How does it work?

Copaxone injection contains the active ingredient glatiramer acetate, which is a type of medicine called an immunomodulator. Glatiramer acetate consists of synthetic polypeptides that are made up of four naturally occurring amino acids: L- glutamic acid, L-alanine, L-tyrosine and L-lysine.

Copaxone is used to treat multiple sclerosis (MS). In some people, this disease follows a course of relapse and remission, where symptoms worsen for a while, then improve before worsening again. It is these people who can benefit from treatment with Copaxone.

It is not fully understood how glatiramer works in MS, because the disease and its cause are not fully understood. However, it is thought to act on the processes in the immune system that are currently believed to be responsible for causing the disease.

The medicine helps to reduce the frequency of the relapses. However, it has not been shown to reduce the severity or duration of the relapses, or to have any effect on the overall progression of disability in people with relapsing-remitting MS.

Copaxone is not effective in all people with multiple sclerosis. It should only be started by a neurologist or specialist in MS.

Copaxone is given by injection under the skin (subcutaneously) once daily. The injection comes as pre-filled syringes and you will be taught how to administer the injection yourself. Sites to use include the abdomen, arms, hips and thighs, and a different site should be used every day.

It is not known how long treatment should be continued for. You will need to have regular check-ups with your specialist after starting treatment to make sure the medicine is still producing a benefit.

What is it used for?

• Relapsing/remitting multiple sclerosis (characterised by at least two relapses over the previous two years, without evidence of progression of the disease between relapses) in people who are able to walk unaided.

The medicine is licensed for reducing the frequency of relapses in this group of people.

Warning!

• Carefully follow the instructions provided with your injections and given by your doctor. The injection must only be administered under the skin (subcutaneously) and not into a vein (intravenously) or a muscle (intramuscularly). A different injection site should be used for each dose.
• You may get a reaction within a few minutes of having an injection that involves flushing, chest pain, shortness of breath, difficulty breathing, awareness of your heartbeat (palpitations) or a racing heartbeat. These symptoms normally go away on their own within half an hour, but if they last longer than this or become severe you should stop using the medicine and consult a doctor. Medical attention should also be sought immediately in the rare event that you experience an allergic reaction after having an injection, for example seizures (fits), swelling of the eyelids, face, lips or throat, hives, sudden wheezing or fainting.
• Copaxone pre-filled syringes should be stored in a refrigerator (2°C to 8°C). Make sure they are kept out of the reach of children. If they can’t be stored in a refrigerator, they can be stored at room temperature (15°C to 25°C), once for up to one month. Keep the syringes in the outer carton to protect them from light.

Use with caution in

• Elderly people.
• People with decreased kidney function.
• Heart disease, such as angina, heart failure or irregular heartbeats (arrhythmias).

Not to be used in

• Primary or secondary progessive multiple sclerosis.
• Pregnancy.
• People allergic to mannitol and/or glatiramer acetate.
• The safety and efficacy of this medicine have not been established in children and adolescents less than 12 years of age. It is not recommended for this age group.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been established. It should not be used during pregnancy. Women who could get pregnant should use a reliable method of contraception to avoid getting pregnant while being treated with this medicine.
• It is not known if this medicine passes into breast milk. This medicine should be used with caution by breastfeeding mothers, and only if the expected benefit to the mother is greater than any possible risk to the baby. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

• Injection site reactions, such as redness, pain, swelling or itching at injection site.
• Awareness of your heartbeat (palpitations).
• Flushing.
• Chest pain.
• Shortness of breath.
• Disturbances of the gut, such as nausea, constipation, diarrhoea.
• Rash or sweating.
• Flu-like symptoms, feeling weak.
• Dizziness.
• Stiffness in the muscles.
• Joint pain (arthralgia) or back pain.
• Headache.
• Depression or anxiety.

Common (affect between 1 in 10 and 1 in 100 people)

• Allergic reactions.
• Increased heart rate or blood pressure.
• Migraine.
• General feeling of being unwell (malaise).
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).
• Weight gain.
• Fainting.
• Tremor.
• Confusion.
• Memory loss.
• Swollen glands (lymphadenopathy).
• Herpes simplex infections, such as cold sores.
• Benign abnormal skin growths.
• Eye disorders.
• Fungal infection of the vagina.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

The effect of this medicine on other medicines has not been formally studied.

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while using this one, to ensure that the combination is safe.

You may be more likely to experience injection site reactions if you are being treated with corticosteroids in combination with this medicine.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain glatiramer acetate as the active ingredient.