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
December 19, 2011
Health Canada has issued new restrictions concerning the use of Aclasta® (zoledronic acid). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
ASA allergy: Although not reported with zoledronic acid, people who are allergic to acetylsalicylic acid (ASA) have had breathing problems after using other medications in the same family as zoledronic acid. Let your doctor know if you are allergic to ASA.
Atrial fibrillation: This medication has been shown to increase the risk of atrial fibrillation (irregular heartbeat) in some clinical trials. Contact your doctor if you feel palpitations, a rapid and irregular heartbeat, dizziness, weakness, or shortness of breath.
Atypical femur fracture: There is evidence that long term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur). If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Deterioration of the jaw bone: People with cancer who are being treated with zoledronic acid (or other bisphosphonates) have a higher risk of developing osteonecrosis of the jaw (deterioration of the jaw bone). If you take zoledronic acid, report any pain, swelling, or infection of the jaw to your doctor, and avoid invasive dental procedures such as tooth extractions.
Hydration: If you are using this medication, you must be well-hydrated, especially if you are taking diuretics (water pills). On the day that zoledronic acid is given, you should eat normally and drink at least 2 glasses (500 mL or 2 cups) of water before and after receiving the medication.
Kidney function: As with other bisphosphonates, the use of zoledronic acid has been associated with kidney problems. If you have kidney disease, or have a history of kidney disease, let your doctor know about these conditions before starting this medication, as it may aggravate kidney problems. The use of zoledronic acid is not recommended for people with severe kidney impairment.
Low blood calcium levels: Before starting zoledronic acid, people who have low blood calcium levels must adjust their levels with calcium and vitamin D supplements as recommended by their doctors. If you take zoledronic acid, you should take calcium and vitamin D supplements to prevent low blood calcium levels. Your doctor will recommend an appropriate dose for these supplements based on your needs.
Pregnancy: Zoledronic acid should not be used during pregnancy as it may harm the fetus. If you become pregnant while receiving this medication, contact your doctor immediately.
Breast-feeding: It is not known if zoledronic acid passes into breast milk. It should not be taken while breast-feeding.
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 less than 18 years of age.