The active ingredient in Copaxone® is glatiramer acetate. Glatiramer acetate is a mix of four amino acids which form a protein very similar to the basic protein which makes up myelin. Glatiramer acetate appears to block myelin-specific autoimmune responses. Researchers are still investigating exactly how this process works. Glatiramer acetate is a different class of medication to the interferons.
Clinical trials found that Copaxone® (glatiramer acetate) has a significant beneficial effect in people with relapsing-remitting MS by reducing the accumulation of permanent physical disability, frequency of relapses and disease activity measured by active MS lesions on brain magnetic resonance images (MRI).
Copaxone® is available in two dosing formats:
On 22 April 2022, the Pharmaceutical Benefits Advisory Committee (PBAC) recommended the listing on the PBS of a new form of Copaxone® as a 40mg in 1 mL single dose pre-filled pen under the same conditions as the PBS-listed glatiramer pre-filled syringe. It has yet to be approved for listing on the PBS by the Australian Government.
Copaxone® helps most people with MS, but it may have side effects in some people. All medications have side effects. It is important to notify your health professional if you experience any side effects or are feeling unwell.
Some common side effects include pain, redness, itching, hardening of the skin or an infection at the site where you have injected yourself, nausea, pain in the joints, sore muscles, feeling of weakness, dizziness and constipation.
Some patients may experience a side effect known as the Immediate Post Injection Reaction. This reaction consists of the following symptoms: reddening of the face and/or neck, chest pain or tightness, heart palpitations, anxiety and difficulty in breathing. These are mild side effects of this medication and are usually temporary, settling after a couple of hours. Some patients may experience only one episode during their entire treatment period with Copaxone®.
Your health professional or pharmacist can provide comprehensive information on the use of Copaxone®, including precautions and side effects.
In clinical trials with a limited number of pregnant women and women of childbearing age, Copaxone® did not show an increase in the frequency of malformation or other harmful effects on the human fetus. In animal studies, this medication has also not shown evidence of an increased occurrence of fetal damage.
If you are currently pregnant or trying to become pregnant, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.
No information is available on the excretion of glatiramer (the ingredient in Copaxone) into breastmilk. However, data from the manufacturer indicates that after subcutaneous injection, glatiramer undergoes rapid degradation to amino acids and shorter peptides and that it cannot be detected in the plasma, urine or faeces.
Furthermore, any glatiramer that did reach the breastmilk would probably be destroyed in the infant’s gastrointestinal tract and not absorbed, except perhaps in newborns. Limited information indicates that maternal use of glatiramer does not cause any adverse effects in breastfed infants.
The Multiple Sclerosis Centre of Excellence on Reproduction and Child Health considers glatiramer to be “moderately safe” to use during breastfeeding. Glatiramer appears to be the preferred disease-modifying agent for treating MS during breastfeeding.
If you are currently breastfeeding, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.
Copaxone® has been approved by the Therapeutic Goods Administration for the treatment of relapsing-remitting MS and is available on the Pharmaceutical Benefit Scheme (PBS). Please discuss with your neurologist whether Copaxone® is the right treatment for you. There are a number of criteria you must meet before your doctor can receive authority to write this prescription.
For details of the criteria required to receive a prescription for Copaxone® treatment through the PBS, please visit the official PBS website at: http://www.pbs.gov.au/medicine/item/10416F
You will need to click on the red Authority Required (STREAMLINED) link.
If you are eligible for medications through the PBS, you will need to pay a contribution fee each time your prescription is dispensed. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card. The amount of this fee is set each year by the Federal Government.
Further information about the PBS, your entitlements and details regarding the PBS safety net (which protects patients and their families requiring a large number of PBS items) is available through the Medicare Australia website at: www.medicare.gov.au
If you are not eligible for Copaxone® through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. In this instance you will have to pay the full cost to the pharmacy that dispenses your medication. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS.
Most pharmacies do not keep Copaxone® in stock. Instead, they will place an order with the manufacturer to have stock delivered especially for you. It is therefore important to let your pharmacist know a few days before you need the medication.
Copaxone® prefilled syringes need to be kept between 2-8°C. If the outside temperature is warm it is a good idea to take your medication home in an ice cooler. Your pharmacist may be able to assist with this.
Speak to your neurologist about what treatment best suits your individual circumstances.
MS Nurses can also provide information, training and ongoing support in managing your immunotherapy.
MS Australia does not recommend any specific disease-modifying treatment for people living with MS. Decisions about any treatments, taking into consideration the potential benefits and side effects for each individual’s circumstances, should be made in careful consultation with the person’s neurologist.