"Oct. 5, 2011 -- People with multiple sclerosis (MS) may soon have a second needle-free option to control their disease.
Last year, the FDA approved the first disease-modifying pill, a drug called Gilenya, to treat MS.
- Patient Information:
Details with Side Effects
Read this information carefully before you use COPAXONE (glatiramer acetate) . Read the information you get when you refill your COPAXONE (glatiramer acetate) prescriptions because there may be new information. This information does not take the place of your doctor's advice. Ask your doctor or pharmacist if you do not understand some of this information or if you want to know more about this medicine.
What is COPAXONE (glatiramer acetate) ?
COPAXONE (glatiramer acetate) (co-PAX-own) is a medicine you inject to treat Relapsing-Remitting Multiple Sclerosis. Although COPAXONE (glatiramer acetate) is not a cure; patients treated with COPAXONE (glatiramer acetate) have fewer relapses.
Who should not use COPAXONE (glatiramer acetate) ?
- Do not use COPAXONE if you are allergic to glatiramer acetate or mannitol.
What are the possible side effects of COPAXONE (glatiramer acetate) ?
- Call your doctor right away if you develop any of the following symptoms: hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. Do not give yourself any more injections until your doctor tells you to begin again.
- The most common side effects of COPAXONE (glatiramer acetate) are redness, pain, swelling, itching, or a lump at the injection site. These reactions are usually mild and seldom require medical care.
- Some patients report a short-term reaction right after injecting COPAXONE (glatiramer acetate) . This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain with heart palpitations, anxiety, and trouble breathing. These symptoms generally appear within minutes after an injection, last a few minutes, and then go away by themselves without further problems.
- A permanent depression under the skin at the injection site may occur, due to a local destruction of fat tissue.
- If symptoms become severe, call the emergency phone number in your area. Do not give yourself any more injections until your doctor tells you to begin again.
These are not all the possible side effects of COPAXONE (glatiramer acetate) . For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects you have while taking COPAXONE (glatiramer acetate) .
Information for pregnant and nursing women
- COPAXONE (glatiramer acetate) has not been studied in pregnant women. Talk to your doctor about the risks and benefits of COPAXONE (glatiramer acetate) if you are pregnant or planning a pregnancy.
- It is not known if COPAXONE (glatiramer acetate) passes into breastmilk. Talk to your baby's doctor about the risks and benefits of breastfeeding while using COPAXONE (glatiramer acetate) .
How should I use COPAXONE (glatiramer acetate) ?
- The recommended dose of COPAXONE (glatiramer acetate) for the treatment of Relapsing-Remitting of Multiple Sclerosis is 20 mg once a day injected subcutaneously (in the fatty layer under the skin).
- Look at the medicine in the prefilled syringe. If the medicine is cloudy or has particles in it, do not use it. Instead, call Shared Solutions® at 1-800-887-8100 for assistance.
- Have a friend or relative with you if you need help, especially when you first start giving yourself injections.
- Each prefilled syringe should be used for only one injection. Do not reuse the prefilled syringe. After use, throw it away properly.
- Do not change the dose or dosing schedule or stop taking the medicine without talking with your doctor.
How do I inject COPAXONE (glatiramer acetate) ?
There are 3 basic steps for injecting COPAXONE (glatiramer acetate) prefilled syringes:
- Gather the materials.
- Choose the injection site.
- Give yourself the injection.
Step 1: Gather the materials
- First, place each of the items you will need on a clean, flat surface in
a well-lit area:
- 1 blister pack with COPAXONE (glatiramer acetate) Prefilled Syringe
Remove only 1 blister pack from the COPAXONE (glatiramer acetate) Prefilled Syringe carton.
Keep all unused syringes in the Prefilled Syringe carton and store them in the refrigerator.
- Alcohol prep (wipe)
- Dry cotton ball (not supplied)
- 1 blister pack with COPAXONE (glatiramer acetate) Prefilled Syringe
- Let the blister pack with the syringe inside warm up to room temperature for 20 minutes.
- To prevent infection, wash and dry your hands. Do not touch your hair or skin after washing.
- There may be small air bubbles in the syringe. To avoid loss of medicine when using COPAXONE (glatiramer acetate) prefilled syringes, do not expel (or do not attempt to expel) the air bubble from the syringe before injecting the medicine.
Step 2: Choose the injection site
- There are 7 possible injection areas on your body: arms, thighs, hips and lower stomach area (abdomen) (See Figure 1).
- Each day, pick a different injection area from one of the 7 areas. Do not inject in the same area more than once a week.
- Within each injection area there are multiple injection sites. Have a plan for rotating your injection sites. Keep a record of your injection sites, so you know where you have injected.
- There are some sites in your body that may be hard to reach for self-injection (like the back of your arm), and you may need help.
- Do not inject in sites where skin depression has occurred, because further injections in these sites may make the depression deeper.
Step 3: Give yourself the injection
- Remove the syringe from its protective blister pack by peeling back the paper label. Before use, look at the liquid in the syringe. If it is cloudy or contains any particles, do not use it and call Shared Solutions® at 1-800-887-8100 for assistance. If the liquid is clear, place the syringe on the clean, flat surface.
- Choose an injection site on your body. Clean the injection site with a new alcohol prep and let the site air dry to reduce stinging.
- Pick up the syringe as you would a pencil. Remove the needle shield from the needle.
- With your other hand, pinch about a 2-inch fold of skin between your thumb and index finger (See Figure 2).
- Insert the needle at a 90-degree angle (straight in), resting the heel of your hand against your body. When the needle is all the way in release the fold of skin (See Figure 3).
- To inject the medicine, hold the syringe steady and push down the plunger.
- When you have injected all of the medicine, pull the needle straight out.
- Press a dry cotton ball on the injection site for a few seconds. Do not rub the injection site.
- Throw away the syringe in a safe hard-walled plastic container.
What is the proper use and disposal of prefilled syringes?
Each prefilled syringe should be used for only 1 injection. Throw away all used prefilled syringes in a hard-walled plastic container, such as an empty liquid laundry detergent bottle. Keep the container closed tightly and out of the reach of children. When the container is full, check with your doctor, pharmacist, or nurse about proper disposal, as laws vary from state to state.
How should I store COPAXONE (glatiramer acetate) prefilled syringes?
Keep the COPAXONE (glatiramer acetate) prefilled syringe carton in the refrigerator, out of the reach of children.
The COPAXONE (glatiramer acetate) package should be refrigerated at 36-46°F (2-8°C). You can store it at room temperature, 59-86°F (15-30°C), for up to one month. Do not store
COPAXONE (glatiramer acetate) at room temperature for longer than one month. Do not freeze COPAXONE (glatiramer acetate) . If a COPAXONE (glatiramer acetate) prefilled syringe freezes, throw it away in a proper container.
COPAXONE (glatiramer acetate) is light sensitive. Protect it from light when not injecting. Do not use the prefilled syringe if the solution contains particles or is cloudy.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use COPAXONE (glatiramer acetate) for a condition for which it was not prescribed. Do not give COPAXONE (glatiramer acetate) to other people, even if they have the same condition you have. It may harm them.
This leaflet summarizes the most important information about COPAXONE (glatiramer acetate) . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about COPAXONE (glatiramer acetate) that is written for health professionals. Also, you can call Shared Solutions® for any questions about COPAXONE (glatiramer acetate) and its use. The phone number for Shared Solutions® is 1-800-887-8100.
Last reviewed on RxList: 4/15/2009
This monograph has been modified to include the generic and brand name in many instances.
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