Procrit Information and Uses

Procrit

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Procrit Overview Follow Medication

Procrit (generic: epoetin alfa) is a prescription medication used to treat anemia (low red blood cell count) caused by kidney failure, cancer chemotherapy, or zidovudine (a medication used to treat HIV infection). Procrit is also used before or after surgery to eliminate the need for blood transfusions. Procrit belongs to a group of drugs called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow to make more red blood cells.

This medication comes in an injectable form that is injected just under the skin, or directly into a vein (IV). It is usually given 1 to 3 times a week.

Common side effects of Procrit include joint, muscle or bone pain, fever, rash, and cough.

Uses of Procrit

Procrit is a prescription medication used to treat a lower than normal number of red blood cells (anemia) if it is caused by:

Chronic kidney failure (you may or may not be on dialysis)
Chemotherapy that is used for at least two months to treat some types of cancer
A medicine called zidovudine (AZT) used to treat HIV infection

Procrit may also be used if you are scheduled for certain surgeries with a lot of blood loss to reduce the chance you will need red blood cell transfusions.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Procrit

Procrit may cause serious side effects. See Black Box Warning and Drug Precautions.

Other side effects of Procrit, which may also be serious, include:

High blood pressure in patients with chronic kidney failure. Your blood pressure may go up or be difficult to control with blood pressure medicines while taking Procrit. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine.
Seizures. If you have any seizures while taking Procrit, get medical help right away and tell your healthcare provider.
Antibodies to Procrit. Your body may make antibodies to Procrit. These antibodies can block or lessen your body's ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting. You may need to stop taking Procrit.
Serious allergic reactions. Serious allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness and fainting because of a drop in blood pressure, swelling around your mouth or eyes, fast pulse, or sweating. If you have a serious allergic reaction, stop using Procrit and call your healthcare provider or get medical help right away.
Dangers of giving Procrit to newborns, infants, and pregnant or breastfeeding women. Do not use Procrit from multi-dose vials in newborns, infants, pregnant or breastfeeding women because the Procrit in these vials contains benzyl alcohol. Benzyl alcohol has been shown to cause brain damage, other serious side effects, and death in newborn and premature babies. Procrit that comes in singledose vials does not contain benzyl alcohol.

Common side effects of Procrit include:

joint, muscle, or bone pain
fever
cough
rash
nausea
vomiting
soreness of mouth
itching
headache
redness and pain in the skin where Procrit shots were given

These are not all of the possible side effects of Procrit. Your healthcare provider can give you a more complete list. Tell your healthcare provider about any side effects that bother you or that do not go away.

Procrit Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Your doctor may need to adjust the doses of your medicines or monitor you carefully for side effects. Do not start taking a new medicine without telling your doctor.

Procrit Precautions

For patients with cancer:

Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe Procrit. Before you can begin to receive Procrit, you must sign the patient-healthcare provider acknowledgment form. When you sign this form, you are stating that your healthcare provider talked with you about the risks of taking Procrit. These risks include that your tumor may grow faster and you may die sooner if you choose to take Procrit.

You should talk with your healthcare provider about:

Why Procrit treatment is being prescribed for you.
What are the chances you will get red blood cell transfusions if you do not take Procrit.
What are the chances you will get red blood cell transfusions even if you take Procrit.
How taking Procrit may affect the success of your cancer treatment.

After you have finished your chemotherapy course, Procrit treatment should be stopped.

For all patients who take Procrit, including patients with cancer or chronic kidney disease:

If you decide to take Procrit, your healthcare provider should prescribe the smallest dose of Procrit that is needed to reduce your chance of getting red blood cell transfusions.
You may get serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with Procrit to reach a normal or near-normal hemoglobin level.
You may get blood clots at any time while taking Procrit. If you are receiving Procrit for any reason and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery. Clots can form in blood vessels (veins), especially in your leg (deep venous thrombosis or DVT). Pieces of a blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).

Call your healthcare provider or get medical help right away if you have any of these symptoms of blood clots:

Chest pain
Trouble breathing or shortness of breath
Pain in your legs, with or without swelling
A cool or pale arm or leg
Sudden confusion, trouble speaking, or trouble understanding others’ speech
Sudden numbness or weakness in your face, arm, or leg, especially on one side of your body
Sudden trouble seeing
Sudden trouble walking, dizziness, loss of balance or coordination
Loss of consciousness (fainting)
Hemodialysis vascular access stops working

Do not take Procrit if you:

Have cancer and have not been counseled by your healthcare provider regarding the risks of Procrit and signed the ESA APPRISE Oncology Program Patient and Healthcare Professional (HCP) Acknowledgement Form before you begin to receive Procrit.
Have high blood pressure that is not controlled (uncontrolled hypertension).
Have been told by your healthcare provider that you have or have ever had a type of anemia called Pure Red Cell Aplasia (PRCA) that starts after treatment with Procrit or other erythropoietin medicines.
Have allergies to any of the ingredients in Procrit

Do not give Procrit from multidose vials to:

Pregnant or breastfeeding women
Babies

Procrit Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Procrit there are no specific foods that you must exclude from your diet when receiving Procrit.

Inform MD

Tell your healthcare provider about all your health conditions, including if you:

Have heart disease.
Have high blood pressure.
Have had a seizure (convulsion) or stroke.
Have any other medical conditions.
Are pregnant or planning to become pregnant. It is not known if Procrit may harm your unborn baby. Talk with your healthcare provider about possible pregnancy and birth control choices that are right for you.
Are breast-feeding or planning to breast-feed. It is not known if Procrit passes into breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Procrit and Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. It is not known if Procrit may harm your unborn baby. Talk with your doctor about possible pregnancy and birth control choices that are right for you.

Procrit and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Procrit is excreted in human breast milk or if it will harm your nursing baby.

Procrit Usage

Continue to follow your healthcare provider’s instructions for diet and medicines, including medicines for
high blood pressure, while taking Procrit.
Have your blood pressure checked as instructed by your healthcare provider.
If you or your caregiver has been trained to give Procrit shots (injections) at home:
Be sure that you read, understand, and follow the “Instructions for Use” that come with Procrit.
Take Procrit exactly as your healthcare provider tells you to. Do not change the dose of Procrit unless told to do so by your healthcare provider.
Your healthcare provider will show you how much Procrit to use, how to inject it, how often it should be injected, and how to safely throw away the used vials, syringes, and needles.
If you miss a dose of Procrit, call your healthcare provider right away and ask what to do.
If you take more than the prescribed amount of Procrit , call your healthcare provider right away.

Procrit Dosage

If you are injecting Procrit (not receiving it at your doctor's office) take Procrit exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Procrit must be individualized. Your doctor may start you on a low dose of Procrit and adjust your dose based on your hemoglobin levels.

Procrit Overdose

If you take too much Procrit, call your local Poison Control Center or seek emergency medical attention right away.

Forms of Procrit

How Supplied:

Single-dose, Preservative-free Vial (Tray): Each 1 mL of solution contains 2000 , 3000, 4000 , or 10,000 Units of epoetin alfa. Each strength is supplied in dispensing packs containing 25 single-dose vials.

Single-dose, Preservative-free Vial (in phosphate-buffered formulation): Each 1 mL of solution contains 40,000 Units of epoetin alfa and is supplied in dispensing packs containing 4 single-dose vials.

Multidose, Preserved Vial: 2 mL (20,000 Units total; 10,000 Units/mL). Each 1 mL of solution contains 10,000 Units of epoetin alfa and is supplied in dispensing packs containing 4 multidose vials.

Multidose, Preserved Vial: 2 mL (20,000 Units total; 10,000 Units/mL). Each 1 mL of solution contains 10,000 Units of epoetin alfa and is supplied in dispensing packs containing 6 multidose vials.

Multidose, Preserved Vial: 1 mL (20,000 Units/mL). Each 1 mL of solution contains 20,000 Units of epoetin alfa and is supplied in dispensing packs containing 4 multidose vials.

Multidose, Preserved Vial: 1 mL (20,000 Units/mL). Each 1 mL of solution contains 20,000 Units of epoetin alfa and is supplied in dispensing packs containing 6 multidose vials.

Active Ingredient: epoetin alfa

Inactive Ingredients:

Multidose vials contain benzyl alcohol.
All vials contain albumin (human), sodium citrate, sodium chloride, and citric acid.
Single-dose vials containing 40,000 Units of Procrit also contain sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrate.

Other Requirements

Store Procrit in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze. Do not use a vial of Procrit that has been frozen.
Keep away from direct light.
Do not shake Procrit.
Throw away multidose vials of Procrit after 21 days from the first day that you put a needle into the vial.
Single use vials of Procrit should be used only one time. Throw the vial away after use even if there is medicine left in the vial.
Keep Procrit and all medicines out of the reach of children.

Procrit FDA Warning

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks.
Use the lowest Procrit dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Procrit to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit www.esa-apprise.com or call 1-866-284-8089 for further assistance.
To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
Use ESAs only for anemia from myelosuppressive chemotherapy.
ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
Discontinue following the completion of a chemotherapy course.

Perisurgery: