ADR that result in revision of patient information
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| Canada: Important Safety Information: Zofran (ondansetron) - Dosage and Administration of Intravenous Ondansetron in Geriatrics (>65 years of age) |
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GlaxoSmithKline Inc., in consultation with Health Canada, would like to provide you with important new safety information regarding the dosing and administration of intravenous (IV) ondansetron (ZOFRAN) in geriatrics. New dosing restrictions are recommended to mitigate the risk of QT prolongation in elderly patients (>65 years of age).
In geriatrics, ZOFRAN is indicated for the prevention of nausea and vomiting associated with emetogenic chemotherapy, including high dose cisplatin, and radiotherapy. There is a risk of dose dependent QT interval prolongation, which is expected to be greater with faster rate of infusion and larger doses for the IV administration. The dosing restrictions for geriatrics are summarized below:
- In patients ≥75 years of age, the initial IV dose must not exceed 8 mg.
- In patients <75 years of age, the initial IV dose must not exceed 16 mg.
- Subsequent IV doses must not exceed 8 mg and may be given 4 and 8 hours after the initial dose.
- All IV doses must be diluted in 50–100 mL of saline or other compatible fluid.
- All IV doses must be infused over no less than 15 minutes.
There are no changes to the recommended oral dosing.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../39943a-eng.php
In Hong Kong, there are 21 registered pharmaceutical products containing ondansetron, 7 of which are injectable products. All of them are prescription-only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction report on QT prolongation in connection with the drug. Safety alerts on intravenous (IV) ondansetron has been released by various overseas regulatory authorities and letters were sent to draw the attention of healthcare professionals to the issue on 16 September 2011 and 3 July 2012. The Registration Committee of the Pharmacy and Poisons Board (the Committee) discussed the issue in February 2012 and July 2013, and decided that the sales packs or package inserts of the products should include safety information on risk of QT prolongation associated with the drug and dose restrictions. For the brand product Zofran Injection, the certificate holder GlaxoSmithKline Limited has updated the package insert of its IV product Zofran to include the guidance for dosing in geriatrics. In view of Health Canada's announcement on specific dosing restrictions for geriatrics, the matter will be discussed in the meeting of the Committee for consideration of modification of dosing instruction in geriatrics.
Ends/ Friday, June 13, 2014
Issued at HKT 14:00
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