Glatiramer acetate (COPAXONE)

1. Health Canada Product Monograph — Glatiramer acetate

• Glatiramer acetate is used to treat ambulatory patients with relapsing-remitting multiple sclerosis (RRMS), including those who have had a single demyelinating event with MRI findings typical of MS.
• Glatiramer acetate reduces the frequency of MS relapses and reduces the number and size of active brain lesions seen on MRI.
• Glatiramer acetate has not been shown to be effective for chronic progressive forms of MS.

• There are no adequate, well-controlled studies of glatiramer acetate in pregnant women.
• Animal studies have not shown evidence of harm to reproduction or the developing fetus.
• Follow-up data on more than 2,000 pregnancies exposed to glatiramer acetate found rates of pregnancy loss and birth defects similar to the general population.
• Because well-controlled human studies are lacking, glatiramer acetate should be used during pregnancy only if clearly needed, weighing the potential benefits against any possible risks.

• It is not known whether glatiramer acetate passes into human breast milk.
• Caution is advised when using glatiramer acetate while breastfeeding, since many drugs do pass into breast milk.
• Animal studies did not show effects on the growth or development of nursing offspring.

• No data are available on the use of glatiramer acetate in patients 65 years of age and older, so Health Canada has not authorized an indication for use in this age group.

• No data are available on the use of glatiramer acetate in patients under 18 years of age, so Health Canada has not authorized an indication for pediatric use.

• COPAXONE 20 mg/mL is injected under the skin once per day.
• COPAXONE 40 mg/mL is injected under the skin three times per week, with injections spaced at least 48 hours apart.
• The 20 mg/mL and 40 mg/mL strengths are not interchangeable; only one regimen should be used at a time.
• The first injection should be given under the supervision of a qualified healthcare professional, with subsequent injections self-administered after proper training in aseptic injection technique.
• Injection sites should be rotated regularly to help reduce the risk of skin reactions, including tissue breakdown (lipoatrophy) at the injection site.
• COPAXONE must only be given by subcutaneous injection; it should never be given into a vein or muscle.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Cases of overdose with glatiramer acetate, involving doses up to several times the usual daily amount, have been reported without any adverse reactions beyond those already known to occur with normal use.
• In case of overdose, patients should be monitored and given appropriate supportive and symptom-based treatment.

• Redness at the injection site is very common.
• Pain at the injection site is very common.
• A lump or mass at the injection site is common.
• Itching at the injection site is common.
• Swelling at the injection site is common.
• Weakness or lack of energy (asthenia) may occur.
• Flushing or feeling hot (vasodilatation) may occur.
• Skin rash may occur.
• Shortness of breath (dyspnea) may occur.
• Nausea may occur.
• Headache may occur.
• Back pain or joint pain may occur.
• Anxiety or depression may occur.
• Swollen lymph nodes may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Life-threatening and fatal anaphylactic (severe allergic) reactions have occurred with glatiramer acetate, sometimes years after starting treatment.
• An immediate post-injection reaction can occur, involving at least two of the following: flushing, chest pain, heart palpitations, anxiety, shortness of breath, throat tightness, or hives.
• Transient chest pain, sometimes unrelated to the immediate post-injection reaction, has been reported.
• Very rare cases of severe liver injury, including liver failure and fulminant hepatitis requiring liver transplant, have been reported.
• Permanent loss of fatty tissue at injection sites (lipoatrophy) can occur, and there is no known treatment for it once it develops.
• Rarely, skin death (necrosis) at the injection site has been reported.
• A life-threatening case of serum sickness has been reported.
• Seek emergency medical attention immediately for facial or throat swelling, difficulty breathing, chest pain, or a widespread allergic reaction, even if these symptoms overlap with a typical post-injection reaction.

• Use with caution in patients with a history of severe allergic reactions, asthma, or other obstructive lung disease, as COPAXONE has not been studied in these groups.
• Use with caution in patients with pre-existing liver disease or a history of liver injury from other MS therapies; liver enzyme tests should be checked before starting and periodically during treatment.
• Use with caution in patients with kidney impairment, and monitor kidney function during treatment.
• Use with caution regarding injection technique and site rotation to reduce the risk of lipoatrophy and injection-site skin breakdown.
• Patients should be monitored for the first dose and made aware that immediate post-injection symptoms can resemble anaphylaxis, requiring prompt medical evaluation.

• Contraindicated in patients with known hypersensitivity to glatiramer acetate or to any ingredient in the formulation.
• Contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis; treatment must be permanently stopped after such a reaction unless a clear alternative cause is identified.

• Interactions between glatiramer acetate and other drugs have not been fully studied.
• No significant interactions have been identified with medications commonly used in multiple sclerosis, including short courses of corticosteroids used for up to 28 days.

• Glatiramer acetate is given by injection under the skin, so food does not affect how it works.

• COPAXONE injections can be given at any convenient time of day; for the 20 mg/mL strength, avoid giving two injections within the same 12-hour period, and for the 40 mg/mL strength, keep injections at least 48 hours apart.

• Store COPAXONE pre-filled syringes and pens in the refrigerator, between 2°C and 8°C; do not freeze.
• If refrigeration is not available, COPAXONE may be stored at room temperature, between 15°C and 30°C, for up to 1 month.
• Protect COPAXONE from light when not being used for an injection.

• Learn and follow proper injection technique, and rotate injection sites regularly to help prevent skin problems.
• Know the signs of a serious allergic reaction, such as swelling of the face or throat, chest tightness, or trouble breathing, and seek emergency care right away if they occur.
• Some symptoms right after an injection, such as flushing or chest tightness, are common and usually pass on their own, but tell your healthcare professional about them.
• Keep all appointments for liver function and other monitoring tests.
• Tell your doctor right away if you become pregnant while using this medication.
• Dispose of used syringes and pens safely in a puncture-resistant sharps container.