Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
HEALTH CANADA ADVISORY
May 5, 2017
Health Canada has issued new restrictions concerning the use of Aranesp (darbepoetin alfa). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergies: This medication can cause severe allergic reactions. Contact your doctor immediately if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities, and which in some cases can cause death. Your doctor will monitor your hemoglobin level closely with blood tests during treatment with this medication. If you experience symptoms such as sharp pain and swelling in the leg, or difficulty breathing, contact your doctor immediately.
Cancer: Darbepoetin alfa is used to treat anemia caused by chemotherapy treatment of non-myeloid cancers. It is not used to treat anemia that is due to the cancer itself. Under some conditions, this medication may cause tumours to progress or reoccur more quickly than for people who are not using darbepoetin alfa.
Cardiovascular disease: This medication often affects blood pressure and can contribute to symptoms of heart disease. If you have high blood pressure, heart disease such as heart failure, angina, or a previous heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you are taking blood pressure pills to control blood pressure, it is important to continue taking them regularly while you are on darbepoetin alfa. Your doctor will monitor your hemoglobin (the protein in red blood cells that carry oxygen) until an appropriate dose of darbepoetin alfa has been determined.
Kidney disease: This medication may be used by people with chronic kidney disease who are receiving dialysis and who are not receiving dialysis - the dose may be different for each. Your doctor will monitor you closely for your response to the medication.
Pure red cell aplasia: Cases of pure red cell aplasia (PRCA) have been reported among people treated with darbepoetin alfa. PRCA is a condition in which a person's bone marrow stops producing red blood cells, leading to severe anemia. People who develop PRCA may experience a new or worsening feeling of tiredness or shortness of breath. If you are experiencing such symptoms, call your doctor as soon as possible. Do not stop your medication without contacting your doctor first.
Seizure: This medication may contribute to an increase in seizures although the relationship between darbepoetin and seizures is not clear. If you experience seizures or have a history of seizure disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Stroke: Darbepoetin can increase the risk of blood clots forming in the blood vessels. If you have a past history of stroke, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience signs and symptoms of a stroke, blurred vision or difficulty speaking, sudden headache or loss of coordination, contact your doctor immediately.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if darbepoetin alfa passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.