Pronunciation:

e-POE-e-tin AL-fa - epbx

Brand Names:

• Retacrit

Dosage Forms:

• Solution

Warnings:

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 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 epoetin alfa-epbx 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.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:Due to increased risk of deep venous thrombosis (DVT), DVT prophylaxis is recommended .

Classifications:

Therapeutic—

Hematopoietic

Pharmacologic—

Epoetin Alfa

Uses of This Medicine:

Epoetin alfa-epbx injection causes the bone marrow to produce red blood cells. If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly. Epoetin alfa-epbx may be used for patients on kidney dialysis or for those not on dialysis. Anemia can also occur in people who are receiving cancer treatment to treat cancer or in patients with HIV who are receiving zidovudine. Epoetin alfa-epbx is used to treat severe anemia in these patients.

Epoetin alfa-epbx injection is also used to lessen or avoid the need for blood transfusion in patients scheduled for any type of surgery where a lot of blood loss is expected.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epoetin alfa-epbx single-dose vial in children 1 month of age and older. Safety and efficacy have not been established in children younger than 1 month of age with chronic kidney disease on dialysis, in children not on dialysis, or in children younger than 5 years of age with cancer. Epoetin alfa-epbx multiple-dose vial should not be used in newborn or infants.

Older adults—

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

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.

Other 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.

Other interactions—

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:

• Bleeding or
• Infection or inflammation or
• Iron or vitamin deficiency or
• Metabolic or chronic inflammatory conditions—May cause a delay in response to treatment. These conditions must be corrected first before using this medicine.

• Cancer—May cause some tumors to progress or come back.

• Heart bypass surgery or
• Heart or blood vessel disease or
• Stroke, history of—The chance of side effects may be increased.

• Hypertension (high blood pressure), uncontrolled or
• Pure red cell aplasia (rare bone marrow disease)—Should not be used in patients with these conditions.

• Patients receiving dialysis—May require an increase in the dose of blood thinner (eg, heparin) to prevent the blood from clotting too much.

• Phenylketonuria—Use with caution. This medicine contains phenylalanine which may cause serious unwanted effects in patients with this condition.

• Seizures, history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Epoetin alfa-epbx injection is usually given by a doctor in a hospital or clinic. However, medicines given by injection are sometimes used at home. If you will be using epoetin alfa-epbx at home, your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

It may be given as a shot under your skin or into a vein. If your doctor tells you to inject it in a certain way, follow your doctor's instructions.

This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is available in single-dose vial or multiple-dose vial. Your doctor will tell which form is right for you.

If you are using this medicine at home:

• Use a new needle and syringe each time you inject your medicine.
• Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given.
• You might not use all of the medicine in each vial (glass container). Use each vial only once and throw any extra medicine away. Do not save an opened vial.

Do not shake the container of medicine before you use it, and do not use this medicine if it has been frozen.

If the medicine in the vial has changed color, or if you see particles in it, do not use it.

Carefully follow your doctor's instructions about any special diet. You may need to eat foods that contain iron, folic acid, or vitamin B12 such as eggs, certain cereals, meats, and vegetables, or you may take an iron, folic acid, or vitamin B12 supplement while you are using this medicine.

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 (solution):
  • For anemia from cancer treatment:
    • Adults—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 3 times a week or 40,000 units injected under the skin once a week. Your doctor may adjust the dose as needed.
    • Children 5 years of age and older—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 adjust the dose as needed.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.
  • For anemia from chronic kidney failure on dialysis:
    • Adults—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 3 times a week. Your doctor may adjust the dose as needed.
    • Children 1 month to 16 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 3 times a week. Your doctor may adjust the dose as needed.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.
  • For anemia from chronic kidney failure not on dialysis:
    • Adults—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 3 times a week. Your doctor may adjust the dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For anemia from HIV treatment:
    • 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 3 times a week for 8 weeks. Your doctor may adjust the dose as needed.
    • Children—Use and dose must be determined by your doctor.
  • For anemia from surgery:
    • Adults—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—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

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

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

If you use the multiple-dose vial that has enough medicine for more than one dose, put it back in the refrigerator and store for up to 21 days.

Precautions While Using This Medicine:

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

It is very important that your doctor check your or your child's blood 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.

Using epoetin alfa-epbx multiple-dose vial while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

Epoetin alfa-epbx multiple-dose vial contains benzyl alcohol, which may cause serious reactions to newborn or premature babies. Discuss this with your doctor if you are concerned.

This medicine may increase your risk of having blood clots. This is more likely in patients who use high doses of this medicine, or who use this medicine before major surgery. If you have chest pain, trouble breathing, or pain, redness, or swelling in your arms or legs while using this medicine, call your doctor right away. If you are getting kidney dialysis treatments, tell your doctor right away if you notice blood clots at your injection site. Your doctor may give you a blood thinner before surgery to help prevent blood clots.

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

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

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

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

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 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.

In addition to epoetin, your body needs iron and vitamins to make red blood cells. Your doctor may direct you or your child to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully. Epoetin alfa-epbx will not work properly if there is not enough iron or vitamins in your body.

Side Effects of This Medicine:

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

Black, tarry stools

blurred vision

body aches or pain

bone pain

chest pain

chills

cough

dizziness

dry mouth

ear congestion

fever

flushed, dry skin

fruit-like breath odor

headache

increased hunger

increased thirst

increased urination

itching, skin rash

loss of voice

nausea

nervousness

pain, redness, or swelling in the arm or leg

painful or difficult urination

pounding in the ears

runny or stuffy nose

slow or fast heartbeat

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

swollen glands

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

Anxiety

decreased urine

difficulty swallowing

fainting

irregular heartbeat

loss of appetite

mood changes

muscle pain or cramps

numbness or tingling in the hands, feet, or lips

seizures

swelling

Incidence not known

Blistering, peeling, or loosening of the skin

dark urine

diarrhea

fluid-filled skin blisters

hives

joint pain

light-colored stools

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

sensitivity to the sun

skin thinness

tightness in the chest

yellow eyes or skin

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

Decreased weight

difficulty in moving

injection site irritation or pain

muscle spasm or stiffness

swelling or inflammation of the mouth

swollen joints

trouble sleeping

Less common

Discouragement

feeling sad or empty

irritability

loss of interest or pleasure

trouble concentrating

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.