)

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SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the label:

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice.

Patients With Chronic Kidney Disease

Adult Patients

Three double-blind, placebo-controlled studies, including 244 patients with CKD on dialysis, were used to identify the adverse reactions to Epogen. In these studies, the mean age of patients was 48 years (range: 20 to 80 years). One hundred and thirty-three (55%) patients were men. The racial distribution was as follows: 177 (73%) patients were white, 48 (20%) patients were black, 4 (2%) patients were Asian, 12 (5%) patients were other, and racial information was missing for 3 (1%) patients.

Two double-blind, placebo-controlled studies, including 210 patients with CKD not on dialysis, were used to identify the adverse reactions to Epogen. In these studies, the mean age of patients was 57 years (range: 24 to 79 years). One hundred and twenty-one (58%) patients were men. The racial distribution was as follows: 164 (78%) patients were white, 38 (18%) patients were black, 3 (1%) patients were Asian, 3 (1%) patients were other, and racial information was missing for 2 (1%) patients.

The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below:

Table 3: Adverse Reactions in Patients With CKD on Dialysis

Adverse Reaction Epogen-treated Patients
(n = 148)
Placebo-treated Patients
(n = 96)
Hypertension 27.7% 12.5%
Arthralgia 16.2% 3.1%
Muscle spasm 7.4% 6.3%
Pyrexia 10.1% 8.3%
Dizziness 9.5% 8.3%
Medical Device Malfunction (artificial kidney clotting during dialysis) 8.1% 4.2%
Vascular Occlusion (vascular access thrombosis) 8.1% 2.1%
Upper respiratory tract infection 6.8% 5.2%

An additional serious adverse reaction that occurred in less than 5% of epoetin alfa-treated dialysis patients and greater than placebo was thrombosis (2.7% Epogen and 1% placebo) [see WARNINGS AND PRECAUTIONS].

The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients and that occurred at a ≥ 1% higher frequency than in placebo-treated patients are shown in the table below:

Table 4: Adverse Reactions in Patients With CKD Not on Dialysis

Adverse Reactions Epogen-treated Patients
(n = 131)
Placebo-treated Patients
(n = 79)
Hypertension 13.7% 10.1%
Arthralgia 12.2% 7.6%

Additional serious adverse reactions that occurred in less than 5% of epoetin alfa-treated patients not on dialysis and greater than placebo were erythema (0.8% Epogen and 0% placebo) and myocardial infarction (0.8% Epogen and 0% placebo) [see WARNINGS AND PRECAUTIONS].

Pediatric Patients

In pediatric patients with CKD on dialysis, the pattern of adverse reactions was similar to that found in adults.

Zidovudine-Treated Patients With HIV-infection

A total of 297 zidovudine-treated patients with HIV-infection were studied in 4 placebo-controlled studies. A total of 144 (48%) patients were randomly assigned to receive Epogen and 153 (52%) patients were randomly assigned to receive placebo. Epogen was administered at doses between 100 and 200 Units/kg 3 times weekly subcutaneously for up to 12 weeks.

For the combined Epogen treatment groups, a total of 141 (98%) men and 3 (2%) women between the ages of 24 and 64 years were enrolled. The racial distribution of the combined Epogen treatment groups was as follows: 129 (90%) white, 8 (6%) black, 1 (1%) Asian, and 6 (4%) other.

In double-blind, placebo-controlled studies of 3 months duration involving approximately 300 zidovudine-treated patients with HIV-infection, adverse reactions with an incidence of ≥ 1% in patients treated with Epogen were:

Table 5: Adverse Reactions in Zidovudine-treated Patients with HIV-infection

Adverse Reaction Epogen
(n = 144)
Placebo
(n = 153)
Pyrexia 42% 34%
Cough 26% 14%
Rash 19% 7%
Injection site irritation 7% 4%
Urticaria 3% 1%
Respiratory tract congestion 1% Not reported
Pulmonary embolism 1% Not reported

Patients With Cancer On Chemotherapy

The data below were obtained in Study C1, a 16-week, double-blind, placebo-controlled study that enrolled 344 patients with anemia secondary to chemotherapy. There were 333 patients who were evaluable for safety; 168 of 174 patients (97%) randomized to Epogen received at least 1 dose of study drug, and 165 of 170 patients (97%) randomized to placebo received at least 1 placebo dose. For the once weekly Epogen-treatment group, a total of 76 men (45%) and 92 women (55%) between the ages of 20 and 88 years were treated. The racial distribution of the Epogen-treatment group was 158 white (94%) and 10 black (6%). Epogen was administered once weekly for an average of 13 weeks at a dose of 20,000 to 60,000 IU subcutaneously (mean weekly dose was 49,000 IU).

The adverse reactions with a reported incidence of ≥ 5% in Epogen-treated patients that occurred at a higher frequency than in placebo-treated patients are shown in the table below:

Table 6: Adverse Reactions in Patients with Cancer

Adverse Reaction Epogen
(n = 168)
Placebo
(n = 165)
Nausea 35% 30%
Vomiting 20% 16%
Myalgia 10% 5%
Arthralgia 10% 6%
Stomatitis 10% 8%
Cough 9% 7%
Weight decrease 9% 5%
Leukopenia 8% 7%
Bone pain 7% 4%
Rash 7% 5%
Hyperglycemia 6% 4%
Insomnia 6% 2%
Headache 5% 4%
Depression 5% 4%
Dysphagia 5% 2%
Hypokalemia 5% 3%
Thrombosis 5% 3%

Surgery Patients

Four hundred sixty-one patients undergoing major orthopedic surgery were studied in a placebo-controlled study (S1) and a comparative dosing study (2 dosing regimens, S2). A total of 358 patients were randomly assigned to receive Epogen and 103 (22%) patients were randomly assigned to receive placebo. Epogen was administered daily at a dose of 100 to 300 IU/kg subcutaneously for 15 days or at 600 IU/kg once weekly for 4 weeks.

For the combined Epogen treatment groups, a total of 90 (25%) and 268 (75%) women between the ages of 29 and 89 years were enrolled. The racial distribution of the combined Epogen treatment groups was as follows: 288 (80%) white, 64 (18%) black, 1 (< 1%) Asian, and 5 (1%) other.

The adverse reactions with a reported incidence of ≥ 1% in Epogen-treated patients that occurred at a higher frequency than in placebo-treated patients are shown in the table below:

Table 7: Adverse Reactions in Surgery Patients

Adverse Reaction Study S1 Study S2
Epogen 300 U/kg
(n = 112)a
Epogen 100 U/kg
(n = 101)a
Placebo
(n = 103)a
Epogen 600 U/kg x 4 weeks
(n = 73)b
Epogen 300 U/kg x 15 days
(n = 72)b
Nausea 47% 43% 45% 45% 56%
Vomiting 21% 12% 14% 19% 28%
Pruritus 16% 16% 14% 12% 21%
Headache 13% 11% 9% 10% 18%
Injection site pain 13% 9% 8% 12% 11%
Chills 7% 4% 1% 1% 0%
Deep vein thrombosis 6% 3% 3% 0%c 0%c
Cough 5% 4% 0% 4% 4%
Hypertension 5% 3% 5% 5% 6%
Rash 2% 2% 1% 3% 3%
Edema 1% 2% 2% 1% 3%
aStudy included patients undergoing orthopedic surgery treated with Epogen or placebo for 15 days.
bStudy included patients undergoing orthopedic surgery treated with Epogen 600 U/kg weekly for 4 weeks or 300 U/kg daily for 15 days.
cDVTs were determined by clinical symptoms.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Epogen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to epoetin alfa with the incidence of antibodies to other products may be misleading.

Neutralizing antibodies to epoetin alfa that cross-react with endogenous erythropoietin and other ESAs can result in PRCA or severe anemia (with or without other cytopenias) [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Epogen (Epoetin Alfa)

© Epogen Patient Information is supplied by Cerner Multum, Inc. and Epogen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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