INFORMATION FOR PATIENTS
This patient package insert contains information and directions for patients (and their caregivers) whose doctor has determined that they may receive injections of EPOETIN® at home. Please read it carefully.
This patient package insert does not include all information about EPOETIN® and does not replace talking with your doctor. You should discuss any questions about treatment with EPOETIN® with your doctor. Only your doctor can prescribe EPOETIN® and determine if it is right for you.
What important information should I know about EPOETIN®?
EPOETIN® works by stimulating your bone marrow to make more red blood cells. You will be asked to have blood tests that will measure the number of red blood cells to see if EPOETIN® is working. Your doctor may refer to the results of your blood tests as hemoglobin and/or hematocrit. It is important to keep all appointments for blood tests to allow your doctor to adjust the dosage of EPOETIN® as needed.
If your hemoglobin is kept too high (over 12 g/dL):
You increase the chance of heart attack, stroke, heart failure, blood clots and death
Your tumor may grow faster (if you are a patient with cancer)
If you are a patient with cancer, who has completed all of your planned chemotherapy treatment,
EPOETIN® treatment may increase your chance of death regardless of hemoglobin level.
If you undergo surgery while taking EPOETIN®, EPOETIN® treatment increases your chance of a blood clot. Therefore, your physician may prescribe a blood thinner to prevent blood clots.
You should talk to your doctor if you have any questions or concerns about this important safety information.
Please also read What are the possible or reasonably likely side effects of EPOETIN®? below.
What is EPOETIN®?
EPOETIN® (EE-PO-JEN) is a man-made form of the protein human erythropoietin
(ee-rith-row-po-eh-tin). EPOETIN® works by stimulating your bone marrow to make red blood cells.
After two to six weeks of treatment, your red blood cell counts may increase and if so, you may be able to avoid the need for red blood cell transfusion. Your doctor will prescribe the lowest dose of EPOETIN® needed to avoid red blood cell transfusions because of the concerns discussed in What important information should I know about EPOETIN®?
EPOETIN® is used to treat anemia (a lower than normal number of red blood cells).
EPOETIN® may be used to treat your anemia if it is caused by:
chronic kidney failure (you may or may not be on dialysis)
chemotherapy used to treat cancer
certain scheduled surgeries (in order to reduce the need for blood transfusions or if you are at risk for significant blood loss)
HIV and take a medicine called Zidovudine (AZT)
While you are being treated with EPOETIN®, you will be having blood tests (called hemoglobin and/or hematocrit) to check the number of red blood cells your body is producing. The amount of time it takes to reach the red blood cell level that is right for you, and the dose of EPOETIN® needed to make the red blood cell level rise, is different for each person. You may need EPOETIN® dose adjustments before you reach your correct dose of EPOETIN® and the correct dose may change over time.
Who should not take EPOETIN®?
You should not take EPOETIN® if you have:
High blood pressure that is not controlled (uncontrolled hypertension).
Allergies to EPOETIN® or other erythropoietins.
Previous allergic reactions to any of the ingredients in EPOETIN®. See the list of ingredients in EPOETIN® at the end of the leaflet.
Talk to your doctor if you are not sure if you have these conditions or if you have any questions about this information.
What should I tell my doctor before taking EPOETIN®?
Tell your doctor about all your health conditions and all the medicines you take including prescription and over-the-counter medicines, vitamins, supplements, and herbals. Be sure to tell your doctor if you have:
High blood pressure
Any history of seizures or strokes
Blood disorders (such as sickle cell anemia, clotting disorders)
In addition, you should tell your doctor if you are:
Pregnant or nursing
Planning to become pregnant
EPOETIN® has not been studied in pregnant women and its effects on developing babies are not known. It is also not known if EPOETIN® can get into human breast milk. Talk to your doctor if you are not sure if you have these conditions or if you have any questions about this information.
Your doctor may monitor your blood pressure and the amount of iron in your blood before you start EPOETIN® and while you are taking EPOETIN®. You or your caregiver may also be asked to monitor your blood pressure every day and to report any changes. When the number of red blood cells increases, your blood pressure may also increase, so your doctor may prescribe new or more blood pressure medicine. You may be asked to have certain blood tests, such as hemoglobin, hematocrit or blood iron levels. Also, your doctor may prescribe iron for you to take. Be sure to follow your doctors orders.
What are the possible or reasonably likely side effects of EPOETIN®?
Your blood pressure may increase when the number of red blood cells rises, so your doctor or caregiver may monitor your blood pressure more frequently. Some people have also had infections, low blood pressure, fevers, headaches, muscle aches or soreness, nausea, diarrhea, leg swelling, cough, or chest pain. If you experience any of these symptoms, you should call your doctor.
If you are on hemodialysis, there is a risk of blood clots forming at your vascular access. Call your doctor or dialysis center if you think your access is blocked.
Some patients may have an increased risk of blood clots forming in blood vessels, especially in the leg veins (venous thrombosis). In some patients, pieces of blood clot may travel to the lungs and block the blood circulation in the lungs (pulmonary embolus).
Call your doctor if you experience chest pain, shortness of breath, or pain in the legs with or without swelling.
It is possible that your body may make antibodies against EPOETIN®. Antibodies to EPOETIN® can block or reduce your body's ability to make red blood cells. If you experience unusual tiredness and lack of energy, call your doctor.
Some people experience redness, swelling, pain or itching at the site of injection. This reaction may be an allergy to the ingredients in EPOETIN®, or it may be a local irritation. If you notice any signs of redness, swelling, or itching at the site of injection, talk to your doctor.
Serious allergic reactions can also happen. These reactions can cause a rash over the whole body, shortness of breath, wheezing, a drop in blood pressure, swelling around the mouth or eyes, fast pulse, or sweating. If at any time a serious allergic reaction occurs, stop using EPOETIN® and call your doctor or emergency medical personnel immediately.
The most common side effects you may have when taking EPOETIN® are:
Increased blood pressure
Swelling in your legs and arms
Shortness of breath
Some side effects are more common depending on the reasons for which you are taking EPOETIN®. Talk to your doctor for more information about side effects. Make sure to report any side effects to your doctor.
Call your doctor right away if:
You take more than the amount prescribed
You are currently taking EPOETIN® and experience any of these symptoms which may be a sign of a serious problem.
o Unusual tiredness and lack of energy
o Redness, swelling, pain or itching at the site of injection and spreading rash over the whole body, shortness of breath, wheezing, a drop in blood pressure, swelling around the mouth and or eyes, fast pulse, or sweating
o Convulsion, confusion, dizziness, loss of consciousness
o Increased blood pressure, chest pain, irregular heartbeats
o Stroke, chest pain, shortness of breath, or pain and/or swelling in the legs
o Blood clots in your hemodialysis vascular access port
How should I take EPOETIN®?
In those situations where your doctor has determined that you, as a home dialysis patient, and/or your caregiver can administer EPOETIN® at home, always follow the instructions of your doctor concerning the dose, how to administer and how often to administer EPOETIN®. Ask your doctor what to do if you miss a dose of EPOETIN®.
Always keep a spare syringe and needle on hand.
When you receive your EPOETIN® from the dialysis center, doctor's office or pharmacy, always check to see that:
1. The name EPOETIN® appears on the carton and vial label.
2. You will be able to use EPOETIN® before the expiration date stamped on the package.
The EPOETIN® solution in the vial should always be clear and colorless. Do not use EPOETIN® if the contents of the vial appear discolored or cloudy, or if the vial appears to contain lumps, flakes, or particles. In addition, if the vial has been shaken vigorously, the solution may appear to be frothy and should not be used. Care should be taken not to shake the EPOETIN® vial before use.
Always use the correct syringe.
Your doctor has instructed you on how to give yourself the correct dosage of EPOETIN®. This dosage will usually be measured in Units per milliliter or ccs. It is important to use a syringe that is marked in tenths of milliliters (for example, 0.2 mL or cc). Using the wrong syringe can lead to a mistake in your dose, and you may receive too much or too little EPOETIN®. Too little EPOETIN® may not be effective in increasing the number of red blood cells. Too much EPOETIN® may lead to serious problems because too many red blood cells are being produced (a hemoglobin or hematocrit that is too high).
Injecting the dose:
EPOETIN® can be injected into your body using two different ways as described below. Make sure you discuss with your doctor and understand which way is best for you. In patients on hemodialysis, the IV route is recommended.
1. SUBCUTANEOUS Route: EPOETIN® can be injected directly into a layer of fat under your skin.
This is called a subcutaneous injection. When receiving subcutaneous injections, always change the site for each injection as directed by your doctor. You may wish to record and track the site where you have injected. Do not inject EPOETIN® into an area that is tender, red, bruised, hard, or has scars or stretch marks. Recommended sites for injection are presented in the figure below, including the outer area of the upper arm, the abdomen (except for the twoinch area around the navel), the front of the middle thighs, and the outer area of the buttocks.
2. INTRAVENOUS Route: EPOETIN® can be injected in your vein through a special access port put in by your doctor. This type of EPOETIN® injection is called an intravenous injection. This route is usually for hemodialysis patients. If you have a dialysis vascular access, to make sure it is working, continue to check your access as your doctor or nurse has shown you. Be sure to let your healthcare provider know right away if you are having any problems, or if you have any questions.
Using the subcutaneous route:
1. With one hand, hold the area surrounding the cleaned skin either by spreading it or by pinching up a large area. Do not touch the cleansed area.
2. Double-check that the correct amount of EPOETIN® is in the syringe.
3. Hold the syringe with the other hand, as you would a pencil, insert the needle into the skin at a 45-degree angle. Let go of the skin and pull the plunger back slightly. If blood comes into the syringe, do not inject EPOETIN®, as the needle has entered a blood vessel; withdraw the syringe, clean a new area, follow steps 1 and 2 and inject at a different site. If blood does not enter the syringe, inject the EPOETIN® by pushing the plunger all the way down.
4. Pull the needle straight out of the skin and immediately press the antiseptic swab over the injection site for several seconds.
Using the intravenous injection route (hemodialysis patients):
1. Insert the needle of the syringe into the clean venous port and inject the EPOETIN®.
How should I store EPOETIN®?
EPOETIN® should be stored in the refrigerator, but NEVER in the freezer. Do not use a vial of EPOETIN® that has been frozen. Do not leave the vial in direct sunlight. If you have any questions about EPOETIN® that has been exposed to temperature extremes, be sure to check with your doctor.
When traveling, transport EPOETIN® in its original carton in an insulated container with a coolant such as blue ice. To avoid freezing, make sure the EPOETIN® vial does not touch the coolant. Once you arrive, your EPOETIN® should be placed in a refrigerator as soon as possible.
General information about EPOETIN®
Doctors can prescribe medicines for conditions that are not in this leaflet. Use EPOETIN® only for what your doctor prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
Active Ingredients: Epoetin
Inactive Ingredients: All formulations include Albumin (human), sodium citrate, sodium chloride, and citric acid in water for injection. In addition, certain formulations may contain: benzyl alcohol, sodium phosphate monobasic monohydrate or sodium phosphate dibasic anhydrate.