Glatiramer acetate: also a risk of anaphylactic reactions long after starting treatment

News will | 08-15-2024 | 10:00

What is glatiramer acetate?

Glatiramer acetate is a medicine intended to treat ‘relapsing’ forms of the disease multiple sclerosis (MS). MS is a disease of the nervous system in which inflammation occurs that affects the nerves. In relapsing variants of the disease, periods of attacks and improvements alternate.

What’s going on?

Patients receive glatiramer acetate by injection under the skin. It is known that allergic reactions may occur after the injection (including rash, fainting). If an allergic reaction occurs, the patient must go to the hospital immediately. An anaphylactic reaction is a serious allergic reaction that can occur shortly after you are given glatiramer acetate.

Research in the European Union using all the data available worldwide on glatiramer acetate has shown that these anaphylactic reactions can also occur in patients who have been receiving glatiramer acetate for months or even years.

Allergic reactions must be distinguished from post-injection reactions which may include redness of the chest or face, shortness of breath, chest pain and rapid heartbeat. These reactions usually do not cause any problems and disappear after 30 minutes. If these last longer than 30 minutes, the patient must go to the hospital.

Advice for health care providers

• Inform patients and their caregivers about signs and symptoms of anaphylactic reactions;
• Advise them to seek emergency medical care immediately if an anaphylactic reaction occurs;
• Discontinue treatment with glatiramer acetate if an anaphylactic reaction occurs.

Advice for patients

• Be aware of the symptoms of an anaphylactic reaction. Consider:
  • widespread skin rash (red spots or hives);
  • swelling of the eyelids, face, lips, mouth, throat or tongue;
  • sudden shortness of breath, difficulty breathing or wheezing;
  • convulsions, difficulty swallowing or speaking;
  • fainting, feeling dizzy or faint; fall apart.

Some of these symptoms may overlap with those seen as post-injection reactions. These symptoms are also mentioned in section 4 of the package leaflet (‘Potential side effects’).

• If you have an anaphylactic reaction, call your doctor right away or go to the emergency room.

Risk information letter

Marketing authorization holders of glatiramer acetate medicines have sent a letter on this subject. This is called Direct Healthcare Professional Communication (DHPC). The letter with this important risk information has been sent in consultation with the MEB, the European Medicines Agency EMA and the Inspectorate for Healthcare and Youth (IGJ) to the following neurology departments and healthcare providers : neurologists, neurology nurses, general practitioners, emergency room doctors and (hospital) pharmacists.