40 mg/mL

glatiramer acetate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Copaxone Pen 40 mg/mL.

Copaxone Pen is a single use, fixed dose device that contains a pre-filled syringe of Copaxone 40 mg/mL. This device will assist in the administration of Copaxone.

It does not contain all the available information. It does not take the place of talking to your doctor and pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

If you have any concerns regarding using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Copaxone Pen 40mg/mL is used for

Copaxone Pen forty mg/mL is used for the management of relapsing forms of Multiple Sclerosis (MS).

Copaxone Pen may also be used in patients who, for the first time, have experienced symptoms and have MRI changes that indicate a high risk for development of MS. Your doctor will rule out any other reasons which could explain these symptoms before you are treated.

The cause of MS is not yet known. MS affects the brain and spinal cord. In MS, the body’s immune system reacts against its own myelin (the ‘insulation’ surrounding nerve fibres). In relapsing forms of MICROSOFT, people can have ‘exacerbations’ from time to time (e. g. blurred vision, weakness in the legs or arms, or loss of control of bowel or bladder function). These are followed by periods associated with recovery.

Although the exact mechanism of how Copaxone works in MS is unknown, it is thought that Copaxone works by changing the immune processes that are believed to be responsible for the disease.

Copaxone has been shown to be effective in reducing the number of relapses in patients with relapsing remitting MS. Although it is not a cure, individuals treated with Copaxone generally find that they will experience fewer relapses.

Your doctor, however , may prescribe Copaxone Pen 40mg/mL for another purpose.

Ask your physician or pharmacist if you have any questions about why it has been prescribed for you.

This medicine is only available with a doctor’s prescription.

When you must not use it

Do not use Copaxone if you are allergic to it or any of the ingredients listed at the end of this leaflet.

Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty within swallowing or breathing.

Usually do not give Copaxone to children.

There is no experience with its use in children under 12 years of age.

Do not use it after the expiry date (EXP) printed on the pack.

If you use it after the expiry date has passed, it may not work as well.

Do not use it if the packaging is damaged or even shows signs of tampering.

Before you start to use it

Tell your doctor or pharmacist if you have allergies to:

any of the ingredients listed at the end of this leaflet

any other medicines

any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the risks and benefits of using it if you are pregnant.

Tell your doctor in case you are breast-feeding or plan to breast-feed.

It is not known whether Copaxone passes into breast milk. Your doctor will discuss the potential risks and benefits of using it if you are breast-feeding or planning to breast-feed.

Tell your doctor if you have or have ever had any medical conditions, especially the following:

asthma

a history of severe allergic reactions

Tell your physician if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you use Copaxone Pen 40mg/mL.

Taking other medicines

Tell your doctor or pharmacist in case you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.

Some medicines may interfere with the absorption of Copaxone.

These medicines may be affected by Copaxone, or may affect how well it works. You may need to use different amounts of your medicine, or take different medicines. Your doctor or pharmacist will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or even avoid while using Copaxone Pencil 40 mg/mL.

How to use it

Follow all directions given to you by your doctor, MS education nurse or pharmacist.

They may differ from the information contained in this leaflet.

How much to use

The recommended dose of this medication is one 40 mg/mL pre-filled syringe (1mL) injected three times a week and at least 48 hours apart.

Copaxone Pen 40 mg/mL should be given, if possible, at the same time and on the same three days each week (for example, Monday, Wednesday and Friday) at least 48 hours apart.

Do not change the dosage or dosing schedule or stop using Copaxone Pencil without talking to your doctor.

How to use it

Copaxone Pen 40 mg/mL is given by an injection into the fatty layer under the skin (subcutaneous injection).

Many people with MS learn to give themselves the injection or have it given by a carer.

Self-injection needs to be taught and practised. It is important that a qualified healthcare professional supervises your first injection.

Your doctor may teach you to self-inject or arrange for an MICROSOFT education nurse to do so.

You may have a friend attend the shot training session as your assistant. Especially when you first start giving yourself injections, your assistant should be with you.

Talk to your doctor or the MS Society or even telephone 1800 502 802 in Australia or 0800 502 802 in New Zealand for more information.

Patient support kits that include a self-injection device are available by telephoning 1800 502 802 in Australia (0800 502 802 in New Zealand).

After being taught to self-inject, you can refer to this particular leaflet for step-by-step instructions about how to prepare and inject Copaxone 40 Pen mg/mL.

The following instructions clarify how to inject Copaxone Pen 40 mg/mL yourself.

Tend not to attempt self-injection until you are confident that you understand how to put in yourself.

Please read these instructions carefully.

Before you Inject

Copaxone Pencil 40 mg/mL contains a pre-filled injection of Copaxone 40 mg/mL that is pre-mixed plus ready for you to use.

Make sure that the pen is taken out of the particular refrigerator for 20 minutes before you use it.

It is important that the solution is at room temperature when you inject it. If you need to delay your injection, return the pen to its original carton in the refrigerator.

Never attempt to remove the syringe from the Copaxone Pen device.

Always inspect Copaxone Pen forty mg/mL before you use it for damage or evidence of tampering. Do not inject the solution if it is cloudy or has particles in it.

Do not use when the cap has been removed or damaged.

Gathering the Materials

Gather the following items on a towel that is laid on a flat surface in a clean, well-lit area:

One Copaxone Pen 40 mg/mL (at room temperature — as described above)

A dry cotton ball

An alcohol swab

A disposal unit for used pens (such as a sharps container)

Wash and dry your hands. Do not touch your hair or even skin afterwards.

This will help prevent infection.

Deciding where to Inject

There are seven injection areas on your body; arms, thighs, back from the hips and stomach (belly). Within each injection area there are multiple injection sites (Figure 1).

Rotate the injection sites within an region.

You should not use any site more than one time a week. Choose a different site for each injection. This will reduce the likelihood of irritation, pain or loss of fatty tissue (lipoatrophy) at the site of shot.

Marking a calendar will help you keep track of the sites you have used each week.

Do not inject in an area of skin that is bruised, inflamed or damaged.

Giving Yourself the Injection

Do not administer Copaxone Pen by some other method or route other than subcutaneous injection using the technique as demonstrated by your physician in accordance with this leaflet or the separate “Instructions for use” guide.

Speak to your doctor if you are unsure.

Some sufferers may experience a side-effect known as the Immediate Post Injection Reaction (see the information underneath the heading ‘Side effects’ below).

Proper use of the pre-filled pen

Do not reuse the pen.

Each pen should be used only for one injection.

Ask your doctor or nurse regarding obtaining a “sharps container”.

After use, place almost all used pens in a hard-walled plastic container, such as a liquid laundry detergent container or sharps container.

It is very important that you keep the cover of the container tightly shut and that you store it out of the reach of children. When the container is full, check with your doctor or even nurse about proper removal.

Refer to the “Instructions with regard to Use” leaflet with this medicine for helpful hints on where you should inject if you are unsure.

When to utilize it

Give yourself the particular injection at the same time on the same three days of the week (for example, Monday, Wednesday and Friday) at least 48 hrs apart.

Choose a time when you feel strongest

How long to use it

Do not stop using Copaxone Pen without checking with your doctor first.

The positive effects of Copaxone are not seen immediately. They occur with long-term treatment.

If you forget to use it

If you miss a dose of Copaxone Pen 40 mg/mL, you should take your next dose as soon as you remember or are able to take it, then skip the following day. If possible, you should return to your regular administration schedule the following week.

Do not use a double dose to make up for forgotten individual doses.

This may increase the chance of you getting an unwanted side-effect.

If you are not sure what to do, ask your doctor or pharmacist.

In case you have trouble remembering when to use your medicine, ask your pharmacologist or MS education health professional for some hints.

It is important not to miss injections as this can affect the success of your treatment.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone Australia 13 11 26 or 0800 POISON or 0800 764 766 in New Zealand), or go to Accident plus Emergency at your nearest hospital, if you think that you or anyone else may have used too much Copaxone 40 mg/mL. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Things you must do

Tell all the doctors, dentists and pharmacists who are treating you that you are using Copaxone.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are using Copaxone Pen 40 mg/mL.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are using this medication.

If you become pregnant while you are using this medicine, talk to your doctor to discuss whether ongoing Copaxone treatment is appropriate for you.

Things you must not do

Do not use more than the recommended dose unless your physician tells you to.

Do not provide this medicine to other people, even if they have the same condition as you.

Side effects

All medications have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor or druggist as soon as possible if you do not feel well while you are using Copaxone Pen 40 mg/mL.

It helps most people with MS, but it may have unwanted side effects in a few people.

Tell your doctor if you notice any of the following and they worry a person:

pain, redness, itchiness, hardening of the skin or even an infection at the site to have injected yourself

nausea (feeling sick)

pain within the joints

sore muscles

feeling of weakness

dizziness

constipation

yellowing of the skin or eyes

dark urine

abdominal pain

vomiting

loss of appetite

weight loss

unusual tiredness

These side effects were reported by patients who utilized Copaxone 20 mg/mL every day and by patients who use Copaxone 40 mg/mL 3 times a week.

Some patients might experience a side-effect known as the Immediate Post Injection Reaction. This reaction consists of these symptoms:

reddening of the face and/or neck,

chest pain or even tightness,

feeling your heart beat quickly (heart palpitations),

anxiety and difficulty in breathing.

These are mild side effects of this medicine and usually are short-lived.

Some patients may experience only one episode during the therapy period.

Stop administering Copaxone Pen and contact your doctor immediately if the above symptoms are severe.

If some of the following happen, stop by using this medicine and tell your physician immediately or go to Accident and Emergency at your nearest hospital:

swelling of the encounter, lips, mouth or throat, which may cause difficultly in swallowing or breathing

hives

chest pain

trouble breathing

severe pain, redness or swelling at the injection site that does not go away.

These are very serious negative effects. If you have them, you may have had a serious allergic reaction to Copaxone. You may need urgent medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or even pharmacist if you notice anything else which is making you feel unwell.

Other side effects not listed above may occur in some patients.

Do not be alarmed by this list of possible side effects.

You may not encounter any of them.

Ask your physician or pharmacist to answer any questions you may have.

After using it

For those who have any queries about any kind of aspect of your medicine, or any questions regarding the information with this leaflet, discuss them with your doctor or pharmacist.

Storage

Keep Copaxone Pencil 40 mg/mL in the group until it is time to use it. Protect from direct light.

The particular medicine will not keep as well if taken out of the packaging.

Keep Copaxone Pen forty mg/mL in the refrigerator at 2°C to 8°C. In the event of refrigeration being unavailable, Copaxone Pen 40 mg/mL may be stored between 15°C : 25°C on one occasion for up to one month.

Copaxone Pen 40 mg/mL must not be frozen. Do not place in the freezer or freezing compartment of a refrigerator.

Do not store it or some kind of other medicine in the bathroom, near a sink or even on a windowsill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it where children cannot reach this.

Disposal

Please read the package insert carefully for full details, including self disposal associated with needles and syringes after use.

If your doctor tells you to stop using Copaxone Pen 40 mg/mL, or the medicine has passed its expiration date, ask your pharmacist what to do with any which are left over.

Return any unused medicine to your pharmacist.

What it looks like

Copaxone Pen contains Copaxone 40 mg/mL which is a clear, colourless solution supplied in a 1mL glass single use pre-filled syringe fitted with a staked ½ inch needle and safety shield.

Copaxone 40 mg/mL pens are supplied within packs containing 3, 12 or 36 pre-filled syringes.

Not all pack sizes might be marketed.

Ingredients

Active Ingredient:

Each Copaxone 40 mg/mL pen consists of 40 mg glatiramer acetate.

Inactive Ingredients:

Each injection also contains:

mannitol

water for injections

Distributor

Copaxone Pen forty mg/mL is distributed in Australia by:

Teva Pharma Australia Pty Ltd

Level 1, 37 Epping Road

Macquarie Park 2113

NSW, Sydney

Copaxone Pen 40 mg/mL is distributed in Brand new Zealand by:

Teva Pharma (New Zealand)

Limited

PO Box 128 244

Remuera

Auckland 1541

Australian Register Number:

AUST R 316728

This leaflet was prepared in January 2021

^® Copaxone Pen is a registered trademark of Teva Pharmaceuticals Industries Ltd.