Epoetin alfa-epbx (Injection)

Epoetin alfa-epbx (Injection) helps the bone marrow make red blood cells. If the body does not make enough red blood cells, severe anemia can happen. This is common in people with chronic kidney failure when their kidneys are not working well. Epoetin alfa-epbx may be used for patients on kidney dialysis or for those who are not on dialysis. Anemia can also happen in people getting cancer treatment or in patients with HIV who are taking zidovudine. Epoetin alfa-epbx is used to treat severe anemia in these patients.

Epoetin alfa-epbx (Injection) is also used to reduce or prevent the need for blood transfusions 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.

People with severe anemia often feel very tired and unwell. When epoetin alfa-epbx starts to work, most people begin to feel better. Some people may be able to be more active. However, epoetin alfa-epbx only treats anemia. It does not improve kidney disease, cancer, or any other medical condition that requires ongoing medical care. Even if you feel much better, it is crucial that you do not miss any appointments with your doctor or any dialysis treatments.

It is essential for your doctor to check your or your child's blood regularly while using this medicine. You may also need to monitor your blood pressure at home. If you notice any changes in your recommended blood pressure, contact your doctor immediately.

Using epoetin alfa-epbx multiple-dose vial during pregnancy can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment. If you think you might be pregnant while using this medicine, inform your doctor right away.

Epoetin alfa-epbx multiple-dose vial contains benzyl alcohol, which may cause serious reactions in newborns or premature babies. Discuss this with your doctor if you have concerns.

This medicine may increase your risk of blood clots. This risk is higher in patients who use high doses of this medicine or who use it before major surgery. If you experience chest pain, difficulty breathing, or pain, redness, or swelling in your arms or legs while using this medicine, contact your doctor immediately. If you are undergoing kidney dialysis treatments, inform your doctor right away if you notice blood clots at your injection site. Your doctor may prescribe a blood thinner before surgery to help prevent blood clots.

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

When used in patients with certain types of cancer (for example, breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has been associated with shorter survival and worsening of the tumor or cancer in some patients. If you are worried about this, speak with your doctor.

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

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

Serious skin reactions can happen with this medicine. Contact your doctor immediately if you notice blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while using this medicine.

Many people with kidney problems need to follow a special diet. Additionally, people with high blood pressure (which may be caused by kidney disease or epoetin treatment) may need to follow a special diet or take medication to manage their blood pressure. After their anemia has been treated, some people feel so much better that they want to eat more than before. To prevent your kidney disease or high blood pressure from worsening, it is crucial that you or your child stick to your special diet and take your medications regularly, even if you feel better.

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

In deciding to use a medicine, you and your doctor need to think about the risks and benefits of the medicine. For this medicine, consider the following:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies to date have not shown any pediatric-specific issues that would limit the usefulness of epoetin alfa-epbx single-dose vial in children aged 1 month and older. Safety and effectiveness have not been established in children under 1 month of age with chronic kidney disease on dialysis, in children not on dialysis, or in children under 5 years of age with cancer. Epoetin alfa-epbx multiple-dose vial should not be used in newborns or infants.

Geriatric

Studies performed to date have not shown any geriatric-specific issues that would limit the usefulness of epoetin alfa-epbx injection in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Bleeding or
• Infection or inflammation or
• Iron or vitamin deficiency or
• Metabolic or chronic inflammatory conditions—These may delay the response to treatment and need to be corrected before using this medicine.

• Cancer—This may cause some tumors to progress or return.

• Heart bypass surgery or
• Heart or blood vessel disease or
• History of stroke—The risk of side effects may be higher.

• Uncontrolled hypertension (high blood pressure) or
• Pure red cell aplasia (a rare bone marrow disease)—This medicine should not be used in patients with these conditions.

• Patients on dialysis—May need a higher dose of blood thinner (e.g., heparin) to prevent excessive clotting.

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

• History of seizures—Use with caution. This may worsen the condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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. 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.

In the U.S.

• Retacrit

Available Dosage Forms:

• Solution

Therapeutic Class: Hematopoietic

Pharmacologic Class: Epoetin Alfa

Find detailed information on biosimilars for this medication.

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.

• What biosimilars have been approved in the United States?