"The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfiel"...
Aranesp Consumer (continued)
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.
Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, confusion, loss of consciousness.
This medication may rarely cause blood clots. Seek immediate medical attention 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, 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, seek immediate medical attention 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.
Read the Aranesp (darbepoetin alfa) Side Effects Center for a complete guide to possible side effects »
PRECAUTIONS: 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 (e.g., 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.
This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: uncontrolled high blood pressure.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure (treated/controlled), blood disorders (e.g., sickle cell anemia, white blood cell or platelet problems, bone marrow problems), bleeding/clotting problems, blood vessel problems (e.g., stroke), heart problems (e.g., angina, heart failure), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).
Infrequently, patients with long-term kidney failure on dialysis may be at increased risk of seizures during the first 3 months of treatment with this medication, possibly caused by the number of red blood cells increasing too quickly. Therefore, these patients should use caution and avoid activities such as driving or using machinery during this period. Limit alcoholic beverages because alcohol may also increase the risk of seizures.
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. In some women of child-bearing age, menstrual periods have resumed during treatment with a similar drug (epoetin alfa). If this occurs with darbepoetin alfa treatment, it may be possible to get pregnant while using this medication. Discuss the need for birth control with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
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