Glatiramer Acetate Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] Immediate Post-Injection Reaction [see Warnings and Precautions ( 5.2 )] Chest Pain [see Warnings and Precautions ( 5.3 )] Lipoatrophy and Skin Necrosis [see Warnings and Precautions ( 5.4 )] Potential Effects on Immune Response [see Warnings and Precautions ( 5.5 )] Hepatic Injury [see Warnings and Precautions ( 5.6 )] In controlled studies of Glatiramer Acetate Injection 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain ( 6.1 ) In a controlled study of Glatiramer Acetate Injection 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 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 placebo-controlled 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 (n=563) % Placebo (n=564) % Blood And Lymphatic System Disorders Lymphadenopathy 7 3 Cardiac Disorders Palpitations 9 4 Tachycardia 5 2 Eye Disorders Eye Disorder 3 1 Diplopia 3 2 Gastrointestinal Disorders Nausea 15 11 Vomiting 7 4 Dysphagia 2 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 Asthenia 22 21 Pain 20 17 Injection Site Edema 19 4 Chest Pain 13 6 Injection Site Inflammation 9 1 Edema 8 2 Injection Site Reaction 8 1 Pyrexia 6 5 Injection Site Hypersensitivity 4 0 Local Reaction 3 1 Chills 3 1 Face Edema 3 1 Edema Peripheral 3 2 Injection Site Fibrosis 2 1 Injection Site Atrophy* 2 0 Immune System Disorders Hypersensitivity 3 2 Infections And Infestations Infection 30 28 Influenza 14 13 Rhinitis 7 5 Bronchitis 6 5 Gastroenteritis 6 4 Vaginal Candidiasis 4 2 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 Migraine 4 2 Syncope 3 2 Speech Disorder 2 1 Psychiatric Disorders Anxiety 13 10 Nervousness 2 1 Renal And Urinary Disorders Micturition Urgency 5 4 Respiratory, Thoracic And Mediastinal Disorders Dyspnea 14 4 Cough 6 5 Laryngospasm 2 1 Skin And Subcutaneous Tissue Disorders Rash 19 11 Hyperhidrosis 7 5 Pruritus 5 4 Urticaria 3 1 Skin Disorder 3 1 Vascular Disorders Vasodilatation 20 5 *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.