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Glatiramer

 
  Generic Name: Glatiramer (injection) (gla TIR a mer)
 
  Brand Names: Copaxone  
     
   
 

What is glatiramer?

Glatiramer is a combination of four amino acids (proteins) that affect the immune system.

Glatiramer is used to treat multiple sclerosis (MS) and to prevent relapse of MS.

This medication will not cure MS, but it can make relapses occur less often.

Glatiramer may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about glatiramer?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Glatiramer is given as an injection under your skin. You may be given instructions on how to inject your medicine at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.

Do not stop using glatiramer without first talking with your doctor.

Glatiramer vials and prefilled syringes are for a single use only. Throw away the vial or syringe after each injection.

Store the prefilled syringes and vials (bottles) of glatiramer in the refrigerator. Do not allow the medicine to freeze. You may also store glatiramer at room temperature, away from moisture, light, and high heat. Glatiramer will keep for up to 30 days if stored at room temperature. Throw away any unused glatiramer that has been at room temperature for longer than 30 days. Some people receiving a glatiramer injection have had a severe reaction. Tell your caregiver right away if you feel anxious, warm, itchy, tingly, or have a pounding heartbeat, tightness in your throat, or trouble breathing during the injection. This type of reaction may occur even after you have been using glatiramer for several months.

What should I discuss with my healthcare provider before using glatiramer?

Do not use this medication if you are allergic to glatiramer or to mannitol.

Before using glatiramer, tell your doctor if you are allergic to any drugs, or if you have any other illness or if you take any other medicines. You may not be able to use glatiramer, or you may require a dosage adjustment or special monitoring during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether glatiramer passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use glatiramer?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Glatiramer is given as an injection under the skin of your thigh, hip, upper arm, or stomach. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Wash and dry your hands before preparing the syringe and giving the injection.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

The powder form of glatiramer must be mixed in a syringe with the liquid (diluent) that comes with the medicine. Gently swirl this mixture and let it stand at room temperature until the powder is completely dissolved. Then use the injection right away. Do not save it for later use.

Use a different place on your body each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject glatiramer into the same place two times within 1 week.

Do not stop using glatiramer without first talking with your doctor.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Glatiramer vials and prefilled syringes are for a single use only. Throw away the vial or syringe after each injection.

Store the prefilled syringes and vials (bottles) of glatiramer in the refrigerator. Do not allow the medicine to freeze.

Before using the prefilled syringe, take it out of the refrigerator and let it warm at room temperature for 20 minutes. Do not warm the medication in a microwave or hot water. Do not remove air bubbles from the prefilled syringe or you may accidentally remove a small amount of the medicine.

You may also store glatiramer at room temperature, away from moisture, light, and high heat. Glatiramer will keep for up to 30 days if stored at room temperature. Throw away any unused glatiramer that has been at room temperature for longer than 30 days.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a glatiramer overdose are not known.

What should I avoid while using glatiramer?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using glatiramer.

Glatiramer side effects

Some people receiving a glatiramer injection have had a severe reaction. Tell your caregiver right away if you feel anxious, warm, itchy, tingly, or have a pounding heartbeat, tightness in your throat, or trouble breathing during the injection. This type of reaction may occur even after you have been using glatiramer for several months. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

  • chest pain;

  • fast heart rate;

  • fever, chills, body aches, flu symptoms; or

  • severe pain where the injection is given.

Less serious side effects include:

  • redness, minor pain, swelling, irritation, or a hard lump where the injection was given;

  • warmth, redness, or tingly feeling under the skin;

  • weakness, dizziness;

  • white patches or sores inside your mouth or on your lips;

  • joint pain;

  • nausea, diarrhea;

  • muscle tension or stiffness;

  • runny nose;

  • changes in your menstrual periods; or

  • increased urge to urinate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Glatiramer Dosing Information

Usual Adult Dose for Multiple Sclerosis:

For reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis:

20 mg subcutaneously once a day.

What other drugs will affect glatiramer?

There may be other drugs that can affect glatiramer. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about glatiramer.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with other, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.03. Revision Date: 08/05/2009 8:39:37 AM.;
 
 
 
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