Glatiramer Acetate 20 mg/ml solution for injection in pre-filled syringe Taj Pharma

  1. Name of the medicinal product

Glatiramer Acetate 20 mg/ml solution for injection in pre-filled syringe

  1. Qualitative and quantitative composition

1 pre-filled syringe (1 ml) of solution for injection contains 20 mg glatiramer acetate*, equivalent to 18 mg of glatiramer.

*Glatiramer acetate is the acetate salt of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine, in molar fraction ranges of 0.129-0.153, 0.392-0.462, 0.086-0.100 and 0.300-0.374, respectively. The average molecular weight of glatiramer acetate is in the range of 5,000-9,000 daltons. Due to its compositional complexity, no specific polypeptide can be fully characterised, including in terms of amino acid sequence, although the final glatiramer acetate composition is not entirely random.

For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

Solution for injection

Clear solution free of visible particles

The solution for injection has a pH of 5.5 – 7.0 and an osmolarity of about 265 mOsmol/L.

  1. Clinical particulars

4.1 Therapeutic indications

Glatiramer Acetate is indicated for the treatment of relapsing forms of multiple sclerosis (MS) (see section 5.1 for important information on the population for which efficacy has been established).

Glatiramer Acetate is not indicated in primary or secondary progressive MS.

4.2 Posology and method of administration

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

Posology

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.

Renal impairment

Glatiramer Acetate has not been specifically studied in patients with renal impairment (see section 4.4).

Elderly

Glatiramer Acetate has not been specifically studied in the elderly.

Paediatric population

The safety and efficacy of glatiramer acetate in children and adolescents has not been established.

However, limited published data suggest that the safety profile in adolescents from 12 to 18 years of age receiving Glatiramer Acetate 20 mg subcutaneously every day is similar to that seen in adults. There is not enough information available on the use of Glatiramer Acetate in children below 12 years of age to make any recommendation for its use. Therefore, Glatiramer Acetate should not be used in this population.

Method of administration

Glatiramer Acetate is for subcutaneous use.

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 should be chosen for every injection, 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.

The CSYNC device is available should the patients want to make their injection with an injection device. The CSYNC device is an autoinjector to be used with Glatiramer Acetate pre-filled syringes and it has not been tested with other pre-filled syringes. The CSYNC device should be used as recommended in the information provided by the device manufacturer.

4.3 Contraindications

Glatiramer Acetate is contraindicated under the following conditions:

  • Hypersensitivity to the active substance (glatiramer acetate) or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

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

The treating physician should explain to the patient that a reaction associated with at least one of the following symptoms may occur within minutes of a Glatiramer Acetate injection: vasodilatation (flushing), chest pain, dyspnoea, palpitations or tachycardia (see section 4.8). The majority of these symptoms is short-lived and resolves spontaneously without any sequelae. Should a severe adverse event occur, the patient must immediately stop Glatiramer Acetate 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 for these reactions. Nevertheless, caution should be exercised when administering Glatiramer Acetate 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 Glatiramer Acetate should be discontinued.

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

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

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

4.5 Interaction with other medicinal products and other forms of interaction

Interaction between Glatiramer Acetate and other medicinal products have not been formally evaluated.

Observations from existing clinical trials and post-marketing experience do not suggest any significant interactions of Glatiramer Acetate with therapies commonly used in MS patients, including the concurrent use of corticosteroids for up to 28 days.

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 Glatiramer Acetate has, theoretically, the potential to affect the distribution of protein-bound substances, concomitant use of such medicinal products should be monitored carefully.

4.6 Fertility, pregnancy and lactation

Pregnancy

Studies in animals have not shown reproductive toxicity (see section 5.3).

Current data on pregnant women indicate no malformative or feto/neonatal toxicity of Glatiramer Acetate. To date, no relevant epidemiological data are available. As a precautionary measure, it is preferable to avoid the use of Glatiramer Acetate during pregnancy unless the benefit to the mother outweighs the risk to the foetus.

Breastfeeding

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 (see section 5.3).

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 Acetate therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

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 Acetate. In controlled studies, the proportion of patients reporting these reactions, at least once, was higher following treatment with Glatiramer Acetate (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 (see section 4.4). This reaction may occur within minutes of a Glatiramer Acetate injection. At least one component of this Immediate Post-Injection Reaction was reported at least once by 31% of patients receiving Glatiramer Acetate compared to 13% of patients receiving placebo.

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

System Organ Class (SOC)Very Common (≥1/10)Common (≥1/100 to <1/10)Uncommon (≥1/1,000 to <1/100)
Infections and infestationsInfection, InfluenzaBronchitis, 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, NeoplasmSkin Cancer
Blood and lymphatic system disordersLymphadenopathy*Leukocytosis, Leukopenia, Splenomegaly Thrombocytopenia, Lymphocyte Morphology Abnormal
Immune system disordersHypersensitivity
Endocrine disordersGoitre, Hyperthyroidism
Metabolism and nutrition disordersAnorexia, Weight Increased*Alcohol Intolerance, Gout, Hyperlipidaemia, Blood Sodium Increased, Serum Ferritin Decreased
Psychiatric disordersAnxiety*, DepressionNervousnessAbnormal Dreams, Confusional State, Euphoric Mood, Hallucination, Hostility, Mania, Personality Disorder, Suicide Attempt
Nervous system disordersHeadache,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 disordersDiplopia, Eye Disorder*Cataract, Corneal Lesion, Dry Eye, Eye Hemorrhage, Eyelid Ptosis, Mydriasis, Optic Atrophy
Ear and labyrinth disordersEar Disorder
Cardiac disordersPalpitations*, Tachycardia*Extrasystoles, Sinus Bradycardia, Tachycardia Paroxysmal
Vascular disordersVasodilatation*Varicose Vein
Respiratory, thoracic and mediastinal disordersDyspnoea*Cough, Rhinitis SeasonalApnoea, Epistaxis, Hyperventilation, Laryngospasm, Lung Disorder, Choking Sensation
Gastrointestinal disordersNausea*Anorectal Disorder, Constipation, Dental Caries, Dyspepsia, Dysphagia, Faecal Incontinence, Vomiting*Colitis, Colonic Polyp, Enterocolitis, Eructation, Oesophageal Ulcer, Periodontitis Rectal Haemorrhage, Salivary Gland Enlargement
Hepatobiliary disordersLiver Function Test AbnormalCholelithiasis, Hepatomegaly
Skin and subcutaneous tissue disordersRash*Ecchymosis, Hyperhidrosis, Pruritus, Skin Disorder*, UrticariaAngioedema, Dermatitis Contact, Erythema Nodosum, Skin Nodule
Musculoskeletal and connective tissue disordersArthralgia, Back Pain*Neck PainArthritis, Bursitis, Flank Pain, Muscle Atrophy, Osteoarthritis
Renal and urinary disordersMicturition Urgency, Pollakiuria, Urinary RetentionHaematuria, Nephrolithiasis, Urinary Tract Disorder, Urine Abnormality
Pregnancy, puerperium and perinatal ConditionsAbortion
Reproductive system and breast disordersBreast Engorgement, Erectile Dysfunction, Pelvic Prolapse, Priapism, Prostatic Disorder, Smear Cervix Abnormal, Testicular Disorder, Vaginal Haemorrhage, Vulvovaginal Disorder
General disorders and administration site conditionsAsthenia, Chest Pain*, Injection Site Reactions*§, Pain*Chills*, Face Oedema*, Injection Site Atrophy, Local Reaction*, Oedema Peripheral, Oedema, PyrexiaCyst, Hangover, Hypothermia, Immediate Post-Injection Reaction, Inflammation, Injection Site Necrosis, Mucous Membrane Disorder
Injury, poisoning and procedural complicationsPost Vaccination Syndrome

* More than 2% (>2/100) higher incidence in the Glatiramer Acetate 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 localized 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 Acetate 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 Acetate in uncontrolled clinical trials and from post-marketing experience with Glatiramer Acetate: hypersensitivity reactions (including rare occurrence of anaphylaxis, >1/10000, < 1/1000.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose

Symptoms

A few cases of overdose with Glatiramer Acetate (up to 300 mg glatiramer acetate) have been reported. These cases were not associated with any adverse reactions other than those mentioned in section 4.8.

Management

In case of overdose, patients should be monitored and the appropriate symptomatic and supportive therapy instituted.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunostimulants

Mechanism of action

The mechanism by which glatiramer acetate exerts therapeutic effects in relapsing forms of MS is not fully elucidated but is presumed to involve modulation of immune processes. Studies in animals and MS patients suggest glatiramer acetate acts on innate immune cells, including monocytes, dendritic cells and B cells, which in turn modulate adaptive functions of B and T cells inducing anti-inflammatory and regulatory cytokine secretion. Whether the therapeutic effect is mediated by the cellular effects described above is not known because the pathophysiology of MS is only partially understood

Clinical efficacy and safety

RRMS:

A total of 269 patients have been treated with Glatiramer Acetate in three controlled trials. The first was a two-year study involving 50 patients (Glatiramer Acetate n=25, placebo n=25) who were diagnosed with relapsing-remitting MS by the then-applicable standard criteria, and who had at least two attacks of neurological dysfunction (exacerbations) during the preceding two years. The second study applied the same inclusion criteria and included 251 patients treated for up to 35 months (Glatiramer Acetate n=125, placebo n=126). The third study was a nine-month study involving 239 patients (Glatiramer Acetate n=119, placebo n=120) where inclusion criteria were similar to those in the first and second studies with the additional criterion that patients had to have at least one gadolinium-enhancing lesion on the screening MRI.

In clinical trials in MS patients receiving Glatiramer Acetate, a significant reduction in the number of relapses, compared with placebo, was seen.

In the largest controlled study, the relapse rate was reduced by 32% from 1.98 under placebo to 1.34 under glatiramer acetate.

Exposure data are available for up to twelve years in 103 patients treated with Glatiramer Acetate.

Glatiramer Acetate has also demonstrated beneficial effects over placebo on MRI parameters relevant to relapsing-remitting MS.

Glatiramer Acetate 20 mg/mL: In the controlled study 9001/9001E, which enrolled 251 patients, who were followed for up to 35 months (including a blinded phase extension 9001E of the 9001 study), the cumulative percentage of patients who developed 3-month confirmed disability progression was 29.4% for placebo and 23.2% for Glatiramer Acetate-treated patients (p=0.199).

There is no evidence that Glatiramer Acetate treatment has an effect on relapse duration or severity.

There is currently no evidence for the use of Glatiramer Acetate in patients with primary or secondary progressive disease.

Single clinical event suggestive of MS:

One placebo-controlled study involving 481 patients (Glatiramer Acetate n=243, placebo n=238) was performed in patients with a well-defined, single, unifocal neurological manifestation and MRI features highly suggestive of MS (at least two cerebral lesions on the T2-weighted MRI above 6 mm diameter). Any disease other than MS that could better explain signs and symptoms of the patient had to be excluded. The placebo-controlled period was followed by an open label treatment: Patients who either presented with MS symptoms or were asymptomatic for three years, whichever came first, were assigned to active drug treatment in an open-label phase for an additional period of two years, not exceeding a maximal total treatment duration of 5 years. Of the 243 patients initially randomised to Glatiramer Acetate, 198 continued Glatiramer Acetate treatment in the open-label phase. Of the 238 patients initially randomised to placebo, 211 switched to Glatiramer Acetate treatment in the open-label phase.

During the placebo-controlled period of up to three years, Glatiramer Acetate delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) according to Poser criteria in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 45% (Hazard Ratio = 0.55; 95% CI [0.40; 0.77], p-value=0.0005). The proportion of patients who converted to CDMS was 43% for the placebo group and 25% in the Glatiramer Acetate group.

The favourable effect of treatment with Glatiramer Acetate over placebo was also demonstrated in two secondary MRI endpoints, i.e. number of new T2 lesions and T2 lesion volume.

Post-hoc subgroup analyses were performed in patients with various baseline characteristics to identify a population at high risk to develop the second attack. For subjects with baseline MRI with at least one T1 Gd-enhancing lesion and 9 or more T2 lesions, conversion to CDMS was evident for 50% of the placebo subjects vs. 28% of the Glatiramer Acetate subjects in 2.4 years. For subjects with 9 or more T2 lesions at baseline, conversion to CDMS was evident for 45% of the placebo subjects vs. 26% on Glatiramer Acetate in 2.4 years. However, the impact of early treatment with Glatiramer Acetate on the long term evolution of the disease is unknown even in these high-risk subgroups as the study was mainly designed to assess the time to the second event. In any case, treatment should only be considered for patients classified at high risk.

The effect shown in the placebo-controlled phase was sustained in the long-term follow-up period of up to 5 years. The time progression from the first clinical event to CDMS was prolonged with earlier Glatiramer Acetate treatment as compared to delayed treatment, reflecting a 41% risk reduction with earlier versus later treatment (Hazard Ratio = 0.59; 95% CI [0.44; 0.80], p-value=0.0005). The proportion of subjects in the Delayed Start group who progressed was higher (49.6%) compared to those in the Early Start group (32.9%).

A consistent effect in favour of early treatment over delayed treatment across time was shown for the annualised number of lesions over the entire study period in new T1 Gd-enhancing lesions (reduced by 54%; p<0.0001), new T2 lesions (reduced by 42%; p<0.0001) and new T1 hypointense lesions (reduced by 52%; p<0.0001). An effect in reductions in favour of early versus delayed treatment was also observed for the total number of new T1 Gd-enhancing lesions (reduced by 46%; p=0.001), T1 Gd-enhancing lesion volume (a mean difference of -0.06 ml; p<0.001), as well as the total number of new T1 hypointense lesions (reduced by 46%; p<0.001) measured over the entire study period.

No appreciable differences between the Early Start and Delayed Start cohorts were observed for either hypointense T1 lesion volume or brain atrophy over 5 years. However, analysis of brain atrophy at last observed value (adjusted to treatment exposure) showed a reduction in favour of early treatment with GA (the mean difference of percent change in brain volume was 0.28%; p=0.0209).

5.2 Pharmacokinetic properties

Pharmacokinetic studies in patients have not been performed. In vitro data and limited data from healthy volunteers indicate that with subcutaneous administration of glatiramer acetate, the active substance is readily absorbed and that a large part of the dose is rapidly degraded to smaller fragments already in subcutaneous tissue.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction, beyond the information included in other sections of the SPC. Due to the lack of pharmacokinetic data in humans, margins of exposure between humans and animals cannot be established.

Immune complex deposition in the glomeruli of the kidney was reported in a small number of rats and monkeys treated for at least 6 months. In a 2 years rat study, no indication of immune complex deposition in the glomeruli of the kidney was seen.

Anaphylaxis after administration to sensitized animals (guinea pigs or mice) was reported. The relevance of these data for humans is unknown.

Toxicity at the injection site was a common finding after repeated administration in animals.

In rats, a slight but statistically significant reduction in body weight gain of offspring born to dams treated during pregnancy and throughout lactation was observed at subcutaneous doses ≥ 6mg/kg/day (2.83-times the maximum recommended human daily dose for a 60 kg adult based on mg/m2) in comparison to control. No other significant effects on offspring growth and behavioural development were observed.

  1. Pharmaceutical particulars

6.1 List of excipients

Mannitol

Water for Injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Keep the pre-filled syringes in the outer carton, in order to protect from light.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

If the pre-filled syringes cannot be stored in a refrigerator, they can be stored between 15°C and 25°C, once for up to one month.

After this one-month period, if the Glatiramer Acetate 20 mg/ml pre-filled syringes have not been used and are still in their original packaging, they must be returned to storage in a refrigerator (2°C to 8°C).

6.5 Nature and contents of container

A pre-filled syringe containing Glatiramer Acetate solution for injection consists of a 1 ml colourless type I glass syringe barrel with staked needle, a polypropylene (optional polystyrene) plunger rod, a rubber plunger stopper and a needle shield.

Each pre-filled syringe is packed separately in a PVC blister pack.

Glatiramer Acetate is available in packs containing 7, 28 or 30 pre-filled syringes of 1 ml solution for injection or a multipack containing 90 (3 packs of 30) pre-filled syringes of 1 ml solution for injection.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

For single use only.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Glatiramer Acetate 20mg/ml, Solution For Injection, Pre-Filled Syringe

Package leaflet: Information for the user

glatiramer acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  1. What Glatiramer Acetate is and what it is used for
    2. What you need to know before you use Glatiramer Acetate
    3. How to use Glatiramer Acetate
    4. Possible side effects
    5. How to store Glatiramer Acetate
    6. Contents of the pack and other information
  2. What Glatiramer Acetate is and what it is used for

Glatiramer Acetate is a medicine used for the treatment of relapsing forms of multiple sclerosis (MS). It modifies the way in which your body’s immune system works and it is classed as an immunomodulating agent. The symptoms of MS are thought to be caused by a defect in the body’s immune system. This produces patches of inflammation in the brain and spinal cord.

Glatiramer Acetate is used to reduce the number of times you suffer attacks of MS (relapses). It has not been demonstrated to help if you have any form of MS which does not have relapses, or hardly any relapses. Glatiramer Acetate may not have any effect on the length of time an MS attack lasts, or how badly you suffer during an attack.

It is used to treat patients who are able to walk without help.

Glatiramer Acetate may also be used in patients who have experienced symptoms for the first time which indicate a high risk of developing MS. Your doctor will rule out any other reasons which could explain these symptoms before you are treated.

2.What you need to know before you use Glatiramer Acetate

Do not use Glatiramer Acetate:

  • if you are allergic to glatiramer acetate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Glatiramer Acetate if you have any kidney or heart problems as you may need to have regular tests and check-ups.

Children

Glatiramer Acetate is not to be used in children below the age of 12 years.

Elderly

Glatiramer Acetate has not been specifically studied in the elderly. Please ask your doctor for advice.

Other medicines and Glatiramer Acetate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice and consideration regarding Glatiramer Acetate treatment during pregnancy and/or lactation.

Driving and using machines

Glatiramer Acetate is not known to influence the ability to drive or operate machinery.

  1. How to use Glatiramer Acetate

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended daily dose in adults and adolescents aged 12 years and over is one pre-filled syringe (20 mg of glatiramer acetate), administered under the skin (subcutaneously).

It is very important to inject Glatiramer Acetate properly:

  • Into the tissue under the skin (subcutaneous use) only (see “Instructions for use”).
  • At the dose instructed by your doctor. Use only the dose prescribed by your doctor.
  • Never use the same syringe more than once. Any unused product or waste must be discarded.
  • Do not mix or co-administer the content of Glatiramer Acetate pre-filled syringes with any product.
  • If the solution contains particles, do not use it. Use a new syringe.

The first time you use Glatiramer Acetate you will be given full instructions and will be supervised by a doctor or nurse. They will be with you while you give yourself the injection and for half an hour afterwards, just to make sure you do not have any problems.

Instructions for use

Read these instructions carefully before using Glatiramer Acetate.

Before the injection, make sure you have everything you need:

  • One blister with one Glatiramer Acetate pre-filled syringe
  • Disposal unit for used needles and syringes.
  • For each injection, take only one blister with one pre-filled syringe from the package. Keep all remaining syringes in the box.
  • If your syringe has been stored in the refrigerator, take the blister containing the syringe out at least 20 minutes before you will inject the medicine so that it warms up to room temperature.

Wash your hands thoroughly with soap and water.

If you wish to use an injection device to make your injection, the CSYNC device can be used with Glatiramer Acetate. The CSYNC device is only approved to be used with Glatiramer Acetate and has not been tested with other products. Please refer to the instructions for use provided together with the CSYNC injection device.

Choose the injection site, within the areas, using the diagrams. There are seven possible areas on your body for injection:

  • Area 1: Stomach area (abdomen) around the belly button. Avoid 5 cm around the belly button,
  • Area 2 and 3: Thighs (above your knees),
  • Area 4, 5, 6 and 7: Back of the upper arms, and upper hips (below your waist).

Within each injection area there are several injection sites. Choose a different site for the injection every day. This will reduce the likeliness of any irritation or pain at the site of the injection. Rotate injection areas and also rotate the injection sites within an area. Do not use the same site each time.

Please note: do not inject in any area that is painful or discoloured or where you feel firm knots or lumps.You should consider having a planned schedule for rotating injection sites and making a note of it in a diary.There are some sites on your body that may be difficult for self-injection (like the back of your arms). If you want to use these, you may require assistance.

How to inject:

  • Remove the syringe from its protective blister by peeling back the blister lid.
  • Remove the shield from the needle, do not remove the shield with your mouth or teeth.
  • Gently pinch up the skin with the thumb and forefinger of the free hand (Figure 1).
  • Push the needle into the skin as shown in Figure 2.
  • Inject the medicine by steadily pushing the plunger all the way down until the syringe is empty.
  • Pull the syringe and needle straight out.
  • Discard the syringe in a safe disposal container. Do not put used syringes into the household waste but dispose of them carefully in a puncture-proof container as recommended by your doctor or nurse.

If you have the impression that the effect of Glatiramer Acetate is too strong or too weak, talk to your doctor.

If you use more Glatiramer Acetate than you should

Talk to your doctor immediately.

If you forget to use Glatiramer Acetate

Use it as soon as you remember but do not use a double dose to make up for forgotten individual doses. Use the next dose 24 hours later.

If you stop using Glatiramer Acetate

Do not stop using Glatiramer Acetate without consulting your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions (hypersensitivity)

You may rarely develop a serious allergic reaction to this medicine.

Stop using Glatiramer Acetate and contact your doctor immediately or go to the casualty department at your nearest hospital, if you notice any sign of these side effects:

  • rash (red spots or nettle rash)
  • swelling of the eyelids, face or lips
  • sudden shortness of breath
  • convulsions (fits)
  • fainting

Other reactions following injection (immediate post-injection reaction)

It’s uncommon but some people may get one or more of the following symptoms within minutes after injecting Glatiramer Acetate. They normally do not cause any problems and usually disappear within half an hour.

However, if the following symptoms last longer than 30 minutes, contact your doctor immediately or go to the casualty department at your nearest hospital:

  • flushing (reddening) of the chest or face (vasodilatation)
  • shortness of breath (dyspnoea)
  • chest pain
  • pounding and rapid heartbeat (palpitations, tachycardia)

The following side effects have been reported with Glatiramer Acetate:

Very common: may affect more than 1 in 10 people

  • infection, flu
  • anxiety, depression
  • headache
  • feeling sick
  • skin rash
  • pain in the joints or back
  • feeling weak, skin reactions at the injection site including reddening of skin, pain, formation of wheals, itching, tissue swelling, inflammation and hypersensitivity (these injection site reactions are not unusual and normally decrease over time), non-specific pain

Common: may affect up to 1 in 10 people

  • inflammation of the respiratory tract, gastric flu, cold sore, inflammation of the ears, runny nose, tooth abscess, vaginal thrush
  • non-malignant skin growth (non-malignant neoplasm of skin), tissue growth (neoplasm)
  • lymph node swelling
  • allergic reactions
  • loss of appetite, weight gain
  • nervousness
  • altered taste, increased tightness of muscle tone, migraine, speech disorder, fainting, tremor
  • double vision, eye disorder
  • ear disorder
  • cough, hay fever
  • disorder of anus or rectum, constipation, tooth decay, indigestion, difficulty in swallowing, bowel incontinence, vomiting
  • abnormal liver function test
  • bruising, excessive sweating, itching, skin disorder, nettle rash
  • neck pain
  • urge to empty your bladder, frequent urination, inability to empty your bladder appropriately
  • chill, face swelling, wasting of tissue under the skin at injection site, local reaction, peripheral swelling due to build-up of fluid, fever

Uncommon: may affect up to 1 in 100 people

  • abscess, inflammation of skin and the soft tissue underneath, boils, shingles, inflammation of kidney
  • skin cancer
  • increased white blood cell count, reduced white blood cell count, spleen enlargement, low blood platelet count, change in form of white blood cells
  • enlarged thyroid, overactive thyroid
  • low alcohol tolerance, gout, increase in blood fat levels, increase in blood sodium, decrease in serum ferritin
  • abnormal dreams, confusion, euphoric mood, seeing, hearing, smelling, tasting or feeling something that is not there (hallucinations), aggression, abnormal elevated mood, personality disorder, suicide attempt
  • hand numbness and pain (carpal tunnel syndrome), mental disorder, fits (convulsion), problems with handwriting and reading, muscle disorders, problems with movement, muscle spasm, nerve inflammation, abnormal nerve-muscle link leading to abnormal muscle function, involuntary rapid movement of the eyeballs, paralysis, foot drop (peroneal nerve palsy), unconscious state (stupor), visual blind spots
  • cataract, eye lesion in the cornea, dry eye, eye bleeding, droopy upper eyelid, pupil widening, wasting of the optic nerve leading to visual problems
  • extra heart beats, slow heart beats, episodic fast heart beats
  • varicose vein
  • periodic stops in breathing, nose bleeding, abnormally fast or deep breathing (hyperventilation), tight feeling in the throat, lung disorder, inability to breathe due to throat tightness (choking sensation)
  • bowel inflammation, polyps in the colon, intestine inflammation, burping, ulcer in the gullet, inflammation of the gums, rectal bleeding, enlarged salivary glands
  • gallstones, liver enlargement
  • swelling of the skin and soft tissues, skin contact rash, painful red skin lumps, skin lumps
  • swelling, inflammation and pain of joints (arthritis or osteoarthritis), inflammation and pain of fluid-sacs lining the joint (exist in some of the joints), flank pain, decrease in the mass of muscles
  • blood in the urine, kidney stones, urinary tract disorder, urine abnormality
  • abortion
  • breast swelling, difficulties getting an erection, fall down or slip out of the place of pelvic organs (pelvic prolapse), sustained erections, disorders of prostate, abnormal PAP smear test (Smear Cervix Abnormal), testes disorder, vaginal bleeding, vaginal disorder
  • cyst, hangover, low body temperature (hypothermia), non-specific inflammation, destruction of tissue at the injection site, problems with mucous membranes
  • disorders after vaccination

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaftet. You can also report side effects directly. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Glatiramer Acetate

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton (EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Glatiramer Acetate pre-filled syringes can be kept for up to one month outside the refrigerator between 15°C and 25°C. You can do this only once. After one month any Glatiramer Acetate pre-filled syringes that have not been used and are still in their original packaging must be returned to the refrigerator.

Do not freeze.

Keep the pre-filled syringes in the outer carton in order to protect from light.

Dispose of any syringes that contain particles.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. Contents of the pack and other information

What Glatiramer Acetate contains

  • The active substance is glatiramer acetate. 1 ml solution for injection (the contents of one pre-filled syringe) contains 20 mg glatiramer acetate, equivalent to 18 mg of glatiramer.
  • The other ingredients are mannitol and water for injections.

What Glatiramer Acetate looks like and contents of the pack

Glatiramer Acetate solution for injection in pre-filled syringe is a clear solution, free of visible particles.

Each pre-filled syringe is packed separately in a PVC blister pack.

Glatiramer Acetate is available in packs containing 7, 28 or 20 pre-filled syringes of 1 ml solution for injection or in a multipack, of 90 pre-filled syringes comprising 3 cartons, each containing 30 pre-filled syringes of 1 ml of solution for injection.

Not all pack sizes may be marketed.

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com