Pronunciation:

gla-TIR-a-mer AS-e-tate

Brand Names:

• Copaxone
• Glatopa

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Glatiramer injection is used to treat relapsing-forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This medicine will not cure multiple sclerosis, but may extend the time between relapses.

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

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 this medicine, the following should be considered:

Allergies—

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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.

Other medical problems—

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.

• Liver disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

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. Do not inject this medicine into your veins.

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.

This medicine comes in a prefilled syringe. It may also be given using an autoinjector that is compatible with glatiramer. Do not use an autoinjector that is not meant to be used with this medicine. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medicine. Also, read all instructions carefully to make sure you know how to use your device.

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.

Dosing—

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.

Missed dose—

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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

Precautions While Using This Medicine:

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 have depressed or indented skin, blue-green to black skin discoloration, or pain, redness, or sloughing (peeling) of the skin at the injection site.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, liver failure, hepatitis with jaundice).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

Check with your doctor immediately if any of the following side effects occur:

More common

Anxiety

bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the injection site

chest pain

cough or hoarseness

excessive muscle tone

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

fever or chills

joint pain

lower back or side pain

neck pain

painful or difficult urination

redness of the face, neck, arms, and occasionally, upper chest

skin rash

swelling or puffiness of the face

swollen, painful, or tender lymph glands in the neck, armpit, or groin

trouble breathing

Less common

Agitation

bloating or swelling

chest tightness

confusion

difficulty with swallowing

feeling faint, dizzy, or lightheaded

headache, severe and throbbing

itching of the vagina or outside genitals

muscle aches or pain

pain during sexual intercourse

purple spots under the skin

red streaks on the skin

shakiness in the legs, arms, hands, or feet

small lumps under the skin

spasm of the throat

strong urge to urinate

sweating

swelling of the fingers, arms, feet, or legs

thick, white curd-like vaginal discharge without odor or with mild odor

tingling of the hands or feet

trembling or shaking of the hands or feet

unusual weight gain or loss

Rare

Blood in the urine

burning or stinging of the skin

continuous, uncontrolled back-and-forth or rolling eye movements

decreased sexual ability

diarrhea

difficulty with moving

ear pain

fast breathing

irritation of the mouth and tongue (thrush)

loss of appetite

menstrual pain or changes

painful cold sores or blisters on the lips, nose, eyes, or genitals

sensation of motion, usually whirling, either of oneself or of one's surroundings

speech problems

vision problems

Incidence not known

Abnormal vaginal bleeding or discharge

back pain, sudden and severe

bleeding gums

blindness

blurred or decreased vision

chest discomfort or heaviness

clear or bloody discharge from the nipple

cloudy urine

coughing up blood

dark urine

decreased urine output

difficult or frequent urination

dilated neck veins

dimpling of the breast skin

drowsiness

extreme tiredness or weakness

eye pain

gaseous stomach pain

general feeling of discomfort or illness

general tiredness and weakness

hair loss

headache

heartburn

increased menstrual flow or vaginal bleeding

indigestion

inverted nipple

joint swelling

large amount of cholesterol in the blood

light-colored stools

lump in the breast or under the arm

lump or swelling in the stomach

muscle weakness, sudden and progressing

nausea

nerve pain

nosebleed

pain or discomfort the in arms or jaw

paralysis

persistent crusting or scaling of the nipple

prolonged bleeding from cuts

puffiness or swelling of the eyelids or around the eyes, lips, or tongue

rapid, shallow breathing

recurrent fever

red or black, tarry stools

redness or swelling of the breast

seizures

sore on the skin of the breast that does not heal

sore throat

stiff neck or back

stomach bloating, burning, cramping, or pain

tearing

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Lack or loss of strength

stuffy or runny nose

Less common

Double vision

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.