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Copaxone

Last reviewed on RxList: 1/10/2020
Copaxone Side Effects Center

Last reviewed on RxList 1/10/2020

What Is Copaxone?

Copaxone (glatiramer acetate) is a combination of four amino acids (proteins) used to treat multiple sclerosis (MS) and to prevent relapse of MS. Copaxone will not cure MS, but it can make relapses occur less often.

What Are Side Effects of Copaxone?

Common side effects of Copaxone include:

Immediately after injection with Copaxone, you may experience:

  • flushing (warmth, redness, or tingly feeling),
  • chest pain,
  • fast heartbeat,
  • anxiety,
  • shortness of breath, or
  • itching.

These symptoms usually disappear quickly and usually do not require treatment. Tell your doctor if you have serious side effects of Copaxone including:

  • dizziness,
  • fainting,
  • infection (such as fever, persistent sore throat),
  • mental/mood changes (such as depression),
  • severe pain at the injection site,
  • shakiness (tremor), or
  • vision problems.

Dosage for Copaxone

Copaxone is injected subcutaneously (just beneath the skin) in a dose of 20 mg/day. There may be other drugs that can interact with Copaxone.

What Drugs, Substances, or Supplements Interact with Copaxone?

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.

Copaxone During Pregnancy and Breastfeeding

During pregnancy, Copaxone should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Copaxone (glatiramer acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

Multiple Sclerosis (MS) Symptoms and Treatment See Slideshow
Copaxone Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur within minutes after an injection. Tell your doctor if you have any of these symptoms: itching, rash, swelling, warmth, skin redness, tingling, anxiety, fast or pounding heartbeats, chest pain, tightness in your throat, or trouble breathing.

This type of reaction may occur even after you have been using glatiramer for several months.

Call your doctor at once if you have:

  • chest pain (may occur alone or with other side effects shortly after an injection); or
  • hollowing or other skin changes where the injection was given.

Common side effects include:

  • feeling short of breath;
  • flushing (sudden warmth, redness, or tingly feeling);
  • rash; or
  • redness, pain, itching, swelling, or a lump where the injection was given.

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.

Read the entire detailed patient monograph for Copaxone (Glatiramer Acetate)

QUESTION

What kind of disease is multiple sclerosis? See Answer
Copaxone Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Immediate Post-Injection Reaction [see WARNINGS AND PRECAUTIONS]
  • Chest Pain [see WARNINGS AND PRECAUTIONS]
  • Lipoatrophy and Skin Necrosis [see WARNINGS AND PRECAUTIONS]
  • Potential Effects on Immune Response [see WARNINGS AND PRECAUTIONS]

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
(n=563)
%
Placebo
(n=564)
%
Blood And Lymphatic System DisordersLymphadenopathy73
Cardiac DisordersPalpitations94
Tachycardia52
Eye DisordersEye Disorder31
Diplopia32
Gastrointestinal DisordersNausea1511
Vomiting74
Dysphagia21
General Disorders And Administration Site ConditionsInjection Site Erythema4310
Injection Site Pain4020
Injection Site Pruritus274
Injection Site Mass266
Asthenia2221
Pain2017
Injection Site Edema194
Chest Pain136
Injection Site Inflammation91
Edema82
Injection Site Reaction81
Pyrexia65
Injection Site Hypersensitivity40
Local Reaction31
Chills31
Face Edema31
Edema Peripheral32
Injection Site Fibrosis21
Injection Site Atrophy*20
Immune System DisordersHypersensitivity32
Infections And InfestationsInfection3028
Influenza1413
Rhinitis75
Bronchitis65
Gastroenteritis64
Vaginal Candidiasis42
Metabolism And Nutrition DisordersWeight Increased31
Musculoskeletal And Connective Tissue DisordersBack Pain1210
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)Benign Neoplasm of Skin21
Nervous System DisordersTremor42
Migraine42
Syncope32
Speech Disorder21
Psychiatric DisordersAnxiety1310
Nervousness21
Renal And Urinary DisordersMicturition Urgency54
Respiratory, Thoracic And Mediastinal DisordersDyspnea144
Cough65
Laryngospasm21
Skin And Subcutaneous Tissue DisordersRash1911
Hyperhidrosis75
Pruritus54
Urticaria31
Skin Disorder31
Vascular DisordersVasodilatation205
*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:

Frequent: Abscess

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.

Cardiovascular:

Frequent: Hypertension.

Infrequent: Hypotension, midsystolic click, systolic murmur, atrial fibrillation, bradycardia, fourth heart sound, postural hypotension, and varicose veins.

Digestive:

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.

Endocrine:

Infrequent: Goiter, hyperthyroidism, and hypothyroidism.

Gastrointestinal:

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.

Musculoskeletal:

Infrequent: Arthritis, muscle atrophy, bone pain, bursitis, kidney pain, muscle disorder, myopathy, osteomyelitis, tendon pain, and tenosynovitis.

Nervous:

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.

Respiratory:

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.

Special Senses:

Frequent: Visual field defect.

Infrequent: Dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis, optic neuritis, photophobia, and taste loss.

Urogenital:

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
(n=943)
%
Placebo
(n=461)
%
General Disorders And Administration Site ConditionsInjection Site Erythema222
Injection Site Pain102
Injection Site Mass60
Injection Site Pruritus60
Injection Site Edema60
Pyrexia32
Influenza-like Illness32
Injection Site Inflammation20
Chills20
Chest Pain21
Infections And InfestationsNasopharyngitis119
Respiratory Tract Infection Viral32
Respiratory, Thoracic and Mediastinal DisordersDyspnea30
Vascular DisordersVasodilatation30
Gastrointestinal DisordersNausea21
Skin And Subcutaneous Tissue DisordersErythema20
Rash21

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.

Postmarketing Experience

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)

Related Resources for Copaxone

Read the Copaxone User Reviews »

© Copaxone Patient Information is supplied by Cerner Multum, Inc. and Copaxone Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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