Glatect (Glatiramer) belongs to a group of medications known as immunomodulators. Immunomodulators modify the way our body's defence system works. Glatect (Glatiramer) is used to treat the relapsing-remitting form of Multiple Sclerosis (MS). Glatect (Glatiramer) is also used to delay the onset of MS in people who have experienced a single flare-up of symptoms and have changes that suggest MS in their magnetic resonance imaging (MRI) scans.

MS is a disease that affects the way the nerves in our body work. It is an autoimmune disease (the immune system attacks the body) and cannot be spread from person to person. In MS, damage occurs to the myelin sheath, a protective layer that wraps around a nerve, like insulation around electrical wiring. Normally, this sheath allows electrical messages to be sent down the nerve quickly and efficiently. If this insulation is injured, electrical signals in the central nervous system will not be sent properly. For unknown reasons, in MS, the immune system sees the myelin as foreign and attacks it.

It is thought that Glatect (Glatiramer) works by altering the immune system to reduce its harmful effects on the myelin sheath. It does not cure MS, but it may decrease the frequency of relapses and reduce the number of damaged brain areas as seen on MRI scans.

Glatect (Glatiramer) may be available under multiple brand names and/or in several different forms. Any specific brand name of Glatect (Glatiramer) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Glatect (Glatiramer) may not be used for all of the conditions discussed here.

Your doctor may have suggested Glatect (Glatiramer) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given Glatect (Glatiramer), speak to your doctor. Do not stop using Glatect (Glatiramer) without consulting your doctor.

Do not give Glatect (Glatiramer) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use Glatect (Glatiramer) if their doctor has not prescribed it.

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The recommended dose of Glatect (Glatiramer) is 20 mg injected subcutaneously (under the skin) once a day.

Glatect (Glatiramer) is available as an injection only. It comes in single-use prefilled syringes.

There are special directions enclosed in the package with the injection. Read these directions carefully before using the medication. Follow the instructions closely to avoid accidentally contaminating the medication or needle and giving yourself an infection, or from damaging the equipment or losing the medication.

Glatect (Glatiramer) is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject Glatect (Glatiramer) on your own until you completely understand how to inject a dose.

Rotate the injection sites (arms, thighs, upper buttocks, or stomach) to minimize injection site skin irritation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take Glatect (Glatiramer) exactly as prescribed by your doctor. If you miss a dose, inject it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not inject a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the prefilled syringes in the refrigerator (2°C  to 8°C) and protect from light. The prefilled syringes may also be stored at room temperature for up to one month. Keep Glatect (Glatiramer) out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Glatect (Glatiramer). If you are concerned about side effects, discuss the risks and benefits of Glatect (Glatiramer) with your doctor.

The following side effects have been reported by at least 1% of people taking Glatect (Glatiramer). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• back pain
• Constipation
• flushing
• headache
• injection site reactions (e.g., bleeding, hard lump, Hives or welts, itching, pain, redness, or swelling)
• joint pain
• nausea
• neck pain
• a "dent" in the skin at injection site

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• anxiety
• breathing problems
• fast or racing heartbeat
• high blood pressure (e.g., headache, dizziness, blurred vision or shortness of breath)
• Low Blood Pressure (e.g., dizziness, fatigue, nausea)
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of infection, symptoms may include:
• Fever or chills
• headache
• listlessness
• prolonged dizziness
• severe Diarrhea
• shortness of breath
• stiff neck
• weight loss
• skin rash
• swelling of fingers, arms, feet, or legs
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

• chest pain
• chest tightness or wheezing
• irregular or pounding heartbeat
• swelling or puffiness of face
• signs of a serious allergic reaction, i.e.:
• abdominal cramps
• difficulty breathing
• nausea and vomiting
• swelling of the face and throat

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Glatect (Glatiramer).

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20 mg/mL
Each 1.0 mL prefilled syringe contains 20 mg of Glatect (Glatiramer). Nonmedicinal ingredients: mannitol and sterile water for injection.

Do not use Glatect (Glatiramer) if you are allergic to Glatect (Glatiramer) or any ingredients of the medication.

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There may be an interaction between Glatect (Glatiramer) and any of the following:

• bacillus Calmette-Guérin (BCG)
• Denosumab
• echinacea
• Fingolimod
• Leflunomide
• Natalizumab
• Pimecrolimus
• Roflumilast
• Tacrolimus
• Tofacitinib
• Trastuzumab
• vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Glatect (Glatiramer). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Glatect (Glatiramer).

Breathing problems: Glatect (Glatiramer) can cause shortness of breath and difficulty breathing, causing symptoms of lung disease to worsen. If you have COPD (Chronic Obstructive Pulmonary Disease), Asthma, or a history of severe allergic reactions, discuss with your doctor how Glatect (Glatiramer) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Glatect (Glatiramer), and whether any special monitoring is needed.

Cardiovascular effects: Glatect (Glatiramer) may have effects on the heart and circulatory (blood vessels) system. If you have heart disease, high blood pressure, and other diseases of the heart and blood system, discuss with your doctor how Glatect (Glatiramer) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Glatect (Glatiramer), and whether any special monitoring is needed.

Chronic progressive multiple sclerosis (MS): The safety and effectiveness of using Glatect (Glatiramer) by people with chronic progressive MS have not been established. Currently, Glatect (Glatiramer) is only recommended for people with the relapsing-remitting form of MS.

Immunosuppression (weak immune system): Glatect (Glatiramer) can modify the immune response and could interfere with useful immune function. If you have a suppressed or reduced immune system, discuss with your doctor how Glatect (Glatiramer) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Glatect (Glatiramer), and whether any special monitoring is needed.

Infections: Glatect (Glatiramer) may increase the risk of infections. If you notice any signs of an infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness, contact your doctor immediately.

Kidney Disease: Glatect (Glatiramer) has not been studied for use by people with reduced kidney function. If you have kidney problems, discuss with your doctor how Glatect (Glatiramer) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Glatect (Glatiramer), and whether any special monitoring is needed.

Post-injection reaction: Some people have a rare reaction that starts immediately after the injection and consists of flushing, chest tightness with racing or pounding heartbeat, anxiety, and difficulty breathing. The symptoms of this reaction usually last about 15 minutes and go away without further problems. Nevertheless, if you experience any dizziness, hives and itching, sweating, chest pain, or difficulty breathing, you should contact a doctor right away.

Vaccination: Glatect (Glatiramer) can modify the immune response and could interfere with useful immune function. People receiving a vaccination should let their doctor know they are taking Glatect (Glatiramer).

Pregnancy: Glatect (Glatiramer) has not been adequately studied for use by pregnant women. Glatect (Glatiramer) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Glatect (Glatiramer), contact your doctor immediately.

Breast-feeding: It is not known if Glatect (Glatiramer) passes into breast milk. If you are a breast-feeding mother and are taking Glatect (Glatiramer), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Glatect (Glatiramer) have not been established for children and adolescents under 18 years old.

Seniors: The safety and effectiveness of using Glatect (Glatiramer) have not been established for people over 65 years of age.

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