Important Safety Information on COPAXONE (glatiramer acetate) and the Risk of Anaphylactic Reactions Which May Occur at Any Time Following Initiation of Treatment

COPAXONE (glatiramer acetate), a medication used in the treatment of ambulatory patients with relapsing remitting multiple sclerosis (RRMS), can cause anaphylactic reactions, which may be fatal and can occur at any time during treatment, from as early as after the first dose or even months, up to years, after initiation of treatment.  

 

Audience

Healthcare professionals including neurologists, emergency room physicians and staff, nurses, and pharmacists.  
 

Key messages

• Anaphylactic reactions may occur shortly following administration of COPAXONE (glatiramer acetate), from as early as after the first dose or even months, up to years, after initiation of treatment. Cases with a fatal outcome have been reported.
• Healthcare professionals are advised to:
  • Inform patients and/or caregivers about the signs and symptoms of anaphylactic reactions, which may overlap with those of an immediate post-injection reaction.
  • Instruct patients to seek immediate emergency medical care in the event of an anaphylactic reaction.
  • Instruct patients to discontinue treatment with COPAXONE (glatiramer acetate) if an anaphylactic reaction occurs.
• Health Canada has updated the Canadian Product Monograph (CPM) for COPAXONE (glatiramer acetate), including the Serious Warnings and Precautions Box, to include new information on the risk of anaphylaxis which can occur at any time following initiation of treatment.
   

Background

COPAXONE (glatiramer acetate) is indicated for the treatment of ambulatory patients with RRMS to decrease the frequency of clinical exacerbations and to reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.

Following a Health Canada review of all available data, it was determined that anaphylactic reactions can be associated with COPAXONE (glatiramer acetate) use, and that they may occur at any time during treatment, from as early as after the first dose or even months, up to years, after initiation of treatment. In most of the reported cases, anaphylaxis occurred within an hour of COPAXONE (glatiramer acetate) administration. At least 11 Canadian cases have been reported with no fatalities involved. Some cases required treatment with epinephrine and other appropriate medical treatment. Cases with a fatal outcome have been reported internationally.

Anaphylactic reactions following COPAXONE (glatiramer acetate) injection were reported to be uncommon in occurrence (≥0.1% to <1%).

The CPM for COPAXONE (glatiramer acetate) was updated to include new information regarding the risk of anaphylactic reactions, including anaphylaxis occurring at any time following initiation of treatment.
 

Information for consumers

COPAXONE (glatiramer acetate) is an injection used to treat patients with relapsing forms of multiple sclerosis.

Anaphylaxis (a serious, life-threatening allergic reaction) may happen shortly after receiving COPAXONE (glatiramer acetate) injection. This reaction may occur as early as after the first dose, or even months, up to years, after treatment initiation even if patients did not have an allergic reaction before.

Patients should stop taking COPAXONE (glatiramer acetate) and seek immediate medical help if they experience symptoms of an anaphylactic reaction. Symptoms generally appear within one hour of injection and may include:

• Sudden shortness of breath, wheezing or difficulty breathing
• Swelling of the eyelids, face, lips, mouth, tongue or throat
• Uncontrolled shaking
• Fainting or dizziness
• Trouble swallowing or speaking
• Widespread rash, hives
• Collapse

These symptoms can quickly progress to more serious symptoms and may be life-threatening.

Patients should not restart COPAXONE (glatiramer acetate) if they have experienced anaphylaxis unless another clear cause for anaphylaxis is identified.

Patients should be aware that the early symptoms of anaphylaxis can be similar to a common but different type of reaction known as immediate post-injection reaction.  Immediate post-injection reaction is a temporary reaction that occurs immediately after or within minutes following an injection of the medicine into the skin. This reaction goes away on its own, with no specific treatment and can occur with the first dose, or after doses administered months, or even years, after starting treatment. This immediate post-injection reaction typically includes at least 2 of the following symptoms:

• Flushing
• Chest pain
• Palpitations
• Anxiety
• Shortness of breath
• Hives

Patients should contact a healthcare professional if they have any of these immediate post-injection reaction symptoms, and stop taking more injections until their healthcare professional advises them to do so.

 

Information for healthcare professionals

Healthcare professionals should be aware that, although uncommon, COPAXONE (glatiramer acetate) can cause anaphylactic reactions, which may be fatal and can occur at any time during treatment, from as early as after the first dose, or even months, up to years, after initiation of treatment. Symptoms of anaphylactic reactions may be similar to and may overlap with those of common immediate post-injection reactions. Symptoms of immediate post-injection reactions such as flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction or urticaria typically occur within minutes after an injection and are generally transient, self-limited, and resolve without specific treatment within 30 minutes. Symptoms associated with anaphylactic reactions generally appear within one hour of injection and are typically more severe, worsen over time and require treatment.

Healthcare professionals are advised to:

• Educate patients on the signs and symptoms of anaphylaxis and immediate post-injection reactions.
• Instruct patients to seek immediate medical attention by going to an emergency room or calling 911 if they experience any symptoms of anaphylaxis, and to contact a healthcare professional if they experience an immediate post-injection reaction.
• Instruct patients to discontinue treatment with COPAXONE (glatiramer acetate) if an anaphylactic reaction occurs.
• Do not restart the medicine in patients who experience anaphylaxis unless a clear alternative etiology is identified.
   

Action taken by Health Canada

Health Canada, in collaboration with Teva Canada Innovation, updated the CPM for COPAXONE (glatiramer acetate) to include new information on the risk of anaphylaxis, which can occur at any time following initiation of therapy. The Department is also working with the manufacturers of other glatiramer acetate products to update their respective CPMs. Health Canada has worked with Teva Canada Innovation to prepare this alert. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system.

 

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving COPAXONE (glatiramer acetate) should be reported to Teva Canada Innovation or Health Canada.

Manufactured for:
Teva Canada Innovation
Montréal, Quebec H2Z 1S8
 

To correct your mailing address or fax number, contact Teva Canada Innovation

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax.

 

For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd-dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 1-800-465-7735

Original signed by

Didier Reymond, M.D.
Country Medical Director
Teva Canada Innovation