ROFERON®-A
Interferon alfa-2a
3, 4.5, 6 or 9 million IU in 0.5 mL prefilled syringes for injection
18 MIU in 0.6 mL multidose cartridge for injection
What is in this leaflet
This leaflet answers some common questions about ROFERON-A.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you using ROFERON-A against the benefits expected for you.
If you have any concerns about using this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What ROFERON-A is used for
ROFERON-A contains an active ingredient called interferon alfa-2a.
ROFERON-A belongs to a group of medicines called interferons. It is a similar
form of interferon to one of the interferons made naturally by your own immune
system as a defence against viruses and tumours. ROFERON-A works by slowing the
growth of certain tumour cells and viruses, and by boosting the effects of your
own immune system to fight these.
ROFERON-A is used in the treatment of some types of cancers (including some
carcinomas, leukaemias, lymphomas, sarcomas, melanomas, myelomas and some other
types of cancer), hepatitis B and C, genital warts, as well as to increase the
number of blood-clotting cells in the blood.
When used for treating hepatis C, ROFERON-A is sometimes used in combinations
with a medicine called COPEGUS® (ribavirin). If you are also taking
COPEGUS, please read the Consumer Medicine Information for COPEGUS - it contains
important information on how to use COPEGUS safely.
Your doctor, however, may have prescribed ROFERON-A for another reason.
Ask your doctor if you have any questions why ROFERON-A has been
prescribed for you.
Roferon-A is not addictive.
This medicine is available only with a doctor's prescription.
Before you use ROFERON-A
When you must not use ROFERON-A
Do not use ROFERON-A if:
- you have had an allergic reaction to alfa interferons or to any of the
ingredients listed at the end of this leaflet - you have heart disease, or have had it in the past
- you have severe kidney disease or liver disease
- you have a severe bone marrow disorder
- you might receive a bone marrow transplant in the near future
- you have hepatitis and advanced liver disease
- you have hepatitis and have recently been treated with medicines that
suppress your immune system - you suffer from seizures e.g. epilepsy and/or other nervous disorders
- you are a child less than 3 years old
A rare but serious condition in newborn
babies has been linked with benzyl alcohol, an ingredient in ROFERON-A. - the package is torn or shows signs of tampering
- the expiry date printed on the pack has passed
If you use this medicine after the expiry
date has passed it may not work as well.
If you are not sure if you should be using ROFERON-A talk to your doctor.
Use in children
ROFERON-A is not recommended for use in children and adolescents under the
age of 18. The safety and effectiveness of ROFERON-A have not been
established in children and adolescents under 18 years of age.
Before you start to use ROFERON-A
Tell your doctor if:
- you are pregnant or plan to become pregnant
It is not known whether ROFERON-A is harmful
to an unborn baby when used by a pregnant woman. If there is a need to use
ROFERON-A when you are pregnant your doctor will discuss the risk and benefits
to you and the unborn baby.
Both males and females are recommended to use effective contraception while
taking ROFERON-A. - you are breast-feeding or plan to breast-feed
Because interferon alfa-2a occurs naturally
in the body, it has not been possible to determine whether ROFERON-A passes
into the breast milk following injection. Breast-feeding is not recommended
while taking ROFERON-A. Your doctor will discuss with you whether to stop
breast-feeding or stop taking ROFERON-A. - you have any other health problems, especially the following:
- poor kidney or liver function
- bone marrow disease or bone marrow suppression
- you have had an organ transplant (eg kidney or bone marrow) or an organ
transplant is planned for you in the immediate future - autoimmune disease (a disease where your immune system attacks parts of
your body), or hepatitis with a history of autoimmune disease - depression or any other mental illness, or a history of depression or
other mental illnesses - psoriasis (a skin disease)
- raised blood sugar levels or diabetes
- high blood pressure (hypertension)
- visual disturbances
- you are allergic to any other medicines, foods, dyes or preservatives
If you have not told your doctor about any of the above, tell them before
you start having ROFERON-A.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that
you have bought from a pharmacy, supermarket or health food shop.
Some medicines interfere with ROFERON-A.
You must tell your doctor if you are taking theophylline (Nuelin®),
a medicine used in the treatment of asthma, bronchitis, emphysema and related
conditions, as you may need to take a different dose of ROFERON-A. Your doctor
will advise you.
Your doctor or pharmacist has more information on medicines to be careful
with or avoid while using ROFERON-A.
Ask your doctor or pharmacist if you are not sure about this list of
medicines.
How to use ROFERON-A
Follow all directions given to you by your doctor, nurse or pharmacist
carefully.
They may differ from the information contained in this leaflet.
How to use ROFERON-A
ROFERON-A can be given by your doctor, nurse or pharmacist, or your doctor,
nurse or pharmacist may teach you how to inject yourself with ROFERON-A. Do not
try to inject yourself with ROFERON-A unless you have received training.
ROFERON-A comes in single-use prefilled syringes or in cartridges which can
be used more than once (multi-dose).
ROFERON-A cartridges are designed to be used with the Roferon-Pen device.
Information on how to use the Roferon-Pen/cartridge combination is provided in
the user manual supplied with the device. Read this manual carefully before use.
You should write the date of first use on the label provided with the cartridge
and use within 28 days of this date. A new sterile needle must be used each time
you administer a dose from the Roferon-Pen.
Your doctor or nurse will show you a "sterile technique" that will allow you
to administer the required amount of ROFERON-A safely.
How much ROFERON-A to inject
Use ROFERON-A exactly as your doctor or nurse has prescribed.
The dosage of ROFERON-A is expressed in millions of international units (IU).
The dose of ROFERON-A will be determined by your doctor based on your
condition. The usual dose ranges from 1.5 million IU to 18 million IU. The
dosage is unlikely to exceed 36 million IU on any one day. Your doctor will tell
you how many times a week to take ROFERON-A.
The dosage may be adjusted by your doctor depending on your response to
treatment.
Your doctor will keep track of your response to ROFERON-A by asking questions
and performing laboratory tests as needed.
Do not exceed or change the dose recommended by your doctor.
How to inject ROFERON-A
ROFERON-A is administered by injection - normally subcutaneously (s.c.),
which is injected into the tissue just under the skin.
If your doctor has prescribed subcutaneous injection, you may be able to give
yourself the injections at home.
Directions for subcutaneous self-administration
Your doctor, nurse or pharmacist may discuss whether it would be more
convenient for you to receive your injections at home, in which case you or a
family member would be instructed on how to give the injection properly. This is
a simple procedure and many people prefer it.
If you have decided to receive ROFERON-A at home, please follow the
instructions your doctor, nurse or pharmacist has given you carefully.
Instructions are provided below on how to use the prefilled syringes.
If you have the Roferon-Pen and cartridges, please refer to the
instruction manual that is provided with the pen.
The following directions are for subcutaneous injection with a prefilled
syringe only.
You should read these directions from beginning to end before starting so
that each step of the procedure becomes familiar. These instructions must be
carefully followed. Consult your doctor if you require further instructions.
Remember that cleanliness is vital when preparing and injecting ROFERON-A.
How to inject with the pre-filled syringe
I. Before subcutaneous injection
- Check the expiry date. Do not use ROFERON-A after the expiry date shown on
the pre-filled syringe label. - Check the dose you have been prescribed.
- Check the liquid has no discolouration, cloudiness or particles. The
liquid should look clear and colourless to slightly yellow. - Let the syringe stand for 30 minutes at room temperature.
- Wash your hands thoroughly.
- Place everything you need on a clean surface within easy reach: the
pre-filled syringe, the needle for subcutaneous injection, two alcohol swab
packets and a container for disposal of the needle and syringe.
II. How to prepare the syringe
- Take the sealed needle in both hands and snap the orange cap backwards.
Remove the orange cap. Do not remove the plastic needle shield.
- Remove the rubber tip from the syringe.
- Attach the needle with the plastic shield firmly to the syringe.
- Remove the plastic cover from the needle while holding the orange fitting
hub. Avoid pushing the plunger.
If your dose is less than that contained in the syringe, hold the syringe with
the needle pointing up and push up the plunger slowly to the correct dose. The
syringe is now ready for use.
III. Performing subcutaneous injection
- Choose an injection site. The most suitable places for injection are the
top of the thighs and the abdomen, except for the belly button area (see
diagram below). Rotate injection sites to avoid the risk of soreness at any
one site.
- Remove an alcohol swab from one packet and clean and disinfect the site by
wiping with the swab. Leave the swab on the site.
- Remove the alcohol swab from the site. Allow the injection site to dry for
10 seconds. - Grasp the skin firmly between the thumb and forefingers (without
squeezing) to elevate the subcutaneous tissue.
- Insert the needle fully into the skin at an angle of approximately 45°.
Pull back slightly on the plunger to check that a blood vessel has not been
punctured. If you see blood in the syringe, remove the needle and insert it in
another place. - Inject the liquid slowly and continuously by gently pushing the plunger
down while keeping the skin grasped.
- After injecting, remove the needle and release the skin. Immediately
disinfect the site with a new alcohol swab and apply finger pressure over the
swab for a minute or so.
Remember: Most people can learn to give themselves a subcutaneous
injection, but if you experience difficulty, please do not be afraid to ask for
help and advice from your doctor, nurse or pharmacist.
IV. How to dispose of used needles and syringes
The needle and prefilled syringe are to be used once only. The needle
of the Roferon-Pen is to be used once only. Dispose of the needle and
syringe immediately after injection into a sturdy glass or hard plastic
container away from children. Do not replace the needle cover.
Never put used needles and syringes into your normal household
waste bin.
If you are not sure how to dispose of the needles and syringes, consult your
doctor, nurse or pharmacist on how to properly dispose the syringes and needles.
When to inject ROFERON-A
Your doctor will tell you how often to use this medicine. ROFERON-A is
usually injected a maximum of one injection per day.
If you are injecting this medicine yourself, use it at bedtime as ROFERON-A
may make you very tired or cause flu-like symptoms.
How long to use ROFERON-A
Continue using ROFERON-A until your doctor tells you to stop.
Your ROFERON-A treatment period could range from a few weeks up to 12 months
or more depending on your illness. Your doctor will determine when your
treatment should be stopped.
If you forget to use ROFERON-A
If it is almost time for your injection, skip the injection you missed and
use your next injection when you are meant to. Do not double the dose.
Otherwise, use your medicine as soon as you remember, and then go back to
using it as you would normally.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to use your medicine, ask your
pharmacist for some hints.
In case of overdose
Immediately telephone your doctor or National Poisons Information Centre
(telephone 0800 POISON or 0800 764 766) for advice or go to your nearest
Accident and Emergency Centre if you think that you or anyone else may have used
too much ROFERON-A, even if there are no signs of discomfort or poisoning. You
may need urgent medical attention.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.
While you are using ROFERON-A
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are using ROFERON-A.
Tell your doctor if you become pregnant while using ROFERON-A.
Both males and females are recommended to use effective contraception
while taking ROFERON-A.
Tell your doctor if, for any reason, you have not used ROFERON-A exactly
as prescribed.
Otherwise, your doctor may think that it was not effective and change your
treatment unnecessarily.
Tell your doctor if you feel that ROFERON-A is not working for you.
Be sure to keep all of your appointments with your doctor so that your
progress can be checked.
Things you must not do
Do not stop using ROFERON-A or change the dose without first checking with
your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give ROFERON-A to anyone else even if they have the same condition
as you.
Do not use ROFERON-A to treat other complaints unless your doctor says to.
Do not switch to any other brand of interferon without consulting your
doctor first.
Do not take any other medicines whether they require a prescription or not
without first telling your doctor or consulting with a pharmacist.
Things to be careful of
ROFERON-A may cause dizziness, drowsiness or light-headedness in some people
or cause them to become confused. Be careful driving or operating machinery
until you know how ROFERON-A affects you. If you drink alcohol dizziness,
drowsiness or light-headedness may be worse.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are using ROFERON-A.
ROFERON-A helps most people but it may have unwanted side effects.
All medicines can have side effects. Sometimes they are serious. You may need
medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- flu-like symptoms such as fatigue, fever, chills, appetite loss, muscle or
joint pain, headache and sweating (these symptoms occur frequently and can
usually be relieved by paracetamol) - anxiety (feeling nervous or anxious)
- abnormal thoughts or behaviour
- loss of appetite, taste change or dry mouth, weight loss
- tiredness, weakness, lack of energy, drowsiness
- nausea, vomiting, diarrhoea, mild to moderate abdominal (gut) pain, severe
upper stomach pain - itching
- mild to moderate hair loss (usually reversible after finishing treatment)
- dizziness or vertigo (a spinning sensation)
These are the more common side effects of ROFERON-A.
Tell your doctor immediately or go to an Accident and Emergency Centre if
you notice any of the following:
- depression (feelings of deep sadness and unworthiness, or feeling "down"),
- thoughts about harming yourself, suicidal thoughts or attempts
- confusion, trouble sleeping, thinking or concentrating
- chest pain, fast or irregular heartbeat
- weakness, numbness or tingling sensation
- breathlessness which may be severe and usually worsens on lying down
- swelling of the hands, feet or ankles
- visual disturbances or loss of vision
- convulsions (epileptic fits)
- tremor (shaking)
- anaemia - signs include tiredness, headaches, being short of breath when
exercising, dizziness and looking pale - bleeding or bruising more easily than normal
- frequent infections (symptoms include fever, severe chills, sore mouth or
mouth ulcers) - hypotension (low blood pressure - signs include dizziness and
lightheadedness) - hypertension (high blood pressure)
- kidney disease where you pass little or no urine (symptoms also include
drowsiness, nausea and vomiting and breathlessness) - serious lung infection with fever, chills, shortness of breath and cough
with phlegm and/or occasionally blood - a blue, grey, or dark purple discoloration of the lips, fingers or toes
- loss of consciousness
- excessive thirst, the passing of a greatly increased amount of urine,
increase in appetite with a loss of weight, feeling tired, drowsy, weak,
depressed, irritable and generally unwell
These are serious side effects. You may need urgent medical attention.
This is not a complete list of all possible side effects. Others may occur in
some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel
unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this
list.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After using ROFERON-A
Storage of ROFERON-A
Prior to use, ROFERON-A prefilled syringes and cartridges should be kept in
the closed original pack stored in the fridge at 2 - 8°C. Do not let ROFERON-A
freeze. Protect from light.
When installed in the Roferon-Pen, the cartridge can be stored continually at
room temperature (below 25°C) for up to 28 days. However, where possible,
cartridges should be stored in the fridge and returned to the fridge after each
injection.
Do not shake ROFERON-A prefilled syringes or cartridges.
Protect ROFERON-A from light.
Do not leave ROFERON-A in the car or on windowsills. Heat and dampness
can destroy some medicines.
Keep ROFERON-A where young children cannot reach it. A locked cupboard
at least one-and-a-half metres above the ground is a good place to store
medicines.
ROFERON-A prefilled syringes are for single use only. Each prefilled
syringe should be used only once and any remaining contents should be discarded
along with the syringe and the needle.
ROFERON-A cartridges are multi-use cartridges - each one can be used
several times. Cartridges should be used within 28 days of the first
withdrawal.
Disposal
If your doctor tells you to stop using ROFERON-A, or the product has
passed its expiry date, ask your pharmacist what to do with any prefilled
syringes or cartridges that are left over.
If you are having ROFERON-A at home, you must throw away the needles and
syringes or cartridges in a sturdy glass or hard plastic container that will not
let the needles stick through it. This will help protect you and other people
from accidental needle stick injuries. Being pricked by a needle can pass
disease onto other people.
Product description
Availability
ROFERON-A prefilled syringes come in packs of one. Each pack contains the
prefilled syringe and one needle for subcutaneous injection.
Starter packs of ROFERON-A cartridges are also available, containing two
multi-dose cartridge packs, one Roferon-Pen injector and one pack of 100
needles.
What ROFERON-A looks like
ROFERON-A cartridges are specially designed for use with the ROFERON-Pen.
Each cartridge pack contains one multidose cartridge and one sticker for
recording the date of first withdrawal from the cartridge.
ROFERON-A solution for injection is contained in a glass cartridge. The
solution is clear and colourless to slightly yellowish.
A stainless steel needle is supplied with the syringes for subcutaneous
injection.
Ingredients
Active ingredient - interferon alfa-2a
Inactive ingredients - ROFERON-A solution for injection also contains
ammonium acetate, sodium chloride, benzyl alcohol (1% w/v), polysorbate 80,
glacial acetic acid, sodium hydroxide, water for injection.
ROFERON-A prefilled syringes are available in the following strengths of
interferon alfa-2a:
- 3.0 million IU in 0.5 mL of solution
- 4.5 million IU in 0.5 mL of solution
- 6.0 million IU in 0.5 mL of solution
- 9.0 million IU in 0.5 mL of solution
ROFERON-A cartridges are available as 18 million IU interferon alfa-2a in 0.6
mL of solution