Copaxone

DRUG DESCRIPTION

COPAXONE is the brand name for glatiramer acetate (formerly known as copolymer-1). Glatiramer acetate, the active ingredient of COPAXONE (glatiramer acetate) , consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 9,000 daltons. Glatiramer acetate is identified by specific antibodies.

Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:

(Glu, Ala, Lys, Tyr)xxCH3COOH
(C5H9NO4C3H7NO2C6H14N2O2C9H11NO3)xxC2H4O2
CAS - 147245-92-9

COPAXONE (glatiramer acetate) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of solution contains 20 mg of glatiramer acetate and 40 mg of mannitol. The pH range of the solution is approximately 5.5 to 7.0. The biological activity of COPAXONE (glatiramer acetate) is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.

What are the possible side effects of glatiramer (Copaxone)?

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...

Read All Potential Side Effects and See Pictures of Copaxone

What are the precautions when taking glatiramer acetate (Copaxone)?

Before using glatiramer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chest pain, heart attack).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Copaxone


Copaxone Consumer (continued)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, soreness, and swelling) may occur. Nausea, chills, joint aches, neck pain, or headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Immediately after injection, you may experience flushing, chest pain, fast heartbeat, anxiety, shortness of breath, or itching. This injection reaction usually starts to occur after you have used the drug for a few months but can occur after any injection. These symptoms disappear fairly quickly and usually do not require treatment. If these symptoms do not go away in a few minutes, seek immediate medical attention. Tell your doctor immediately about this reaction before your next injection. Ask your doctor if you should continue using this medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness/fainting, infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., depression), severe pain at the injection site, shakiness (tremor), swelling of the legs/feet (water retention), vision problems.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using glatiramer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chest pain, heart attack).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Copaxone Patient Information Including Side Effects

Brand Names: Copaxone

Generic Name: glatiramer (injection) (Pronunciation: gla TIR a mer)

  • What is glatiramer (Copaxone)?
  • What are the possible side effects of glatiramer (Copaxone)?
  • What is the most important information I should know about glatiramer (Copaxone)?
  • What should I discuss with my healthcare provider before using glatiramer (Copaxone)?
  • How should I use glatiramer (Copaxone)?
  • What happens if I miss a dose (Copaxone)?
  • What happens if I overdose (Copaxone)?
  • What should I avoid while using glatiramer (Copaxone)?
  • What other drugs will affect glatiramer (Copaxone)?
  • Where can I get more information?

What is glatiramer (Copaxone)?

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 are the possible side effects of glatiramer (Copaxone)?

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.

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

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.

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