- SIDE EFFECTS
- Clinical Trials Experience
- Incidence In Controlled Clinical Trials
- Postmarketing Experience
- SIDE EFFECTS
- How Copaxone works
- Copaxone in clinical trials
- Other information
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
The following serious adverse reactions are described elsewhere in the labeling:
- Immediate Post-Injection Reaction
- Chest Pain
- Lipoatrophy and Skin Necrosis
- Potential Effects on Immune Response
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Incidence In Controlled Clinical Trials
COPAXONE 20 mg Per mL Per Day
Among 563 patients treated with COPAXONE in blinded placebo-controlled trials, approximately 5% of the subjects discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were: injection site reactions, dyspnea, urticaria, vasodilatation, and hypersensitivity. The most common adverse reactions were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain.
Table 1 lists signs and symptoms that occurred in at least 2% of patients treated with COPAXONE 20 mg per mL in the placebo-controlled trials. These signs and symptoms were numerically more common in patients treated with COPAXONE than in patients treated with placebo. Adverse reactions were usually mild in intensity.
Table 1: Adverse reactions in controlled clinical trials with an incidence ≥2% of patients and more frequent with COPAXONE (20 mg per mL daily) than with placebo
|COPAXONE 20 mg/mL
|Blood And Lymphatic System Disorders||Lymphadenopathy||7%||3%|
|Eye Disorders||Eye Disorder||3%||1%|
|General Disorders And Administration||Injection Site Erythema||43%||10%|
|Site Conditions||Injection Site Pain||40%||20%|
|Injection Site Pruritus||27%||4%|
|Injection Site Mass||26%||6%|
|Injection Site Edema||19%||4%|
|Injection Site Inflammation||9%||1%|
|Injection Site Reaction||8%||1%|
|Injection Site Hypersensitivity||4%||0%|
|Injection Site Fibrosis||2%||1%|
|Injection Site Atrophy*||2%||0%|
|Immune System Disorders||Hypersensitivity||3%||2%|
|Infections And Infestations||Infection||30%||28%|
|Metabolism And Nutrition Disorders||Weight Increased||3%||1%|
|Musculoskeletal And Connective Tissue Disorders||Back Pain||12%||10%|
|Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)||Benign Neoplasm of Skin||2%||1%|
|Nervous System Disorders||Tremor||4%||2%|
|Renal And Urinary Disorders||Micturition Urgency||5%||4%|
|Respiratory, Thoracic And Mediastinal Disorders||Dyspnea||14%||4%|
|Skin And Subcutaneous Tissue Disorders||Rash||19%||11%|
|*Injection site atrophy comprises terms relating to localized lipoatrophy at injection site|
Adverse reactions which occurred only in 4 to 5 more subjects in the COPAXONE group than in the placebo group (less than 1% difference), but for which a relationship to COPAXONE could not be excluded, were arthralgia and herpes simplex.
Laboratory analyses were performed on all patients participating in the clinical program for COPAXONE. Clinically-significant laboratory values for hematology, chemistry, and urinalysis were similar for both COPAXONE and placebo groups in blinded clinical trials. In controlled trials one patient discontinued treatment due to thrombocytopenia (16 x109/L), which resolved after discontinuation of treatment.
Data on adverse reactions occurring in the controlled clinical trials of COPAXONE 20 mg per mL were analyzed to evaluate differences based on sex. No clinically-significant differences were identified. Ninety-six percent of patients in these clinical trials were Caucasian. The majority of patients treated with COPAXONE were between the ages of 18 and 45. Consequently, data are inadequate to perform an analysis of the adverse reaction incidence related to clinically-relevant age subgroups.
Other Adverse Reactions
In the paragraphs that follow, the frequencies of less commonly reported adverse clinical reactions are presented. Because the reports include reactions observed in open and uncontrolled premarketing studies (n= 979), the role of COPAXONE in their causation cannot be reliably determined. Furthermore, variability associated with adverse reaction reporting, the terminology used to describe adverse reactions, etc., limit the value of the quantitative frequency estimates provided. Reaction frequencies are calculated as the number of patients who used COPAXONE and reported a reaction divided by the total number of patients exposed to COPAXONE. All reported reactions are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Reactions are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: Frequent adverse reactions are defined as those occurring in at least 1/100 patients and infrequent adverse reactions are those occurring in 1/100 to 1/1,000 patients.
Body As A Whole
Infrequent: Injection site hematoma, moon face, cellulitis, hernia, injection site abscess, serum sickness, suicide attempt, injection site hypertrophy, injection site melanosis, lipoma, and photosensitivity reaction.
Infrequent: Hypotension, midsystolic click, systolic murmur, atrial fibrillation, bradycardia, fourth heart sound, postural hypotension, and varicose veins.
Infrequent: Dry mouth, stomatitis, burning sensation on tongue, cholecystitis, colitis, esophageal ulcer, esophagitis, gastrointestinal carcinoma, gum hemorrhage, hepatomegaly, increased appetite, melena, mouth ulceration, pancreas disorder, pancreatitis, rectal hemorrhage, tenesmus, tongue discoloration, and duodenal ulcer.
Infrequent: Goiter, hyperthyroidism, and hypothyroidism.
Frequent: Bowel urgency, oral moniliasis, salivary gland enlargement, tooth caries, and ulcerative stomatitis.
Hemic And Lymphatic
Infrequent: Leukopenia, anemia, cyanosis, eosinophilia, hematemesis, lymphedema, pancytopenia, and splenomegaly.
Metabolic And Nutritional
Infrequent: Weight loss, alcohol intolerance, Cushing’s syndrome, gout, abnormal healing, and xanthoma.
Infrequent: Arthritis, muscle atrophy, bone pain, bursitis, kidney pain, muscle disorder, myopathy, osteomyelitis, tendon pain, and tenosynovitis.
Frequent: Abnormal dreams, emotional lability, and stupor.
Infrequent: Aphasia, ataxia, convulsion, circumoral paresthesia, depersonalization, hallucinations, hostility, hypokinesia, coma, concentration disorder, facial paralysis, decreased libido, manic reaction, memory impairment, myoclonus, neuralgia, paranoid reaction, paraplegia, psychotic depression, and transient stupor.
Frequent: Hyperventilation and hay fever. Infrequent: Asthma, pneumonia, epistaxis, hypoventilation, and voice alteration.
Skin And Appendages
Frequent: Eczema, herpes zoster, pustular rash, skin atrophy, and warts.
Infrequent: Dry skin, skin hypertrophy, dermatitis, furunculosis, psoriasis, angioedema, contact dermatitis, erythema nodosum, fungal dermatitis, maculopapular rash, pigmentation, benign skin neoplasm, skin carcinoma, skin striae, and vesiculobullous rash.
Frequent: Visual field defect.
Infrequent: Dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis, optic neuritis, photophobia, and taste loss.
Frequent: Amenorrhea, hematuria, impotence, menorrhagia, suspicious papanicolaou smear, urinary frequency, and vaginal hemorrhage.
Infrequent: Vaginitis, flank pain (kidney), abortion, breast engorgement, breast enlargement, carcinoma in situ cervix, fibrocystic breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis, abnormal sexual function, and urethritis.
COPAXONE 40 mg Per mL Three Times Per Week
Among 943 patients treated with COPAXONE 40 mg per mL three times per week in a blinded, placebo-controlled trial, approximately 3% of the subjects discontinued treatment because of an adverse reaction. The most common adverse reactions were injection site reactions, which were also the most common cause of discontinuation.
Table 2 lists signs and symptoms that occurred in at least 2% of patients treated with COPAXONE 40 mg per mL in the blinded, placebo-controlled trial. These signs and symptoms were numerically more common in patients treated with COPAXONE 40 mg per mL than in patients treated with placebo. Adverse reactions were usually mild in intensity.
Table 2: Adverse reactions in a controlled clinical trial with an incidence ≥2% of patients and more frequent with COPAXONE (40 mg per mL three times per week) than with placebo
|COPAXONE 40 mg/mL
|General Disorders And Administration Site Conditions||Injection Site Erythema||22%||2%|
|Injection Site Pain||10%||2%|
|Injection Site Mass||6%||0%|
|Injection Site Pruritus||6%||0%|
|Injection Site Edema||6%||0%|
|Injection Site Inflammation||2%||0%|
|Infections And Infestations||Nasopharyngitis||11%||9%|
|Respiratory Tract Infection Viral||3%||2%|
|Respiratory, Thoracic and Mediastinal Disorders||Dyspnea||3%||0%|
|Skin And Subcutaneous Tissue Disorders||Erythema||2%||0%|
No new adverse reactions appeared in subjects treated with COPAXONE 40 mg per mL three times per week as compared to subjects treated with COPAXONE 20 mg per mL per day in clinical trials and during postmarketing experience. Data on adverse reactions occurring in the controlled clinical trial of COPAXONE 40 mg per mL were analyzed to evaluate differences based on sex. No clinically significant differences were identified. Ninety-eight percent of patients in this clinical trial were Caucasian and the majority were between the ages of 18 and 50. Consequently, data are inadequate to perform an analysis of the adverse reaction incidence related to clinically-relevant age groups.
The following adverse reactions have been identified during postapproval use of COPAXONE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: sepsis; SLE syndrome; hydrocephalus; enlarged abdomen; allergic reaction; anaphylactoid reaction
Cardiovascular System: thrombosis; peripheral vascular disease; pericardial effusion; myocardial infarct; deep thrombophlebitis; coronary occlusion; congestive heart failure; cardiomyopathy; cardiomegaly; arrhythmia; angina pectoris
Digestive System: tongue edema; stomach ulcer; hemorrhage; liver function abnormality; liver damage; hepatitis; eructation; cirrhosis of the liver; cholelithiasis
Hemic and Lymphatic System: thrombocytopenia; lymphoma-like reaction; acute leukemia
Metabolic and Nutritional Disorders: hypercholesterolemia
Musculoskeletal System: rheumatoid arthritis; generalized spasm
Nervous System: myelitis; meningitis; CNS neoplasm; cerebrovascular accident; brain edema; abnormal dreams; aphasia; convulsion; neuralgia
Respiratory System: pulmonary embolus; pleural effusion; carcinoma of lung
Special Senses: glaucoma; blindness
Urogenital System: urogenital neoplasm; urine abnormality; ovarian carcinoma; nephrosis; kidney failure; breast carcinoma; bladder carcinoma; urinary frequency
Read the entire FDA prescribing information for Copaxone (Glatiramer Acetate)
Copaxone (glatiramer acetate) is a disease-modifying therapy marketed by Teva Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsing-remitting multiple sclerosis (RRMS). The medicine has been shown to reduce the number of relapses in multiple sclerosis (MS) patients.
How Copaxone works
MS is a progressive neurodegenerative disorder in which the immune system mistakenly targets the myelin protein. Myelin is the main component of the protective sheath that insulates nerve fibers. This triggers inflammation and causes damage to the brain and spinal cord, leading to a wide range of symptoms.
Copaxone is a small synthetic protein, made to mimic a fragment of myelin. It consists of four amino acids, the building blocks of proteins, that are found in myelin.
The exact mechanism of how Copaxone reduces the frequency of relapses in RRMS is not known, but it is thought that the medicine modifies the immune response against myelin. For example, Copaxone may act to increase the immune system’s tolerance to myelin through repeated exposure, in a similar way to a vaccine.
Another mechanism could be that Copaxone may alter which immune cells are active; it may be able to induce a type of immune cells called suppressor T-cells that secrete anti-inflammatory proteins and prevent damage. Copaxone may also act to prevent the activation of T-cells that target and attack myelin.
While Copaxone can reduce the rate of relapses and slow the progression of MS, it cannot reverse or cure the disease.
Copaxone in clinical trials
Copaxone has been studied in several clinical trials.
The key clinical trial that led to Copaxone’s approval for marketing was a study called the Copolymer 1 Multiple Sclerosis Study, carried out in the 1990s. The randomized, double-blind, placebo-controlled Phase 3 trial enrolled 251 patients with RRMS who received either Copaxone or a placebo daily for two years.
The initial results, published in the journal Neurology, demonstrated that patients receiving Copaxone had a 29 percent reduction in their relapse rate compared to those who received placebo. Patients also were assessed in terms of their change on the expanded disability status scale, after two years of treatment compared to the start of the trial. On average, patients taking Copaxone had an improved score after two years, while the score of patients in the placebo group had worsened. The treatment was well-tolerated, with the most common side effect being a reaction at the injection site.
Following the end of the trial, patients were given the chance to continue treatment in an optional extension study. The results of this extension study showed that after one to 11 months of follow-up treatment, the benefits of Copaxone were maintained, and no long-term complications were observed.
A total of 208 patients of the original 251 opted to participate in this open-label extension study in which all of them received Copaxone. A final report of the trial and the extension, which spanned a total of about six years, was published in the journal Multiple Sclerosis. Copaxone continued to provide a sustained reduction in relapse rate and slowed worsening disability.
More recently, the effectiveness of Copaxone given at a higher dose, three times weekly instead of daily, was assessed in a randomized placebo-controlled Phase 3 trial (NCT01067521) called GALA. A total of 1,404 participants with RRMS were recruited worldwide to receive Copaxone or a placebo for one year. This also was followed by an open label extension study.
The results, published in the Annals of Neurology, confirmed that Copaxone reduced the number of relapses compared to placebo, by about 34 percent. The patients also were assessed by magnetic resonance imaging (MRI) to check for lesions, or areas of damage, in the brain. Copaxone was associated with a significant reduction in the number of lesions compared to the placebo.
Copaxone is administered as an injection under the skin. Common side effects include reactions at the injection site (such as itching, swelling, redness, pain, or bruising), anxiety, chest pain, shortness of breath, palpitations (pounding or irregular heartbeat), flushing, hives, and swollen lymph nodes.
The FDA originally approved the therapy to treat RRMS in 1996, and in March 2009 expanded this to include clinically isolated syndrome. In 2014, the FDA approved the higher-dose of Copaxone taken three times a week as a prescription, following the results of the GALA trial.
Generic versions of Copaxone also are now available.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
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 defence system works. Glatiramer is used to treat the relapsing-remitting form of multiple sclerosis (MS). This medication is also used to delay the onset of MS in people who have experienced a single flare-up of symptoms and have changes that suggest MS in their magnetic resonance imaging (MRI) scans.
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.
It is thought that glatiramer works by altering the immune system to reduce its harmful effects on the myelin sheath. It does not cure MS, but it may decrease the frequency of relapses and reduce the number of damaged brain areas as seen on MRI scans.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using 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 use this medication if their doctor has not prescribed it.
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What form(s) does this medication come in?
Each 1.0 mL prefilled syringe contains 20 mg of glatiramer. Nonmedicinal ingredients: mannitol and sterile water for injection.
Each 1.0 mL prefilled syringe contains 40 mg of glatiramer. Nonmedicinal ingredients: mannitol and sterile water for injection.
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How should I use this medication?
The recommended dose of glatiramer is 20 mg injected subcutaneously (under the skin) once a day.
Glatiramer is available as an injection only. It comes in single-use prefilled syringes.
There are special directions enclosed in the package with the injection. Read these directions carefully before using the medication. Follow the instructions closely to avoid accidentally contaminating the medication or needle and giving yourself an infection, or from damaging the equipment or losing the medication.
Glatiramer is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject this medication on your own until you completely understand how to inject a dose.
Rotate the injection sites (arms, thighs, upper buttocks, or stomach) to minimize injection site skin irritation.
Many things can affect the dose of 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 using the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, inject it as soon as you remember. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not inject a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store the prefilled syringes in the refrigerator (2°C to 8°C) and protect from light. The prefilled syringes may also be stored at room temperature for up to one month. Keep this medication out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use this medication if you are allergic to glatiramer or any 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.
- back pain
- injection site reactions (e.g., bleeding, hard lump, hives or welts, itching, pain, redness, or swelling)
- joint pain
- neck pain
- a “dent” in the skin at injection site
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:
- breathing problems
- fast or racing heartbeat
- high blood pressure (e.g., headache, dizziness, blurred vision or shortness of breath)
- low blood pressure (e.g., dizziness, fatigue, nausea)
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of infection, symptoms may include:
- fever or chills
- prolonged dizziness
- severe diarrhea
- shortness of breath
- stiff neck
- weight loss
- skin rash
- swelling of fingers, arms, feet, or legs
- vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
- chest pain
- chest tightness or wheezing
- irregular or pounding heartbeat
- swelling or puffiness of face
- signs of a serious allergic reaction, i.e.:
- abdominal cramps
- difficulty breathing
- nausea and vomiting
- swelling of the face and throat
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.
Breathing problems: Glatiramer can cause shortness of breath and difficulty breathing, causing symptoms of lung disease to worsen. If you have chronic obstructive pulmonary disease, asthma, or a history of severe allergic reactions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Cardiovascular effects: This medication may have effects on the heart and circulatory (blood vessels) system. If you have heart disease, high blood pressure, and other diseases of the heart and blood system, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Chronic progressive multiple sclerosis (MS): The safety and effectiveness of using this medication by people with chronic progressive MS have not been established. Currently, glatiramer is only recommended for people with the relapsing-remitting form of MS.
Immunosuppression (weak immune system): Glatiramer can modify the immune response and could interfere with useful immune function. If you have a suppressed or reduced immune system, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infections: Glatiramer may increase the risk of infections. If you notice any signs of an infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness, contact your doctor immediately.
Kidney disease: Glatiramer has not been studied for use by people with reduced kidney function. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Post-injection reaction: 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.
Vaccination: Glatiramer can modify the immune response and could interfere with useful immune function. People receiving a vaccination should let their doctor know they are taking this medication.
Pregnancy: Glatiramer has not been adequately studied for use by pregnant women. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if glatiramer passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children and adolescents under 18 years old.
Seniors: The safety and effectiveness of using this medication have not been established for people over 65 years of age.
What other drugs could interact with this medication?
There may be an interaction between glatiramer and any of the following:
- bacillus Calmette-Guérin (BCG)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Copaxone