Glatiramer Other names: Glatiramer acetate

Chemical formula: C₂₅H₄₅N₅O₁₃  Molecular mass: 623.301 g/mol 

Interactions

Glatiramer interacts in the following cases:

Convulsions, anaphylactoid reactions, allergic reactions, hypersensitivity reactions

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.

Pregnancy

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.

Nursing mothers

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.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Adverse reactions


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).

Infections and infestations

Very common: Infection, Influenza

Common: Bronchitis, Gastroenteritis, Herpes Simplex, Otitis Media, Rhinitis, Tooth Abscess, Vaginal Candidiasis*

Uncommon: Abscess, Cellulitis, Furuncle, Herpes Zoster, Pyelonephritis

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Common: Benign Neoplasm Of Skin, Neoplasm

Uncommon: Skin Cancer

Blood and lymphatic system disorders

Common: Lymphadenopathy*

Uncommon: Leukocytosis, Leukopenia, Splenomegaly Thrombocytopenia, Lymphocyte Morphology Abnormal

Immune system disorders

Common: Hypersensitivity

Endocrine disorders

Uncommon: Goitre, Hyperthyroidism

Metabolism and nutrition disorders

Common: Anorexia, Weight Increased*

Uncommon: Alcohol Intolerance, Gout, Hyperlipidaemia, Blood Sodium Increased, Serum Ferritin Decreased

Psychiatric disorders

Very common: Anxiety*, Depression

Common: Nervousness

Uncommon: Abnormal Dreams, Confusional State, Euphoric Mood, Hallucination, Hostility, Mania, Personality Disorder, Suicide Attempt

Nervous system disorders

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

Eye disorders

Common: Diplopia, Eye Disorder*

Uncommon: Cataract, Corneal Lesion, Dry Eye, Eye Haemorrhage, Eyelid Ptosis, Mydriasis, Optic Atrophy

Ear and labyrinth disorders

Common: Ear Disorder

Cardiac disorders

Common: Palpitations*, Tachycardia*

Uncommon: Extrasystoles, Sinus Bradycardia, Tachycardia Paroxysmal

Vascular disorders

Very common: Vasodilatation*

Uncommon: Varicose Vein

Respiratory, thoracic and mediastinal disorders

Very common: Dyspnoea*

Common: Cough, Rhinitis Seasonal

Uncommon: Apnoea, Epistaxis, Hyperventilation, Laryngospasm, Lung Disorder, Choking Sensation

Gastrointestinal disorders

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

Hepatobiliary disorders

Common: Liver Function Test Abnormal

Uncommon: Cholelithiasis, Hepatomegaly

Skin and subcutaneous tissue disorders

Very common: Rash*

Common: Ecchymosis, Hyperhidrosis, Pruritus, Skin Disorder*, Urticaria

Uncommon: Angioedema, Dermatitis Contact, Erythema Nodosum, Skin Nodule

Musculoskeletal and connective tissue disorders

Very common: Arthralgia, Back Pain*

Common: Neck Pain

Uncommon: Arthritis, Bursitis, Flank Pain, Muscle Atrophy, Osteoarthritis

Renal and urinary disorders

Common: Micturition Urgency, Pollakiuria, Urinary Retention

Uncommon: Haematuria, Nephrolithiasis, Urinary Tract Disorder, Urine Abnormality

Pregnancy, puerperium and perinatal Conditions

Uncommon: Abortion

Reproductive system and breast disorders

Uncommon: Breast Engorgement, Erectile Dysfunction, Pelvic Prolapse, Priapism, Prostatic Disorder, Smear Cervix Abnormal, Testicular Disorder, Vaginal Haemorrhage, Vulvovaginal Disorder

General disorders and administration site conditions

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

Injury, poisoning and procedural complications

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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