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ROFERON-A INJECTION 18MIU/0.6ML

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PACKAGE LEAFLET: INFORMATION FOR THE USER

10135261 GB 1111.1083

Roferon -A
®

18 million international units (MIU)
solution for injection in cartridge
Interferon alfa-2a
Read all of this leaflet carefully
before you start using this medicine.
 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. Do not pass it on to others.
It may harm them, even if their
symptoms are the same as yours.
 If any of the side effects become
serious, or if you notice any side effects
not listed in this leaflet, please tell
your doctor or pharmacist.

Pregnancy
Do not use Roferon-A if you are
pregnant, think you may be pregnant,
or are planning to become pregnant,
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.

In this leaflet:
1. What Roferon-A is and what
it is used for
2. Before you use Roferon-A
3. How to use Roferon-A
4. Possible side effects
5. How to store Roferon-A
6. Further information

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, 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.

Breast-feeding
Ask your doctor or pharmacist for advice
before taking any medicine. It is not
known whether this product 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 medicinal
products.

2. Before you use Roferon-A
Do not use Roferon-A:
 if you are allergic (hypersensitive)
to interferon alfa-2a or any of the other
ingredients of Roferon-A (listed
in Section 6: Further information).
 if you suffer or have suffered from
heart disease.
 if you have a severe kidney or liver
condition.
 if you have a liver disease or liver
cirrhosis
 if you have a bone marrow disorder.
 if you suffer from seizures e.g. epilepsy
and/or other central nervous system
disorders.
 If you are or have recently been treated
with medication for chronic liver
disease that weakens your immune
response.

Driving and using machines
Do not drive or use machinery if you feel
drowsy, tired or confused while using
Roferon-A.
Important information about
some of the ingredients of Roferon-A
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 product contains less than 1 mmol
sodium (23 mg) per 0.5 ml, i.e. essentially
“sodium free”.

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).

3. How to use Roferon-A
Always use Roferon-A exactly as your
doctor has told you.
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.

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.

The cartridge in combination with
the Roferon-Pen is for the injection
of Roferon-A beneath your skin
(subcutaneous). The Roferon-Pen
user manual contains detailed
instruction for use of the Roferon-Pen /
cartridge combination. Read this manual
carefully before use.
Roferon-A cartridges are for multidose
use. This means that multidose injections
are possible with this presentation.
You should write the date of first use
on the label provided with the cartridge
and use within 28 days of this date.
Your doctor or nurse will show you an
“aseptic technique” that will allow you
to administer the required amount
of Roferon-A safely. A new sterile needle
must be used each time you administer
a dose.

Take special care with 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 medicinal
products.
 if you are taking any other medicines
(including those not prescribed by your
doctor).

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
(MIU) 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.

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.

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

Using other medicines
Please tell your doctor or pharmacist
if you are taking or have recently taken
any other medicines including medicines
obtained without a prescription.
The effects of those drugs could either
be increased, decreased, or altered when
administered concomitantly with
interferons. In particular the plasma
concentration of theophylline, an asthma
drug from the xanthine family, can be
increased when it is administered
concomitantly with interferon and may
request a dosage adjustment.

Cutaneous T-Cell Lymphoma
The dose will normally be increased
from 3 MIU to 18 MIU taken once a day
over an initial treatment period
of 12 weeks.
AIDS-related Kaposi’s Sarcoma
The dose will normally be increased
from 3 MIU to 18 MIU taken once a day
to a maximum of 36 MIU over an initial
treatment period of 10 - 12 weeks.
Renal Cell Carcinoma
Combination with vinblastine
The dose will normally be increased
from 3 MIU to 18 MIU taken three times
a week over an initial treatment period
of 12 weeks.

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.

Combination with bevacizumab (Avastin)
9 MIU under the skin (subcutaneously)
three times a week until your disease
progresses or for up to 1 year.

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.

Chronic Hepatitis B
2.5 - 5 MIU/square metre body surface
area three times a week for 4 - 6 months.

Tests and investigations:
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.

Chronic Hepatitis C
3 - 6 MIU three times a week
for 6 months.
Follicular Non-Hodgkin’s Lymphoma
(with chemotherapy)
6 MIU/square metre body surface area
from day 22 to day 26 of each 28-day
cycle

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Malignant Melanoma
3 MIU three times a week for 18 months.

Cardiac, vascular and respiratory
disorders:
Temporary low or high blood pressure,
irregular heart beat, slowing of the heart
rate, palpitations, chest pain and heart
attack have been observed in patients
using Roferon-A. Build-up of fluid
in the lungs (which may cause breathing
problems) and a bluish discolouration
of the skin or lips (caused by a lack
of oxygen in the blood) have also been
reported. Serious heart and lung
problems occur rarely.

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.

Breathlessness, cough and vasculitis
(inflammation of the blood vessels) have
been reported rarely.

Other important instructions

Liver and kidney disorders:
Sometimes, mild effects on your liver
may occur, but these will not normally
require a change in dosage. In rare cases,
Roferon-A may cause the liver to work
less well than usual and may result
in severe liver abnormalities, including
liver failure and hepatitis.

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.

Urine tests may show protein
and increased cell counts in your urine.
In rare cases, kidney failure or worsening
of kidney function may occur, mainly
in cancer patients who already suffer
from kidney disease.

If you forget to use Roferon-A:
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.

Skin and mucous membranes:
Increased sweating, rash, dryness
or itching of your skin, psoriasis
or worsening of psoriasis, runny nose
and nose bleeds may occur. Hair thinning
or hair loss sometimes occurs, but this
is usually reversible on completion
of treatment.

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

4. Possible side effects
Like all medicines, Roferon-A can
cause side effects, although not everybody
gets them.

You may get a slight
reaction around
the area of skin where
you are injected with
Roferon-A. In very rare
cases this may cause
a dead patch of skin
around the injection site.

Important side effects
to look out for:

Musculoskeletal disorders:
Muscle and joint pain, rarely systemic
lupus erythematosus, arthritis.

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

Other side effects:
Flu-like illness, tiredness, fever,
loss of appetite, chest pain.

 If you develop signs of a severe allergic
reaction (such as difficulty in
breathing, wheezing or hives) while
on this medication.

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.
Some changes may occur in your blood
which your doctor will check for.

 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.

If any of the above side effects gets
serious, or if you notice any side effects
not listed in this leaflet, please tell
your doctor or pharmacist.

Other possible side effects:
It is 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.

5. How to store Roferon-A
Keep out of the reach and sight
of children.
Do not use Roferon-A after the expiry
date, which is stated on the carton
and on the label. The expiry date refers
to the last day of that month.

Infections:
Pneumonia, cold sores and genital herpes
occur rarely.

Store in a refrigerator (2 ºC - 8 ºC).
Do not freeze. Keep cartridge in the outer
carton in order to protect from light.

Blood and lymphatic system
disorders:
Changes in blood cell counts have been
reported, including:
 Lower numbers of red blood cells
(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.
 Lower white cell counts. The signs
include increased number
of infections.

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.
Once opened, the product may be
stored for a maximum of 28 days at 25 ºC.
However, it is recommended that
the Roferon-Pen/cartridge combination
be returned to the fridge after each
injection.
Medicines should not be disposed
of via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines that are no longer required.
These measures will help to protect
the environment.

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.

6. Further information
What Roferon-A contains
 The active substance is interferon
alfa-2a, 18 MIU/0.6ml
 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

Immune system and endocrine
disorders:
Autoimmune conditions (where
the body attacks its own cells), such
as arthritis, hypersensitivity reactions
including wheals, swelling of the face,
lips and throat, wheezing and allergic
type reactions, such as a rash, have been
reported rarely.

What Roferon-A looks like
and the contents of the pack
Roferon-A is a solution for injection
(0.6 ml in cartridges).

Sarcoidosis (a disease that results from
inflammation of tissues of the body)
has been very rarely reported. Sarcoidosis
can affect almost any body organ, but
most often starts in the lungs or lymph
nodes.

Pack sizes: Packs of 1, 3 or 6 . Not all
pack sizes may be marketed. The solution
is clear, colourless to slightly yellowish.
Marketing Authorisation Holder

Rarely, abnormal functioning of the
thyroid gland has been reported.

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Transplant rejections have been
reported very rarely.
Gastrointestinal, metabolism
and nutrition disorders:
Anorexia (an eating disorder causing
weight loss) and nausea are side effects
which occur frequently. Bitter taste,
dry mouth and weight loss may occur
less frequently. Other side effects which
may affect the stomach and bowel,
such as stomach pains, diarrhoea,
vomiting, heartburn, constipation and
flatulence (wind), have been observed less
frequently. In rare cases, the pancreas
may work abnormally. In very rare cases,
worsening or return of a peptic ulcer
and intestinal bleeding have occurred.

Manufacturer
Roche Pharma AG
Emil-Barell-Str. 1
D-79639 Grenzach-Wyhlen
Germany
This medicinal product
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.

Low blood calcium, electrolyte
imbalance (abnormal blood test results
for sodium and other elements),
dehydration and, very rarely, diabetes
(a disease resulting from high blood
sugar) and hypertriglyceridaemia (high
levels of some lipids/fats in the blood)
have been reported.

This leaflet was last approved in:
November 2011

Nervous system and psychiatric
disorders:
Headache, dizziness, pins and needles,
trembling, numbness, sleep disturbances,
nervousness, anxiety states,
forgetfulness, drowsiness, confusion,
changed or abnormal behaviour,
depression and suicidal behaviour have
occurred. You should tell your doctor
if you experience any symptoms
of depression.
Rarely, vertigo, transient or temporary
impotence (male sexual dysfunction),
convulsions (fits), stroke and coma have
been reported.
Eye disorders:
Conjunctivitis, eye discharge, visual
disturbances, such as blurred vision and,
very rarely, loss of eyesight, have been
reported.

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Expand Transcript

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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