Copaxone (Glatiramer acetate) is a drug that acts as an immune-modulator. It is used as a subQ injection either daily or thrice weakly in patients with relapsing forms of MS (multiple sclerosis.

Copaxone (Glatiramer acetate) Uses:

• Multiple sclerosis:

  • It is indicated for the treatment of patients with relapsing forms of MS (multiple sclerosis)

Copaxone (Glatiramer acetate) Dose in Adults

Copaxone (Glatiramer acetate) Dose in the treatment of Relapsing Multiple sclerosis (MS):

Note:

• • The 20 mg/mL and 40 mg/mL formulations of glatriamer acetate are not interchangeable.
• 20 mg subQ injection once a day or 40 mg three times a week administered at least 48 hours apart.

Copaxone (Glatiramer acetate) Use in Children:

Not inidcated.

Pregnancy Risk Factor B

• Negative events have not been reported in animal reproduction studies.
• Because of the limited information available to pregnant women, discontinuing treatment may be possible.

Use of glatiramer acetate during lactation

• It is unknown if the drug will be excreted into breastmilk.
• It is not bioavailable when given orally but it is recommended that lactating mothers avoid it.

Copaxone (Glatiramer acetate) Dose in Liver disease: 

The manufacturer has not recommended any dose adjustment in patients with kidney disease.

Copaxone (Glatiramer acetate) Dose in Liver disease:

The manufacturer has not recommended any dose adjustment in patients with liver disease.

Common Side Effects of Copaxone (Glatiramer acetate):

• Central Nervous System:

  • Pain
  • Anxiety

• Dermatologic:

  • Skin Rash
  • Diaphoresis

• Gastrointestinal:

  • Nausea

• Hypersensitivity:

  • Immediate Hypersensitivity

• Immunologic:

  • Development Of Igg Antibodies

• Infection:

  • Infection

• Local:

  • Inflammation At Injection Site
  • Erythema At Injection Site
  • Pain At Injection Site
  • Itching At Injection Site
  • Residual Mass At Injection Site
  • Swelling

• Neuromuscular & Skeletal:

  • Weakness
  • Back Pain

• Respiratory:

  • Dyspnea
  • Flu-Like Symptoms
  • Nasopharyngitis

Less Common Side Effects Of Copaxone (Glatiramer acetate):

• Cardiovascular:

  • Palpitations
  • Edema
  • Tachycardia
  • Facial Edema
  • Peripheral Edema
  • Syncope
  • Hypertension

• Central Nervous System:

  • Migraine
  • Chills
  • Nervousness
  • Speech Disturbance
  • Abnormal Dreams
  • Emotional Lability
  • Stupor

• Dermatologic:

  • Hyperhidrosis
  • Pruritus
  • Erythema
  • Urticaria
  • Skin Atrophy
  • Warts
  • Eczema
  • Pustular Rash

• Endocrine & Metabolic:

  • Weight Gain
  • Amenorrhea
  • Hypermenorrhea

• Gastrointestinal:

  • Vomiting
  • Gastroenteritis
  • Dysphagia
  • Aphthous Stomatitis
  • Bowel Urgency
  • Dental Caries
  • Enlargement Of Salivary Glands
  • Oral Candidiasis

• Genitourinary:

  • Urinary Urgency
  • Vulvovaginal Candidiasis
  • Abnormal Pap Smear
  • Hematuria
  • Vaginal Hemorrhage
  • Impotence

• Hematologic & Oncologic:

  • Bruise
  • Lymphadenopathy
  • Benign Skin Neoplasm

• Hypersensitivity:

  • Hypersensitivity

• Infection:

  • Abscess
  • Herpes Zoster

• Local:

  • Bleeding At Injection Site
  • Hypersensitivity Reaction At Injection Site
  • Fibrosis At Injection Site
  • Lipoatrophy At Injection Site
  • Abscess At Injection Site

• Neuromuscular & Skeletal:

  • Neck Pain
  • Tremor
  • Laryngospasm

• Ophthalmic:

  • Diplopia
  • Visual Field Defect

• Respiratory:

  • Rhinitis
  • Bronchitis
  • Cough
  • Laryngismus
  • Viral Respiratory Tract Infection
  • Hyperventilation

• Miscellaneous:

  • Fever

Contraindications to Copaxone (Glatiramer acetate):Allergy reactions to mannitol, glatiramere acetate, or any other component of the formulation

Warnings and precautions

• Chest pain

  • After the injections, chest pain can occur.
  • Most chest pain is temporary and disappears in a matter of minutes. It may also be associated with other systemic symptoms.
  • Chest pain episodes can begin up to a month after treatment is initiated.

• Hypersensitivity reactions

  • Anaphylaxis and serious hypersensitivity reactions may occur.

• Reaction:

  • Glatiramer Acetacetate may cause immune dysfunction, which can be a theoretical danger.
  • It may also interfere with the body's recognition of foreign antigens and weaken the body's defense system against infection and tumors.

• Lipoatrophy

  • The injection site may be the cause of lipoatrophy or skin necrosis.
  • Lipoatrophy can be more common if injections are administered to the same spot frequently. Lipoatrophy can occur after several months of treatment.
  • It is important that patients are taught how to rotate injection sites regularly.

• Systemic reactions

  • There are possible injection site reactions. It is possible to experience systemic reactions immediately following injection. These usually occur within seconds to minutes.
  • Most symptoms, such as anxiety, chest pains, pain in the throat and shortness of breath, are temporary and self-limiting.
  • These symptoms usually appear after several months of treatment.

Glatiramer acetate: Drug Interaction

Monitoring Parameters:

Monitor for hypersensitivity reactions and lipoatrophy at the injection sites.

How to administer Copaxone (Glatiramer acetate)?

• It is only intended for subQ administration.
• It should be administered in the upper arms, anterior abdomen (between 3 and 5 cms from the navel), hips or thighs.
• To reduce the risk of injection-site lipoatrophy, it is important to change the injection site. It is best to avoid intravenous administration. 
• You should administer the 40 mg dose three times per week, with at least 48 hour intervals, preferably on the same day of the week (example: Monday through Wednesday and Friday).
• Before administering the injection, the drug should be left at room temperature for at most 20 minutes. 
• After administering the drug, it is important to dispose of the entire injection as well as any unused parts.

Mechanism of action of Copaxone (Glatiramer acetate):

• Glatiramer Acetate is a combination of four amino acids L alanine (L-glutamic acid), L-lysine (L-tyrosine) and L-glutamic Acid (L-glutamic acid).
• These four amino acids are similar to basic myelin proteins. Myelin sheaths are the essential component of the neuronal structure, which are made up myelin proteins.
• Glatiramer acid acetate blocks the function and activation of T lymphocytes that are specifically activated by the myelin antibody. 
• It activates the T-lymphocyte suppressor cell and interferes with the functions antigen-presenting cells.

Distribution:

• A small amount of the intact and partially hydrolyzed drug enters the lymphatic circulation.

Metabolism:

• It is hydrolyzed locally at the site of subQ administration.

International Brands of Glatiramer acetate:

• Copaxone
• Glatopa
• Copaxone S.C.
• Glatimmune
• Glatiramyl
• Glitaxon

Glatiramer acetate Brand Names in Pakistan:

No Brands Available in Pakistan.