PROCRIT - erythropoietin injection, solution 
Physicians Total Care, Inc.

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MEDICATION GUIDE

PROCRIT® (PRO'–KRIT)
(epoetin alfa)

Read this Medication Guide:

This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Talk with your healthcare provider regularly about the use of PROCRIT and ask if there is new information about PROCRIT.

What is the most important information I should know about PROCRIT?

Using PROCRIT can lead to death or other serious side effects.

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:

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:

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

See "What are the possible side effects of PROCRIT ?" below.

What is PROCRIT?

PROCRIT is a man-made form of the protein human erythropoietin that is given to reduce or avoid the need for red blood cell transfusions. PROCRIT stimulates your bone marrow to make more red blood cells. Having more red blood cells raises your hemoglobin level. If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems which may result in death. These serious health problems may happen even if you take PROCRIT and do not have an increase in your hemoglobin level.

PROCRIT may be used to treat a lower than normal number of red blood cells (anemia) if it is caused by:

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

PROCRIT should not be used for treatment of anemia:

PROCRIT has not been proven to improve quality of life, fatigue, or well-being.

PROCRIT should not be used to reduce the chance of red blood cell transfusions if:

Who should not take PROCRIT?

Do not take PROCRIT if you:

Do not give PROCRIT from multidose vials to:

What should I tell my healthcare provider before taking PROCRIT?

PROCRIT may not be right for you. Tell your healthcare provider about all your health conditions, including if you:

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

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider when you get a new medicine.

How should I take PROCRIT?

See "What is the most important information I should know about PROCRIT?"

For patients with cancer:

Before you begin to receive PROCRIT, your healthcare provider will:

For all patients who take PROCRIT:

What are the possible side effects of PROCRIT?

PROCRIT may cause serious side effects.

Common side effects of PROCRIT include:

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.

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

How should I store PROCRIT?

Keep PROCRIT and all medicines out of the reach of children.

General information about PROCRIT

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use PROCRIT only for the condition for which it has been prescribed. Do not give PROCRIT to other patients even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about PROCRIT. If you would like more information about PROCRIT, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about PROCRIT that is written for healthcare professionals. For more information, go to the following website: www.PROCRIT.com or call 1-800-JANSSEN (1-800-526-7736).

What are the ingredients in PROCRIT?

Active Ingredient: epoetin alfa

Inactive Ingredients:

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 U.S.A.

Manufactured for:

Janssen Products, LP
Horsham, Pennsylvania 19044
© Janssen Products, LP 2000
Printed in U. S. A.

Revised: 05/2012

Revised: 01/2013
 
Physicians Total Care, Inc.