This medicine is a synthetic erythropoietin analog used to treat anemia in certain patients with chronic kidney disease, anemia caused by chemotherapy in certain cancer patients, or anemia caused by taking zidovudine in certain HIV patients. It is also used to reduce the need for blood transfusions in certain patients who are at high risk of blood loss caused by certain types of surgeries. It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get this medicine refilled. This medicine is usually given as an injection at your doctor's office, hospital, or clinic. IF YOU ARE USING THIS MEDICINE AT HOME, a health care provider will teach you how to use it. Be sure you understand how to use this medicine. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions. DO NOT USE THIS MEDICINE if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged. WHEN DRAWING A DOSE INTO A SYRINGE, 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. ALWAYS CAREFULLY CHECK that you have drawn up the correct dose before administration. DO NOT SHAKE this medicine. Do NOT use this medicine if it has been shaken. Do NOT use this medicine if it has been frozen. DO NOT DILUTE this medicine. Do NOT mix it with other solutions unless your doctor directs you otherwise. IF YOU ARE USING A SINGLE-DOSE VIAL, throw away any medicine left in the vial after you have used your dose. Ask your doctor, pharmacist, or other health care provider if you have questions about whether you are using a single-dose vial. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. THIS MEDICINE IS USUALLY HANDLED AND STORED by a health care provider. If you are using this medicine at home, store this medicine as directed by your pharmacist or health care provider. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and pets. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor immediately.
WARNING: Clinical studies have shown this medicine to increase the risk of serious side effects (eg, blood clots, stroke, heart attack, heart failure) and death in some cases. It has also been shown to shorten the 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. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of cancer, seizures, kidney problems (eg, decreased kidney function; kidney failure), blood problems (eg, sickle cell anemia, porphyria, hemolytic anemia, thalassemia), bleeding or clotting problems, stroke, heart attack or other heart problems (eg, congestive heart failure, ischemic heart disease), diabetes, high blood pressure, allergies, pregnancy, or breast-feeding. Tell your doctor if you have blood in your stools; an infection or recent injury; certain bone problems (eg, osteofibrosis cystica); an inflammatory condition (eg, bowel disease, rheumatoid arthritis); low blood iron, folic acid, or vitamin B12 levels; or high blood aluminum levels. Tell your doctor if you are on hemodialysis, have recently had surgery, or are scheduled to have surgery. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have uncontrolled high blood pressure. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have developed a certain type of anemia called pure red cell aplasia (PRCA) after receiving a previous dose of this medicine or other erythropoietin protein medicines (eg, darbepoetin). THIS MEDICINE MAY CONTAIN BENZYL ALCOHOL, which may cause serious and sometimes fatal reactions in premature infants and newborns. Check with your doctor or pharmacist to see if you product has benzyl alcohol in it. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while using this medicine include cough, headache, joint or bone pain, mild muscle pain, mild pain or redness at the injection site, muscle spasms, nausea, trouble sleeping, vomiting, or weight loss. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience calf or leg pain, redness, tenderness, or swelling; chest, jaw, or left arm pain; confusion; coughing up blood; depression; fainting; fast or irregular heartbeat; fever, chills, or sore throat; muscle pain, weakness, or cramping; new or worsening pale skin color, or tiredness or weakness; numbness of an arm or leg; one-sided weakness; seizures; severe or persistent pain or irritation at the injection site; shortness of breath; sudden, severe headache, dizziness, or vomiting; sudden trouble walking, or loss of balance or coordination; swelling of the fingers, ankles, or legs; swelling or soreness of the mouth or tongue; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; drowsiness; flushing; rapid breathing; fruity breath odor); trouble swallowing; vision or speech problems; or weight gain. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. 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.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include severe or persistent headache or dizziness.
FOLLOW THE DIET AND EXERCISE PROGRAM AND DIALYSIS INSTRUCTIONS exactly as they were given to you by your health care provider. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.