Betaferon®

This section does not contain all the available information regarding drug therapy. It does not take the place of talking to your neurologist, general practitioner or pharmacist. Further information is also available from the MS Society in your state and from the pharmaceutical companies.

What is betaferon®?

Betaferon®, the active ingredient of which is interferon beta-1b, is a specially modified form of interferon beta. The interferons are a family of proteins that occur naturally in the body and are involved in the activities of the body's immune system. This is a very complex system involving many specialised cells and proteins, which defend the body against infections and disease.

What does betaferon® do?

Clinical trials found that betaferon® (interferon beta -1b) has a significant beneficial effect in people with relapsing-remitting multiple sclerosis by reducing the frequency and severity of MS exacerbations (attacks). The disease activity measured by gadolinium-enhanced lesions on brain magnetic resonance images (MRI) was also reduced.

Who can get a script for betaferon®?

An authority script for 1 month's supply of betaferon® with 5 repeats may be available to people with multiple sclerosis following consultation with a neurologist or GP if they fulfill the following criteria:

• Have relapsing/remitting MS.
• Able to walk without assistance or support.
• MS diagnosis confirmed by MRI.
• Have had 2 exacerbations (attacks) in the last 2 years.

Before you have an betaferon® injection.You should tell your doctor if you:

• are depressed or have contemplated suicide.
• are pregnant or planning to become pregnant.
• are breastfeeding.
• have had any fits or seizures.
• have had any liver or kidney problems.
• have any heart disease.
• have any blood disorder.

General information

Betaferon® is not stored at the chemist. It will take 1-2 working days for the chemist to receive it from the pharmaceutical company distributing the medication Schering Pty. Ltd. On arrival at home the betaferon® is to be stored below 25°C.

Cost

• Health card holders $3.70/month.
• Non health card holders $23.10/month.
• Syringes, needles and swabs are provided with the medication.
• Sharps container for used needles must be purchased. Cost $8 - $10 (approx).

Who should not have betaferon® injections?

This medication is contraindicated for people who are allergic to interferons and/or human albumin.

Can betaferon® be taken while pregnant?

Discuss with your doctor.

There are no adequate studies on the effect of this medication in pregnant woman. It is important for a woman to inform her doctor if she becomes pregnant or plans to become pregnant while on betaferon®. It is not known if betaferon® is excreted in breast milk.

It is generally recommended that:

• Males - If concerned discuss with your doctor who may wish to contact Schering Pty. Ltd. medical staff regarding individual cases.
• Females - stop betaferon® 1 month before trying to conceive and during pregnancy and breastfeeding.

Side effects

The written material accompanying betaferon® details the side effects.

Symptoms reported more frequently were injection site reactions and flu like symptoms, muscle aches, weakness, chills and fever. These side effects usually occur 3-6 hours after the injection is given and may last for 24 hours.

The side effects are common in the early stages of treatment, decrease dramatically over the first 3 months but may last up to 6 months in some cases.

Most of the side effects may be controlled with:

Paracetamol (Panadol®) - Best for fever/temperature. 1 hour prior to the injection and then every four hours over the next 24-36 hours (8 tablets in 24 hours may be taken).

Ibuprofen (Nurofen®) - Best for flu-like symptoms and headaches. Having the injection in the evening may allow you to sleep through the flu-like symptoms should they occur.

To help reduce the severity of these side effects the neurologist may start you on a half dose of betaferon® for 2 weeks. The betaferon® is then gradually increased to full dose.

Injection site reaction

Correct injection technique can minimise injection site reaction. However, no matter how carefully you inject the betaferon® you may still get injection site reactions.

The following may be helpful in managing this common side effect:

• Rotate the injection sites. Use at least three different areas for injections.
• Some areas are more sensitive than others.
• Try all the areas and use the sites that don't react as much.
• The use of an autoject™, a device used to inject the medication at the correct rate and depth is available free of charge from the NSW MS Society or from your neurologist.
• The depth adjuster should be set on the letter "q".
• If you find some fluid left on your skin after the injection, the next time hold the autoject in place while you count SLOWLY up to 10.
• Before the injection, allow the cold betaferon® solution to reach room temperature.
• If the area around the injection site becomes red within 1 hour you may be having a reaction to the alcohol swab. You need to wait for the alcohol to dry before you inject the betaferon®.
• If you are already doing this - try without using the swab. Don't use the alcohol swab on the injection site after the injection.

The 4 injection sites/areas are the abdomen, thighs, buttocks and arms. Instructions are as follows:

The abdomen

The area between the ribs, pubic bone and hips.

Lean forward until a roll of skin (fat) is formed, this is the site that should be injected. Avoid the area around the navel and waistband. Two fingers from the navel is safe for injecting.

The buttocks

You need to sit down on a hard chair or stool. The side of the buttocks from the hips to the chair is the injection area. The area you sit on and 3cm either side of the crease should not be injected.

The thighs

You need to sit right back on the seat with your legs straight out and no weight on them. This brings the soft tissue (fat) closer to the surface. To measure the injection site place one hand on top of the thigh at the groin and the other hand on the thigh fingers touching the knee. The area between the hands on top and the outside of the thigh are the injection sites. The inside of the thigh should not be injected.

The arms

The arms are not recommended, if this site has to be used, measure the site by imagining a line across the arm from the base of the armpit and placing your hand above your elbow. The back of the arm between the armpit and the hand is the injection site.

• Do not pinch the skin it may force some of the medication back to the s urface. Use the autoject™ on an area with most fat.
• Do not rub the area after the injection, apply gentle pressure to the injection site for a minute or two this will assist the injection site to close and heal.
• Ice applied before and after the injection can reduce the discomfort of the injection and may reduce the site reactions.
• "Stop Itch", xylocaine gel or other preparations used for stings or sunburn may reduce injection site reactions that are painful, itchy or sting. These agents should not be applied until 6 hours after the injection.
• If the marks are pain-free ask your doctor to write a script for 1% hydrocortisone cream.
• If necrotic skin lesions develop it may be necessary to discontinue treatment or change to another medication. Speak to your doctor.

Frequently Asked Questions Concerning Betaferon®

How is betaferon® taken?

Betaferon® is a second daily subcutaneous injection (into the fatty area under the skin), which you or a chosen person is taught to give.

MS Society staff are available to educate you and/or the chosen person in giving the injections. Betaferon® cannot be taken by mouth, as it is a protein and therefore digested (broken down) by gastric juices in the stomach.

Are there any contradictions with other medications?

No significant interactions with any treatments commonly used in MS were noted in the clinical trials. People with hypersensitivity to natural or recombinant interferon beta, albumin, or any other formulation should not take these agents.

Caution should also be exercised in people with severe anaphylactic reactions and asthma, as the treatments have not been studied in these people.

Can I continue having a yearly flu vaccination while on this medication?

Yes. It is suggested you take paracetamol before the flu vax then every 4 hours as needed.

Can alcohol be consumed while on this medication?

There have been no problems reported. If you have a history of liver damage, the doctor may advise you to cut down on alcohol consumption.

Does betaferon® cause drowsiness?

No significant drowsiness has been reported, the effect of the disease or initial side effects may influence your ability to drive and operate heavy machinery. If you are concerned you should discuss this with your doctor.

What does the medication not do?

Betaferon® does not reverse MS. It will not make you physically any better than you are now.

My neurologist told me to contact the MS Society to get information on treatments for MS, what medication do you recommend?

This is a clinical question and treatment choice is made by the doctor in conjunction with the patient. We can offer information on ALL treatments. When you have read all the information you should contact your neurologist to discuss the treatment choice.

My neurologist has ordered betaferon® for me but I will not be able to inject as I am sight impaired/have poor hand control. What do I do?

The NSW MS Society will either teach a family member to inject betaferon® or refer you to the community nurses who will visit second daily.

Why do I need a blood test and how often are they recommended?

Tests are done to determine base levels of liver function test (LFT), white cell count (WCC), platelet count and haemoglobin (Hb) before commencing therapy then 3 monthly after starting therapy.

What time should I inject if I work evening or night shift?

The time of injection depends on the time any side effects occur after the injection. Have the injection so there is time to recover from possible side effects. We suggest you have the injection at the same time every second day so you develop a routine and will be less likely to forget a dose eg. 4 hours before you go to bed.

My betaferon® mixture is bubbly. What should I do?

DO NOT DISCARD.

Place vial in fridge until bubbles settle (1-2 hours). Before use, warm up the vial in your hands.

Why did the bubbles occur?

The bubbles can be caused by any one of the following:

• Pushing the normal saline into the betaferon® vial too quickly.
• Injecting air into the betaferon® liquid.
• Withdrawing the betaferon® solution from the vial into the insulin syringe with too much force.

I am going overseas for 6 months. Is it possible to have all the scripts for betaferon® made up at once?

Yes.

I am travelling overseas. What can I do to ensure I have no problems with customs?

Carry with you a letter from your prescribing doctor explaining why you need the treatment. Photocopies of the letter and the betaferon® prescription for the customs authorities for departure and entry to every country you visit.

If flying through a country that has strong anti drug laws and regulations contact the embassy of the country concerned and discuss the situation. Some require papers to be completed before leaving Australia.

It may be worthwhile obtaining a contact name and phone number of a representative from the Australian embassy in the country concerned.

Are there any special precautions when travelling by air?

Ensure that the betaferon® pack is kept below 25°C but not frozen. This can be achieved by carrying your medication onto the plane with you so remember to notify the Special Handling Department of the airline.

I am going overseas for 1 month how do I handle the medication once I arrive?

If room temperature is below 25°C there is no special handling required.

However if travelling to a hot climate the following may be helpful:

• When booking accommodation check if there is a fridge in the room, always check the fridge is switched on and its temperature.
• Inspect the water jug for signs of freezing.
• If no fridge is available, have the hotel staff refreeze the ice bricks, keep the medication in your room and keep replacing the ice bricks as required.
• It is a good idea to check and see where your bricks are stored.There are two reasons for this. Often they are put in the fridge not the freezer and secondly when you go to collect them other staff may have difficulty locating them.

I am going camping for 3 days. How do I store the medication?

Store your medication in an esky or pack that is kept below 25°C but not frozen.

The medication was delivered frozen from my chemist. Do I have to throw it out?

Yes. The manufacturer does not recommend the use of betaferon® if it has been frozen at any time.

How should betaferon® be transported&$63;

Betaferon® needs to be transported below 25°C. Medication should NOT be left in the boot or glove box of the car, or left for 30 minutes in a parked car.

The medication was left out on my kitchen bench overnight. Must it be discarded?

Not if temperature was less than 25°C.

Yes if temperature was over 25°C.

Where do I dispose of the sharps container when full? Can it be placed in my garbage bin?

No. If you ring your local council, they will provide you with a list of chemists who will take the filled containers.

Where Can I Get More Information?

You can get information from your neurologist, GP or the MS Society Information line on 1800 042 138.

Betaferon® is manufactured by: SCHERING AG

Packed and distributed in Australia by: Schering Pty. Ltd.
27-31 Doody St
Alexandria NSW 2015

Source - The questions and answers included on the sheets are authentic questions asked by people with MS in NSW, who are on treatment or are considering starting immunotherapy treatment. The questions were compiled through the NSW MS Society Information Service and Immunotherapy Support Program.

Immunotherapy Program Coordinator 2003