Discuss the risks and benefits of darbepoetin alfa with your doctor, as this medication may rarely cause very serious (possibly fatal) side effects, including blood clots. It is very important to keep all laboratory test appointments, as your doctor will need to carefully check your red blood cell tests (hemoglobin). The lowest effective dose of this medication should be used.
When used to treat anemia related to cancer, this medication may also increase the risk of death and/or cause your tumor to grow faster. Therefore, your doctor should have special training in order to prescribe this medication and be able to discuss with you the risks and benefits of this medication. This medication should be stopped after completing a treatment course of chemotherapy as directed by your doctor.Who should not take darbepoetin alfa in polysorbate injection?
This medication is used to treat anemia (low red blood cell count) in people with long-term serious kidney disease (chronic kidney failure) and people receiving chemotherapy for some types of cancer (non-myeloid cancers). Darbepoetin alfa helps to reverse anemia. It also helps to reduce the need for blood transfusions. It works by signaling the bone marrow to make more red blood cells. This medication is very similar to the natural substance in your body (erythropoietin) that prevents anemia.
Read the Medication Guide and Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. Learn all preparation and usage instructions in the product package. If you have any questions, ask your doctor or pharmacist.
This medication is given as an injection under the skin or into a vein as directed by your doctor. Hemodialysis patients should receive this medication by injection into a vein.
Do not shake this medication and do not mix it with other drugs or IV solutions. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you are injecting this medication under the skin, change the injection site each time to lessen injury under the skin.
Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.
The dosage is based on your medical condition, weight, and response to treatment. Blood tests should be done often to check how well this medication is working and to decide the correct dose for you. Consult your doctor for more details.
Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week as directed.
Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
It may take 2 to 6 weeks before your red blood cell count increases. Tell your doctor if your symptoms do not improve or if they worsen.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Darbepoetin alfa may sometimes cause or worsen high blood pressure, especially in patients with long-term kidney failure. This effect may be caused by the number of red blood cells increasing too quickly, usually within the first 3 months of starting treatment. If you have high blood pressure, it should be well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check your own blood pressure. If high blood pressure develops or worsens, follow your doctor's instructions about diet changes and starting or adjusting your high blood pressure medication. Lowering high blood pressure helps prevent strokes, heart attacks, and further kidney problems. Keep all laboratory appointments to have your red blood cell count (hemoglobin) tested regularly to reduce the chance of this side effect.
Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that make it work less well, and a very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as increased tiredness, low energy, pale skin color, shortness of breath).
Though very unlikely to occur, this product may contain substances such as viruses that could cause infections because it may contain albumin from human blood. Careful screening of blood donors, special manufacturing methods, and tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor right away if you develop any signs of an infection (such as persistent fever/sore throat, increased tiredness, yellowing eyes/skin, dark urine).
Get medical help right away if you have any very serious side effects, including: seizures.
This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Side Effects section.
Before using darbepoetin alfa, tell your doctor or pharmacist if you are allergic to it; or to other drugs that cause more red blood cells to be made (such as epoetin alfa); or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients (such as polysorbate, latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, other blood disorders (such as sickle cell anemia, white blood cell or platelet problems, bone marrow problems), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as complete blood count that includes hemoglobin and hematocrit, reticulocyte count) must be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.
Blood tests for your iron levels will also be performed and you may be prescribed iron supplements to take. Your doctor may recommend that you eat a well-balanced diet rich in iron (such as raisins, figs, meat, eggs, vegetables, iron-fortified cereals). Follow your doctor's instructions and dietary recommendations.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store in the refrigerator. Do not freeze. Protect it from light. Store the medication in the original carton until ready for use. Let the medication come to room temperature before using. After each dose, discard any unused medication right away. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised January 2015. Copyright(c) 2015 First Databank, Inc.
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