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Procrit

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Procrit

Procrit Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Procrit (epoetin alfa) is a glycoprotein that stimulates red blood cell production. It is used to treat anemia associated with kidney failure, HIV patients undergoing treatment, cancer patients undergoing therapy and certain surgical patients. Procrit is not available in a generic form. Common side effects are hypertension, headache, joint pains, nausea, edema, fatigue and diarrhea.

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. Serious side effects include blood clots, chest pain, seizures, strokes, myocardial infarction and death. The suspension contains benzyl alcohol. Benzyl alcohol has been reported to be associated with an increased incidence of neurological and other complications in premature infants which are sometimes fatal; in pregnancy, risk is weighed against benefit. The drug has been used in the pediatric population with weight-based dose of 600 units/Kg, not to exceed 40,000units. This drug should only be used by practitioners trained in its use.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Procrit in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Procrit Overview - Patient Information: Side Effects

SIDE EFFECTS: Headache, body aches, diarrhea, and irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Epoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your blood count (hemoglobin) tested regularly to reduce the chance of this side effect.

Get medical help right away if you have any very serious side effects, including: seizures.

This medication may rarely cause blood clots. Get medical help right away if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, coughing up blood, sudden vision changes, slurred speech, confusion, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, fainting, blood clots in your hemodialysis vascular access site.

Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of epoetin alfa, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia return (e.g., increased tiredness, low energy, pale skin color, shortness of breath).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Procrit (Epoetin Alfa)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Procrit FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. Neutralizing antibodies to erythropoietin, in association with PRCA or severe anemia (with or without other cytopenias), have been reported in patients receiving PROCRIT® (see WARNINGS: Pure Red Cell Aplasia) during post-marketing experience.

There has been no systematic assessment of immune responses, i.e., the incidence of either binding or neutralizing antibodies to PROCRIT® (epoetin alfa) , in controlled clinical trials.

Where reported, 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 across products within this class (erythropoietic proteins) may be misleading.

Chronic Renal Failure Patients

In double-blind, placebo-controlled studies involving over 300 patients with CRF, the events reported in greater than 5% of patients treated with PROCRIT® (epoetin alfa) during the blinded phase were:

Percent of Patients Reporting Event

Event Patients Treated With PROCRIT®
(n = 200)
Placebo-treated Patients
(n = 135)
Hypertension 24% 19%
Headache 16% 12%
Arthralgias 11% 6%
Nausea 11% 9%
Edema 9% 10%
Fatigue 9% 14%
Diarrhea 9% 6%
Vomiting 8% 5%
Chest Pain 7% 9%
Skin Reaction (Administration Site) 7% 12%
Asthenia 7% 12%
Dizziness 7% 13%
Clotted Access 7% 2%
Significant adverse events of concern in patients with CRF treated in double-blind, placebo-controlled trials occurred in the following percent of patients during the blinded phase of the studies:
Seizure 1.1% 1.1%
CVA/TIA 0.4% 0.6%
MI 0.4% 1.1%
Death 0% 1.7%

In the US PROCRIT® (epoetin alfa) studies in adult patients on dialysis (over 567 patients), the incidence (number of events per patient-year) of the most frequently reported adverse events were: hypertension (0.75), headache (0.40), tachycardia (0.31), nausea/vomiting (0.26), clotted vascular access (0.25), shortness of breath (0.14), hyperkalemia (0.11), and diarrhea (0.11). Other reported events occurred at a rate of less than 0.10 events per patient per year.

Events reported to have occurred within several hours of administration of PROCRIT® (epoetin alfa) were rare, mild, and transient, and included injection site stinging in dialysis patients and flu-like symptoms such as arthralgias and myalgias.

In all studies analyzed to date, PROCRIT® (epoetin alfa) administration was generally well-tolerated, irrespective of the route of administration.

Pediatric CRF Patients: In pediatric patients with CRF on dialysis, the pattern of most adverse events was similar to that found in adults. Additional adverse events reported during the double-blind phase in > 10% of pediatric patients in either treatment group were: abdominal pain, dialysis access complications including access infections and peritonitis in those receiving peritoneal dialysis, fever, upper respiratory infection, cough, pharyngitis, and constipation. The rates are similar between the treatment groups for each event.

Hypertension: Increases in blood pressure have been reported in clinical trials, often during the first 90 days of therapy. On occasion, hypertensive encephalopathy and seizures have been observed in patients with CRF treated with PROCRIT® (epoetin alfa) . When data from all patients in the US phase 3 multicenter trial were analyzed, there was an apparent trend of more reports of hypertensive adverse events in patients on dialysis with a faster rate of rise of hematocrit (greater than 4 hematocrit points in any 2-week period). However, in a double-blind, placebo-controlled trial, hypertensive adverse events were not reported at an increased rate in the group treated with PROCRIT® (epoetin alfa) (150 Units/kg TIW) relative to the placebo group.

Seizures: There have been 47 seizures in 1010 patients on dialysis treated with PROCRIT® (epoetin alfa) in clinical trials, with an exposure of 986 patient-years for a rate of approximately 0.048 events per patient-year. However, there appeared to be a higher rate of seizures during the first 90 days of therapy (occurring in approximately 2.5% of patients) when compared to subsequent 90-day periods. The baseline incidence of seizures in the untreated dialysis population is difficult to determine; it appears to be in the range of 5% to 10% per patient-year.34-36

Thrombotic Events: In clinical trials where the maintenance hematocrit was 35 ± 3% on PROCRIT® (epoetin alfa) , clotting of the vascular access (A-V shunt) has occurred at an annualized rate of about 0.25 events per patient-year, and other thrombotic events (eg, myocardial infarction, cerebral vascular accident, transient ischemic attack, and pulmonary embolism) occurred at a rate of 0.04 events per patient-year. In a separate study of 1111 untreated dialysis patients, clotting of the vascular access occurred at a rate of 0.50 events per patient-year. However, in CRF patients on hemodialysis who also had clinically evident ischemic heart disease or congestive heart failure, the risk of A-V shunt thrombosis was higher (39% vs 29%, p < 0.001), and myocardial infarctions, vascular ischemic events, and venous thrombosis were increased, in patients targeted to a hematocrit of 42 ± 3% compared to those maintained at 30 ± 3% (see WARNINGS).

In patients treated with commercial PROCRIT® (epoetin alfa) , there have been rare reports of serious or unusual thromboembolic events including migratory thrombophlebitis, microvascular thrombosis, pulmonary embolus, and thrombosis of the retinal artery, and temporal and renal veins. A causal relationship has not been established.

Allergic Reactions: There have been no reports of serious allergic reactions or anaphylaxis associated with PROCRIT® (epoetin alfa) administration during clinical trials. Skin rashes and urticaria have been observed rarely and when reported have generally been mild and transient in nature.

There have been rare reports of potentially serious allergic reactions including urticaria with associated respiratory symptoms or circumoral edema, or urticaria alone. Most reactions occurred in situations where a causal relationship could not be established. Symptoms recurred with rechallenge in a few instances, suggesting that allergic reactivity may occasionally be associated with PROCRIT® (epoetin alfa) therapy. If an anaphylactoid reaction occurs, PROCRIT® (epoetin alfa) should be immediately discontinued and appropriate therapy initiated.

Zidovudine-treated HIV-infected Patients

In double-blind, placebo-controlled studies of 3 months duration involving approximately 300 zidovudine-treated HIV-infected patients, adverse events with an incidence of ≥ 10% in either patients treated with PROCRIT® (epoetin alfa) or placebo-treated patients were:

Percent of Patients Reporting Event

Event Patients Treated With PROCRIT®
(n = 144)
Placebo-treated Patients
(n = 153)
Pyrexia 38% 29%
Fatigue 25% 31%
Headache 19% 14%
Cough 18% 14%
Diarrhea 16% 18%
Rash 16% 8%
Congestion, Respiratory 15% 10%
Nausea 15% 12%
Shortness of Breath 14% 13%
Asthenia 11% 14%
Skin Reaction, Medication Site 10% 7%
Dizziness 9% 10%

In the 297 patients studied, PROCRIT® (epoetin alfa) was not associated with significant increases in opportunistic infections or mortality.23 In 71 patients from this group treated with PROCRIT® (epoetin alfa) at 150 Units/kg TIW, serum p24 antigen levels did not appear to increase.25 Preliminary data showed no enhancement of HIV replication in infected cell lines in vitro.23

Peripheral white blood cell and platelet counts are unchanged following PROCRIT® (epoetin alfa) therapy.

Allergic Reactions: Two zidovudine-treated HIV-infected patients had urticarial reactions within 48 hours of their first exposure to study medication. One patient was treated with PROCRIT® (epoetin alfa) and one was treated with placebo (PROCRIT® (epoetin alfa) vehicle alone). Both patients had positive immediate skin tests against their study medication with a negative saline control. The basis for this apparent pre-existing hypersensitivity to components of the PROCRIT® (epoetin alfa) formulation is unknown, but may be related to HIV-induced immunosuppression or prior exposure to blood products.

Seizures: In double-blind and open-label trials of PROCRIT® (epoetin alfa) in zidovudine-treated HIV-infected patients, 10 patients have experienced seizures.23 In general, these seizures appear to be related to underlying pathology such as meningitis or cerebral neoplasms, not PROCRIT® (epoetin alfa) therapy.

Cancer Patients on Chemotherapy

In double-blind, placebo-controlled studies of up to 3 months duration involving 131 cancer patients, adverse events with an incidence > 10% in either patients treated with PROCRIT® (epoetin alfa) or placebo-treated patients were as indicated below:

Percent of Patients Reporting Event

Event Patients Treated With PROCRIT®
(n = 63)
Placebo-treated Patients
(n = 68)
Pyrexia 29% 19%
Diarrhea 21%* 7%
Nausea 17%* 32%
Vomiting 17% 15%
Edema 17%* 1%
Asthenia 13% 16%
Fatigue 13% 15%
Shortness of Breath 13% 9%
Parasthesia 11% 6%
Upper Respiratory Infection 11% 4%
Dizziness 5% 12%
Trunk Pain 3%* 16%
* Statistically significant

Although some statistically significant differences between patients being treated with PROCRIT® (epoetin alfa) and placebo-treated patients were noted, the overall safety profile of PROCRIT® (epoetin alfa) appeared to be consistent with the disease process of advanced cancer. During double-blind and subsequent open-label therapy in which patients (n = 72 for total exposure to PROCRIT® (epoetin alfa) ) were treated for up to 32 weeks with doses as high as 927 Units/kg, the adverse experience profile of PROCRIT® (epoetin alfa) was consistent with the progression of advanced cancer.

Three hundred thirty-three (333) cancer patients enrolled in a placebo-controlled double-blind trial utilizing Weekly dosing with PROCRIT® (epoetin alfa) for up to 4 months were evaluable for adverse events. The incidence of adverse events was similar in both the treatment and placebo arms.

Surgery Patients

Adverse events with an incidence of ≥ 10% are shown in the following table:

Percent of Patients Reporting Event

Event Patients Treated With PROCRIT® (epoetin alfa) 300 U/kg
(n = 112)a
Patients Treated With PROCRIT® (epoetin alfa) 100 U/kg
(n = 101)a
Placebo-treated Patients
(n = 103)a
Patients Treated With PROCRIT® (epoetin alfa) 600 U/kg
(n = 73)b
Patients Treated With PROCRIT® (epoetin alfa) 300 U/kg
(n = 72)b
Pyrexia 51% 50% 60% 47% 42%
Nausea 48% 43% 45% 45% 58%
Constipation 43% 42% 43% 51% 53%
Skin Reaction, Medication Site 25% 19% 22% 26% 29%
Vomiting 22% 12% 14% 21% 29%
Skin Pain 18% 18% 17% 5% 4%
Pruritus 16% 16% 14% 14% 22%
Insomnia 13% 16% 13% 21% 18%
Headache 13% 11% 9% 10% 19%
Dizziness 12% 9% 12% 11% 21%
Urinary Tract Infection 12% 3% 11% 11% 8%
Hypertension 10% 11% 10% 5% 10%
Diarrhea 10% 7% 12% 10% 6%
Deep Venous Thrombosis 10% 3% 5% 0%c 0%c
Dyspepsia 9% 11% 6% 7% 8%
Anxiety 7% 2% 11% 11% 4%
Edema 6% 11% 8% 11% 7%
a Study including patients undergoing orthopedic surgery treated with PROCRIT® (epoetin alfa) or placebo for 15 days
b Study including patients undergoing orthopedic surgery treated with PROCRIT® (epoetin alfa) 600 Units/kg weekly x 4 or 300 Units/kg daily x 15
c Determined by clinical symptoms

Thrombotic/Vascular Events: In three double-blind, placebo-controlled orthopedic surgery studies, the rate of deep venous thrombosis (DVT) was similar among Epoetin alfa and placebo-treated patients in the recommended population of patients with a pretreatment hemoglobin of > 10 g/dL to ≤ 13 g/dL.17,19,26 However, in 2 of 3 orthopedic surgery studies the overall rate (all pretreatment hemoglobin groups combined) of DVTs detected by postoperative ultrasonography and/or surveillance venography was higher in the group treated with Epoetin alfa than in the placebo-treated group (11% vs. 6%). This finding was attributable to the difference in DVT rates observed in the subgroup of patients with pretreatment hemoglobin > 13 g/dL.

In the orthopedic surgery study of patients with pretreatment hemoglobin of > 10 g/dL to ≤ 13 g/dL which compared two dosing regimens (600 Units/kg weekly x 4 and 300 Units/kg daily x 15), 4 subjects in the 600 Units/kg weekly PROCRIT® (epoetin alfa) group (5%) and no subjects in the 300 Units/kg daily group had a thrombotic vascular event during the study period.18

In a study examining the use of Epoetin alfa in 182 patients scheduled for coronary artery bypass graft surgery, 23% of patients treated with Epoetin alfa and 29% treated with placebo experienced thrombotic/vascular events. There were 4 deaths among the Epoetin alfa-treated patients that were associated with a thrombotic/vascular event (see WARNINGS).

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

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Procrit - User Reviews

Procrit User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Procrit sorted by most helpful. Patient Discussions FAQs

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