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Glatiramer (Subcutaneous route)

Pronunciation:

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

Brand Names:

  • Copaxone

Dosage Forms:

  • Solution
  • Powder for Solution
  • Kit

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Glatiramer injection is used to reduce the frequency of relapses (flare-ups) in patients with relapsing-remitting multiple sclerosis (RMMS). This medicine will not cure multiple sclerosis (MS), 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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

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 injection. Read and follow the directions carefully before using the medicine.

This medicine 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 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:
    • 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 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.

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 bright or intense light.

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, 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.

This medicine 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 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.

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 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
Less common
Agitation
bloating or swelling
chills
confusion
difficulty with swallowing
feeling faint, dizzy, or lightheaded
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
sweating
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
tingling of the hands or feet
trembling or shaking of the hands or feet
unusual weight gain or loss
Rare
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
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:

More common
Headache
increased sweating
lack or loss of strength
nausea
sore throat
stuffy or runny nose
unusual tiredness or weakness
vomiting
Less common
Double vision
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.


Last Updated: 4/4/2014

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