Generic Name: Glatiramer Acetate

Active ingredient: Glatiramer Acetate

Description:

Injection is a clear, colorless to slightly yellow, sterile, non-pyrogenic solution for subcutaneous injection. Each 1.0 mL of solution contains 20 mg of glatiramer acetate and 40 mg of mannitol, USP. The pH range of the solution is approximately 5.5 to 7.0.

Indication Usage:
Glatiramer is used to reduce episodes of symptoms in patients with relapsing-remitting multiple sclerosis. Glatiramer is in a class of medications called immunomodulators. It works by stopping the body from damaging its own nerve cells (myelin).

Clinical pharmacology:

Mechanism of Action:The mechanism(s) by which glatiramer acetate exerts its effects in patients with Multiple Sclerosis (MS) is (are) unknown.

Glatiramer acetate is thought to act, however, by modifying immune processes that are currently held to be responsible for the pathogensis of MS. This view of glatiramer acetate derive from knowledge that it reduces the incidence and severity of experimental allergic encephalomyelitise (EAE) - a condition induced in several animal species through immunization against CNS derived material containing myelin and often used as an experimental animal model of MS.

Because glatiramer acetate can modify immune function, concerns exist about its potential to alter naturally occurring immune responses. Results of a limited battery of tests designed to evaluate the risk produced no finding of concern; nevertheless, there is no logical way to absolutely exclude this possibility

Drug interaction:

Glatiramer significantly reduces the frequency of relapses in those who have relapsing-remitting MS. It also slows the number of new lesions (tissue damage) as seen on MRI and decreases disability.

Glatiramer doesn't cause the flu-like symptoms that interferon medicines can cause.

Glatiramer has not been shown to be effective for people who have secondary progressive MS. Also, the medicine is not helpful for people who have primary progressive MS.

Precautions:

• Check medicines with healthcare provider. This medicine may not mix well with other medicines.

• Tell healthcare provider if you are pregnant or plan on getting pregnant.

• Tell healthcare provider if you are breast-feeding.

Side Effects:
Some people may have temporary side effects right after the shot (post-injection reaction), which can include:

• Pain, redness, or swelling at the injection site.
• Flushing.
• Chest pain, rapid heartbeat, and shortness of breath similar to that experienced in a heart attack.
• Anxiety.
• Tightness in the throat.

These side effects are usually mild and go away on their own shortly after the injection. You may have one or several brief episodes of these side effects during your treatment with glatiramer.

Although less common, other side effects may occur, including:

• Weakness.
• Nausea.
• Joint pain.
• Severe muscle tension or spasticity.
• Skin rash.
• Impotence or decreased interest in sex.

Over dosage: If you think you have taken too much of this medicine contact a poison control centre or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

Warning:

• If you have an allergy to glatiramer acetate or any other part of this medicine.

• Tell healthcare provider if you are allergic to any medicine. Make sure to tell about the allergy and how it affected you. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.

Dosage and Administration:

Adults Subcutaneous 20 mg every day
General Advice

• For subcutaneous administration only. Not for intradermal, IM, IV, or intra-arterial administration.
• Allow syringe to warm to room temperature before administering. This may take up to 20 min.
• Rotate injection sites (hips, thighs, abdomen, back of arms). Use a different area than where the last injection was administered. Do not inject into areas that are tender, bruised, red, or hard.
• Do not administer if particulate matter, cloudiness, or discoloration is noted.
• Discard any unused solution. Do not save for future use.

Storage/Stability:

Store pre filled syringes in refrigerator (36° to 46°F). Protect from freezing and exposure to light. Discard any syringes that have been frozen. If a refrigerator is not available, the syringes may be stored at room temperature (59° to 86°F) for up to 1 mo.

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