Chemical formula: C₂₅H₄₅N₅O₁₃ Molecular mass: 623.301 g/mol
Glatiramer interacts in the following cases:
Convulsions and/or anaphylactoid or allergic reactions have been reported rarely.
Serious hypersensitivity reactions (e.g. bronchospasm, anaphylaxis or urticaria) may rarely occur. If reactions are severe, appropriate treatment should be instituted and glatiramer should be discontinued.
Studies in animals have not shown reproductive toxicity.
Current data on pregnant women indicate no malformative or feto/neonatal toxicity of glatiramer. To date, no relevant epidemiological data are available. As a precautionary measure, it is preferable to avoid the use of glatiramer during pregnancy unless the benefit to the mother outweighs the risk to the foetus.
It is unknown whether glatiramer acetate or its metabolites are excreted in human milk. In rats, no significant effects on offspring were observed except for a slight reduction in body weight gains in the offspring of mothers dosed during pregnancy and throughout lactation.
A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from glatiramer therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
No studies on the effects on the ability to drive and use machines have been performed.
In all clinical trials, injection-site reactions were seen to be the most frequent adverse reactions and were reported by the majority of patients receiving glatiramer. In controlled studies, the proportion of patients reporting these reactions, at least once, was higher following treatment with glatiramer (70%) than placebo injections (37%). The most commonly reported injection-site reactions, in clinical trials and in post marketing experience, were erythema, pain, mass, pruritus, oedema, inflammation, hypersensitivity and rare occurrences of lipoatrophy and skin necrosis.
A reaction, associated with at least one or more of the following symptoms, has been described as the immediate post-injection reaction: vasodilatation (flushing), chest pain, dyspnoea, palpitation or tachycardia. This reaction may occur within minutes of a glatiramer injection. At least one component of this Immediate Post-Injection Reaction was reported at least once by 31% of patients receiving glatiramer compared to 13% of patients receiving placebo.
All adverse reactions, which were more frequently reported in glatiramer vs. placebo-treated patients, are presented in the table below. This data was derived from four pivotal, double-blind, placebo-controlled clinical trials with a total of 512 patients treated with glatiramer and 509 patients treated with placebo for up to 36 months. Three trials in relapsing-remitting MS (RRMS) included a total of 269 patients treated with glatiramer and 271 patients treated with placebo for up to 35 months. The fourth trial in patients who have experienced a first clinical episode and were determined to be at high risk of developing clinically definite MS included 243 patients treated with glatiramer and 238 patients treated with placebo for up to 36 months. Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Very common: Infection, Influenza
Common: Bronchitis, Gastroenteritis, Herpes Simplex, Otitis Media, Rhinitis, Tooth Abscess, Vaginal Candidiasis*
Uncommon: Abscess, Cellulitis, Furuncle, Herpes Zoster, Pyelonephritis
Common: Benign Neoplasm Of Skin, Neoplasm
Uncommon: Skin Cancer
Common: Lymphadenopathy*
Uncommon: Leukocytosis, Leukopenia, Splenomegaly Thrombocytopenia, Lymphocyte Morphology Abnormal
Common: Hypersensitivity
Uncommon: Goitre, Hyperthyroidism
Common: Anorexia, Weight Increased*
Uncommon: Alcohol Intolerance, Gout, Hyperlipidaemia, Blood Sodium Increased, Serum Ferritin Decreased
Very common: Anxiety*, Depression
Common: Nervousness
Uncommon: Abnormal Dreams, Confusional State, Euphoric Mood, Hallucination, Hostility, Mania, Personality Disorder, Suicide Attempt
Very common: Headache
Common: Dysgeusia, Hypertonia, Migraine, Speech Disorder, Syncope, Tremor*
Uncommon: Carpal Tunnel Syndrome, Cognitive Disorder, Convulsion, Dysgraphia, Dyslexia, Dystonia, Motor Dysfunction, Myoclonus, Neuritis, Neuromuscular Blockade, Nystagmus, Paralysis, Peroneal Nerve Palsy, Stupor, Visual Field Defect
Common: Diplopia, Eye Disorder*
Uncommon: Cataract, Corneal Lesion, Dry Eye, Eye Haemorrhage, Eyelid Ptosis, Mydriasis, Optic Atrophy
Common: Ear Disorder
Common: Palpitations*, Tachycardia*
Uncommon: Extrasystoles, Sinus Bradycardia, Tachycardia Paroxysmal
Very common: Vasodilatation*
Uncommon: Varicose Vein
Very common: Dyspnoea*
Common: Cough, Rhinitis Seasonal
Uncommon: Apnoea, Epistaxis, Hyperventilation, Laryngospasm, Lung Disorder, Choking Sensation
Very common: Nausea*
Common: Anorectal Disorder, Constipation, Dental Caries, Dyspepsia, Dysphagia, Faecal Incontinence, Vomiting*
Uncommon: Colitis, Colonic Polyp, Enterocolitis, Eructation, Oesophageal Ulcer, Periodontitis Rectal Haemorrhage, Salivary Gland Enlargement
Common: Liver Function Test Abnormal
Uncommon: Cholelithiasis, Hepatomegaly
Very common: Rash*
Common: Ecchymosis, Hyperhidrosis, Pruritus, Skin Disorder*, Urticaria
Uncommon: Angioedema, Dermatitis Contact, Erythema Nodosum, Skin Nodule
Very common: Arthralgia, Back Pain*
Common: Neck Pain
Uncommon: Arthritis, Bursitis, Flank Pain, Muscle Atrophy, Osteoarthritis
Common: Micturition Urgency, Pollakiuria, Urinary Retention
Uncommon: Haematuria, Nephrolithiasis, Urinary Tract Disorder, Urine Abnormality
Uncommon: Abortion
Uncommon: Breast Engorgement, Erectile Dysfunction, Pelvic Prolapse, Priapism, Prostatic Disorder, Smear Cervix Abnormal, Testicular Disorder, Vaginal Haemorrhage, Vulvovaginal Disorder
Very common: Asthenia, Chest Pain*, Injection Site Reactions*§, Pain*
Common: Chills*, Face Oedema*, Injection Site Atrophy♣, Local Reaction*, Oedema Peripheral, Oedema, Pyrexia
Uncommon: Cyst, Hangover, Hypothermia, Immediate Post-Injection Reaction, Inflammation, Injection Site Necrosis, Mucous Membrane Disorder
Uncommon: Post Vaccination Syndrome
* More than 2% (>2/100) higher incidence in the glatiramer treatment group than in the placebo group. Adverse reaction without the “*” symbol represents a difference of less than or equal to 2%.
§ The term ‘Injection site reactions’ (various kinds) comprises all adverse events occurring at the injection site excluding injection site atrophy and injection site necrosis, which are presented separately within the table.
♣ Includes terms which relate to localised lipoatrophy at the injection sites.
In the fourth trial noted above, an open-label treatment phase followed the placebo-controlled period (see section 5.1). No change in the known risk profile of glatiramer was observed during the open-label follow-up period of up to 5 years.
The following adverse reaction reports were collected from MS patients treated with glatiramer in uncontrolled clinical trials and from post-marketing experience with glatiramer: hypersensitivity reactions (including rare occurrence of anaphylaxis, >1/10000, <1/1000.
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