Safety advice on particular drugs or classes of drugs
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| Canada: New important changes to the delivery of FERAHEME (ferumoxytol) and to restrictions of use to further mitigate risks of serious hypersensitivity reactions |
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Further to Takeda Canada’s recent communication of July 11, 2014, in collaboration with Health Canada, informed healthcare professionals and the public about the following important new changes on the use of Feraheme (ferumoxytol), an intravenous (IV) iron product, authorized in Canada for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).
The Product Monograph (PM) is being revised to reflect the following in an effort to further reduce the risk of serious hypersensitivity reactions due to Feraheme:
- Feraheme should only be administered as an intravenous infusion in 50-250 ml of 0.9% sterile sodium chloride or 5% sterile dextrose over a minimum period of 15 minutes following dilution and must no longer be administered by direct injection of the undiluted product.
- Patients should be closely monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Feraheme.
- Feraheme is contraindicated in patients with any known history of drug allergy.
- Elderly patients (> 65 years of age) or patients with multiple co-morbidities who experience a serious hypersensitivity reaction due to Feraheme may have more severe outcomes. The potential risks and benefits of Feraheme administration should be carefully considered in these patients.
In addition, the revised PM will recommend that patients be placed in a reclined or semi-reclined position during infusion and for at least 30 minutes thereafter.
The change of administration from a rapid IV injection to an infusion may reduce the risk of serious hypersensitivity reactions including life-threatening and fatal outcomes reported in the post-market setting, and allow healthcare professionals to better intervene at the first signs of prodromal symptoms of hypersensitivity.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../42607a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was released by Health Canada and European Medicines Agency previously and was posted on the Drug Office website on 12 July 2014 and 14 July 2014 respectively.
Ends/ Saturday, November 22, 2014
Issued at HKT 13:00
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