(dar be poe’ e tin)
Why is this medication prescribed?
Darbepoetin alfa is used to treat anemia (a lower than normal number of red blood cells) in people with serious kidney disease. Darbepoetin alfa is also used to treat anemia caused by chemotherapy (medications used to treat cancer) in patients with some types of cancer. Darbepoetin alfa is in a class of medications called erythropoietic proteins. It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
How should this medicine be used?
Darbepoetin alfa comes as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected once a week or once every two weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use darbepoetin alfa exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Your doctor may start you on a low dose of darbepoetin alfa and gradually increase or decrease your dose, not more than once every month. Your doctor may also tell you to stop using darbepoetin alfa for a time. Follow these instructions carefully. If your doctor tells you to stop using darbepoetin alfa, do not begin using it again until your doctor tells you that you should. It is likely that your doctor will restart your treatment with a lower dose of darbepoetin alfa than you were using.
Darbepoetin alfa controls anemia but does not cure it. It may take 2 to 6 weeks or longer before you feel the full benefit of darbepoetin alfa. Continue to use darbepoetin alfa even if you feel well. Do not stop using darbepoetin alfa without talking to your doctor.
Darbepoetin alfa injections are usually given by a doctor or nurse. Your doctor may decide that you can inject darbepoetin alfa yourself, or that you may have a friend or relative give the injections. Your doctor will train the person who will be injecting the medication and will test him to be sure he can give the injection correctly. Be sure that you and the person who will be giving the injections read the manufacturer’s information for the patient that comes with darbepoetin alfa before you use it for the first time at home.
Darbepoetin alfa comes in prefilled syringes and also in vials to use with disposable syringes. Use vials and prefilled or disposable syringes only once. Do not put a needle through the rubber stopper of a vial more than once. Throw away a vial, syringe, or prefilled syringe after one use, even if it is not empty. Throw away used syringes in a puncture-resistant container, out of the reach of children. Talk to your doctor or pharmacist about how to throw away the puncture-resistant container. There may be special state and local laws for throwing away used needles and syringes.
If you are using vials of darbepoetin alfa, you will need to use disposable syringes to inject your medication. Your doctor or pharmacist will tell you what type of syringe you should use. Do not use any other type of syringe because you may not get the right amount of medication.
Always inject darbepoetin alfa solution in its own syringe; never mix it with any other medication.
If you are injecting darbepoetin alfa subcutaneously, you can inject it just under the skin anywhere on these parts of your body: the outer area of your upper arms, your stomach except for the two-inch area around your navel (belly button), the front of your middle thighs, and the upper outer areas of your buttocks.
Choose a new spot each time you inject darbepoetin alfa. Do not inject darbepoetin alfa into a spot that is tender, red, bruised, hard, lumpy, or swollen, or that has scars or stretch marks.
To prepare a dose using a darbepoetin alfa prefilled syringe, follow these steps:
- Do not prepare your dose until just before you are ready to inject it.
- Find a clean, flat work surface such as a table that is out of the reach of children.
- Tear off one syringe (in wrapper) from the packaging and put the others back in the refrigerator. Keep the syringe in its wrapper until you are ready to prepare your dose. Handle the syringes gently and be careful not to shake them. If you do shake a syringe and the solution looks foamy, do not use that syringe.
- Put the syringe on the flat work surface for about 30 minutes to allow it to reach room temperature. Cover the syringe to protect the liquid from light.
- Set out the following supplies for your injection: alcohol wipe, cotton ball, and puncture-proof needle disposal container.
- Wash your hands with soap and warm water.
- Look at the prefilled syringe to check the expiration date and strength and to make sure the grey needle cover is on and the clear yellow plastic needle guard is covering the barrel of the syringe. If the expiration date has passed, the strength is not what your doctor prescribed, or the needle is not covered, do not use the syringe and call your pharmacist. Look at the syringe to make sure the liquid is clear and colorless. Do not use the syringe if the liquid appears foamy, discolored, or cloudy, or if it contains lumps, flakes, or particles. Do not slide the needle guard over the needle cover before injecting the medication.
- Choose a spot where you will inject darbepoetin alfa, and clean it with an alcohol swab.
- Hold the syringe with the needle pointing up and carefully pull the needle cover straight off. Be careful not to touch the uncovered needle or to let the uncovered needle touch any surface as you continue to prepare your dose.
- Keep the syringe with the needle pointing up and slowly push the plunger to the line on the syringe that is equal to the dose your doctor has prescribed.
- Check the syringe for air bubbles. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Slowly push the plunger up to force the air bubbles out of the syringe.
- Check again to make sure you have the correct dose in the syringe. Follow the steps below to inject darbepoetin alfa subcutaneously or intravenously.
To prepare a dose using a vial of darbepoetin alfa, follow these steps:
- Do not prepare your dose until just before you are ready to use it.
- Find a clean, flat work surface such as a table that is out of the reach of children.
- Remove a vial of darbepoetin alfa from the refrigerator, and put it on the flat work surface for about 30 minutes to allow it to reach room temperature. Cover the vial to protect it from light. Do not shake the vial. If you do shake a vial and the solution looks foamy, do not use that vial.
- Look at the vial of darbepoetin alfa to check the expiration date and strength. If the expiration date has passed, or the strength is not what your doctor prescribed, do not use the vial and call your pharmacist. Look at the vial to make sure the liquid is clear and colorless. Do not use the vial if the liquid appears foamy, discolored, or cloudy, or if it contains lumps, flakes, or particles.
- Set out the following supplies for your injection: alcohol wipes, cotton ball, disposable syringe, and puncture-proof needle disposal container.
- Wash your hands with soap and warm water.
- Take the colored cap off of the vial and clean the rubber stopper with one alcohol wipe.
- Check the package of the disposable syringe to make sure it has not been opened or damaged. If the package has been opened or damaged, do not use that syringe, and throw it away in the puncture-proof container. If the syringe package is undamaged, open the package and remove the syringe.
- Pull the needle cover straight off the syringe. Then, pull back on the plunger to the line on the syringe barrel that is equal to the dose of darbepoetin alfa your doctor has prescribed. Be careful not to touch the uncovered needle or to let the uncovered needle touch any surface as you continue to prepare your dose.
- Keep the vial on the flat work surface and insert the needle straight down through the rubber stopper.
- Push the plunger of the syringe down to inject the air from the syringe into the vial.
- Keep the needle inside the vial and turn the vial upside down. Make sure that the tip of the needle is in the darbepoetin alfa liquid.
- Use one hand to hold the vial upside down. Use your other hand to slowly pull back on the plunger until the top of the plunger is even with the number that matches the dose your doctor told you to inject.
- Keep the vial upside down with the needle in the vial. Check for air bubbles in the syringe. If there are air bubbles, gently tap the syringe with your fingers until the air bubbles rise to the top of the syringe. Then slowly push the plunger up to force the air bubbles out of the syringe. Keep the tip of the needle in the liquid and once again pull the plunger back to the number on the syringe that matches your dose. Check the syringe again for air bubbles. If there are still air bubbles, repeat the steps above to remove them.
- Check to make sure the top of the plunger is even with the number that matches your dose.
- Lay the vial on its side on the flat work surface with the needle still in it to keep the needle from touching anything while you prepare your skin for the injection.
- Choose the spot where you will inject darbepoetin alfa, and clean it with an alcohol swab.
- Check again to make sure you have the correct dose in the syringe. Pull the needle straight out of the vial.
To inject darbepoetin alfa subcutaneously, follow the steps above to prepare your dose from a prefilled syringe or vial of darbepoetin alfa and then follow the steps below to inject your dose:
- If you are using a disposable syringe, hold it by the barrel in one hand. If you are using a prefilled syringe, hold the barrel through the needle guard window. Use the other hand to pinch up a fold of skin at the cleaned injection spot.
- Hold the syringe barrel like a pencil and use a quick, “dart-like” motion to insert the needle either straight up and down (90 degree angle) or at a slight angle (45 degrees) into the skin.
- After the needle is inserted, let go of the skin. Pull the plunger back slightly. If no blood appears, slowly push the plunger all the way down until your dose of darbepoetin alfa is injected. If blood comes into the syringe, do not inject darbepoetin alfa. Pull the syringe straight out and throw it away in the puncture-proof container. Put a cotton ball over the injection spot and press for a few seconds to stop any bleeding. Repeat the steps to choose and clean a new spot for injection and prepare a new dose. Remember to check again for blood before injecting darbepoetin alfa.
- When your dose has been injected, pull the needle out of the skin, put a cotton ball over the injection site, and press for several seconds.
- Do not put the needle cover back on the needle. Keep your hands behind the needle at all times. If you are using a prefilled syringe, you can use the needle guard by holding the finger grip of the syringe with one hand, grasping the needle guard with your free hand, and sliding it completely over the needle until the needle guard clicks into place. If you do not hear a click, the needle guard may not be completely activated.
- Throw away the entire syringe in a puncture-proof container.
If you are being treated with hemodialysis and your doctor has told you to inject darbepoetin alfa into your hemodialysis tubing, follow the steps above to prepare your dose from a prefilled syringe or vial of darbepoetin alfa, and then follow the steps below to inject your dose intravenously:
- Clean the venous port of your hemodialysis tubing with a new alcohol swab.
- Insert the needle of the syringe containing your prepared dose into the cleaned venous port and push the plunger all the way down to inject all the darbepoetin alfa.
- Remove the syringe from the venous port.
- Throw away the syringe in a puncture-proof container.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before using darbepoetin alfa,
- tell your doctor and pharmacist if you are allergic to darbepoetin alfa, epoetin alfa (Epogen, Procrit), medications made from animal cells, albumin, any other medications, or polysorbate 80. Ask your doctor or pharmacist if you don’t know if a medication you are allergic to is made from animal cells.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: estrogen-containing products such as hormone replacement therapy or hormonal contraceptives (birth control pills, patches, rings, injections, or implants); iron supplements; or medications to control high blood pressure. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had bleeding problems or diseases that affect your blood such as sickle cell disease (an inherited blood disease that causes pain, anemia, and organ damage), thalassemia (an inherited blood disease that causes abnormal development and other problems), or porphyria (an inherited blood disease that may cause skin or nervous system problems); blood clots in your heart, legs, or lungs; a heart attack; parathyroid disease (problems with the small glands in the neck that help balance calcium levels in the body), especially if it has affected your bones; seizures; stroke or mini-stroke (TIA); tumors; heart disease, or any disease that affects your brain or nervous system.
- tell your doctor if you have used darbepoetin alfa or another erythropoietic protein such as epoetin alfa (Epogen, Procrit) in the past. Be sure to tell your doctor if your anemia worsened during your treatment with one of these medications, or if you were ever told to stop using one of these medications.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using darbepoetin alfa, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using darbepoetin alfa.
- you should know that your blood pressure may rise while you are using darbepoetin alfa. Tell your doctor if you have or have ever had high blood pressure. Be sure to check your blood pressure as often as your doctor tells you that you should, to call your doctor if your blood pressure is higher than your doctor says it should be, and to take any medications your doctor prescribes to control your blood pressure exactly as directed.
- You should call your doctor if you are planning to travel or if your activity becomes limited, such as spending more time sitting or in bed.
- if you are on hemodialysis, you should know that blood clots may form in the tubing that goes into your vein. Call your doctor if you think there is a clot in your tubing.
What special dietary instructions should I follow?
If you are following a prescribed special diet because you have kidney disease or high blood pressure, follow it carefully, even if you feel better while using darbepoetin alfa. Darbepoetin alfa will not work unless your body has enough iron. Your doctor or dietician will probably tell you to eat foods that are rich in iron. If you cannot get enough iron from your diet, your doctor may prescribe an iron supplement. Take this supplement exactly as directed.
What should I do if I forget a dose?
Call your doctor to ask what to do if you miss a dose of darbepoetin alfa. Do not use a double dose to make up for a missed one.
What side effects can this medication cause?
Darbepoetin alfa may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- headache
- upset stomach
- vomiting
- stomach pain
- diarrhea
- constipation
- joint, arm, or back pain
- redness, swelling, bruising, itching or a lump at the spot where you injected darbepoetin alfa
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- leg pain, swelling, or redness
- muscle aches or soreness
- coughing up blood
- cough that doesn’t go away
- hives
- rash
- itching
- difficulty breathing or swallowing
- wheezing
- hoarseness
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- sweating
- blue-grey color or darkening around mouth or nails
- dry mouth
- sunken eyes
- decreased urination
- fast heartbeat
- irregular heartbeat
- dizziness
- fainting
- blurred vision
- temporary confusion
- slow or difficult speech
- weakness or numbness of an arm or leg
- loss of memory or ability to concentrate
- seizures
- fever, sore throat, chills, cough, and other signs of infection
- chest pain or tightness
- shortness of breath
- weakness
- extreme tiredness or lack of energy
- feeling cold most of the time
- pale skin
You should know that darbepoetin alfa and other erythropoiesis stimulating medications may increase the risk that you will develop severe or life-threatening heart or blood vessel problems such as swelling of the hands, feet, ankles, or lower legs; heart attack or heart failure; high blood pressure; seizures; strokes; and blood clots in your heart, legs, or lungs, especially if you have heart disease. Talk to your doctor about the risks of using darbepoetin alfa.
You should know that people with cancer who use darbepoetin alfa may have an increased risk of developing blood clots in their veins or lungs. If you have cancer, talk to your doctor about the risks of using darbepoetin alfa.
Darbepoetin alfa may cause other side effects. Call your doctor if you have any unusual problems or you do not feel well while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the carton it came in, tightly closed, and out of reach of children. Once a vial or prefilled syringe has been taken out of its carton, keep it covered to protect it from room light until the dose is given. Store darbepoetin alfa in the refrigerator, but do not freeze. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
When traveling, pack darbepoetin alfa in its original carton in an insulated container with a coolant such as blue ice. To avoid freezing, make sure the darbepoetin alfa vial or prefilled syringe does not touch the coolant. Once you arrive, place darbepoetin alfa in a refrigerator as soon as possible.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- headache
- leg pain
- chest pain or tightness
- fast heartbeat
- irregular heartbeat
- shortness of breath
- coughing up blood
- swelling of the hands, feet, or ankles
- blue or grey color or darkening around mouth or nails
- excessive sweating
- dizziness
- fainting
- blurred vision
- temporary confusion
- slow or difficult speech
- weakness or numbness of an arm or leg
- seizures
- coma
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to darbepoetin alfa.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are using darbepoetin alfa.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
Brand names
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Last Revised - 04/01/2006