Darbepoetin Alfa Injection

Conditions Treated

Darbepoetin alfa injection is used to treat anemia (a lower than normal number of red blood cells) in people with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Darbepoetin alfa injection is also used to treat anemia caused by chemotherapy (medications to treat cancer). Darbepoetin alfa is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.

Possible Side Effects

What Side Effects Can This Cause?

Darbepoetin alfa injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• vomiting
• stomach pain
• diarrhea
• constipation
• body, joint, or muscle aches
• 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, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• rash over the whole body
• itching
• difficulty breathing or swallowing
• wheezing
• hoarseness
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• dry mouth
• sunken eyes
• decreased urination
• fever, sore throat, chills, cough, and other signs of infection
• feeling cold most of the time
• pale skin

Darbepoetin alfa injection may cause other side effects. Call your doctor if you have any unusual problems or you do not feel well while using 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/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Darbepoetin alfa injection comes as a solution (liquid) to inject subcutaneously (just under the skin) or intravenously (into a vein). It is usually injected once a week every 1-3 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 injection 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 the lowest possible dose of darbepoetin alfa injection and gradually increase or decrease your dose, not more than once every month. Your doctor may also tell you to stop using darbepoetin alfa injection for a time. Follow these instructions carefully. If your doctor tells you to stop using darbepoetin alfa injection, 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 injection than you were using. Darbepoetin alfa injection is used to reduce the need for red blood cell transfusions. Darbepoetin alfa injection controls anemia but does not cure it. It may take 2-6 weeks or longer before you feel the full benefit of darbepoetin alfa injection. Continue to use darbepoetin alfa injection even if you feel well. Do not stop using darbepoetin alfa injection 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 know the correct dose, how to give the medication, and how often to give the medication. 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 injection before you use it for the first time at home. Darbepoetin alfa injection comes in prefilled syringes, a prefilled automatic injection device, and also in vials to use with disposable syringes. Use vials, prefilled automatic injection devices, and prefilled or disposable syringes only once. Do not put a needle through the rubber stopper of a vial more than once. Follow the directions given to you for throwing away the needle and syringe after use. If you are using vials of darbepoetin alfa injection, 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. Do not shake darbepoetin alfa injection. Always inject darbepoetin alfa in its own syringe; never mix it with any other medication. If you are using darbepoetin alfa vials or prefilled syringes 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 2-inch (5-centimeter) area around your navel (belly button), the front of your middle thighs, and the upper outer areas of your buttocks. If you are using darbepoetin alfa prefilled automatic injection device, you can inject it just under the skin on the outer area of your upper arms or the front of your middle thighs; or if your doctor says it is ok, you can also use your stomach except for the 2-inch (5-centimeter) area around your navel (belly button). Choose a new spot each time you inject darbepoetin alfa. Do not inject darbepoetin alfa into a spot that is tender, red, bruised, hard, or has scars or stretch marks. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient. Carefully read this information and be sure to ask your pharmacist or doctor if you have any questions about how to prepare or inject this medication.

What 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 injection. Darbepoetin alfa injection 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.

Are There Any Special Instructions

Before using darbepoetin alfa injection, tell your doctor and pharmacist if you are allergic to darbepoetin alfa, epoetin alfa (Epogen, Procrit), any other medications, or any of the ingredients in darbepoetin alfa injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. tell your doctor if you have or have had high blood pressure. Your doctor may tell you not to use darbepoetin alfa injection. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. 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 or blood clotting problems; diseases that affect your blood such as hemolytic anemia (condition where a low number of red blood cells occurs because the cells are being destroyed in the body), 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; seizures; stroke or ministroke (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 erythropoiesis-stimulating agent 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 because of a condition called pure red cell aplasia (PRCA; a certain type of anemia). you should know that your blood pressure may increase while you are using darbepoetin alfa injection. Your doctor may ask you to check your blood pressure often. 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.