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|Copaxone

GLATIRAMER ACETATE (Systemic)

Some commonly used brand names are:

In the U.S.—

• Copaxone

Another commonly used name is copolymer-1 .

Category

• Multiple sclerosis (MS) agent

Description

Glatiramer acetate (gla-TIR-a-mer ASS-a-tate) is used in the treatment of the relapsing-remitting form of multiple sclerosis (MS). This medicine will not cure MS, but may extend the time between relapses.

This medicine is available only with your doctor"s prescription, in the following dosage form(s):

• Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For glatiramer acetate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to glatiramer acetate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Glatiramer acetate has not been studied in pregnant women. However, this medicine has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding—It is not known whether glatiramer acetate passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of glatiramer acetate in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of glatiramer acetate in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of glatiramer acetate. Make sure you tell your doctor if you have any other medical problems.

Proper Use of This Medicine

Use this medicine exactly as directed by your doctor in order to help your condition as much as possible.

Special patient directions come with glatiramer acetate injection. Read the directions carefully before using the medicine .

It is important to follow several steps to prepare your glatiramer acetate injection correctly. Before injecting the medication, you need to:

• Gather the items you will need on a clean cloth or towel in a well-lighted area.
• Wash your hands with soap and water. Do not touch your hair or skin afterwards.
• Remove the plastic cover from the glatiramer acetate vial and use an alcohol swab to wipe the rubber top. Do not touch the rubber top after it has been wiped.
• Remove the plastic cover from the diluent vial and use a fresh alcohol swab to wipe the rubber top. Do not touch the rubber top after it has been wiped.
• Let both rubber tops dry for a few seconds.

It is important that you do not touch the tops of the vials or the needles in order to keep everything sterile. Also, use only the diluent (sterile water) provided with the glatiramer acetate to dilute the medicine for injection.

To mix the water and the powder :

• Remove one 3-milliliter (3-mL) syringe from its protective wrapper. Make sure the needle is tightly in place by slightly twisting the plastic cover over the needle. Do not touch the needle itself.
• Hold the syringe in one hand and pull the plastic cover straight off the needle with the other hand. Do not touch the needle.
• Pull the plunger of the syringe back to draw 1.1 mL of air into the syringe. Insert the needle through the rubber top of the diluent (sterile water) vial while it is upright and push the plunger all the way in to inject 1.1 mL of air into the vial.
• Turn the vial upside down using one hand and make sure the tip of the needle is covered by solution. With your other hand, pull back the plunger to withdraw 1.1 mL of diluent into the syringe.
• Pull the syringe out of the vial, and place the vial on the clean surface.
• With the vial of glatiramer acetate still on the table, insert the needle of the syringe through the rubber top and slowly inject the diluent into the vial. The best way is to do this is to point the needle toward the inside wall of the vial, instead of injecting the diluent directly onto the cake of medicine. Remove the needle and syringe from the glatiramer acetate vial, and put the plastic cover back on the needle.
• Gently swirl the vial until all the medication dissolves. Do not shake the vial. Check the solution to make sure it is clear. Do not use the medicine if you can see anything solid in the solution or if the solution is cloudy. Let the vial sit and warm up for about 5 minutes.

To prepare the injection syringe:

• Remove one 1-mL syringe from its protective wrapper. Make sure the needle is tightly in place by slightly twisting the plastic cover over the needle. Remove the cover from the needle, but do not touch the needle itself.
• Pull the plunger back to the 1 mL mark.
• Insert the needle into the rubber top of the glatiramer acetate vial and push the plunger all the way in to inject the air.
• Then turn the vial upside down and slowly withdraw the solution into the syringe to the 1 mL mark. Make sure the tip of the needle is below the level of the solution.
• While still holding the vial and syringe upside down and the needle still in the vial, check the syringe for air bubbles.
• Tap the side of the syringe to make the air bubbles float to the top of the syringe.
• Inject the air back into the vial. You will probably need to draw a little more solution into the syringe to bring the level back to the 1 mL mark.
• Make sure your dose is correct by checking that the position of the plunger is at the 1 mL mark.
• Then remove the needle from the vial, put the plastic cover back on the needle, and place it on a clean surface.

To give yourself the injection:

Before you self-inject the glatiramer acetate dose, decide where you will inject yourself. There are seven injection sites on your body, and you should not use any site more than once each week. Marking a calendar will help you keep track of the sites you have used each day. Try to be consistent and give yourself the injection at the same time each day. Choose a time when you feel strongest.

• Clean the injection site with a fresh alcohol wipe, and let it dry.
• Pick up the 1-mL syringe you already filled with glatiramer acetate. Hold the syringe as you would a pencil, using the hand you write with. Remove the plastic cover from the needle, but do not touch the needle itself.
• Pinch about a 2-inch fold of skin between your thumb and index finger.
• Insert the needle into the 2-inch fold of skin. It may help to steady you hand by resting the heel of your hand against your body.
• When the needle is all the way in, release the fold of skin.
• Inject the medicine by holding the syringe steady while pushing down on the plunger. The injection should take just a few seconds.
• Pull the needle straight out.
• Press a dry clean cotton ball on the injection site for a few seconds, but do not massage it.
• Put the plastic cover back on the needle.

To dispose of needles and syringes:

Needles, syringes and vials should be used for only one injection. Place all used syringes, needles, and vials in a hard-walled plastic container , such as a liquid laundry detergent container. Keep the cover of this container tight and out of the reach of children. When the container is full, check with your physician or nurse about proper disposal, as laws vary from state to state.

Dosing—The dose of glatiramer acetate will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of glatiramer acetate. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection dosage form:
  • For multiple sclerosis (MS):
    • Adults—20 milligrams (mg) once a day, given subcutaneously (under the skin).
    • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from direct light.
• Store the vials of glatiramer acetate in the refrigerator. If refrigeration is not available, the vials may be kept for up to 1 week at room temperature, as long as the temperature does not go above 86 °F.
• Store the vials of diluent at room temperature, as long as the temperature does not go above 86 °F.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Do not stop using this medicine without first checking with your doctor .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The most commonly occurring side effects of glatiramer acetate are redness, pain, inflammation, itching, or a lump at the site of the injection. Some patients have reported a rare reaction that started immediately after the injection and consisted of flushing, chest tightness with racing or pounding heartbeat, anxiety, and difficulty in breathing. The symptoms of this reaction generally lasted approximately fifteen minutes and resolved without any further problems. However, if you inject glatiramer acetate and experience dizziness, hives and itching, sweating, chest pain, difficulty in breathing, or other uncomfortable changes in your general health, call your doctor immediately. If symptoms become severe, or you cannot reach your doctor, call 911 or the appropriate emergency phone number in your area for assistance.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 05/21/1998

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