May 27, 2016
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Procrit

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Procrit




Procrit Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Last reviewed on RxList 7/23/2015

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, nausea, vomiting, trouble swallowing, swelling, fatigue, dizziness, depression, diarrhea, weight loss, sleep problems (insomnia), pain or tenderness where you injected the medication, or cold symptoms (stuffy nose, sneezing, cough, sore throat).

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 well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check 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 red blood cell count (hemoglobin) tested regularly to reduce the chance of this side effect.

Rarely, this medication 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 right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).

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

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.

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

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)

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

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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