Posted by: Thixia | April 11, 2008

Copaxone

Brand Name

 

Glatiramer Acetate (Subcutaneous Route)
 

Common Name

 

Copaxone

 

Description

 

Glatiramer acetate is used in the treatment of the relapsing-remitting form of multiple sclerosis (MS). This medicine will not cure MS, but may extend the time between relapses.

 

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

 

This product is available in the following dosage forms:

Pre-filled syringes.

 

 

How does this medication work? What will it do for me?

 

Glatiramer belongs to a group of medications known as immunomodulators. Immunomodulators modify the way our body’s defense system works. Glatiramer is used to treat the relapsing-remitting form of multiple sclerosis (MS). MS is a disease that affects the way the nerves in our body work. It is an autoimmune disease (the immune system attacks the body), and cannot be spread from person to person.

 

In MS, damage occurs to the myelin sheath, a protective layer that wraps around a nerve, like insulation around electrical wiring. Normally, this sheath allows electrical messages to be sent down the nerve quickly and efficiently. If this insulation is injured, electrical signals in the central nervous system will not be sent properly. For unknown reasons, in MS, the immune system sees the myelin as foreign and attacks it.

 

Glatiramer is thought to help treat multiple sclerosis by altering the immune system in such a way that its harmful effects on the myelin sheath are reduced. It does not cure MS, but it may increase the time between relapses of the disease.

 

Your doctor may have suggested this medication for conditions other than the ones listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

 

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Before Using

 

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.

How should I use this medication?

 

The recommended dose of glatiramer is 20 mg injected under the skin once a day. Glatiramer is available as an injection only. It comes in vials and pre-filled syringes.

 

There are special directions enclosed in the package with the injection. Read these directions carefully before using the medication and follow them closely. If you fail to follow the instructions closely, you may accidentally contaminate the medication or needle and give yourself an infection, or you may damage the equipment or lose the medication.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

 

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as you remember. If you do not remember until the following day, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

 

Store the vials and prefilled syringes in the fridge and protect them from light. The vials contain a powder form of the medication, and come with a separate vial of sterile water to mix with the powder to form the solution for injection. Store the sterile water vials at room temperature. The vials may also be stored at room temperature for up to 2 weeks, and the prefilled syringes at room temperature for up to one week. Each prefilled syringe is for single use only.

Keep this medication out of the reach of children.

What form(s) does this medication come in?

 

Each prefilled syringe contains a sterile solution equivalent with the glatiramer acetate reconstituted solution i.e., 20 mg/mL glatiramer acetate and mannitol 40 mg in Sterile Water for Injection.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take this medication?

Glatiramer should not be taken by anyone who is allergic to any of the ingredients of the medication.

What side effects are possible with this medication?

 

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

 

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

 

The most common side effects of glatiramer occur at the site of injection and may include:

 

·    redness

·    pain

·    swelling

·    itching

·    a lump

 

Some people have a rare reaction that starts immediately after the injection and consists of flushing, chest tightness with racing or pounding heartbeat, anxiety, and difficulty breathing. The symptoms of this reaction usually last about 15 minutes and go away without further problems. Nevertheless, if you experience any dizziness, hives and itching, sweating, chest pain, or difficulty breathing, you should contact a doctor right away.

 

The following side effects may go away as your body becomes used to the medicine; check with your doctor if they continue or become bothersome.

 

More common:

 

·    increased sweating

·    nausea

·    trembling

·    unusual tiredness or weakness

·    vomiting

·    Less common:

·    runny nose

·    weight gain

·    Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

·     

Check with your doctor as soon as possible 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

·    excessive muscle tone

·    flushing

·    irregular or pounding heartbeat

·    joint pain

·    neck pain

·    swelling or puffiness of face

·    swollen lymph glands

·    troubled breathing

·    vaginal yeast infection

·    Less common:

·    agitation

·    bloating or swelling

·    chills

·    confusion

·    fainting

·    fever

·    infections

·    migraine

·    muscle aches

·    pain

·    purple spots under the skin

·    skin rash

·    small lumps under the skin

·    spasm of throat

·    strong urge to urinate

·    swelling of fingers, arms, feet, or legs

·    tightness in chest or wheezing

 

Rare:

 

·    back pain

·    blood in urine

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

·    decreased sexual ability

·    diarrhea

·    ear pain

·    fast breathing

·    fast or racing heartbeat

·    high blood pressure

·    irritation of mouth and tongue (thrush)

·    loss of appetite

·    menstrual pain or changes

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

·    speech problems

·    vision problems

 

 

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

 

Reduced kidney function: Glatiramer has not been studied for use by people with reduced kidney function.

 

Vaccination: Glatiramer can modify the immune response and could interfere with useful immune function. People taking this medication should be cautious when receiving a vaccination.

Immunosuppression (weak immune system): Glatiramer can modify the immune response and could interfere with useful immune function. People with a suppressed or reduced immune system should use caution when taking this medication.

 

Pregnancy

 

 

 

Pregnancy Category

Explanation

All Trimesters

B

Animal 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.

 

 

Breastfeeding

 

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.

 

Children and adolescents:

 

The safety and effectiveness of using this medication have not been established for children and adolescents under 18 years old.

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of glatiramer acetate in children with use in other age groups.

 

Geriatric

 

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of glatiramer acetate in the elderly with use in other age groups.

 

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Responses

  1. I did feel embarrased before but I need to get rid of it, and I did. I feel much confident now.


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