Description
Epoetin alfa-epbx injection is used to treat anemia in patients with chronic kidney disease (CKD) who may or may not be on dialysis. This medicine may also be used to prevent or treat anemia that is caused by surgery or medicines (eg, zidovudine) that are used for other conditions, such as HIV or cancer.
Epoetin alfa-epbx injection is a man-made version of human erythropoietin (EPO). EPO is produced naturally in the body, mostly by the kidneys. It 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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
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 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 and 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.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of epoetin alfa-epbx injection in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Blood clots (history of) or other problems with the blood or
- Cancer, active or
- Congestive heart failure or
- Heart attack, 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—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.
- 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
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 (usually in the buttocks, upper arms, thighs or stomach) 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. Use a different body area each time you give yourself a shot. Do not inject into areas that are tender, red, bruised, hard, or has scars, or stretch marks. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
- Do not shake the vial before using it. Do not use this medicine if it has been frozen.
- Check the liquid in the vial. It should be clear and colorless. Do not use if it is cloudy, discolored, or has lumps, flakes, or particles in it.
- 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.
In addition to this medicine, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor's orders carefully.
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 disease 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 chronic kidney disease 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 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.
- For anemia from cancer treatment:
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
It is very important that your doctor check your or your child's blood on a regular basis while you are using this medicine. Blood tests are needed to check for unwanted effects. 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.
This medicine may increase your risk of having a heart attack, stroke, congestive heart failure, and blood clotting problems. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble breathing, sudden or severe headache, or problems with vision, speech, or walking.
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, cancer, or any other medical problem that needs regular medical attention. 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.
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.
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.
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 (eg, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth of on the lips, or unusual tiredness or weakness.
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.
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
- 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
- chest tightness
- 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
- 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.
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