Aranesp

Generic Name: Darbepoetin Alfa

  • What is Aranesp?

    Aranesp is a man-made form of the protein human erythropoietin used to lessen the need for red blood cell transfusions. Aranesp stimulates your bone marrow to make more red blood cells. Having more red blood cells raises your hemoglobin level.

    Aranesp is used to treat anemia (a lower than normal number of red blood cells) if caused by chronic kidney failure in people who may or may not be on dialysis. Aranesp is also used to treat anemia in people with cancer when the anemia is due to effects of chemotherapy used to treat some types of cancer.

  • What is the most important information I should know about Aranesp?

    If your hemoglobin level stays too high or if your hemoglobin goes up too quickly, this may lead to serious health problems, which may result in death. These serious health problems may happen even if you take Aranesp and do not have an increase in your hemoglobin level.

    Aranesp should not be used for treatment of anemia if you have cancer and you are not receiving chemotherapy that may cause anemia or if your cancer has a high chance of being cured.

    Using Aranesp can lead to death or other serious side effects. You may experience serious heart problems such as heart attack, stroke, heart failure, and may die sooner if you are treated with Aranesp to a hemoglobin level above 12 g/dL (grams per deciliter).

    You may get blood clots at any time while taking Aranesp. If you are receiving Aranesp and you are going to have surgery, talk to your healthcare provider about whether or not you need to take a blood thinner to lessen the chance of blood clots during or following surgery.

    Call your doctor or get medical help right away if you have any symptoms of blood clots, such as chest pain, trouble breathing or shortness of breath, pain in your legs, with or without swelling, cool or pale arm or leg, sudden confusion, trouble speaking, trouble understanding others' speech, sudden numbness or weakness in your face, arm, or leg, especially on one side of your body, sudden trouble seeing or walking, dizziness, loss of balance or coordination, loss of consciousness (fainting), or if your hemodialysis vascular access stops working.

    Your healthcare provider has received special training through the ESA APPRISE Oncology Program in order to prescribe Aranesp for you if you have cancer. Before you can begin to receive Aranesp, you must sign the ESA APPRISE Oncology Patient and Healthcare Professional (HCP) Acknowledgement Form to document that your healthcare provider discussed the risks of Aranesp with you. When you sign this form, you are stating that you are aware of the risks associated with use of Aranesp.

    Discuss with your doctor why Aranesp treatment is being prescribed, your chances of needing red blood cell transfusions if you do not take Aranesp, your chances of needing red blood cell transfusions even if you take Aranesp, and how taking Aranesp may affect the success of your cancer treatment. If you decide to take Aranesp, your healthcare provider should prescribe the smallest dose of Aranesp to lower the chance of getting red blood cell transfusions.

    After you have finished your chemotherapy course, Aranesp treatment should be stopped.

    It is important that your blood pressure be monitored often and to report any changes outside of the guidelines that your doctor has given you, especially if you have heart disease. Certain laboratory tests, such as hemoglobin, hematocrit, or iron level measurements, may also need to be done more often and be reported to your doctor or dialysis center. It is important to keep all follow-up visits with your doctor to allow your doctor to adjust the dosage of Aranesp as needed. Over time, many kidney disease patients also need to take iron.

    If you have high blood pressure with chronic kidney failure, your blood pressure may go up or be difficult to control with blood pressure medicine while taking Aranesp. This can happen even if you have never had high blood pressure before. Your doctor should check your blood pressure often.

    If you have any seizures while taking Aranesp, get medical help right away and tell your doctor.

    Your body may make antibodies to Aranesp. These antibodies can block or lessen your body's ability to make red blood cells and cause you to have severe anemia. Call your healthcare provider if you have unusual tiredness, lack of energy, dizziness, or fainting.

    The needle cover on the prefilled syringe contains a material that is like latex. Tell your doctor if you are allergic to latex.

  • Who should not take Aranesp?

    Do not take Aranesp if you have cancer and have not been counseled by your healthcare provider regarding the risks of Aranesp and signed the ESA APPRISE Oncology Program Patient and Healthcare Professional Acknowledgement Form before you begin to receive Aranesp.

    Do not take Aranesp if you have high blood pressure that is not controlled, have been told by your healthcare provider that you have or have ever had a type of anemia called pure red cell aplasia (PRCA) that starts after treatment with Aranesp or other erythropoietin medicines, or if you have allergies to any of the ingredients in Aranesp.

    Aranesp should not be used for treatment of anemia if you have cancer and you are not receiving chemotherapy that may cause anemia or if your cancer has a high chance of being cured.

    If you have cancer, do not take Aranesp if you have finished your course of chemotherapy.

    Do not take Aranesp you are allergic to Aranesp, other erythropoietins, or any of the ingredients.

    The safety and effectiveness of Aranesp in children less than 1 year of age with chronic kidney failure has not been established.

  • What should I tell my doctor before I take the first dose of Aranesp?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Aranesp. Also, talk to your doctor about your complete medical history, especially if you have or had high blood pressure, heart disease, any history of seizures (convulsions) or strokes, blood disorders such as sickle cell anemia, pure red cell aplasia, clotting disorders (e.g., deep vein thrombosis), cancer, low iron levels, low serum ferritin levels, low serum transferrin saturation, surgery or are scheduled for surgery, are pregnant, plan to become pregnant, are breastfeeding or plan to breastfeed.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Anemia in Cancer

    Adults: The recommended starting dose is 2.25 mcg (micrograms) per 2.2 pounds of body weight administered as a single injection once weekly under the skin. An alternative is 500 mcg of Aranesp given every 3 weeks. You should not receive Aranesp if your hemoglobin levels are ≥10 g/dL. Your dose will depend on maintaining the lowest hemoglobin level sufficient to avoid red blood cell transfusion.

    If you are getting weekly injections and there is <1g/dL increase in hemoglobin after 6 weeks of therapy, your doctor may increase your dose to 4.5 mcg per 2.2 pounds of body weight. Your doctor will discontinue Aranesp if there is no response after 8 weeks as measured by hemoglobin levels or if you still need transfusions. Your doctor will discontinue Aranesp after you complete the course of chemotherapy.

    Anemia in Chronic Kidney Failure

    Adults: The recommended starting dose is 0.45 mcg per 2.2 pounds of body weight, administered as a single injection once weekly under the skin. If you are not receiving dialysis, your doctor may start you on a dose of Aranesp of 0.75 mcg per 2.2 pounds of body weight as a single injection once every 2 weeks. Aranesp is given as an injection intravenously (IV) or under the skin. For people on hemodialysis, the IV method is recommended.

    Your maintenance dose of Aranesp will depend on your response and hemoglobin levels, which are targeted within the range of 10 to 12 grams per deciliter (g/dL). Doses should not exceed a target hemoglobin of 12g/dL. If you have chronic kidney failure and are not receiving dialysis, you may need lower maintenance doses. Maintenance doses of Aranesp may be given as a single injection every week or once every 2 weeks.

  • How should I take Aranesp?

    If you have cancer, your healthcare provider will ask you to review the Aranesp Medication Guide, explain the risks of Aranesp and answer all your questions about Aranesp, have you sign the ESA APPRISE Oncology Program Patient and Healthcare Professional Acknowledgement Form before you begin to receive Aranesp.

    Continue to follow your healthcare provider's instructions for diet, dialysis, and medicines, including medicines for high blood pressure, while taking Aranesp. Have your blood pressure checked as instructed by your healthcare provider.

    If you or your caregiver has been trained to give Aranesp injections at home, be sure that you read, understand, and follow the "Patient Instructions for Use" that come with Aranesp. Take Aranesp exactly as your healthcare provider tells you to. Do not change the dose of Aranesp unless told to do so by your healthcare provider.

    Your healthcare provider will show you how much Aranesp to use, how to inject it, how often it should be injected, and how to safely throw away the used vial, syringes, and needles. If you miss a dose of Aranesp, call your healthcare provider right away and ask what to do. If you take more than the prescribed amount of Aranesp, call your healthcare provider right away.

    Be sure to change the site for each injection to avoid soreness at any one site.

    You should only use a syringe that is marked in tenths of milliliters, or mL (for example, 0.2 mL).

  • What should I avoid while taking Aranesp?

    Avoid missing follow-up appointments with your doctor.

    Avoid becoming pregnant or breastfeeding. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you.

    Do not shake or expose Aranesp to light. Keep Aranesp in carton until it is time for use. Do not use Aranesp if the liquid in the vial or prefilled syringe appears discolored or cloudy or if the liquid appears to contain lumps, flakes, or particles.

    If you or your caregiver is allergic to latex, avoid handling the needle cover on the prefilled syringe that contains a form of latex.

    Avoid reusing any needles, syringes, prefilled SureClickTM autoinjectors or drug product. Follow your doctor's instructions for proper disposal of used Aranesp products. A puncture-resistant container for the disposal of used syringes, autoinjectors, and needles should be available.

  • What are possible food and drug interactions associated with Aranesp?

    No significant interactions have been reported with Aranesp at this time. However, always tell your doctor about any medicines you take, including over-the-counter drugs, vitamins, and herbal supplements.

  • What are the possible side effects of Aranesp?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: faster growing tumors, serious heart problems such as heart attack, stroke, heart failure, blood clots (especially in your legs, in your hemodialysis vascular access, or lungs), chest pain, trouble breathing or shortness of breath, pain in your legs, with or without swelling, cool or pale arm or leg, sudden confusion, trouble speaking, trouble understanding others' speech, sudden numbness or weakness in your face, arm, or leg, especially on one side of your body, sudden trouble seeing, sudden trouble walking, dizziness, loss of balance or coordination, loss of consciousness (fainting), hemodialysis vascular access stops working, increased blood pressure, seizures, antibodies to Aranesp that can block or lessen your body's ability to make red blood cells and cause you to have severe anemia (e.g., unusual tiredness, lack of energy, dizziness, or fainting), serious allergic reactions (e.g., rash over your whole body, shortness of breath, wheezing, dizziness and fainting, swelling around your mouth or eyes, fast pulse, or sweating), swelling in people with cancer, rash, injection site pain including irritation and pain, low blood pressure, fevers, headaches, muscle aches or soreness, nausea, diarrhea, leg swelling, cough or chest pain, lack of energy, infections

  • Can I receive Aranesp if I am pregnant or breastfeeding?

    Tell your doctor immediately if you are pregnant, might be pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Talk to your healthcare provider about possible pregnancy and birth control choices that are right for you. It is not known if Aranesp may harm your unborn baby or if Aranesp passes into breast milk.

  • What should I do if I miss a dose of Aranesp?

    If you miss a dose of Aranesp, call your healthcare provider right away and ask what to do.

  • How should I store Aranesp?

    Do not shake Aranesp. Protect Aranesp from light. Aranesp should be kept in its original carton to protect it from light, and stored in the refrigerator. Do not freeze. Do not use Aranesp that has been frozen.

    Do not use a vial or prefilled syringe of Aranesp that has been frozen, left in light, or improperly refrigerated. It is important that Aranesp be stored and used as stated in the package insert that comes with it.

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