ADR that result in revision of patient information
|
| |
| European Union: Use of multiple sclerosis medicine Lemtrada restricted while PRAC review is ongoing |
| |
European Medicines Agency (EMA) announces that it has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.
As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease-modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.
In addition to the restriction, EMA’s safety committee (PRAC) has recommended an update of the product information for Lemtrada to inform patients and healthcare professionals about cases of:
- immune-mediated conditions, including autoimmune hepatitis (with damage to the liver) and haemophagocytic lymphohistiocytosis (overactivation of the immune system which may affect different parts of the body);
- problems with the heart and blood vessels occurring within 1–3 days of receiving the medicine, including bleeding in the lungs, heart attack, stroke, cervicocephalic arterial dissection (tears in the lining of the arteries in the head and neck);
- severe neutropenia (low levels of neutrophils, a type of white blood cell that fights infections).
Healthcare professionals should consider stopping treatment in patients who develop signs of these conditions and patients should immediately seek medical help if they experience symptoms.
Information for healthcare professionals
- Doctors are being informed in writing of temporary restrictions on the prescription of Lemtrada pending the conclusion of an ongoing review of the medicine and inclusion of new safety warnings in the product information of Lemtrada.
- New treatment should only be initiated in adults with relapsing-remitting multiple sclerosis that is highly active despite a full and adequate course of treatment with at least two other diseasemodifying therapies, or in adults with highly active relapsing-remitting multiple sclerosis where all other disease-modifying therapies are contraindicated or otherwise unsuitable.
- For patients being treated with Lemtrada, vital signs should be monitored before and during the intravenous infusion. If clinically significant changes are observed, discontinuation of infusion and additional monitoring, including ECG, should be considered.
- Liver function tests should be carried out before and during treatment. If patients develop signs of liver damage, unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice or dark urine), Lemtrada should only be re-administered following careful consideration.
- Patients who develop signs of pathological immune activation should be evaluated immediately, and a diagnosis of haemophagocytic lymphohistiocytosis considered. Symptoms of immune activation may occur up to 4 years after the start of treatment.
- Further information will be provided once the review of Lemtrada is concluded.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/documents/../lemtrada-article-20-referral-use-multiple-sclerosis-medicine-lemtrada-restricted-while-ema-review_en.pdf
In Hong Kong, Lemtrada Concentrate For Solution For Infusion 12mg/1.2ml (HK-64543) is a registered pharmaceutical product containing alemtuzumab. The product is registered by Sanofi-Aventis Hong Kong Limited, and is a prescription-only medicine. So far, the Department of Health (DH) has received one case of adverse drug reaction for alemtuzumab related to immune functions.
Related news on warning about rare but serious risks of stroke and blood vessel wall tears associated with Lemtrada (alemtuzumab) was released by the US Food and Drug Administration (FDA) and was posted on the Drug Office website on 30 November 2018. Letters to inform healthcare professionals for the warnings were issued on the same day; and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
In light of the above EMA’s announcement, letters to inform local healthcare professionals will also be issued. Since EMA’s review is on-going, DH will remain vigilant on the conclusion of the EMA review and any safety updates on alemtuzumab issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Saturday, April 13, 2019
Issued at HKT 12:15
|
| |
|
