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Indications and Clinical Use

Glatiramer Acetate Injection (glatiramer acetate) 20 mg/mL once daily is indicated for:

• Treatment of ambulatory patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a single demyelinating event and have lesions typical of multiple sclerosis on brain MRI:
  • To decrease the frequency of clinical exacerbations.
  • To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.

The safety and efficacy in chronic progressive MS have not been established.

Contraindications

• Hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

Most Serious Warnings and Precaution

Route of administration: the only recommended route of administration is the subcutaneous route; it should not be administered intravenously or intramuscularly.

General: Patients should be instructed on aseptic self-injection techniques for safe administration including part III Patient Medication Information; first injection should be performed under the supervision of an appropriately qualified healthcare professional; patient understanding and use of aseptic self-injection techniques and procedures periodically re-evaluated; patients cautioned against the re-use of needles, syringes or pens and instructed in safe disposal procedures, puncture-resistant container for disposal of used needles, syringes and pens should be used; patients instructed on safe disposal of containers.

Localized Adverse Reactions Associated with Subcutaneous Use: At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis; lipoatrophy may occur after treatment onset (sometimes several months) and may be permanent; to assist in possibly minimizing these events the patient should be advised to follow proper injection technique, rotate injection areas/sites on a regular basis.

Cardiovascular: Symptoms of potentially cardiac origin, transient chest pain; immediate post-injection reaction including at least two of the following: flushing, chest pain, palpitations, anxiety, dyspnea, constriction of the throat and urticaria.

Hepatic: Very rare severe liver injury, including liver failure, hepatitis with jaundice, and extremely rare cases of fulminant hepatitis leading to liver transplant, in patients with and without relevant risk factors in their medical history, occurred from days to years after initiating treatment, some cases suggestive of autoimmune hepatitis, most events resolved with discontinuation of treatment. Caution is recommended when considering treatment in patients who have pre-existing liver disease or who have experienced liver injury previously during treatment with other drugs, including other disease modifying therapies (DMTs) for treatment of multiple sclerosis or with concomitant (DILI) risk drugs. Prior to initiating treatment, serum aminotransferase, alkaline phosphate and total bilirubin levels should be obtained (within 6 months) for all patients. Patients should be monitored during treatment for signs of hepatic injury. Evaluation of transaminases is recommended during treatment, as clinically relevant. Patients should be advised to immediately report any signs or symptoms of hepatotoxicity. Discontinue treatment if clinically significant liver injury is suspected.

Immune: considerations involving the use of a product capable of modifying immune responses, antigenic substance and thus it is possible that detrimental host responses can occur with its use. Whether it can alter normal human immune responses, such as the recognition of foreign antigens is unknown. It is possible that treatment may undermine the body’s defenses against infections and tumor surveillance. Continued alteration of cellular immunity due to chronic treatment might result in untoward effects. Anaphylaxis can be associated with the administration of almost any foreign substance and, therefore, this risk cannot be excluded. Particular caution is advised in patients with a history of severe anaphylactoid reactions, obstructive pulmonary disease or asthma, nor in patients under treatment for either of these two latter conditions.

Monitoring and laboratory tests: patients with renal impairment should be monitored for their renal function while treated; liver transaminases should be checked within 6 months before initiating treatment and evaluation recommended during treatment as clinically relevant.

Pregnancy: should be used during pregnancy only when, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Breast-feeding: caution should be exercised when administered to a nursing woman.

Other Relevant Warnings and Precautions:

• Post-injection reaction: Flushing, dizziness, skin eruptions with irritation, sweating, chest pain, chest tightness, irregular heartbeat, anxiety, difficulty in breathing, tightness in the throat, hives appearing immediately after injection
• Low blood pressure: dizziness, fatigue, nausea
• High blood pressure: headache, dizziness, blurred vision, or shortness of breath
• Breathing problems: shortness of breath, difficulty breathing
• Heartbeat: fast heartbeat or skipping a beat
• Pain: pressure or tightness in the chest, back, neck or joint
• Angioedema: swelling of the arms, legs or face
• Depression: change in weight, difficulty sleeping, lack of interest in regular activities
• Vision: changes of vision

For More Information:

Consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for more information about conditions of clinical use, contraindications, warnings, precautions, adverse reactions, interactions, and dosing. The Product Monograph is also available by calling 1-844-596-9526.