Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

The recommended dosage in adults is 20 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection once daily.

At the present time, it is not known for how long the patient should be treated.

A decision concerning long term treatment should be made on an individual basis by the treating physician.

Paediatric Use: Children and adolescents: No prospective, randomised, controlled clinical trials or pharmacokinetic studies have been conducted in children or adolescents. However, limited published data suggest that the safety profile in adolescents from 12 to 18 years of age receiving Copaxone 20 mg subcutaneously every day is similar to that seen in adults.

There is not enough information available on the use of Copaxone in children below 12 years of age to make any recommendation for its use. Therefore, Copaxone should not be used in this population.

Use in the Elderly: Copaxone has not been specifically studied in the elderly.

Use in Patients with Impaired Renal Function: Copaxone has not been specifically studied in patients with renal impairment.

Patients should be instructed in self-injection techniques and should be supervised by a health-care professional the first time they self-inject and for 30 minutes after.

A different site for injection should be chosen every day, so this will reduce the chances of any irritation or pain at the site of the injection. Sites for self-injection include the abdomen, arms, hips and thighs.

Child Dosage

Elderly Dosage

Contra Indications

Copaxone is contraindicated under the following conditions:

• Hypersensitivity to glatiramer acetate or mannitol
• Pregnant women

Special Precautions

Copaxone should only be administered subcutaneously. Copaxone should not be administered by intravenous or intramuscular routes.

The initiation of Copaxone treatment should be supervised by a neurologist or a physician experienced in the treatment of MS.

The treating physician should explain to the patient that a reaction associated with at least one of the following: vasodilatation (flushing), chest pain, dyspnoea, palpitations or tachycardia, may occur within minutes of a Copaxone injection. The majority of these symptoms are short-lived and resolve spontaneously without any sequelae. Should a severe adverse event occur, the patient must immediately stop Copaxone treatment and contact his/her physician or any emergency doctor. Symptomatic treatment may be instituted at the discretion of the physician.

There is no evidence to suggest that any particular patient groups are at special risk from these reactions. Nevertheless, caution should be exercised when administering Copaxone to patients with pre-existing cardiac disorders. These patients should be followed up regularly during treatment.

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 Copaxone should be discontinued.

Glatiramer acetate-reactive antibodies were detected in patients' sera during daily chronic treatment with Copaxone. Maximal levels were attained after an average treatment duration of 3-4 months and, thereafter, declined and stabilised at a level slightly higher than baseline.

There is no evidence to suggest that these glatiramer acetate-reactive antibodies are neutralising or that their formation is likely to affect the clinical efficacy of Copaxone.

In patients with renal impairment, renal function should be monitored while they are treated with Copaxone. Whilst there is no evidence of glomerular deposition of immune complexes in patients, the possibility cannot be excluded.

Interactions

Interaction between Copaxone and other medicinal products have not been formally eva luated.

There are no data on interaction with interferon beta.

An increased incidence of injection site reactions has been seen in Copaxone patients receiving concurrent administration of corticosteroids.

In vitro work suggests that glatiramer acetate in blood is highly bound to plasma proteins but that it is not displaced by, and does not itself displace, phenytoin or carbamazepine. Nevertheless, as Copaxone has, theoretically, the potential to affect the distribution of protein-bound substances, concomitant use of such medicinal products should be monitored carefully.

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 Copaxone. In controlled studies, the proportion of patients reporting these reactions, at least once, was higher following treatment with Copaxone (70%) than placebo injections (37%). The most commonly reported injection-site reactions, which were more frequently reported in Copaxone vs. placebo-treated patients, were erythema, pain, mass, pruritus, oedema, inflammation and hypersensitivity.

A reaction associated with at least one or more of the following symptoms: vasodilatation, chest pain, dyspnoea, palpitation or tachycardia has been described as the Immediate Post-Injection Reaction. This reaction may occur within minutes of a Copaxone injection. At least one component of this Immediate Post-Injection Reaction was reported at least once by 31% of patients receiving Copaxone compared to 13% of patients receiving placebo¹.

All adverse reactions, which were more frequently reported in Copaxone 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 Copaxone 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 Copaxone 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 Copaxone and 238 patients treated with placebo for up to 36 months.

System Organ Class (SOC)	Very Common (>1/10)	Common ( >1/100, 1/10)	Uncommon (>1/1000, 1/100)
Infections And Infestations	Infection, Influenza	Bronchitis, Gastroenteritis, Herpes Simplex, Otitis Media, Rhinitis, Tooth Abscess, Vaginal Candidiasis*	Abscess, Cellulitis, Furuncle, Herpes Zoster, Pyelonephritis
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)		Benign Neoplasm Of Skin, Neoplasm	Skin Cancer
Blood And Lymphatic System Disorders		Lymphadenopathy*	Leukocytosis, Leukopenia, Splenomegaly, Thrombocytopenia, Lymphocyte Morphology Abnormal
Immune System Disorders		Hypersensitivity
Endocrine Disorders			Goitre, Hyperthyroidism
Metabolism And Nutrition Disorders		Anorexia, Weight Increased*	Alcohol Intolerance, Gout, Hyperlipidaemia, Blood Sodium Increased, Serum Ferritin Decreased
Psychiatric Disorders	Anxiety*, Depression	Nervousness	Abnormal Dreams, Confusional State, Euphoric Mood, Hallucination, Hostility, Mania, Personality Disorder, Suicide Attempt
Nervous System Disorders	Headache	Dysgeusia, Hypertonia, Migraine, Speech Disorder, Syncope, Tremor*	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		Diplopia, Eye Disorder*	Cataract, Corneal Lesion, Dry Eye, Eye Haemorrhage, Eyelid Ptosis, Mydriasis, Optic Atrophy
Ear And Labyrinth Disorders		Ear Disorder
Cardiac Disorders		Palpitations*, Tachycardia*	Extrasystoles, Sinus Bradycardia, Tachycardia Paroxysmal
Vascular Disorders	Vasodilatation*		Varicose Vein
Respiratory, Thoracic And Mediastinal Disorders	Dyspnoea*	Cough, Rhinitis Seasonal	Apnoea, Choking Sensation, Epistaxis, Hyperventilation, Laryngospasm, Lung Disorder
Gastrointestinal Disorders	Nausea*	Anorectal Disorder, Constipation, Dental Caries, Dyspepsia, Dysphagia, Faecal Incontinence, Vomiting*	Colitis, Colonic Polyp, Enterocolitis, Eructation, Oesophageal Ulcer, Periodontitis, Rectal Haemorrhage, Salivary Gland Enlargement
Hepatobiliary Disorders		Liver Function Test Abnormal	Cholelithiasis, Hepatomegaly
Skin And Subcutaneous Tissue Disorders	Rash*	Ecchymosis, Hyperhidrosis, Pruritus, Skin Disorder*, Urticaria	Angioedema, Dermatitis Contact, Erythema Nodosum, Skin Nodule
Musculoskeletal And Connective Tissue Disorders	Arthralgia, Back Pain*	Neck Pain	Arthritis, Bursitis, Flank Pain, Muscle Atrophy, Osteoarthritis
Renal And Urinary Disorders		Micturition Urgency, Pollakiuria, Urinary Retention	Haematuria, Nephrolithiasis, Urinary Tract Disorder, Urine Abnormality
Pregnancy, Puerperium And Perinatal Conditions			Abortion
Reproductive System And Breast Disorders			Breast Engorgement, Erectile Dysfunction, Pelvic Prolapse, Priapism, Prostatic Disorder, Smear Cervix Abnormal, Testicular Disorder, Vaginal Haemorrhage, Vulvovaginal Disorder
General Disorders And Administration Site Conditions	Asthenia, Chest Pain*, Injection Site Reactions*§, Pain*	Chills*, Face Oedema*, Injection Site Atrophy♣ , Local Reaction*, Oedema Peripheral, Oedema, Pyrexia	Cyst, Hangover, Hypothermia, Inflammation, Injection Site Necrosis, Mucous Membrane Disorder
Injury, Poisoning And Procedural Complications			Post Vaccination Syndrome

More than 2% (>2/100) higher incidence in the Copaxone 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.

Rare (>1/10000, <1/1000) reports of anaphylactoid reactions were collected from MS patients treated with Copaxone in uncontrolled clinical trials and from post-marketing experience with Copaxone.

¹ The individual components of the Immediate Post-Injection Reaction are listed in the table under their respective frequency.

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