Darbepoetin Alfa Injection
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(dar be poe' e tin)
Using darbepoetin alfa injection increases the risk that blood clots will form in or move to the legs, lungs, or brain. Tell your doctor if you have or have ever had heart disease and if you have ever had a stroke. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: pain, tenderness, redness, warmth, and/or swelling in the legs; coolness or paleness in an arm or leg; shortness of breath; cough that won't go away or that brings up blood; chest pain; sudden trouble speaking or understanding speech; sudden confusion; sudden weakness or numbness of an arm or leg (especially on one side of the body) or of the face; sudden trouble walking, dizziness, or loss of balance or coordination; or fainting. If you are being treated with hemodialysis (treatment to remove waste from the blood when the kidneys are not working), a blood clot may form in your vascular access (place where the hemodialysis tubing connects to your body). Tell your doctor if your vascular access stops working as usual.
Your doctor will adjust your dose of darbepoetin alfa injection so that your hemoglobin level (amount of a protein found in red blood cells) is just high enough that you do not need a red blood cell transfusion (transfer of one person's red blood cells to another person's body to treat severe anemia). If you receive enough darbepoetin alfa to increase your hemoglobin to a normal or near normal level, there is a greater risk that you will have a stroke or develop serious or life-threatening heart problems including heart attack, and heart failure. Call your doctor immediately or get emergency medical help if you experience any of the following symptoms: chest pain, squeezing pressure, or tightness; shortness of breath; nausea, lightheadedness, sweating, and other early signs of heart attack; discomfort or pain in the arms, shoulder, neck, jaw, or back; or swelling of the hands, feet, or ankles.
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 injection. Your doctor may decrease your dose or tell you to stop using darbepoetin alfa injection for a period of time if the tests show that you are at high risk of experiencing serious side effects. Follow your doctor's directions carefully.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with darbepoetin alfa and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of using darbepoetin alfa injection.
In clinical studies, people with certain cancers who received darbepoetin alfa injection died sooner or experienced tumor growth, a return of their cancer, or cancer that spread sooner than people who did not receive the medication. If you have cancer, you should receive the lowest possible dose of darbepoetin alfa injection. You should only receive darbepoetin alfa injection to treat anemia caused by chemotherapy if your chemotherapy is expected to continue for at least 2 months after you begin treatment with darbepoetin alfa injection and if there is not a high chance that your cancer will be cured. Treatment with darbepoetin alfa injection should be stopped when your course of chemotherapy ends.
A program called the ESA APPRISE Oncology Program has been set up to decrease the risks of using darbepoetin alfa injection to treat anemia caused by chemotherapy. Your doctor will need to complete training and enroll in this program before you can receive darbepoetin alfa injection. As part of the program, you will receive written information about the risks of using darbepoetin alfa injection and you will need to sign a form before you receive the medication to show that your doctor has discussed the risks of darbepoetin alfa injection with you. Your doctor will give you more information about the program and will answer any questions you have about the program and your treatment with darbepoetin alfa injection.