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ROFERON-A 9 MILLION INTERNATIONAL UNITS (IU) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): INTERFERON ALFA-2A (RBE)

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Genisys-No.

10166059

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Package Leaflet: Information for the user

Roferon®-A

3 million international units (IU)
4.5 million international units (IU)
6 million international units (IU)
9 million international units (IU)
solution for injection in pre-filled syringe
Interferon alfa-2a

Read all of this leaflet carefully before
you start using this medicine because it
contains important information for you.
● Keep this leaflet. You may need to read it
again.
● If you have any further questions, ask
your doctor or pharmacist.
● This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
● If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

not pregnant now but is of childbearing
age, she must be tested for pregnancy
each month during treatment and for
7 months after treatment has stopped.
You and your partner must each use an
effective contraceptive during the time
you are taking the treatment and for the
7 months after stopping treatment. This
can be discussed with you doctor.
Breast-feeding
If you are breast-feeding, ask your doctor or
pharmacist for advice before taking this
medicine. It is not known whether this
medicine is present in human milk.
Therefore, discuss with your doctor whether
you should suspend breast-feeding or
discontinue Roferon-A. In combination
therapy with ribavirin, take notice of the
respective informing texts of ribavirin
containing medicines.

What is in this leaflet:
1. What Roferon-A is and what it is used for
2. What you need to know before you use
Roferon-A
3. How to use Roferon-A
4. Possible side effects
5. How to store Roferon-A
6. Contents of the pack and other information
7. How to inject Roferon-A

Driving and using machines
Do not drive or use machinery if you feel
drowsy, tired or confused while using
Roferon-A.

1. What Roferon-A is and what it
is used for

Roferon-A contains benzyl alcohol

Roferon-A contains an antiviral agent called
interferon alfa-2a which is similar to a
natural substance produced by the body to
protect against viral infections, tumors and
foreign substances that may invade the body.
Once Roferon-A has detected and attacked a
foreign substance, it alters it by slowing,
blocking, or changing its
growth or function.

Roferon-A contains benzyl alcohol therefore
it must not be given to premature babies or
newborns. It may cause toxic or allergic
reactions in infants and children up to 3
years old.
The medicine contains less than 1 mmol
sodium (23 mg) per
0.5 ml, i.e. essentially
“sodium free”.

Roferon-A is used to treat
the following:
● Viral infections, such
as chronic hepatitis B
and C.
● Cancers of the blood (cutaneous T-cell
lymphoma, hairy cell leukaemia and
chronic myelogenous leukaemia).
● Some other forms of cancer (renal cell
carcinoma, AIDS-related Kaposi’s
sarcoma, follicular non-Hodgkin’s
lymphoma and malignant melanoma).
If you are not sure why you have been
prescribed Roferon‑A, you should discuss
your illness and its treatment with your
doctor.

3. How to use Roferon-A
Always use this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Roferon-A can be given by your doctor or
nurse, or your doctor or nurse may teach you
how to inject yourself with Roferon-A. Do
not try to inject yourself with Roferon-A
unless you have received training. You
should check with your doctor or nurse if
you are not sure.
Roferon-A pre-filled syringes are used to
give an injection beneath your skin
(subcutaneous). See section 7 for detailed
instructions.

2. What you need to know before
you use Roferon-A
Do not use Roferon-A:

The pre-filled syringes are for single use
only.

● if you are allergic to interferon alfa-2a or
any of the other ingredients of this
medicine (listed in Section 6).
● if you suffer or have suffered from heart
disease.
● if you have a severe kidney or liver
condition.
● if you have a bone marrow disorder.
● if you suffer from seizures e.g. epilepsy
and/or other central nervous system
disorders.
● if you have a liver disease or liver cirrhosis
● if you are or have recently been treated
with medication for chronic liver disease
that weakens your immune response.

Roferon-A dosing
Your doctor will decide the best dose for
you. The amount of Roferon-A you need
will depend on why you are being treated
and the side effects you suffer.
Your dose should not normally be more than
36 million International Units (IU) per day.
If you think the effect of your medicine is
too weak or too strong talk to your doctor.
Do not change the amount you take
before talking to your doctor.
The recommended dose is:

Roferon-A is not recommended for use in
children except on the advice of your doctor.
‘Gasping syndrome’ (a serious condition in
children up to 3 years old), has been linked
with benzyl alcohol. Benzyl alcohol is an
inactive ingredient in Roferon-A. Roferon-A
is therefore not a suitable medicine for
young children (including premature babies,
newborns or infants).

Hairy Cell Leukaemia
3 million IU daily for 16‑24 weeks.
Chronic Myelogenous Leukaemia
The dose will normally be increased from
3 million IU to 9 million IU taken once a
day over an initial treatment period of
12 weeks.

For some diseases, Roferon-A may be used
in combination with other drugs. In such
cases any additional restrictions on the use
of Roferon-A will be explained to you by
your doctor.

Cutaneous T-Cell Lymphoma
The dose will normally be increased from
3 million IU to 18 million IU taken once a
day over an initial treatment period of
12 weeks.

Warnings and precautions

AIDS-related Kaposi’s Sarcoma
The dose will normally be increased from
3 million IU to 18 million IU taken once a
day to a maximum of 36 million IU over an
initial treatment period of 10‑12 weeks.

Talk to your doctor or pharmacist before
using Roferon-A.
Tell your doctor:
● if you have mental problems (psychiatric
difficulties) or have ever had a mental
(psychiatric) illness.
● if you have psoriasis (a disease of
recurring dry, patchy, scaly skin lesions).
● if you have kidney, heart or liver problems.
● if you have ever had an autoimmune
disease, e.g. thyroid problems, vasculitis
(inflammation of the blood vessels).
● if you have had an organ transplant (such
as kidney) or bone marrow transplant, or
have one planned in the near future.
● if you are or may be pregnant.
● if you have a low blood cell count.
● if you have diabetes (a disease resulting
from high sugar level in your blood).
● if you have any other problems with your
blood.
● if you are being treated for chronic
hepatitis C.
● if you are also infected with HIV and
being treated with anti-HIV medicines.
● if you are taking any other medicines
(including those not prescribed by your
doctor).
● if you are an adult who has or had a
history of substance abuse (e.g. alcohol or
drugs)

Renal Cell Carcinoma
Combination with vinblastine
The dose will normally be increased from
3 million IU to 18 million IU taken three
times a week over an initial treatment period
of 12 weeks.
Combination with bevacizumab (Avastin)
9 million IU under the skin (subcutaneously)
three times a week until your disease
progresses or for up to 1 year.
Chronic Hepatitis B
2.5‑5 million IU/square metre body surface
area three times a week for 4‑6 months.
Chronic Hepatitis C
3‑6 million IU three times a week for
6‑12 months.
Follicular Non-Hodgkin’s Lymphoma (with
chemotherapy)
6 million IU/square metre body surface area
from day 22 to day 26 of each 28-day cycle
Malignant Melanoma
3 million IU three times a week for
18 months.
If you respond well to initial treatment with
Roferon-A, your doctor may decide that you
should continue treatment for a longer
period of time (maintenance therapy) and
will change your dosage accordingly.

Tell your doctor if you have a blood disorder
or suffer from diabetes. Your doctor may
take samples of your blood at intervals to
check its composition, which may change
during treatment. If needed your doctor may
adjust the dose of your treatment with
Roferon-A and any other treatments you are
receiving at the same time.

Combination therapy with Ribavirin in
chronic hepatitis C
When taking Roferon-A and Ribavirin at the
same time, please follow the dosage regimen
recommended by your doctor.

Other medicines and Roferon-A

Your doctor will tell you when to stop
using Roferon-A. Some illnesses may
require treatment over a period of several
years.

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. The effects of those
medicines could either be increased,
decreased, or altered when administered at
the same time as interferons. In particular
the plasma concentration of theophylline, an
asthma medicine from the xanthine family,
can be increased when it is administered at
the same time as interferon and may require
a dosage adjustment.

If you use more Roferon-A than you
should
Contact your doctor, pharmacist or nearest
hospital immediately.
If you forget to use Roferon-A

Patients who also have HIV infection: Lactic
acidosis and worsening liver function are
side effects associated with Highly Active
Anti-Retroviral Therapy (HAART), an HIV
treatment.

Do not take a double dose to make up for a
forgotten dose.
If you stop using Roferon-A
Contact your doctor or pharmacist as soon
as possible.

If you are receiving HAART, the addition of
Roferon-A and Ribavirin may increase your
risk of lactic acidosis or liver failure. Your
doctor will monitor you for signs and
symptoms of these conditions. Please read
the Ribavirin Package Leaflet.

If you have any further questions on the use
of this medicine, ask your doctor,
pharmacist or nurse.

Blood tests. If you are going to have a blood
test, you should tell the doctor or nurse
performing the test that you are taking
Roferon-A. In some uncommon or rare
cases, Roferon-A may affect the results of
these tests.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

Pregnancy and fertility

Tell your doctor straight away if you
notice any of the following serious side
effects. You may need urgent medical
treatment:

Do not use Roferon-A if you are pregnant,
think you may be pregnant, or are planning
to have a baby, unless your doctor tells you
to. This is because Roferon-A may affect
your baby. It is important that you and your
partner use an effective method of birth
control (contraception) while you are being
treated with Roferon-A.
When Roferon-A is used in combination
with ribavirin, both male and female patients
must take special precautions in their sexual
activity if there is any chance for pregnancy
to occur as ribavirin can be very damaging
to an unborn baby:
- if you are a woman of childbearing age
who is taking Roferon-A in combination
with ribavirin, you must have a negative
pregnancy test before treatment, each
month during therapy and for the 4
months after treatment is stopped. You
and your partner must each use an
effective contraceptive during the time
you are taking the treatment and for
4 months after stopping treatment. This
can be discussed with your doctor.
- if you are a man who is taking RoferonA in combination with ribavirin, do not
have sex with a pregnant women unless
you use a condom. This will lessen the
chance for ribavirin to be left in the
woman’s body. If your female partner is
10166059_NP9345.indd 1

● If you develop signs of a severe allergic
reaction (such as difficulty in breathing,
wheezing or hives) while on this
medication.
● If you notice a decrease in your sight
during or after treatment with Roferon-A.
● If you develop any signs of depression
(such as sadness, feeling worthless or
thoughts of suicide) during your
Roferon-A treatment.
Other possible side effects:
It is very common to experience flu-like
symptoms such as tiredness, chills, muscle or
joint pain, headache, sweating and fever. These
effects can usually be reduced by taking
paracetamol. Your doctor will advise you on the
dose you should take. These kinds of symptoms
usually lessen with continued therapy.
Other very common side effects (may affect
more than 1 in 10 people) are:
● lower white cell counts. The signs include
increased number of infections
● loss of appetite
Please turn over 
1

10166059 GB

22.10.2015 08:49:21

Genisys-No.

10166059

Printing Colour:

Pantone Black

Format:

148x840 mm

Folding Format:

148x210 mm

Type Size

10,5 pt

Drawing Norm

NP9345

make-up code

GB

Checked and
approved
Good To Print

11.08.10

Date

Version

Date

3

22.10.15

Signature

Signature

MMBFMM8W

97.4.3525

MMBFMM8Z

● nausea
● low blood calcium
● diarrhoea
● decreased appetite
● hair thinning or hair loss (this is usually
reversible on completion of treatment)
● flu-like illness. Symptoms may include
tiredness, fever and chills
● headache
● increased sweating
● muscle pain
● joint pain
Common side effects (may affect up to 1 in
10 people):
● lower number of red blood cells or
anaemia (the signs include feeling tired,
pale skin and being short of breath)
● lower numbers of platelets (the signs include
small bruises on the body or bleeding)
● changes in platelet and red blood cell
counts are more likely to occur if you are
undergoing cancer treatments, including
chemotherapy, or have decreased bone
marrow activity. The make-up of your
blood will usually become more normal
after discontinuing Roferon-A.
● irregular heartbeat
● palpitations
● bluish discolouration of the skin or lips
(caused by a lack of oxygen in the blood)
● vomiting or feeling sick
● stomach pains
● dry mouth
● bitter taste or change in the sensation of
taste
● chest pain
● swelling
● weight loss
Uncommon side effects (may affect up to
1 in 100 people):
● dehydration and electrolyte imbalance
(abnormal blood test results for sodium or
potassium)
● depression
● anxiety
● confusion
● changed or abnormal behaviour
● nervousness
● forgetfulness
● sleep disturbances
● muscle weakness
● changes to sensation of
the skin, e.g. pins and
needles, numbness,
● dizziness
● trembling of hands
● drowsiness or
sleepiness
● conjunctivitis or redness of eyes
● visual disturbances
● temporary low or high blood pressure
● itchiness
● psoriasis or worsening of psoriasis
● urine tests may show protein and
increased cell counts in your urine
● blood tests: showing changes in liver
function

● damage to the retina (the back of the eye)
or the blood vessels within the retina (can
lead to blurred vision or in serious cases
to loss of eyesight).
● your doctor may notice changes to the
retina on examination of the eye
including swelling of the main nerve at
the back of the eye
● problems with eyesight related to the
main nerve at the back of the eye
● worsening or return of a peptic ulcer and
intestinal bleeding
● the area of skin where Roferon-A was
injected may have redness, swelling and
pain, and may cause a dead patch of skin
around the injection site.
● problems related to mental state such as
difficulty with thinking, concentration,
personality changes or level of
consciousness. Your doctor may call this
encephalopathy.
Side effects for which the frequency cannot
be determined:
● transplant rejections
● ischaemic colitis (insufficient blood
supply to the bowels) and ulcerative
colitis. Abdominal pain, bloody diarrhoea
and fever are typical colitis signs.
● pulmonary arterial hypertension- a
disease of severe narrowing of the blood
vessels in the lungs resulting in high
blood pressure in the blood vessels that
carry blood from the heart to the lungs.
This may occur in particular in patients
with risk factors such as HIV-infection or
severe liver problems (cirrhosis). The side
effect may develop at various time points
during treatment, typically several
months after starting treatment with
Roferon-A.
Your doctor may decide to combine your
Roferon-A treatment with other medicines.
In such cases you may experience additional
undesirable effects. Where these occur, they
will be explained to you by your doctor.
Reporting of side effects
If you get any side effects talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly
(see details below).
By reporting side effects
you can help provide
more information on the
safety of this medicine.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail:
medsafety@hpra.ie

Rare side effects (may affect up to 1 in
1000 people):
● pneumonia
● cold sores
● genital herpes
● severe decrease in the number of white
blood cells (your doctor may call this
agranulocytosis)
● abnormal breakdown of red blood cells
(your doctor may call this haemolytic
anaemia)
● autoimmune conditions (where your
immune system attacks your cells by
mistake),
● hypersensitivity reactions including
wheals, swelling of the face, lips and
throat, wheezing and allergic type reactions
● increased or decreased activity of the
thyroid
● blood tests showing high blood sugar or
diabetes (a disease resulting from high
blood sugar)
● suicide or thinking about committing
suicide or harming yourself
● coma
● stroke
● convulsions (fits)
● transient or temporary impotence (male
sexual dysfunction)
● visual disturbance due to poor blood flow
to the back of the eye (your doctor may
call this ischaemic retinopathy)
● heart attack
● heart failure
● serious heart and breathing problems
● build-up of fluid in the lungs (which may
cause breathing problems)
● inflammation of the blood vessels
[vasculitis]
● breathlessness
● cough
● inflammation of the pancreas (your doctor
may call this pancreatitis)
● over activity of the bowels (this may
cause diarrhoea)
● constipation
● heartburn
● flatulence (wind)
● the liver may work less well than usual and
may result in severe liver abnormalities,
including liver failure or inflammation of
the liver (also known as hepatitis)
● rash
● dry skin, mouth or lips
● nose bleeds
● dryness or runny nose
● an autoimmune disease where your own
immune system attacks parts of your
body by mistake. It often causes rash and
joint pain but other parts of the body may
be affected. (your doctor may also call it
lupus or SLE)
● arthritis or joint pain
● kidney failure or worsening of kidney
function (mainly in cancer patients who
already suffer from kidney disease)
● blood tests showing changes in kidney
function
● blood tests showing changes in chemicals
called uric acid and lactate dehydrogenase
● mania (episodes of exaggerated elevation
of mood)
Very rare side effects (may affect up to 1 in
10,000 people):
● an autoimmune disease where your own
immune system attacks the platelets (cells
which control clotting) in your blood by
mistake. It can cause a severe decrease in
the number of platelets and you may
develop tiny bruise like spots on your skin
● sarcoidosis (a disease that results from
inflammation of tissues of the body;
sarcoidosis can affect almost any part of
the body, but most often starts in the
lungs or lymph nodes)
● hypertriglyceridaemia and
hyperlipidaemia (high levels of some
lipids/fats in the blood)

United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

5. How to Store Roferon-A
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date, which is stated on the carton and on
the label after EXP. The expiry date refers to
the last day of that month.
Store in a refrigerator (2 ºC to 8 ºC). Do not
freeze. Keep the pre-filled syringe in the
outer carton in order to protect from light.
Do not use Roferon-A if you notice that the
solution is cloudy, if it has floating particles
or if the medicine is any colour besides
colourless to slightly yellowish.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
that you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other
information
What Roferon-A contains
● The active substance is interferon alfa-2a,
at 3 million IU/0.5 ml,
4.5 million IU/0.5 ml,
6 million IU/0.5 ml, or
9 million IU/0.5 ml.
● The other ingredients are ammonium
acetate, sodium chloride, benzyl alcohol
(10 mg/1 ml), polysorbate 80, glacial
acetic acid, sodium hydroxide and water
for injections
What Roferon-A looks like and contents
of the pack
Roferon-A is a solution for injection (0.5 ml
in pre-filled syringes).
Pack sizes: Packs of 1, 5, 6, 12 or 30, and
multipacks containing 12 (2 packs of 6) or
30 (5 packs of 6). Not all pack sizes may be
marketed.
The solution is clear, colourless to slightly
yellowish.
Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW, United Kingdom
Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
This medicine is authorised in the
Member States of the EEA under the
following names:
Roferon-A: Austria, Belgium, Cyprus,
Czech Republic, Estonia, Finland, Germany,
Greece, Hungary, Ireland, Italy, Latvia,
Lithuania, Luxemburg, Netherlands,
Portugal, Slovakia, Slovenia, Spain,
Sweden, United Kingdom.
Roféron-A: France.
Roceron-A: Norway.
This leaflet was last revised in:
June 2015

7. How to inject Roferon-A

Illustrated instructions for subcutaneous injection using Roferon®-A pre-filled
syringe







Syringe with solution for injection

Needle for subcutaneous injection



plunger
protective cap
rear cap
shield
Important: Let the solution warm to room temperature before use (administration).
1
Take the needle from the box. Take off the rear cap from the needle.
Then, take the syringe from the box and take off the protective cap.
Push the needle onto the syringe. Pull off the shield from the needle
(see figure 1).
2

3

Hold the syringe with
the needle pointing up.
Carefully push out any
air by slowly pushing
the plunger in.

Roferon-A can be
injected either into the
thigh or into the lower
abdomen.
It is recommended that
a new site be chosen
for each injection

Figure 2.

Figure 1.

Figure 3.

4
Before injecting yourself, clean the injection site
with an alcohol swab.
Figure 4.
5
Using your thumb and index finger, pinch up a fold of skin
and insert the needle as far as it will go at an angle of 45 degrees
(see figure 5).
Pull back the plunger of the syringe slightly.
If blood appears in the syringe, the needle has entered a blood
vessel. If this happens you cannot inject the Roferon-A.
Discard the unused syringe and needle and start again with a new
injection at a different site with a new syringe and needle.
6

7

Applying steady
pressure, inject
the contents of
the Roferon-A
pre-filled syringe
beneath the skin
until the syringe is
completely empty.

To remove syringe,
press the alcohol
swab lightly on
injection site and
withdraw needle at
a low angle.

Figure 6.

Figure 5.

Figure 7.

The pre-filled syringes are for single use only. You should discard any unused product or waste
material. Ask your doctor or pharmacist for future advice.
The following points should be strictly adhered to regarding the use and disposal of syringes
and other medicinal sharps:
● Needles and syringes should never be reused.
● Place all used needles and syringes into a sharps container (puncture-proof disposable container).
● Keep this container out of the reach of children.
● Placing used sharps containers in the household waste should be avoided.
● Dispose of the full container according to local requirements or as instructed by your
healthcare provider.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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