Glatiramer Subcutaneous

In the U.S.

• Copaxone
• Glatopa

Available Dosage Forms:

• Solution
• Powder for Solution
• Kit

Therapeutic Class: Central Nervous System Agent

Glatiramer injection is used to reduce the frequency of relapses (flare-ups) in patients with relapsing-remitting multiple sclerosis (RMMS). glatiramer will not cure multiple sclerosis (MS), but may extend the time between relapses.

glatiramer is available only with your doctor's prescription.

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

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

glatiramer comes in two dosage strengths: 20 milligrams (mg) and 40 mg prefilled syringes. Your doctor will prescribe which dosage strength is right for you.

To use the injection:

Before you self-inject the glatiramer dose, decide where you will inject yourself. There are 7 possible injection sites on your body (eg, arms, thighs, hips, or lower abdomen or stomach area), 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. Also, do not inject the medicine in a part of the skin that is depressed.

• First, 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 one prefilled syringe from the carton in the refrigerator. Take the syringe out of the protective wrapper. Allow 20 minutes for the syringe to warm up to room temperature before injecting the medicine.
• Check the liquid in the prefilled syringe to see if it is cloudy or contains any particles. If the liquid is cloudy, do not use the syringe. Call the company at 1-800-887-8100 for help. Take out another syringe and follow the same steps for warming.
• If the liquid in the syringe is clear, place it on the clean, flat surface and wait for it to warm to room temperature.
• Choose an injection site on your body. Clean the injection site with a fresh alcohol wipe, and let it dry.
• Pick up the 1-milliliter prefilled syringe and hold it 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 your 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.
• Throw away any unused medicine.

To dispose of the needles and syringes:

Needles and syringes should be used for only one injection. Place all used syringes and needles 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 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. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For multiple sclerosis (MS):
    • Adults—20 milligrams (mg) injected under the skin once a day, or 40 mg injected under the skin three times per week (at least 48 hours apart).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of glatiramer, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also store glatiramer injection at room temperature for up to 1 month. Avoid exposing glatiramer to bright or intense light.

It is very important that your doctor check your progress at regular visits to make sure that glatiramer is working properly and to check for unwanted effects.

Some patients have a reaction to glatiramer a few minutes after receiving a shot. The symptoms might include: chest pain, flushing, a fast, irregular, or pounding heartbeat, anxiety, trouble breathing, a tight feeling in the throat, or hives. These symptoms will usually go away without treatment in a short time. Call your doctor right away if these symptoms become worse or do not go away. This reaction can happen even if you have used the medicine regularly for several months. Also, chest pain can occur by itself, but should not last more than a few minutes.

glatiramer may cause a permanent depression under the skin at the injection site. Contact your doctor right away if you notice any of these side effects at the injection site: depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin.

Do not stop using glatiramer without first checking with your doctor.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.