What is it and how is it used?
What Betaferon is:
Betaferon is a type of medicine known as interferon used to treat multiple sclerosis. Interferons are proteins produced by the body that help fight against attacks on the immune system such as viral infections.
How Betaferon works:
Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord. In MS inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly. This is called demyelination.
The exact cause of MS is unknown. An abnormal response by the body's immune system is thought to play an important part in the process which damages the CNS.
The damage to the CNS can occur within an MS attack (relapse). It can cause disability temporarily, such as difficulty walking. Symptoms may disappear completely or partly.
Interferon beta-1b has been shown to change the response of the immune system and to help to reduce disease activity.
How Betaferon helps fight your disease:
Single clinical event indicating a high risk of developing multiple sclerosis: Betaferon has been shown to delay progression to definite multiple sclerosis.
Relapsing-remitting multiple sclerosis: People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse. Betaferon has been shown to cut down the number of attacks and make them less severe. It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
Secondary progressive multiple sclerosis: In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS. With this, people find themselves becoming increasingly impaired, whether or not they have relapses. Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
What Betaferon is used for:
Betaferon is for use in patients
What do you have to consider before using it?
Do not use Betaferon:
- Tell your doctor if any of the above applies to you.
Take special care with Betaferon:
Your doctor also needs to know the following before you are given Betaferon:
- Tell your doctor if any of these applies to you.
Your doctor also needs to know the following whilst you are using Betaferon:
- Stop using Betaferon and tell your doctor immediately if any of these happens to you.
Other things to consider when using Betaferon:
Injection site reactions:
During Betaferon treatment you are likely to experience injection site reactions. Symptoms include redness, swelling, change in the skin colour, inflammation, pain, and hypersensitivity. Dead skin and tissue around the injection site (necrosis) are reported less frequently. Injection site reactions usually become less frequent over time.
Injection site skin and tissue breakdown can result in scars forming. If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.
To reduce the risk of getting injection site reactions you must:
Injection site reactions may occur less frequently, if you use an auto-injector device. Your doctor can tell you more about this.
If you experience any break in the skin, which may be associated with swelling or fluid leaking out from the injection site:
- Stop injections with Betaferon and talk to your doctor
- If you have only one sore injection site ( lesion) and the tissue damage (necrosis) is not too extensive you may continue using Betaferon.
- If you have more than one sore injection site (multiple lesions)you must stop using Betaferon until your skin has healed.
Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
Using other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No formal interaction studies have been carried out to find out whether Betaferon affects other medicines or is affected by them.
Using Betaferon with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
Betaferon should be used with caution with:
Using Betaferon with food and drink:
Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
Children and adolescents:
There have been no formal clinical trials undertaken in children or adolescents.
However, there is some data available in children and adolescents from 12 to 16 years. This data suggests that the safety profile from this age is the same as in adults for use of Betaferon 8 million IU under the skin (subcutaneously) every other day. Betaferon should not be used in children under 12 years of age as there is no information on this use.
Pregnancy:
If you could get pregnant, use contraception while you are on Betaferon.
- If you are pregnant or you think you may be, tell your doctor. Betaferon treatment should not be started if you are pregnant (see also ‘Do not use Betaferon’).
- If you wish to become pregnant, discuss this with your doctor first.
- If you become pregnant while using Betaferon, stop your treatment and contact your doctor immediately. Your doctor will decide together with you, if your Betaferon treatment will be continued or not.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding:
It is not known whether Interferon beta-1b passes into human breast milk. However, it is theoretically possible that a breast-fed baby could experience serious side effects to Betaferon.
- Discuss it with your doctor first to decide whether to stop breast-feeding or to stop using Betaferon.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving or using machines:
Betaferon may cause side effects in the central-nervous system (see section 4. ‘Possible side effects’). If you are especially sensitive, this might affect your ability to drive or use machines.
Important information about some of the ingredients of Betaferon:
The inactive ingredients of Betaferon include small amounts of mannitol, a naturally occurring sugar and human albumin, a protein. If you know that you are allergic (hypersensitive) to any of the ingredients or if you become so, you must not use Betaferon.
How is it used?
Treatment with Betaferon should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Always use Betaferon exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
Dose:
The usual dose is: every other day (once every two days) , 1.0 ml of the prepared Betaferon solution (see Annex ‘Self-injection procedure’ in the second part of this leaflet) injected under the skin (subcutaneously). This equals 250 microgram (8 million IU) Interferon beta-1b.
When starting treatment with Betaferon it is tolerated best by gradually increasing the dose, i.e.
starting with just 0.25 ml of the medication and then increasing, after every 3 rd injection to 0.5 ml, 0.75 ml and then finally to the full (1 ml) dose of Betaferon. Your doctor may decide, together with you, to change the time interval between increases in the dose depending on side effects you may experience at the start of treatment. To easily increase the dosage during the first 12 injections, you may be given a special titration pack, containing four differently coloured packs with specially marked syringes and with detailed instructions on the separate introductory leaflet for titration pack.
Preparing the injection:
Before injection, the Betaferon solution has to be prepared from a vial of Betaferon powder and 1.2 ml of liquid from the pre-filled solvent syringe. This will either be done by your doctor or his/her assistant or by yourself after you have been carefully trained. For details how the Betaferon solution for injection is prepared see Annex ‘Self-injection procedure’, Part I.
Detailed instructions for self-injection of Betaferon under the skin are provided in Part IE of the Annex ’Self-injection procedure’.
The injection site must be changed regularly. See ‘Take special care with Betaferon’ and follow the instructions in Part II ‘Rotating injection sites’ and Part III (Betaferon Medication Record) of the Annex ’Self-injection procedure’.
At present it is not known how long treatment with Betaferon should last. The length of treatment will be decided by your doctor together with you.
If you use more Betaferon than you should:
Giving many times the dose of Betaferon recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
- Talk to your doctor if you injected too much Betaferon or injected it too often.
If you forget to use Betaferon:
If you have forgotten to give yourself an injection at the right time do it as soon as you remember and then follow on with the next one 48 hours later.
Do not inject a double dose to make up for a forgotten single dose.
If you stop using Betaferon:
Talk to your doctor if you stop or wish to stop treatment. Stopping Betaferon is not known to lead to acute withdrawal symptoms.
What are possible side effects?
Like all medicines, Betaferon can cause side effects, although not everybody gets them.
At the beginning of treatment side effects are common but in general they become less with further treatment.
The most frequently observed side effects are:
To reduce side effects at the start of treatment, your doctor should start you on a low dose of Betaferon and increase it gradually (see section 3. ‘How to use Betaferon’).
Betaferon may also cause serious side effects. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Tell your doctor immediately and stop using Betaferon:
The following side effects listing is based on reports from clinical trials with Betaferon (table 1) and from side effects reported on the marketed product (table 2).
Table 1: Side effects which have occurred in clinical trials with Betaferon very commonly (at least 10 per 100 of the cases) and at a higher percentage than those observed with placebo. The table also includes side effects which occur in less than 10 per 100 but which were significantly associated with the treatment):
How should it be stored?
Do not store above 25°C. Do not freeze.
Do not use after the expiry date which is stated on the pack.
After preparing the solution you should use it immediately. However, if you are not able to do so, it will be okay for 3 hours, if kept at 2-8 °C (in a refrigerator).
Keep out of the reach and sight of children.
Do not use Betaferon if you notice it contains particles or is discoloured.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
