glatiramer (Subcutaneous route)

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

Commonly used brand name(s):

In the U.S.

• Copaxone

Available Dosage Forms:

• Solution
• Powder for Solution
• Kit

Therapeutic Class: Central Nervous System Agent

Uses For glatiramer

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.

Before Using glatiramer

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, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to glatiramer 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.

Pediatric

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.

Geriatric

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.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 glatiramer. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—May decrease your ability to fight infections.

Proper Use of glatiramer

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 the directions carefully before using the medicine.

To use the injection:

Before you self-inject the glatiramer dose, decide where you will inject yourself. There are seven possible injection sites on your body (e.g., 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.

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.
    • 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.

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 one month. Avoid exposing glatiramer to bright or intense light.

Precautions While Using glatiramer

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 with 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.

glatiramer Side Effects

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:

• Anxiety
• bleeding, hard lump, hives or welts, itching, pain, redness, or swelling at the place of injection
• chest pain
• cough
• excessive muscle tone
• fast, irregular, pounding, or racing heartbeat or pulse
• flushing
• joint pain
• lower back or side pain
• neck pain
• painful or difficult urination
• skin rash
• swelling or puffiness of the face
• swollen lymph glands
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• troubled breathing

• Agitation
• bloating or swelling
• chills
• confusion
• difficulty with swallowing
• fainting
• fever
• headache, severe and throbbing
• itching of the vagina or outside genitals
• muscle aches
• pain
• pain during sexual intercourse
• purple spots under the skin
• rapid weight gain
• 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
• swelling of the fingers, arms, feet, or legs
• swelling or puffiness of the face
• thick, white curd-like vaginal discharge without odor or with mild odor
• tightness in the chest or wheezing
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss

• Back pain
• 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
• high blood pressure
• irritation of the mouth and tongue (thrush)
• loss of appetite
• menstrual pain or changes
• muscle pain
• 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

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:

• Increased sweating
• lack or loss of strength
• nausea
• unusual tiredness or weakness
• vomiting

• Double vision
• runny nose
• seeing double
• weight gain

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.

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