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Generic Name: epoetin alfa (Injection route)

e-POE-e-tin AL-fa

Injection route(Solution)

Erythropoiesis-stimulating agents (ESAs) increase the risks for death, myocardial infarction, stroke, and other serious cardiovascular events. In patients with chronic kidney disease (CKD), patients are at a greater risk for death, serious adverse cardiovascular reactions, and stroke when administered ESAs to target Hb levels of 11 g/dL and above in clinical studies. No trial has identified a Hb target level, ESA dose, or dosing strategy that does not increase these risks. Therefore, in patients with CKD, use at the lowest sufficient dose is recommended. In cancer patients with certain tumor types (ie, breast, non-small cell lung, head and neck, lymphoid, cervical), ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies. In patients with cancer, use the lowest ESA dose needed to avoid RBC transfusions and serious cardiovascular and thromboembolic reactions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy, and discontinue following the completion of a chemotherapy course. Prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program (www.esa-apprise.com or 1-866-284-8089) to prescribe and/or dispense epoetin alfa to patients with cancer. Patients receiving myelosuppressive chemotherapy should not be treated with ESAs when the anticipated outcome is cure. Deep venous thrombosis prophylaxis should be considered when epoetin alfa is used preoperatively .

Commonly used brand name(s)

In the U.S.

  • Epogen
  • Procrit

Available Dosage Forms:

  • Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Erythropoietin

Uses For Epogen

Epoetin injection is a man-made version of human erythropoietin (EPO). EPO is produced naturally in the body, mostly by the kidneys. It stimulates the bone marrow to produce red blood cells. If the body does not produce enough EPO, severe anemia can occur. This often occurs in patients whose kidneys are not working properly. Epoetin is used to treat severe anemia in patients with kidney disease.

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Epoetin may also be used to prevent or treat anemia that is caused by surgery or medicines that are used for other conditions, such as AIDS or cancer.

This medicine is available only with your doctor's prescription.

Before Using Epogen

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epoetin injection in children over the age of one month.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of epoetin injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Aluminum poisoning, severe or
  • Bleeding, severe or
  • Blood disorders (e.g., thalassemia, myelodysplastic syndrome) or
  • Bone problems or
  • Folic acid, iron, or vitamin B12 deficiencies or
  • Infection, inflammation, or cancer or
  • Porphyrin (red blood cell pigment) metabolism disorder or
  • Sickle cell anemia—Epoetin may not work properly.
  • Blood clots (history of) or other problems with the blood or
  • Congestive heart failure or
  • Heart attacks, history of or
  • Heart bypass surgery or
  • Heart or blood vessel disease or
  • Seizures, history of or
  • Stroke, history of or
  • Thrombosis, at risk for—The chance of side effects may be increased.
  • Cancer, history of—May cause some tumors to progress or come back.
  • Hypertension (high blood pressure), uncontrolled or
  • Pure red cell aplasia (rare bone marrow disease)—Should not be used in patients with these conditions.

Proper Use of epoetin alfa

This section provides information on the proper use of a number of products that contain epoetin alfa. It may not be specific to Epogen. Please read with care.

Epoetin injection is usually given by a doctor after a kidney dialysis treatment or in a hospital or clinic. It may be given as a shot under your skin or into a vein. However, medicines given by injection are sometimes used at home. If you will be using epoetin at home, your doctor will teach you how the injections are to be given. You will also have a chance to practice giving them. Be sure that you understand exactly how the medicine is prepared and injected.

Cancer patients who use epoetin injection must read about and become familiar with the ESA APPRISE Oncology Program. Your doctor will explain the program to you and your child. Make sure you understand how the program works and talk to your doctor if you have any questions.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you are using this medicine at home:

  • Store the vials (glass containers) in the refrigerator and protect them from bright light. Do not allow the vials to freeze.
  • Do not shake the vial before you use it.
  • When you are ready for a dose, carefully look at the medicine in the vial. If the medicine has changed color, or if you see specks (particles) floating in it, do not use it.
  • Use a new needle and syringe each time you inject your medicine.
  • You will be shown the body areas where this shot can be given.
  • If you use the vials that have one dose, you might not use all of the medicine in each vial. Use each vial only one time and throw any extra medicine away. Do not save an opened vial.
  • If you use the vial that has enough medicine for more than one dose, put it back in the refrigerator after your dose. Write the date on the vial that you first used it and throw away any unused medicine after 21 days.
  • Throw away used needles in a hard closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For anemia from chronic kidney failure:
      • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 to 100 units per kilogram (kg) injected into a vein or under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
      • Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 units per kg injected into a vein or under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
      • Infants younger than 1 month of age—Use and dose must be determined by your doctor.
    • For anemia from cancer chemotherapy:
      • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 150 units per kilogram (kg) injected under the skin three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
      • Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 600 units per kg injected into a vein once a week. Your doctor may need to adjust the dose to determine the best dose for you.
      • Infants younger than 1 month of age—Use and dose must be determined by your doctor.
    • For anemia from HIV therapy:
      • Adults—Dose is based on body weight and must be determined by your doctor. The starting dose is 100 units per kilogram (kg) injected into a vein or under the skin three times a week for 8 weeks. Your doctor may need to adjust the dose to determine the best dose for you.
      • Children and teenagers 8 months to 17 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 units per kg injected into a vein or under the skin two or three times a week. Your doctor may need to adjust the dose to determine the best dose for you.
      • Infants younger than 8 months of age—Use and dose must be determined by your doctor.
    • For anemia from surgery:
      • Adults and teenagers—Dose is based on body weight and must be determined by your doctor. The starting dose is 300 units per kilogram (kg) injected under the skin for 10 days before the surgery, on the day of the surgery, and for 4 days after surgery.
      • Children 1 month to 12 years of age—Dose is based on body weight and must be determined by your doctor.
      • Infants younger than 1 month of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Protect the medicine from bright light. Keep your medicine in the original package until you are ready to use it.

Precautions While Using Epogen

It is very important that your doctor check the blood of you or your child on a regular basis while you are using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended blood pressure, call your doctor right away. .

Do not use this medicine if you or your child have had an allergic reaction to albumin or products derived from human or animal cells.

This medicine contains benzyl alcohol which may cause serious reactions to newborn or premature infants. Discuss this with your doctor if you are concerned.

Epoetin sometimes causes convulsions (seizures), especially during the first 90 days of treatment. During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause serious injury if a seizure occurs while you are performing them.

People with severe anemia usually feel very tired and sick. When epoetin begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active. However, epoetin only corrects anemia. It has no effect on kidney disease or any other medical problem that needs regular medical attention. Therefore, even if you or your child are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments. .

This medicine may increase your risk of having serious heart and blood vessel problems, such as congestive heart failure, heart attacks, or stroke. Check with your doctor right away if you or your child start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking. .

This medicine may increase your risk of having blood clots, especially in patients who use epoetin alfa before a major surgery. Check with your doctor right away if you or your child have chest pain; trouble with breathing; a sudden problem with vision; or pain, redness, or swelling in your arms or legs while using this medicine.

This medicine may cause blood clots to form in the access port (A-V shunt) for patients with chronic kidney disease who receive dialysis treatments. This would cause the access port to stop working. Tell your doctor right away if you or your child see blood clots forming in the access port.

When used in patients with certain types of cancer (e.g., breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the cancer for some patients. If you or your child are concerned about this, talk with your doctor.

Epoetin is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by epoetin treatment) may need to be on a special diet and/or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you or your child follow your special diet and take your medicines regularly, even if you are feeling better.

This medicine may cause serious allergic reactions. Stop using this medicine and call your doctor right away if you or your child have a rash; itching; dizziness, lightheadedness, or fainting; shortness of breath; trouble breathing; or any swelling of your hands, face, or mouth after you receive the medicine.

In addition to epoetin, your body needs iron to make red blood cells. Your doctor may direct you or your child to take iron supplements and vitamins (e.g., folic acid or vitamin B12) that help the iron work better. You may need to eat more foods that contain iron, folic acid, or vitamin B12, such as eggs, certain cereals, meats, and vegetables. Do not change your diet or take extra supplements before talking to your doctor. Be sure to follow your doctor's orders carefully, because epoetin will not work properly if there is not enough iron in your body.

Epogen Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Chest pain
  • fever
  • headache
  • increased blood pressure
  • shortness of breath
  • swelling of the face, fingers, ankles, feet, or lower legs
  • weight gain
Less common
  • Anxiety
  • blurred vision
  • change in skin color
  • change in vision
  • convulsions (seizures)
  • cough
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • migraine headache
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, tenderness, or swelling of the foot or leg
  • pains in the chest, groin, or legs, especially calves of the legs
  • pale skin
  • partial or complete loss of vision in the eye
  • severe headaches of sudden onset
  • skin rash or hives
  • slurred speech
  • sore throat
  • sudden and severe inability to speak
  • sudden loss of coordination
  • sudden vision changes
  • sweating
  • temporary blindness
  • tenderness, pain, swelling, warmth, or skin discoloration at the injection site
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vision problems
  • vomiting
  • weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain and swelling
  • bone or joint pain, muscle aches, chills, shivering, or sweating
  • constipation
  • diarrhea
  • dizziness
  • general feeling of tiredness or weakness
  • heartburn or belching, acid or sour stomach
  • inability to sleep
  • itching or stinging at the injection site
  • loss of strength or energy
  • muscle pain or weakness
  • skin pain
  • stomach discomfort, upset, or pain
  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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