Rebif®

Interferon beta - 1a (rch)

What is in this leaflet

This leaflet answers some common questions about Rebif.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of
you using Rebif against the benefits it will have for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this information with your medicine. You may want to read it again
later.

What Rebif is for

Rebif belongs to a class of medicines known as Interferons. The active
substance of Rebif is Interferon beta-1a, a recombinant human Interferon beta
produced in Chinese hamster ovary cells.

Rebif is used in patients who have relapsing forms of multiple sclerosis
(MS). It is usually started after you have experienced two or more relapses
(attacks) within the last two years.

Rebif has been shown to reduce the number of attacks that occur, decrease
the severity of attacks and increase the time between attacks. Treatment with
Rebif also delays the progression in disability and lowers the number
of times people need to be hospitalised because of attacks.

Your doctor may prescribe Rebif for another reason. Ask your doctor if you
have any questions about why Rebif has been prescribed for you.

Rebif is not addictive.

The effects of the disease or of Rebif treatment may influence your ability
to drive a car or operate machinery. You should discuss this with your doctor
if you are concerned.

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

Before you use Rebif

When you must not use it

Do not use Rebif if:

• you have a history of allergy to interferon beta, albumin, or any other
  inactive ingredients (listed under 'Product Description')
• you are feeling depressed (feeling of severe sadness and unworthiness)
  or have thoughts of suicide
• you are an epileptic with fits or convulsions not adequately controlled
  by treatment
• you are pregnant or intend to become pregnant. Tell your doctor if you
  are pregnant or intend to become pregnant. Women of childbearing age should
  take appropriate contraceptive measures while using Rebif.

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

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

Do not take Rebif, if the packaging shows sign of tampering

If it has expired or is damaged, return it to your pharmacist for disposal

Rebif is not recommended for use in children under 16 years of age with MS
as there is no clinical experience in this age group.

If you are not sure whether you should start using Rebif, contact your
doctor.

Before you start to use it

Tell your doctor before you start to use Rebif if you are breastfeeding or
intend to breastfeed. It is not known whether Rebif passes into breast milk.
If you want to breastfeed while using Rebif, discuss this matter with your
doctor.

Before starting Rebif, tell your doctor if you suffer or have suffered from
any of the following:

• seizures (fits or convulsions)
• depression
• heart disorders
• kidney disease
• liver disease
• blood disorder (for eg. low counts of platelets, red and white blood
  cells)
• allergy to any other medicines, foods, dyes or preservatives
• alcohol abuse

If you want to have children, you should discuss this matter with your
doctor.Rebif has a potential for causing severe liver injury. Therefore, it is
recommended that serum liver enzymes should be checked whilst taking Rebif.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that
you buy without prescription from your pharmacy, supermarket or health food
shop.

The following medicines which are commonly used by people with MS are safe
to take while using Rebif:

• corticosteroids such as hydrocortisone, prednisone or prednisolone
• ACTH (adrenocorticotrophic hormone)

Rebif may interact with some other medicines that are broken down by the
liver:

• Medicine to treat epilepsy
• Medicine used for sedation or to treat anxiety
• Medicine to treat depression.

Your doctor may have to adjust the dose of your other medicines while you
are using Rebif. It is therefore important that you tell your doctor about all
the medicine that you are taking.

How Rebif is given

Treatment with Rebif should be started under the supervision of a
specialist doctor experienced in the treatment of MS.

How to inject

Rebif is intended to be injected by yourself by subcutaneous (under the
skin) injection. Your doctor or nurse will instruct and assist you in learning
the procedure and technique of self-injection. Do not attempt self-injection
until you are sure of how to do it.

Before the injection, you should allow the cold Rebif solution to reach
room temperature this will minimise discomfort during administration.

Where to inject

The best areas for injection are loose and soft (flabby) skin away from
joints and nerves. Use a different injection site each day you inject.
Suitable injection sites are:

• Arms (upper back portion)
• Stomach (except around navel and waistline)
• Buttocks
• Thighs (front and sides except at groin and knee)

Do not inject into any areas in which you feel lumps, firm knots,
depressions, pain or discolouration. Talk to your doctor if you find anything
unusual when injecting.

How much to inject

Your doctor will tell you how much Rebif to inject.

When first starting treatment with Rebif, the dose is gradually increased
over the first few weeks. Your doctor will explain this to you. The usual
maintenance dose is 44 micrograms injected subcutaneously three times a week.

If you forget to inject it

If you forget an injection by one day, administer it the day after the
missed dose and push back the days of injection for the remainder of the week
by one day. Resume your regular schedule the following week.

If you miss the injection by two days, skip the missed injection (that is
do not double dose on any day) and resume regular schedule.

Ask your doctor if you are not sure what to do or have trouble remembering
to inject your medicine.

If you inject too much

Immediately contact your doctor or the Poisons Information Centre (In
Australia telephone 131 126. In New Zealand telephone 0800 764 766) if you are
concerned that you have given yourself too much Rebif

While you are using Rebif

Things you must do

Tell your doctor immediately if you become pregnant while using Rebif.

Change the injection site each time you inject. Today's injection should
not be given in the same area as the last one. Keep a record of where and when
you last gave yourself an injection. You may use a site again after waiting
one week, if the skin area is not red or irritated. If all areas become
tender, talk to your doctor about choosing other injection sites.

Tell your doctor if you start any new medicines while using Rebif.

Things you must not do

Do not stop using Rebif, or change the dose, without first checking with
your doctor.

Do not give this medicine to anyone else, even if their symptoms seem
similar to yours or if they have the same condition as you.

Do not use Rebif to treat any other complaints.

Things to be careful of

Tell your doctor if you become depressed or have suicidal thoughts while
using Rebif.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are
taking Rebif. Rebif helps most people with MS, but it may have unwanted side
effects in a few people. All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical treatment if
you get some of the side effects.

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

• Injection site reactions including redness, swelling bruising, pain or
  itching
• Flu-like symptoms including fever, chills, and muscular pain. These may
  be relieved if paracetamol is taken when the injection is given
• Abdominal pain
• Diarrhoea and nausea
• Muscle pain and aches, back pain or painful joints.

Tell your doctor immediately if you experience any of the following:

• Infected area at site of injection (swollen and painful area, with or
  without discharge)
• Depression and having problems with sleeping
• Anxiety/nervousness
• Suicidal thoughts
• Fits/convulsions
• A yellow appearance to your skin colour
• Extreme feeling of tiredness
• Severe allergic reaction
• The following symptoms alone or in combination may mean that your
  thyroid gland is not working properly and needs to be checked by your
  doctor: Persistent rapid heart beat or palpitations, insomnia, weight loss
  or weight gain, hair loss, tremor, neck lumps, irritability, abnormal
  menstrual cycles.

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

Tell your doctor if you notice anything else that is making you feel
unwell.

Do not be alarmed by this list of possible side effects. You may not
experience any of them.

After using Rebif

Storage

Keep this medicine where young children cannot reach it.

Keep Rebif stored in a refrigerator where the temperature is between 2 to
8°C (Refrigerate. Do Not Freeze) and it is not exposed to light. Should
refrigeration be unavailable, Rebif can be stored at 25°C for a short period
(approximately one month).

Do NOT store it in the freezer.

Disposal

Rebif should be used once only. After injecting, you should discard the
syringe even if you have not injected all its contents. Syringes should be
discarded in an appropriate disposal unit.

If your doctor tells you to stop using Rebif or if it has passed its expiry
date, ask your doctor or pharmacist what to do with any syringes that are left
over.

Product description

What it looks like

Rebif is supplied as clear solution packed in pre-filled syringes ready for
use. Each pre-filled syringe contains 0.5mL of solution.

Two strengths of Rebif are available:

• 22 micrograms, and
• 44 micrograms of
  
  Interferon beta-1a (rch).

Rebif is available in packs containing 1, 3 or 12 pre-filled syringes.

Rebif may also be administered with a suitable autoinjector.

Ingredients

Active ingredient:

• interferon beta-1a

Inactive Ingredients:

• mannitol
• albumin
• sodium acetate
• Water for Injections
• acetic acid and/or sodium hydroxide for pH adjustment

Rebif does NOT contain lactose.