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ROFERON-A 3 MILLION INTERNATIONAL UNITS (IU) SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

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

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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.

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

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

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

Warnings and precautions
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)
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.

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.

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

Roferon-A contains benzyl alcohol
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”.

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.
The pre-filled syringes are for single use only.
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:
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.
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.
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.
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.
Your doctor will tell you when to stop using
Roferon-A. Some illnesses may require
treatment over a period of several years.

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

If you forget to use Roferon-A
Do not take a double dose to make up for a
forgotten dose.

Other medicines and Roferon-A

If you stop using Roferon-A

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.

Contact your doctor or pharmacist as soon as
possible.

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

Pregnancy and fertility
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 Roferon- A
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 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.
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If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.

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

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

● 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.

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, Italy, Latvia, Luxemburg,
Netherlands, Portugal, Slovakia, Slovenia,
Spain, Sweden, United Kingdom.
Roféron-A: France.
Roceron-A: Norway.
This leaflet was last revised in:
September 2016

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.

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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