Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glatiramer acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Brabio 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 multiple sclerosis (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. Brabio 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. Brabio may not have any effect on the length of time an MS attack lasts, or how badly you suffer during an attack.
What you need to know before you take it
e Brabio Do not use Brabio 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 Brabio if you have any kidney or heart problems as you may need to have regular tests and check-ups. if you have or have had any liver problems (including those due to alcohol consumption). Brabio can cause severe allergic reactions, some of which may be life-threatening. These reactions may occur shortly after administration, even months up to years after starting treatment and even if previous
administrations were without allergic reactions. The signs and symptoms of allergic reactions may overlap with post-injection reactions. Your doctor will inform you on the signs of an allergic reaction. Children Brabio is not to be used in children below the age of 18 years. Elderly Brabio has not been specifically studied in the elderly. Please ask your doctor for advice. Other medicines and Brabio 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, think you may be pregnant or are planning to have a baby, ask your doctor for advice and consideration regarding brabio treatment during pregnancy. Brabio may be used during pregnancy upon advice from your doctor. Limited data in humans showed no negative effects of glatiramer acetate on breastfed newborns/infants. Brabio can be used during breast-feeding. Driving and using machines Brabio is not known to influence the ability to drive or operate machinery.
How to take it
Brabio Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose in adults is one pre-filled syringe (40 mg of glatiramer acetate), administered under the skin (subcutaneously) three times a week, injected at least 48 hours apart, for example Monday Wednesday and Friday. It is recommended to administer the drug on the same days every week. It is very important to inject Brabio properly: Into the tissue under the skin (subcutaneous tissue) only (see "Instructions for Use" below). 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 Brabio pre-filled syringes with any product. If the solution contains particles, do not use it. Use a new syringe. The first time you use Brabio 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 Brabio. Before the injection, make sure you have everything you need: One blister with one Brabio 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 MyJECT device can be used with Brabio. The MyJECT device is only approved to be used with Brabio and has not been tested with other products. Please refer to the instructions for use provided with the MyJECT injection device. Choose the injection site, within the area, 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, end of 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 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 arm). 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.
Figure 1
Figure 2
If you have the impression that the effect of Brabio is too strong or too weak, talk to your doctor. If you use more Brabio than you should Talk to your doctor immediately.
If you forget to use Brabio Use it as soon as you remember or are able to use it, then skip the following day. Do not use a double dose to make up for forgotten individual doses. If possible you should return to your regular administration schedule the following week. If you stop using Brabio Do not stop using Brabio without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions (hypersensitivity, anaphylactic reaction) You may develop a serious allergic reaction to this medicine shortly after administration. This is an uncommon side effect. These reactions may occur months up to years after starting treatment with Brabio, even if previous administrations were without allergic reactions. Stop using Brabio and contact your doctor immediately or go to the emergency department at your nearest hospital, if you notice any sudden sign of these side effects: widespread rash (red spots or nettle rash), swelling of the eyelids, face, lips, mouth, throat or tongue, sudden shortness of breath, difficulty breathing or weezing, convulsions (fits), trouble swallowing or speaking, fainting, feeling dizzy or faint, collapse. Other reactions following Injection (Immediate post-injection reaction) 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, tell 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).
Liver problems Liver problems or worsening of liver problems, including liver failure (some cases resulting in liver transplantation), can occur rarely with Brabio. Contact your doctor right away if you have symptoms such as: nausea, loss of appetite, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal.
In general the side effects reported by patients using glatiramer acetate 40 mg/ml three times a week were also reported in patients who used glatiramer acetate 20 mg/ml (see the following list). The following side effects have been reported with glatiramer acetate: Very common (may affect more than 1 in 10 people) Infections, 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 breath 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 • 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 leaflet. You can also report side effects directly via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Brabio Keep this medicine out of the sight and reach of children. Store in a refrigerator (2°C – 8°C). Brabio pre-filled syringes can be kept for up to one month outside the refrigerator between 15oC and 25oC. You can do this only once. After one month any Brabio 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. Do not use this medicine after the expiry date which is stated on the label and carton after 'EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month. Dispose of any syringes that contain particles. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Brabio contains The active substance is glatiramer acetate. 1 ml solution for injection (the contents of one pre-filled syringe) contains 40 mg glatiramer acetate. The other excipients are mannitol and water for injections. What Brabio looks like and contents of the pack Brabio solution for injection in pre-filled syringe is a sterile, clear colourless to slightly yellow/brownish solution. If the solution contains particles, throw it away and start again. Use a new syringe. 3 pre-filled syringes 12 pre-filled syringes 36 (3×12) pre-filled syringes Not all pack sizes may be marketed. Marketing Authorisation Holders: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturers: Synthon Hispania SL Castelló 1, Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain Synthon BV
Microweg 22, 6545 CM Nijmegen, The Netherlands This leaflet was last revised in 11/2024.
Frequently asked questions about Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe
How do I take Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe?
Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe comes as injection containing 40mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe?
The active substance in Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe is glatiramer acetate.
Are there equivalent medicines to Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe?
Medicines with the same active substance, strength and form include: Copaxone 40 mg/ml solution for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: glatiramer acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
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 40 mg of glatiramer acetate (one pre-filled syringe), administered as a subcutaneous injection three times a week with at least 48 hours apart.
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. There is not enough information available on the use of glatiramer acetate 40 mg/ml TIW in children and adolescents below 18 years of age to make any recommendation for its use. Therefore, glatiramer acetate 40 mg/ml TIW should not be used in this population.
Method of administration
Brabio 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 MyJECT device is available should the patients want to make their injection with an injection device. The MyJECT device is an autoinjector to be used with Brabio pre-filled syringes and it has not been tested with other pre-filled syringes. The MyJECT 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.
Glatiramer acetate can cause post-injection reactions as well as anaphylactic reactions (see section 4.8):
Post-injection reactions
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.
Anaphylactic reactions
Anaphylactic reactions may occur shortly following administration of glatiramer acetate, even months up to years after initiation of treatment (see section 4.8). Cases with fatal outcome have been reported. Some signs and symptoms of anaphylactic reactions may overlap with post-injection reactions.
All patients receiving treatment with [product name] and caregivers should be informed about the signs and symptoms specific for anaphylactic reactions and that they should seek immediate emergency medical care in case of experiencing such symptoms (see section 4.8).
If an anaphylactic reaction occurs, treatment with [product name] must be discontinued (see section 4.3).
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 glatiramer acetate.
Rare cases of severe liver injury have been observed (including hepatitis with jaundice, liver failure, and in isolated cases liver transplantation). Liver injury occurred from days to years after initiating treatment with glatiramer acetate. Most instances of severe liver injury resolved with discontinuation of treatment. In some cases, these reactions have occurred in the presence of excessive alcohol consumption, existing or history of liver injury and use of other potentially hepatotoxic medication. Patients should be regularly monitored for signs of hepatic injury and instructed to seek immediate medical attention in case of symptoms of liver injury. In case of clinically significant liver injury, discontinuation of glatiramer acetate should be considered.
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.
There are no data on interaction with interferon beta.
An increased incidence of injection site reactions has been seen in glatiramer acetate 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 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
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity.
Animal studies do not indicate reproductive toxicity (see section 5.3).
The use of Brabio may be considered during pregnancy, if necessary.
Breast-feeding
The physico-chemical properties and low oral absorption suggest that exposure of newborns/infants to glatiramer acetate via human breast milk is negligible. A non-interventional retrospective study in 60 breastfed infants of mothers exposed to glatiramer acetate compared to 60 breastfed infants of mothers not exposed to any disease modifying therapy and limited post-marketing human data showed no negative effects of glatiramer acetate.
Brabio can be used during breast-feeding.
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
Most glatiramer acetate safety data were accumulated for glatiramer acetate 20 mg/ml administered as a subcutaneous injection once daily. This section presents accumulated safety data from four placebo-controlled trials with glatiramer acetate 20 mg/ml administered once daily, and from one placebo-controlled trial with glatiramer acetate 40 mg/ml administered three times a week.
A direct comparison of the safety between glatiramer acetate 20 mg/ml (administered daily) and 40 mg/ml (administered three times per week) in the same study has not been performed.
Glatiramer acetate 20 mg/ml (administered once daily)
In all clinical trials with glatiramer acetate 20 mg/ml, 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 20 mg/ml (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 20 mg/ml compared to 13% of patients receiving placebo.
Adverse reactions identified from clinical trials and post marketing experience are presented in the table below. Data from clinical trials was derived from four pivotal, double-blind, placebo-controlled clinical trials with a total of 512 patients treated with glatiramer acetate 20 mg/day 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 20 mg/day 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 20 mg/day 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)
Rare
(≥1/10,000 to <1/1,000)
Not known
(cannot be estimated from the available data)
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
Anaphylactic reaction
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, Epistaxis, Hyperventilation, Laryngospasm, Lung disorder, Choking sensation
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
Toxic hepatitis, Liver injury
Hepatic failure#
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
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, Immediate post-injection reaction, Inflammation, Injection site necrosis, Mucous membrane disorder
Injury, poisoning and procedural complications
Post 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 localised lipoatrophy at the injection sites.
# Few cases were reported with liver transplantation.
In the fourth trial noted above, an open-label treatment phase followed the placebo-controlled period. No change in the known risk profile of glatiramer acetate 20 mg/ml was observed during the open-label follow-up period of up to 5 years.
Glatiramer acetate 40 mg/ml (administered three times per week)
The safety of glatiramer acetate 40 mg/ml was assessed based on a double-blind, placebo-controlled clinical trial in RRMS patients with a total of 943 patients treated with glatiramer acetate 40 mg/ml three times per week, and 461 patients treated with placebo for 12 months.
In general, the kind of adverse drug reactions seen in patients treated with glatiramer acetate 40 mg/ml administered three times per week were those already known and labeled for glatiramer acetate 20 mg/ml administered daily. In particular, adverse injection site reactions (ISR) and immediate post-injection reactions (IPIR) were reported at lower frequency for glatiramer acetate 40 mg/ml administered three times per week than for glatiramer acetate 20 mg/ml administered daily (35.5 % vs. 70 % for ISRs and 7.8 % vs. 31 % for IPIRs, respectively).
Injection site reactions were reported by 36% of the patients on glatiramer acetate 40 mg/ml compared to 5% on placebo. Immediate post-injection reaction was reported by 8% of the patients on glatiramer acetate 40 mg/ml compared to 2% on placebo.
A few specific adverse reactions are noted:
• Anaphylactic reactions may occur shortly following administration of glatiramer acetate, even months up to years after initiation of treatment (see section 4.4).
• No injection site necrosis was reported.
• Skin erythema and pain in extremity, not labelled for glatiramer acetate 20 mg/ml, were reported each by 2.1% of the patients on glatiramer acetate 40 mg/ml (Common: ≥1/100 to < 1/10).
• Drug-induced liver injury and toxic hepatitis were each reported by one patient (0.1%) on glatiramer acetate 40 mg/ml (Uncommon: ≥1/1,000 to < 1/100).
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 via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
💬 Ask about this leaflet
Ask anything about Brabio 40 mg/mL Solution for Injection, Pre-filled Syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.