Medical Editor: John P. Cunha, DO, FACOEP
What Is Glatopa?
Glatopa (glatiramer acetate injection) is an immunomodulator used to treat patients with relapsing forms of multiple sclerosis (MS), including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS. Glatopa is generic version of Copaxone.
What Are Side Effects of Glatopa?
Glatopa may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- chest pain,
- fast heartbeat,
- shortness of breath,
- loss of appetite,
- stomach pain,
- yellowing of the eyes or skin (jaundice),
- dark urine,
- sore throat,
- mood changes,
- severe pain at the injection site,
- swelling of the feet or legs,
- vision problems, and
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Glatopa include:
- injection site reactions,
- skin redness,
- throat constriction, and
- chest pain
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Glatopa
The dose of Glatopa is 20 mg/mL once daily.
What Drugs, Substances, or Supplements Interact with Glatopa?
Glatopa may interact with other drugs. Tell your doctor all medications and supplements you use.
Glatopa During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Glatopa. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Glatopa (glatiramer acetate injection) 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.
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]
- Hepatic Injury [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
Glatiramer Acetate Injection 20 mg per mL Per Day
Among 563 patients treated with glatiramer acetate injection 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 glatiramer acetate injection 20 mg per mL in the placebocontrolled trials. These signs and symptoms were numerically more common in patients treated with glatiramer acetate injection 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 Glatiramer Acetate Injection (20 mg per mL daily) than with Placebo
|Glatiramer Acetate Injection 20 mg/mL|
|Blood And Lymphatic System Disorders||Lymphadenopathy||7||3|
|Eye Disorders||Eye Disorder||3||1|
|General Disorders And Administration Site Conditions||Injection Site Erythema||43||10|
|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 glatiramer acetate injection group than in the placebo group (less than 1% difference), but for which a relationship to glatiramer acetate injection could not be excluded, were arthralgia and herpes simplex.
Laboratory analyses were performed on all patients participating in the clinical program for glatiramer acetate injection. Clinically-significant laboratory values for hematology, chemistry, and urinalysis were similar for both glatiramer acetate injection and placebo groups in blinded clinical trials. In controlled trials one patient discontinued treatment due to thrombocytopenia (16 x 109/L), which resolved after discontinuation of treatment.
Data on adverse reactions occurring in the controlled clinical trials of glatiramer acetate injection 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 glatiramer acetate injection 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 glatiramer acetate injection 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 glatiramer acetate injection and reported a reaction divided by the total number of patients exposed to glatiramer acetate injection. 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.
Glatiramer Acetate Injection 40 mg per mL Three Times Per Week
Among 943 patients treated with glatiramer acetate injection 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 glatiramer acetate injection 40 mg per mL in the blinded, placebo-controlled trial. These signs and symptoms were numerically more common in patients treated with glatiramer acetate injection 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 Glatiramer Acetate Injection (40 mg per mL three times per week) than with Placebo
|Glatiramer Acetate Injection 40 mg/mL|
|General Disorders And||Injection Site Erythema||22||2|
|Administration Site||Injection Site Pain||10||2|
|Conditions||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||Erythema||2||0|
No new adverse reactions appeared in subjects treated with glatiramer acetate injection 40 mg per mL three times per week as compared to subjects treated with glatiramer acetate injection 20 mg per mL per day in clinical trials and during postmarketing experience. Data on adverse reactions occurring in the controlled clinical trial of glatiramer acetate injection 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 glatiramer acetate injection. 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; eructation
Hemic and Lymphatic System: thrombocytopenia; lymphoma-like reaction; acute leukemia
Hepatobiliary Disorders: cholelithiasis; liver function abnormality; cirrhosis of the liver; hepatitis; hepatic injury [see WARNINGS AND PRECAUTIONS]
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 Glatopa (glatiramer acetate Injection)
© Glatopa Patient Information is supplied by Cerner Multum, Inc. and Glatopa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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