Slideshows Images Quizzes

Procrit

Last reviewed on RxList: 2/22/2017
Procrit Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/14/2016

Procrit (epoetin alfa) is a glycoprotein that stimulates red blood cell production used to treat anemia associated with kidney failure, HIV patients undergoing treatment, cancer patients undergoing therapy, and certain surgical patients. Common side effects of Procrit are:

  • high blood pressure (hypertension),
  • headache,
  • joint pain,
  • bone pain,
  • muscle pain or spasms,
  • body aches,
  • nausea,
  • vomiting,
  • trouble swallowing,
  • swelling,
  • fatigue,
  • dizziness,
  • depression,
  • diarrhea,
  • weight loss,
  • sleep problems (insomnia),
  • pain/tenderness/irritation where Procrit is injected, or
  • cold symptoms (stuffy nose, sneezing, cough, sore throat).

Serious side effects of Procrit include:

Procrit is available in vials; 1 mL of solution contains 2000, 3000, 4000 or 10,000 Units of Epoetin alfa. Single and multidose vials are available. Dose is determined by the prescribing doctor and the patient's condition. Procrit may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Procrit. It is unknown if Procrit will harm a fetus. It is unknown if Procrit passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Procrit 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.

Procrit Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor if you feel weak, lightheaded, or short of breath, or if your skin looks pale. These may be signs that your body has stopped responding to this medication.

Epoetin alfa can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use epoetin alfa. Seek emergency medical help if you have symptoms of heart or circulation problems, such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance; or
  • pain, swelling, warmth, or redness in one or both legs.

Stop using epoetin alfa and call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling short of breath, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • seizure (black-out or convulsions);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, cough, sore throat;
  • joint pain, bone pain;
  • muscle pain, muscle spasm;
  • dizziness, depression, mild headache;
  • weight loss;
  • sleep problems (insomnia);
  • nausea, vomiting, trouble swallowing; or
  • pain or tenderness where you injected the 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.

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

Procrit Professional Information

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 PROCRIT. 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 PROCRIT. 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 PROCRIT-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 PROCRIT-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% PROCRIT and 1% placebo) [see WARNINGS AND PRECAUTIONS].

The adverse reactions with a reported incidence of ≥ 5% in PROCRIT-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 PROCRIT-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% PROCRIT and 0% placebo) and myocardial infarction (0.8% PROCRIT 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 HIV-infected Patients

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

For the combined PROCRIT 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 PROCRIT 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 HIV-infected patients, adverse reactions with an incidence of ≥ 1% in patients treated with PROCRIT were:

Table 5: Adverse Reactions in Zidovudine-treated HIV-infected Patients

Adverse Reaction PROCRIT
(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

Cancer Patients 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 PROCRIT 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 PROCRIT-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 PROCRIT-treatment group was 158 white (94%) and 10 black (6%). PROCRIT 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 PROCRIT-treated patients that occurred at a higher frequency than in placebo-treated patients are shown in the table below:

Table 6: Adverse Reactions in Cancer Patients

Adverse Reaction PROCRIT
(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 PROCRIT and 103 (22%) patients were randomly assigned to receive placebo. PROCRIT 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 PROCRIT 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 PROCRIT 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 PROCRIT-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
PROCRIT 300 U/kg
(n = 112)a
PROCRIT 100 U/kg
(n = 101)a
Placebo
(n = 103)a
600 U/kg x 4 weeks
(n = 73)b
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%
a Study included patients undergoing orthopedic surgery treated with PROCRIT or placebo for 15 days.
b Study included patients undergoing orthopedic surgery treated with PROCRIT 600 U/kg weekly for 4 weeks or 300 U/kg daily for 15 days.
c DVTs were determined by clinical symptoms.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during postmarketing use of PROCRIT:

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. 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].

The incidence 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 PROCRIT with the incidence of antibodies to other products may be misleading.

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

Related Resources for Procrit

Related Health

Read the Procrit User Reviews »

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

Health Solutions From Our Sponsors