Before you begin using 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 use this medication.
HEALTH CANADA ADVISORY
May 15, 2014
Health Canada has issued new restrictions concerning the use of Aloxi (palonosetron). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Allergy: Before you take palonosetron, inform your doctor about any previous side effects or reactions you have had to medications. Contact your doctor at once if you experience signs of an allergic reaction such as skin rash, itching, difficulty breathing, or swelling of the face and throat. If you have had an allergic reaction to ondansetron, dolasetron, or granisetron, do not take palonosetron.
Heart rhythm: Very rarely, palonosetron can affect the heart's electrical activity and cause an abnormal heart rhythm called QT prolongation. People with heart problems (e.g., an irregular heartbeat, QT prolongation) or a family history of QT prolongation or sudden cardiac death before the age of 50, should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you are taking other medications that can also affect heart rhythm, inform your doctor before using palonosetron.
Kidney problems: The safety and effectiveness of using this medication have not been established for people with end-stage kidney disease.
Pregnancy: The safety of palonosetron for use by pregnant women has not been established. 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 palonosetron 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 under 18 years of age. Its use by this age group is not recommended.