Other safety alerts
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| The United Kingdom: Brimonidine gel (Mirvaso): risk of exacerbation of rosacea |
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The Medicines and Healthcare products Regulatory Agency (MHRA) advised that some patients may have exacerbation or rebound symptoms of rosacea associated with the use of Brimonidine gel (Mirvaso). It is important to initiate treatment with a small amount of gel and increase the dose gradually, based on tolerability and treatment response.
Brimonidine (Mirvaso) is a topical gel indicated for the symptomatic treatment of facial erythema of rosacea in adults. Symptom exacerbation has been reported very commonly in patients treated with brimonidine gel, including cases of a rebound effect after the therapeutic effect wears off (approximately 8–12 hours after application) and cases in which exacerbation of symptoms (particularly erythema and flushing) occurred during treatment soon after it was applied.
Across all clinical studies, 16% of patients who were receiving brimonidine gel had symptom exacerbation. Most patients recovered on stopping treatment. The potential mechanism is currently unknown.
Following an EU-wide review, prescribing advice has been updated in the UK. Patients should start treatment with a small amount of gel (less than the maximum dose) for at least 1 week and increase the dose gradually, based on tolerability and response to treatment. This will help enable patients to find the best balance between therapeutic and adverse effects.
The MHRA advised healthcare professionals of the following:
• exacerbation of rosacea symptoms occurred in up to 16% of patients treated with brimonidine gel in clinical studies; in most cases, erythema and flushing resolve after stopping treatment
• initiate treatment with a small amount of gel (less than the maximum dose) for at least 1 week and increase the dose gradually, based on tolerability and response to treatment
• advise patients carefully on how to apply the gel and on the importance of not exceeding the maximum daily dose (which is 1 g of gel in total weight, approximately 5 pea-sized amounts)
• advise patients to stop treatment and consult a doctor if their symptoms worsen during treatment (increased redness or burning)
Please refer to the following website in MHRA for details:http://www.gov.uk/drug-safety-update/brimonidine-gel-mirvaso-risk-of-exacerbation-of-rosacea
In Hong Kong, Mirvaso Gel 0.33% (HK-63413) containing brimonidine (as tartrate) is a pharmaceutical product registered by Galderma Hong Kong Limited (Galderma), and is a prescription only medicine. So far, the Department of Health (DH) has not received any adverse drug reaction report related to brimonidine. Galderma has updated the package insert of the product to include erythema and flushing as special warnings with precaution for use. In view of MHRA’s new prescribing advice for healthcare professionals, letters to inform local healthcare professionals will be issued. DH will remain vigilant on safety update of the drug by other overseas drug regulatory authorities.
Ends/ Wednesday, November 09, 2016
Issued at HKT 15:00
As confirmed with the MHRA, the black triangle symbol has been removed from the announcement as Mirvaso (brimonidine gel) is not subject to any additional monitoring requirements.
Content last updated: Friday, December 09, 2016
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