What is Glatiramer?

Glatiramer injection is used to treat relapsing-forms of multiple sclerosis (MS). This medicine will not cure multiple sclerosis, but may extend the time between relapses.

This medicine is available only with your doctor's prescription.

A nurse or other trained health professional will give you this medicine. It is given as a shot under your skin, usually in the hips, stomach, thighs, or upper arms. You or your caregiver may be trained to prepare and inject the medicine at home. Be sure that you understand how to use the medicine.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into skin areas that have scars or dents.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the injection:

• 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. It should be clear or colorless to slightly yellow. If the liquid is cloudy or has particles in it, do not use the syringe. Take out another syringe and follow the same steps for warming.
• 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.

The dose of this medicine 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 this medicine. 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 (solution):
  • For multiple sclerosis (MS):
    • Adults—20 milligrams (mg) injected under the skin once a day, or 40 mg injected under the skin 3 times per week (at least 48 hours apart).
    • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, 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.

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 this medicine to higher temperatures or bright or intense light.

Throw away used needles in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.

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 this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of glatiramer injection in the pediatric population. Safety and efficacy have not been established.

Appropriate studies on the relationship of age to the effects of glatiramer injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tofacitinib

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to mannitol—Should not be used in patients with this condition.

• Infection—May decrease your body's ability to fight infections.

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

Some patients have a reaction to this medicine a few minutes after receiving a shot. The symptoms might include: chest pain, flushing, 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.

This medicine may cause serious skin problems, including a permanent depression (dent) 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 this medicine without first checking with your doctor.