[ad_1]
New blood pressure, lungs, and liver of patients with relapsing-remitting multiple sclerosis (MS) who are taking alemtuzumabLemtrada, Genzyme) The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is in the process of being reviewed.
In addition to the restrictions, PRAC has recommended an update of the product information for patients with immune-mediated conditions, including autoimmune hepatitis and hemophagocytic lymphohistiocytosis; with heart attack, stroke, and cervicocephalic arterial dissection; and severe neutropenia.
Last year, the US Food and Drug Administration warns about the potential for "rare but serious" cases of ischemic and hemorrhagic stroke and cervicocephalic arterial dissection badociated with alemtuzumab therapy, as reported by Medscape Medical News.
For now, the EMA advises that treatment with alemtuzumab only be initiated in adults with relapsing-remitting that is highly active in other diseases-modifying therapies or in those who can not take other disease-modifying therapies.
For patients currently receiving alemtuzumab, vital signs should be monitored before and during intravenous infusion. Clinically significant changes are observed, discontinuation of infusion and additional monitoring, including ECG, should be considered, the EMA said.
Liver function tests before and during treatment are also advised. Evidence of liver damage, unexplained elevations in liver enzyme levels, or suggestive symptoms of hepatic dysfunction, the drug should only be readministered after careful consideration.
"Patients who develop signs of pathological immune activation should be badessed immediately, and have a diagnosis of hemophagocytic lymphohistiocytosis." Symptoms of immune activation may occur up to 4 years after the start of treatment, "the EMA said.
Patients being treated with alemtuzumab who are benefiting from it may be treated with their physician, the PRAC said.
The committee will provide further information of their reviews of alemtuzumab is finished.
For more Medscape Neurology news, join us on Facebook and Twitter
[ad_2]
Source link
