"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...
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 well controlled before beginning treatment with this medication. Your blood pressure should be checked often. Ask your doctor if you should learn how to check 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 red blood cell count (hemoglobin) tested regularly to reduce the chance of this side effect.
Rarely, this medication may suddenly stop working well after a period of time because your body may make antibodies that make it work less well, and a very serious anemia can result. Tell your doctor right away if symptoms of anemia return (such as 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 right away if you develop any signs of an infection (such as persistent fever/sore throat, increased tiredness, yellowing eyes/skin, dark urine).
Get medical help right away if you have any very serious side effects, including: seizures.
This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, heart failure, stroke, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes, blood clots in your hemodialysis vascular access site.
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.
Read the Aranesp (darbepoetin alfa) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Side Effects section.
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 (such as 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, other blood disorders (such as sickle cell anemia, white blood cell or platelet problems, bone marrow problems), seizure disorder, a certain metabolic disorder (porphyria), certain vitamin deficiencies (folic acid, vitamin B12).
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.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
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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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