HOW TO USE: 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 location of the injection site every time to avoid problem areas 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 performed frequently to check how well this medication is working and to determine the correct dose for you. Consult your doctor for more details.Do not increase your dose or use this medication more often than directed. 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.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.
SIDE EFFECTS: Headache, body aches, diarrhea, and irritation at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.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 adequately controlled before beginning treatment with this medication. Your blood pressure should be checked frequently. Ask your doctor if you should learn how to monitor 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 blood count tested regularly to reduce the chance of this side effect.Get medical help right away if you have any very serious side effects, including: seizures.This medication may rarely cause blood clots. Get medical help right away if you notice any of the following rare but very serious side effects: pain/redness/swelling/weakness of the arms or legs, calf pain/swelling that is warm to the touch, new/worsening shortness of breath, coughing up blood, sudden vision changes, slurred speech, confusion, weakness on one side of the body, sudden severe headache, chest/jaw/left arm pain, irregular heartbeat, fainting, blood clots in your hemodialysis vascular access site.Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that reduce the effectiveness of darbepoetin alfa, and a very serious anemia can result. Tell your doctor immediately if symptoms of anemia return (e.g., 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 immediately if you develop any signs of an infection (e.g., persistent fever/sore throat, increased tiredness, yellowing eyes/skin, dark urine).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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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