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Glatiramer (Copaxone) - Patient Information

 

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Brand Name
  • "Copaxone"


What it is

  • Glatiramer acetate is a self-injectable medication consisting of 4 naturally occurring proteins, specifically: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. It was chemically designed to mimic myelin basic protein, which is involved with the activation of the immune system to attack the myelin that covers the neurons in the central nervous system. Copaxone“ is sometimes referred to as one of the “injectables” or “A, B, C therapy.”


What it does

  • In studies, glatiramer has been shown to decrease relapse rates in patients with relapsing-remitting multiple sclerosis. Some data suggest that it may slow the progression of multiple sclerosis, and offer a neuroprotective effect.


How it works

  • Although the mechanism is not completely understood, glatiramer is thought to work by modifying the way in which certain white blood cells, including T-helper cells and T-suppressor cells, react to myelin, which is one major target in multiple sclerosis. When administered to multiple sclerosis patients, glatiramer is presented to these T-cells, which induces a protective state that is normally present in non-multiple sclerosis patients.


How it’s given

  • Copaxone“ is available in cartons of 30 single-use prefilled syringes so it does not have to be prepared or drawn up ahead of time.

                    o Each syringe should only be used once and then discarded appropriately.

  • Dose: 20 mg every day
  • Copaxone“ is injected subcutaneously (under the skin)
  • A nurse or your physician should show you how to inject this medication.

                o You should review the Copaxone® injection patient information leaflet, which will be presented to you before you begin Copaxone“ therapy and with each refill.
                o Your first, self-administered dose should be done under the direct supervision of an appropriately qualified health care practitioner.

Storage

  • Prefilled Copaxone“ syringes should be kept in their original blister package and in the original carton, under refrigeration (36-46oF or 2-8oC).

            o You may store Copaxone“ in its original blister packages and in the original carton at room temperature (59-86oF or 15-30oC), for up to 30 days.
                    - Do not store Copaxone“ at room temperature for longer than 30 days and NEVER in the freezer.
            o Copaxone“ is sensitive to light, meaning that it will degrade with excessive exposure, so you should always protect the syringes from direct light until its time to inject it.
            o Do not use a syringe if the solution appears cloudy or you see that it contains particles. Return it to your pharmacy.

General Injection Information

Refer to the COPAXONE® INJECTION PATIENT INFORMATION Leaflet for more information. Shared Solutions™ at (800)-887-8100 has several educational materials that may also be helpful.

  • If storing Copaxone“ under refrigeration, remove the syringe from the refrigerator 20 minutes before you inject, allowing it to warm to room temperature.
  • Always wash and dry your hands before and after injecting.
  • Never inject into the same area on your body more than once a week.

                o Acceptable sites: stomach, right and left arm, right and left thigh, right and left hip.
                        - Chose a site that is at least 2 inches from the last site of injection.

  • Do not rub the injection site on the same day as you have injected yourself.
  • After the injection, dispose the used syringe into a hard-welled container.


Possible Side Effects

  • Redness, pain, swelling, itching, or a lump at the injection site
  • A permanent depression under the skin at the injection site may occur
  • Swelling of the lymph nodes in the neck, armpits or groin areas
  • Fluid retention, facial swelling, weight gain
  • Nausea, vomiting, shortness of breath, sweating
  • Tremor, muscle pain, neck pain, weakness
  • Anxiety, hand shakes
  • Low blood pressure – dizziness, heart beating fast when standup
  • Immediate Post-Injection Reaction (IPIR)

                o In approximately 10% of patients given Copaxone“ in trials, a post-injection reaction occurred, usually within minutes after injecting, and included flushing (feeling warmth and/or appearing red), chest tightness or pain with palpitations, anxiety and trouble breathing. Referred to as the Immediate Post-Injection Reaction (IPIR), symptoms lasted for only a few minutes and resolved without any treatment required. Generally, this reaction happens several months after starting the medication but may occur anytime. Most patients only have it once but it can happen several times. If you experience this after being on Copaxone“ for a while, it is important to try to relax, keep your head upright, and breathe slowly. If this reaction does not go away on its own or if you have symptoms of tongue or face swelling, or experience extreme trouble breathing, seek immediate medical attention. Either way, you should contact your physician describing the experience, and do not give yourself anymore injections until your physician tells you to begin again.

  • Chest pain

                o In trials, several patients experienced chest pain as a lone symptom that was not related to any other symptom as described above with the IPIR and did not necessarily occur immediately after injecting. It lasted only a few minutes and most episodes occurred after at least one month of therapy.

  • Increased risk of infection (theoretical, as this has not been observed or evaluated)


Tips

  • Do not stop taking this medication or change the dose or dosing schedule without speaking with your physician.

                o Always call your refills in to your pharmacy well before you are out of medication to avoid any disruption in therapy. Most mail order pharmacies require at least a week to confirm your prescription and ship the medication.

  • Taking this medication may make you more susceptible to infections so you should avoid contact with sick people and wash your hands often.
  • You should not use this medication if you are allergic to glatiramer or mannitol.
  • This medication should not be used if you are pregnant or breastfeeding.

                o Always use birth control to prevent pregnancy while on this medication and speak with your physician or pharmacist before breastfeeding while on this medication.
                        - For information about birth control options, speak with your physician or pharmacist.

When to contact your healthcare provider

  • If you think you have had an Immediate Post-Injection Reaction (IPIR) as described above. Do not give yourself any more injections until your physician tells you to begin again.
  • Severe injection site pain or severe pain anywhere
  • Painful lumps in the neck, groin or armpits
  • Chest tightness, trouble breathing, wheezing
  • Rash, hives or severe itching
  • Swelling of face, lips, tongue or throat
  • High fever, severe sore throat or any other signs of infection
  • Fast heartbeat, sweating, confusion
  • You should not become pregnant or breastfeed an infant while using this medication without discussing it with your physician first.

                    o Contact your physician if you are or if you think you may be or if you would like to become pregnant or breastfeed an infant.


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