Learn more about usage, cautions, and possible side effects .
Chemical Name: DARBEPOETIN ALFA (dar-be-POE-e-tin AL-fa), POLYSORBATE 80 (POL-ee-SOR-bate)
This medicine increases red blood cell production and is used to treat anemia in patients with chronic kidney failure or certain types of cancers. It may also be used to treat other conditions as determined by your doctor.
WARNING: Clinical studies have shown this medicine to increase the risk of serious side effects (eg, blood clots, stroke, heart attack and heart failure) and death in some cases. It has also been shown to shorten overall survival and/or increase the risk of tumor growth or recurrence in patients with certain types of cancer. Talk with your doctor about the risks and benefits of using this medicine. Do not use more than the recommended dose without checking with your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are also using other blood-related medicines such as erythropoietin alfa. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including heart problems (eg,congestive heart failure), blood problems (eg, sickle cell anemia, porphyria, hemolytic anemia, or thalassemia), blood in your stools, low levels of certain vitamins or minerals in your blood (eg, folic acid or vitamin B12), hemodialysis, seizures, high blood pressure, recent infection or injury, cancer, certain bone problems (eg, osteofibrosis cystica), bone marrow problems (fibrosis), inflammatory conditions (eg, bowel disease or rheumatoid arthritis), allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have high blood pressure that is not under control or severe high blood pressure, certain red blood cell problems (eg, certain types of aplasia), or you are allergic to products made from mammalian cells. USE OF THIS MEDICINE IN CHILDREN with chronic kidney failure younger than 1 year old or CHILDREN with cancer is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. THIS MEDICINE IS USUALLY ADMINISTERED as an injection into a vein or under the skin at your doctor's office, hospital, or clinic. THIS MEDICINE IS SOMETIMES USED AT HOME as an injection. If you are using this medicine at home, a healthcare professional will provide detailed instructions for its appropriate use. Ask them any questions that you may have about your medicine or giving injections. DO NOT USE THIS MEDICINE if it is discolored, cloudy, or contains particles or if the vial or syringe is cracked or damaged in any way. DO NOT SHAKE this medicine. DO NOT MIX this medicine with IV solutions or with other injectable medicines. IF YOU ARE USING MEDICINE THAT COMES IN A VIAL, be sure to follow the procedure demonstrated to you to prevent contamination of the vial, syringe, or medicine. Never touch the rubber stopper of the vial or the needle of the syringe with your fingers. CAREFULLY CHECK that you have drawn the correct dose into the syringe before administration. CHOOSE A NEW SITE each time you inject this medicine. Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks. DO NOT USE PAST THE EXPIRATION DATE on the vial or prefilled syringe. DISCARD ANY UNUSED PORTION of medicine left in the vial or syringe. STORE THIS MEDICINE in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). PROTECT FROM LIGHT. DO NOT FREEZE. When travelling, transport this medicine in the original carton in a cool carrier with a coolant, such as blue ice. To avoid freezing, be sure the medicine does not touch the coolant. Once you arrive, place the medicine in the refrigerator as soon as possible. Use this medicine regularly to receive the most benefit from it. Using this medicine at the same times each week will help you to remember. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT use 2 doses at once.
DO NOT USE THIS MEDICINE if you have had an allergic reaction to it or to similar medicines (such as erythropoietin), or are allergic to any ingredient in this product. IT MAY TAKE 2 to 6 WEEKS for this medicine to work. Do not stop using this medicine without checking with your doctor. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Laboratory and/or medical tests, including blood pressure, blood counts, kidney function, blood electrolyte levels, and blood iron levels, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. IT IS IMPORTANT TO KEEP YOUR BLOOD PRESSURE UNDER CONTROL during treatment with this medicine. Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor's instructions for diet and blood pressure monitoring. THIS MEDICINE CONTAINS ALBUMIN, which comes from human blood. There is an extremely rare risk of developing a viral disease, or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral disease or Creutzfeldt-Jakob disease from albumin have been identified. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. If you are or will be breast-feeding while using this medicine, discuss with your doctor the benefits and risks to your baby.
SIDE EFFECTS that may occur while using this medicine include dizziness; cough; constipation; mild headache; or mild nausea, vomiting, or diarrhea. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience pain, swelling, irritation, redness, or bruising at the injection site; or muscle, joint, back, stomach, or arm pain. CONTACT YOUR DOCTOR IMMEDIATELY if you experience redness, tenderness, swelling, or pain of the calf or leg; shortness of breath; chest pain; unusual tiredness or weakness; swelling of the arms or legs; flu-like symptoms including fever, chills, sore throat; blurred vision or sudden vision changes; fast or irregular heartbeat; seizures; one-sided weakness; slurred speech; confusion; severe headache; or dehydration. AN ALLERGIC REACTION to this medicine is unlikely but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
If your symptoms do not improve within a few weeks or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out.
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