Australia - English - Department of Health (Therapeutic Goods Administration)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about INTRON A. It does
not contain all of the available
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 INTRON A
against the benefits they expect it
will have for you.
If you have any concerns about
using this medicine, ask your
doctor or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again.
What INTRON A is
INTRON A belongs to a group of
medicines called interferons.
Interferons are a family of naturally
occurring, small protein molecules.
They are produced and secreted by
cells in response to viral infections or
various synthetic and biological
Interferons modify the body's
immune system response.
INTRON A is used to treat patients
with the following conditions:
Hairy cell leukaemia
Kaposi's sarcoma in AIDS
Chronic myelogenous leukaemia
Chronic hepatitis B
Chronic hepatitis C
Your doctor, however, may prescribe
INTRON A for another purpose.
Before you use
When you must not use it:
Do not use INTRON A if you are
interferon alfa-2b or any of the
ingredients listed at the end of
Do not use INTRON A if you are
pregnant or breastfeeding unless
your doctor says so. Ask your
doctor about the risks and benefits
If you are a woman of childbearing
age make sure you do not become
pregnant while using INTRON A.
Do not use INTRON A if
packaging is torn or shows signs of
Do not use INTRON A after the
expiry date (EXP) printed on the
If you use it after the expiry date it
may have no effect at all, or worse,
an unexpected effect.
If you are not sure whether you
should start using INTRON A, talk
to your doctor.
Before you start to use it
You must tell your doctor:
if you are allergic to:
any other medicines or any food,
dyes or preservatives
if you have any of these medical
heart disease, high blood pressure
or you have ever had a heart
poor kidney or liver function
advanced liver disease
hepatitis and have been treated
recently with medicines that
suppress the immune system
a history of convulsions or mental
you have ever been treated for
depression or any other
a history of autoimmune disease
or skin disease (psoriasis)
a history of diabetes, lung disease
or respiratory disease
thyroid disease or blood clotting
you are taking any other
medicines, including medicines
that you buy without a
prescription from a pharmacy,
supermarket or health food
Be sure to tell your doctor if
you are taking theophylline for
asthma, as you may need to
take different amounts of your
Use in Children
There is limited experience with the
use of INTRON A in children.
INTRON A is not intended for use in
premature infants or neonates.
Effect on Fertility
Fertile women should not use
INTRON A unless effective
contraception is used during
treatment with INTRON A.
INTRON A should be used with
caution in fertile men.
How to use INTRON A
How much to inject
Your doctor has determined the exact
schedule according to your needs.
Your dose may be adjusted by your
doctor during therapy according to
Do not exceed the recommended
How to inject
Your doctor or nurse will tell you
how to give the injection under the
skin if you are injecting this medicine
INTRON A can also be injected into
a vein. This would normally be
carried out by your doctor.
How to use INTRON A
INTRON A Injectable Solution is
available in single dose vials.
The solution may be injected directly
under the skin after withdrawal of the
appropriate doses from the vial with
a sterile syringe and needle.
When to inject
If you are injecting this medicine
yourself, use it at bedtime as
interferons may cause unusual
tiredness and flu-like symptoms.
How long to use it
Do not stop using this medicine
without first checking with your
Your doctor will determine when
your treatment should be stopped.
If you forget to use it
If it is almost time for your
injection, skip the injection you
missed and take your next
injection when you are meant to.
Otherwise, use it as soon as you
remember, and then go back to
using it as you would normally.
Do not take a double injection to
make up for the injection that you
If you have trouble remembering
when to use your medicine, ask your
pharmacist for some hints.
If you use too much
Immediately telephone your doctor
or Poisons Information Centre
(telephone 13 11 26) for advice, or
go to casualty at your nearest
hospital, if you think you or
anyone else may have used too
much INTRON A. Do this even if
there are no signs of discomfort or
poisoning. You may need urgent
Keep telephone numbers for these
While you are using
Things you must do
Use INTRON A exactly as your
doctor has prescribed.
Tell all doctors, dentists and
pharmacists who are treating you
that you are using INTRON A.
Tell your doctor immediately if
you become pregnant while you
are using INTRON A.
Things you must not do
INTRON A may cause dizziness
and drowsiness in some people. If
you become drowsy from this
medicine do not drive or use
Do not use it to treat any other
complaints unless your doctor says
Do not give this medicine to anyone
else, even if their symptoms seem
similar to yours.
Do not switch to any other brands
of interferon unless advised by
your doctor as your response to
other interferons may be different.
Things to be careful of
Check with your doctor about
drinking alcoholic beverages or
taking sleeping pills, sedatives or
Your doctor may want you to
drink extra fluids.
This will help prevent low blood
pressure while you are using
Check with your doctor if you
think you are developing
symptoms associated with a cold or
other respiratory infection.
While receiving INTRON A, you
may temporarily have a greater risk
of getting an infection.
Check with your doctor
immediately if you notice unusual
bleeding or bruising.
Your blood may temporarily take a
longer time to clot.
Tell your doctor if you notice
any changes in your eyes or
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are using INTRON
All medicines 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.
Ask your doctor or pharmacist any
questions you may have.
Check with your doctor
immediately if any of the following
side effects occur:
an allergic reaction such as hives
or difficulty in breathing
chest pain or irregular heartbeat
confusion, aggressive behaviour,
suicidal feelings, depression,
trouble sleeping, thinking or
numbness or tingling sensation
black or tar-like stools, blood in
stool or urine, painful or difficult
fever or chills beginning after a
few weeks of treatment
lower back or side pain
unusual bruising or bleeding
You may need urgent medical
Tell your doctor if you notice any
of the following and they worry
flu symptoms including muscle
ache, fever, chills and headache
loss of appetite, taste change or
tiredness, sleepiness or dizziness
feeling sick, vomiting or
low blood pressure
These side effects may go away as
your body adjusts to the medicine.
Tell your doctor, if they continue
or are severe.
Other side effects not listed above
may also occur in some patients.
Check with your doctor as soon as
possible if you have any problems
while using INTRON A even if you
do not think the problems are
connected with the medicine or the
side effects are not listed in this
Do not be alarmed by this list of
possible side effects. You may not
experience any of them.
After using INTRON A
Keep INTRON A where children
cannot reach it.
Before use: Store in the
refrigerator (2°C to 8°C). Do not
freeze. Do not leave it in the car.
Use each vial once and discard any
Discard after the last dose is used.
Return any unused medicine to
What it looks like
INTRON A Injectable Solution is a
clear colourless solution.
Each vial contains:
sodium phosphate dibasic
sodium phosphate monobasic
m-cresol as preservative
Merck Sharp & Dohme (Australia)
Level 1, Building A
26 Talavera Road
Macquarie Park, NSW 2113
10 MIU/1 mL AUST R 63274
18 MIU/3 mL AUST R 60021
25 MIU/2.5 mL AUST R 60024
Date of Preparation
02 July 2019
NAME OF THE MEDICINE
Interferon alfa-2b (rbe)
INTRON A is a sterile, stable formulation of highly purified interferon alfa-2b produced by
recombinant DNA techniques. Recombinant interferon alfa-2b is a water soluble protein with
a molecular weight of approximately 19,300 daltons. It is obtained from a clone of E. coli
which has a genetically engineered plasmid containing an interferon alfa-2 gene from human
The activity of INTRON A is expressed in terms of International Units (IU). The specific
activity of INTRON A is approximately 2.6 x 10
INTRON A Injectable (HSA-free) Solution
INTRON A HSA-free Injectable Solution is a clear, colourless solution and is available in
single dose vials. Each single dose vial of INTRON A HSA-free Injectable Solution contains,
10 million IU/1 mL, 18 million IU/3 mL or 25 million IU/2.5 mL of recombinant interferon alfa-
disodium edetate, sodium chloride, polysorbate 80, water for injections and m-cresol.
a family of naturally occurring, small protein molecules produced and
secreted by cells in response to viral infections or various synthetic and biological inducers.
Interferons exert their cellular activities by binding to specific membrane receptors on the cell
surface. Preliminary studies to characterise these membrane receptors and to determine the
subsequent fate of the human interferon-receptor complex have been carried out using
labelled recombinant interferon alfa-2b. Human interferon receptors, as isolated from human
lymphoblastoid (Daudi) cells, appear to be highly asymmetric membrane proteins. They
exhibit selectivity for human but not murine interferons, suggesting species specificity.
Studies with other interferons have demonstrated species specificity.
The results of several studies suggest that, once bound to the cell membrane, the interferon
initiates a complex sequence of intracellular events which include the induction of certain
enzymes. It is thought that this process, at least in part, is responsible for the various cellular
responses to interferons, including inhibition of virus replication in virus-infected cells,
suppression of cell proliferation and such immunomodulating activities as enhancement of
the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of
lymphocytes for target cells. These activities possibly contribute to the therapeutic effects of
Recombinant interferon alfa-2b has exhibited antiproliferative effects in preclinical studies
employing both cell culture systems and human tumour xenografts in animals, and has
demonstrated significant immunomodulatory activity in vitro. Recombinant interferon alfa-2b
also inhibits viral replication in vitro and in vivo.
The antiproliferative activity of recombinant interferon alfa-2b was evaluated in vitro using
mouse and human leukaemia cell lines, and human osteosarcoma, melanoma, and normal
pronounced against human osteosarcoma cells and the human lymphocytic leukaemia cell
line RPMI-8402; growth of both cell lines was inhibited 80-100%. No activity was seen in
mouse leukaemia cells, which again suggests species specificity.
The immunomodulating activity of recombinant interferon alfa-2b was demonstrated in vitro
by its augmentation of the spontaneous "natural killer" activity of human lymphocytes, its
enhancement of the tumoricidal activity of human monocytes against human tumour cells
and its induction of Class I histocompatibility antigens on the surface of a number of cell
types. These effects appear to be dose-dependent.
Subcutaneous administration of recombinant interferon alfa-2b at a dose of 0.2 million
IU/day inhibited the growth of implanted human breast tumour xenografts in athymic mice by
about 50% after 23 days. However, intra-peritoneal administration of recombinant interferon
alfa-2b (0.1 - 1 million IU for 9 days) demonstrated no effect on the growth of human tumour
xenografts in athymic mice or on murine leukaemia cells implanted in BDFI mice.
interferon alfa-2b in combination with doxorubicin. Study results suggested that a schedule-
interferon alfa-2b were combined in the cell lines tested. Antagonistic effects or cell growth
enhancement over control levels were not observed.
Preliminary studies with isolated and perfused rabbit kidneys have shown that the kidney
may be the main site of interferon alfa catabolism.
immunologic competence, commonly characterised by the baseline T4 count or T4/T8 ratio,
have been noted to be highly predictive of the status of AIDS patients and their likelihood of
response to INTRON A treatment. In patients with baseline T4 counts above 400, the overall
response rate to INTRON A can be expected to be as high as 78%. Few patients with
baseline T4 counts less than 200 can be expected to respond to INTRON A.
Chronic hepatitis B: Studies in patients with compensated liver disease and evidence of
chronic hepatitis B virus infection (serum HBsAg positive) and HBV replication (serum
HBeAg positive and serum HBV-DNA positive) have demonstrated that INTRON A therapy
can produce virological remission of this disease (loss of serum HBeAg) and normalisation
of serum aminotransferases.
In clinical studies, 39% (15/38) of responding patients lost HBeAg 1 to 6 months following
the end of INTRON A therapy. Virological response was associated with a reduction in
serum ALT to normal or near normal (
1.5 times the upper limit of normal) in 87% (13/15) of
patients responding to INTRON A therapy at 5 million IU daily. Of responding patients who
lost HBsAg, 58% (7/12) did so 1 to 6 months post-treatment.
Chronic hepatitis C: Studies in patients with compensated liver disease and a history of
blood or blood product exposure and/or positive HCV antibody demonstrated that INTRON A
normalisation of serum ALT and reduction in liver necrosis and degeneration.
A multicentre study comparing treatment of chronic hepatitis C using INTRON A (i) 3 million
IU three times weekly for a duration of 18 months, (ii) 3 million IU three times weekly for
6 months then 1 million IU three times weekly for 12 months and (iii) 3 million IU three times
weekly for 6 months showed that treatment with 3 million IU three times weekly for a
duration of 18 months produced significantly superior histological improvement, virological
response and sustained ALT response than the regimens involving a lower dose or shorter
duration of treatment.
Similarly, an Australian multicentre study evaluated the efficacy of INTRON A (i) 3 million IU
three times weekly for 6 months, (ii) 5 million IU three times weekly for 6 months and (iii)
3 million IU three times weekly for 24 months. Treatment for a duration of up to 24 months
significantly improved the sustained response in patients who achieved normalisation of ALT
at 24 weeks of therapy compared to the two 6-month treatment regimens. Sustained ALT
inflammation. This study confirmed that INTRON A 3 million IU three times weekly remains
the optimal dose; increasing the dose to 5 million IU three times weekly did not significantly
improve the ALT response rate or sustained ALT response.
Malignant melanoma: The safety and efficacy of INTRON A was evaluated as adjuvant to
surgical treatment in patients with melanoma who were free of disease (post-surgery) but at
high risk for systemic recurrence. These included patients with lesions of Breslow thickness
>4 mm, or patients with lesions of any Breslow thickness with primary or recurrent nodal
involvement. In a randomised, controlled trial in 280 patients, 143 patients received INTRON
A therapy at 20 million IU/m
intravenously five times per week for 4 weeks (induction phase)
(maintenance phase). INTRON A therapy was begun
56 days after surgical resection. The
remaining 137 patients were observed.
INTRON A therapy produced a significant increase in relapse-free and overall survival.
Median time to relapse for the INTRON A treated patients versus observation patients was
1.72 years versus 0.98 years (p<0.01, stratified Log Rank). The estimated 5-year relapse-
free survival rate, using the Kaplan-Meier method, was 37% for INTRON A treated patients
versus 26% for observation patients. Median overall survival time for INTRON A treated
patients was 3.82 years versus 2.78 years (p=0.047, stratified Log Rank). The estimated 5-
year overall survival rate, using the Kaplan-Meier method, was 46% for INTRON A treated
patients versus 37% for observation patients.
The INTRON A dose was modified because of adverse events in 65% (n=93) of the patients.
INTRON A therapy was discontinued because of adverse events in 8% of the patients during
induction and 18% of the patients during maintenance. The most frequently reported
adverse reaction was fatigue which was observed in 96% of patients. Other adverse
reactions that were recorded in >20% of INTRON A treated patients included neutropenia
(92%), fever (81%), myalgia (75%), anorexia (69%), vomiting/nausea (66%), increased
SGOT (63%), headache (62%), chills (54%), depression (40%), diarrhoea (35%), alopecia
(29%), altered taste sensation (24%), dizziness/vertigo (23%), and anaemia (22%).
Adverse reactions classified as severe or life-threatening (ECOG Toxicity Criteria grade 3 or
4) were recorded in 66% and 14% of INTRON A treated patients, respectively. Severe
neutropenia/leucopenia (26%), fatigue (23%), fever (18%), myalgia (17%), headache (17%),
chills (16%), and increased SGOT (14%). Grade 4 fatigue was recorded in 4% and grade 4
depression was recorded in 2% of INTRON A treated patients. No other grade 4 adverse
event was reported in more than 2 INTRON A treated patients. Lethal hepatotoxicity
occurred in 2 INTRON A treated patients early in the clinical trial. No subsequent lethal
hepatotoxicities were observed with adequate monitoring of liver function tests.
intramuscularly and as a 30-minute intravenous infusion has been studied in healthy male
determined by a radio-immunoassay (RIA) with a detection limit of 10 IU/mL. The mean
serum interferon concentrations following subcutaneous and intramuscular injections were
comparable. Maximum serum levels (18-116 IU/mL) occurred at 3 to 12 hours post-injection.
The elimination half-lives of interferon following both injections were 2 to 3 hours. Serum
levels were below the detection limit 16 hours post-injection.
After intravenous administration, serum interferon levels peaked (135-273 IU/mL) at the end
of the infusion, then declined at a slightly more rapid rate than after subcutaneous or
elimination half-life was approximately 2 hours.
In another study also involving 12 subjects, single 10 million IU doses were administered by
the same three routes of administration. Mean serum interferon concentrations were again
comparable following intramuscular and subcutaneous injections, with maximum serum
levels (150-180 IU/mL) occurring at 6 to 8 hours post-injection. The elimination half-lives
following both injections were 6 to 7 hours. Serum levels were below the detection limit of 25
IU/mL 24 hours post-injection.
As with the other study, after intravenous administration, serum interferon levels peaked
undetectable 4 hours after the infusion.
Urine levels of interferon were below the detection limit following each of the three routes of
administration in both studies.
Interferon neutralising factor assays were performed on serum samples of patients who
received INTRON A in Schering-Plough monitored clinical trials. The clinical incidence of
developing in cancer patients treated systemically is 2.9% and in
hepatitis patients, 6.9%. The detected titres are low in almost all cases and have not been
regularly associated with loss of response or any other autoimmune phenomenon.
Hairy cell leukaemia: INTRON A is indicated for the treatment of hairy cell leukaemia in
splenectomised or non-splenectomised patients.
Kaposi’s sarcoma in AIDS: INTRON A is indicated for the treatment of Kaposi’s sarcoma in
patients with acquired immune deficiency syndrome (AIDS).
Chronic myelogenous leukaemia: INTRON A is indicated for the treatment of Philadelphia
chromosome positive chronic myelogenous leukaemia in the chronic phase.
myeloma once control has been achieved by chemotherapy. The effect on overall survival
has not as yet been determined.
Follicular non-Hodgkin's lymphoma: INTRON A is indicated as an adjuvant treatment of high
tumour burden Stage III or IV follicular non-Hodgkin's lymphoma in conjunction with an
demonstrated anthracycline chemotherapy was employed.
Malignant Melanoma: INTRON A is indicated as an adjuvant therapy of malignant melanoma
following surgery in patients who are at high risk of recurrence. The potential benefit to the
patient should be assessed carefully. Although toxicity of the treatment may be substantial,
for most patients, the benefit of therapy outweighed the risk.
Chronic hepatitis B: INTRON A injection is indicated for the treatment of adults with
histologically proven compensated chronic active hepatitis B. Patients should be serum
HBsAg positive and have evidence of HBV replication (such as serum HBeAg positive) and
reference range) for at least 6 months. [See Pharmacology for response rate].
Chronic hepatitis C: INTRON A is indicated for the treatment of histologically proven
compensated chronic hepatitis due to hepatitis C (HCV antibody positive) in adult patients
with persistently elevated serum alanine aminotransferase (ALT). Studies in these patients
demonstrate that INTRON A Injection therapy can produce normalisation of serum ALT,
clearance of serum HCV RNA and improvement in liver histology.
A history of hypersensitivity to recombinant interferon alfa-2b or any other components of
INTRON A contraindicates its use. Hypersensitivity to other forms of interferon alfa should
lead to extreme caution with the use of INTRON A.
Patients with decompensated liver disease, autoimmune hepatitis or a history of autoimmune
liver disease, and patients who are immunosuppressed transplant recipients should not be
treated with INTRON A for chronic hepatitis. There are reports of worsening liver disease,
including jaundice, hepatic encephalopathy, hepatic failure and death following INTRON A
therapy in such patients.
Patients with severe renal dysfunction or creatinine clearance <50 mL/min must not be
treated with INTRON A Injection when used in combination with ribavirin.
INTRON A is not intended for use in premature infants or neonates.
Acute, serious hypersensitivity reactions (eg urticaria, angioedema, bronchoconstriction,
anaphylaxis) to INTRON A have been observed rarely during INTRON A therapy. If any such
instituted immediately. Transient rashes do not necessitate interruption of treatment.
Moderate to severe adverse experiences may require modification of the patient's dosage
regimen, or in some cases, termination of INTRON A therapy.
INTRON A should be used cautiously in patients with debilitating medical conditions, such as
those with a history of pulmonary disease (e.g. chronic obstructive pulmonary disease) or
diabetes mellitus prone to ketoacidosis. Caution should be observed also in patients with
Administration of INTRON A in combination with other chemotherapeutic agents may lead to
increased risk of toxicity (severity and duration), which may be life-threatening or fatal as a
result of the concomitantly administered drug. The most commonly reported potentially life-
impairment and electrolyte disturbance. Because of the risk of increased toxicity, careful
adjustments of doses are required for INTRON A and for the concomitant chemotherapeutic
interferon therapy, other causes of persistent fever should not be overlooked.
In patients with liver disease, exacerbation of hepatic enzyme abnormalities may occur.
Monitoring of liver function tests is advised. Hepatotoxicity resulting in fatality has been
observed rarely. INTRON A increases the risk of hepatic decompensation and death in
patients with cirrhosis. Therefore, any patient developing liver function abnormalities during
treatment with INTRON A should be monitored closely and treatment discontinued if signs
and symptoms progress.
In patients considered for treatment of hepatitis, a liver biopsy should be performed to
document diagnosis and extent of disease. Patients with causes of chronic hepatitis other
than chronic hepatitis B or chronic hepatitis C, including autoimmune hepatitis, should be
excluded. Prior to initiation of INTRON A therapy, the physician should establish that the
patient has compensated liver disease. INTRON A should not be used in patients with
decompensated liver disease.
Patients with chronic hepatitis B with evidence of decreasing hepatic synthetic function (e.g.
decreasing albumin or prolongation of prothrombin time), who nevertheless meet the criteria
Precautions]. In considering these patients for INTRON A therapy, the potential risks must
be evaluated against the potential benefits of treatment.
Results of two studies indicate that the efficacy of interferon therapy remains uncertain in
chronic active hepatitis B in children or in adults where the presumed route of transmission is
Infrequently, patients treated for chronic hepatitis C with INTRON A developed thyroid
abnormalities (hypothyroid or hyperthyroid). In clinical trials <1% (4/426) developed thyroid
dysfunction. The mechanism by which INTRON A may alter thyroid status is unknown. Prior
to initiation of INTRON A therapy for the treatment of chronic hepatitis C, serum thyroid-
stimulating hormone (TSH) levels should be evaluated. Any thyroid abnormality detected at
that time should be treated with conventional therapy. INTRON A treatment may be initiated
if TSH levels can be maintained in the normal range by medication.
Monitor hepatic function with serum bilirubin, ALT (alanine transaminase), AST (aspartate
aminotransferase), alkaline phosphatase and LDH (lactate dehydrogenase) at 2, 8, and 12
weeks following initiation of INTRON A, then every 6 months while receiving INTRON A.
Permanently discontinue INTRON A for evidence of severe (Grade 3) hepatic injury or
hepatic decompensation (Child-Pugh score >6 [class B and C]).
If, during the course of INTRON A therapy, a patient develops symptoms consistent with
possible thyroid dysfunction, TSH levels should be evaluated. In the presence of thyroid
dysfunction, INTRON A treatment may be continued only if TSH levels can be maintained in
the normal range by medication. Discontinuation of INTRON A therapy has not reversed
thyroid dysfunction occurring during treatment.
Hypertriglyceridaemia and aggravation of hypertriglyceridaemia, sometimes severe, have
been observed. Monitoring of lipid levels is, therefore, recommended.
Due to reports of interferon alfa exacerbating pre-existing psoriatic disease and sarcoidosis,
use of INTRON A in patients with psoriasis or sarcoidosis is recommended only if the
potential benefit justifies the potential risk.
Hypotension may occur during INTRON A administration or up to two days post-therapy and
may require supportive therapy. Adequate hydration should be maintained in patients
undergoing INTRON A therapy since hypotension related to fluid depletion has been seen in
some patients. Fluid replacement to maintain intravascular volume may be necessary.
Patients with a history of cardiac disease (e.g.,congestive heart failure, myocardial infarction
and/or previous or current arrhythmic disorders), or with AIDS-related Kaposi’s sarcoma who
cardiomyopathy has been reported rarely in AIDS- related Kaposi’s sarcoma patients treated
with INTRON A Those patients who have pre-existing cardiac abnormalities and/or are in
advanced stages of cancer, should have electrocardiograms taken prior to and during the
course of treatment. Cardiac arrhythmias (primarily supraventricular) occurred rarely and
appeared to be correlated with pre-existing conditions and prior therapy with cardiotoxic
agents. These adverse experiences usually respond to conventional therapy but may require
discontinuation of INTRON A therapy.
Cardiomyopathy was reported in approximately 2% of the AIDS-related Kaposi's sarcoma
patients treated with INTRON A. Cardiomyopathy has also been reported in AIDS patients
not receiving INTRON A therapy. Baseline chest X-rays are suggested and should be
repeated if clinically indicated.
Pulmonary infiltrates, pneumonitis and pneumonia, including fatality, have been observed
rarely in patients treated with interferon alfa including those treated with INTRON A. The
aetiology has not been defined. Any patient developing fever, cough, dyspnoea or other
respiratory symptoms should have a chest X-ray taken. If the chest X-ray shows pulmonary
infiltrates or there is evidence of pulmonary function impairment, the patient should be
monitored closely, and if appropriate, interferon alfa treatment should be discontinued. While
this has been reported more often in patients with chronic hepatitis C treated with interferon
alfa, it has also been reported in patients with oncological diseases treated with interferon
with resolution of
Moreover, these symptoms have been reported more frequently when shosaikoto, a Chinese
herbal medicine, is administered concomitantly with interferon-alfa.
Patients with a pre-existing psychiatric condition or a history of severe psychiatric disorder
should not be treated with INTRON A.
Treatment with interferons may be associated with exacerbated symptoms of psychiatric
disorders in HCV infected patients with co-occurring psychiatric and substance use disorders.
If treatment with interferons is judged necessary in patients with prior history or existence of
psychiatric condition or with substance use disorders, in order to reach successful adherence
to treatment with interferons, adequate management of psychiatric symptoms and substance
use requires individualized screening strategies and frequent psychiatric symptom monitoring.
substance use is recommended.
If severe central nervous system (CNS) effects, particularly depression, are observed,
INTRON A therapy should be discontinued. Severe central nervous system (CNS) effects
particularly depression, homicidal ideation, suicidal ideation, suicide or attempted suicide have
been observed in some patients during INTRON A therapy. Other CNS effects including
aggressive behaviour, sometimes directed towards others, psychosis including hallucinations,
confusion and alterations of mental status have been observed
These adverse effects have
occurred in patients treated with recommended doses, as well as in patients treated with
encephalopathy, have been observed in some patients, usually elderly, treated at higher
doses. While these effects are generally reversible, in a few patients full resolution took up to
three weeks. Very rarely seizures have occurred with high doses of INTRON A. If patients
develop psychiatric or CNS problems, including clinical depression, it is recommended that
the patients be carefully monitored by the prescribing physician during treatment and in the 6
symptoms persist or worsen, or suicidal or homicidal ideation or aggressive behaviour
discontinued, and the patient followed with psychiatric intervention as appropriate.
sedatives should be
administered with caution if administered
concomitantly with INTRON A.
Because of reports of exacerbating pre-existing psoriatic disease, INTRON A should be
used in patients with psoriasis only if the potential benefit justifies the potential risk.
The use of INTRON A has been associated with the exacerbation of autoimmune disease,
therefore, when administering INTRON A to patients with a history of, or predisposition to
autoimmune disease, this should be considered.
In patients with AIDS-related Kaposi's Sarcoma, INTRON A therapy should not be used in
the presence of rapidly progressive visceral disease. With the exception of zidovudine, there
is a lack of safety data for the combination of INTRON A with reverse transcriptase
neutropenia than that expected with zidovudine alone. The effects of INTRON A when
combined with other drugs used in the treatment of AIDS-related disease are unknown.
Ophthalmologic disorders, including retinal haemorrhages, cotton wool spots, retinal artery or
vein obstruction and serous retinal detachment have been reported in rare instances after
treatment with alfa interferons (see ADVERSE EFFECTS). All patients should have a baseline
eye examination. Any patient complaining of ocular symptoms, including loss of visual acuity or
visual field must have a prompt and complete eye examination. Because these ocular events
may occur in conjunction with other disease states, periodic visual examinations during
INTRON A therapy are recommended in patients with disorders that may be associated with
retinopathy, such as diabetes mellitus or hypertension. Discontinuation of INTRON A should be
considered in patients who develop new or worsening opthalmological disorders.
Preliminary data indicated that interferon alfa therapy may be associated with an increased
rate of kidney graft rejection. Liver graft rejection has also been reported but a causal
association with interferon alfa therapy has not been established.
Effect on Fertility
abnormalities of the menstrual cycle have been observed. Decreased serum oestradiol and
progesterone concentrations have been reported in women treated with human leucocyte
interferon. Therefore, fertile women should not receive INTRON A unless they are using
effective contraception during the treatment period. INTRON A should be used with caution
in fertile men.
Use in Pregnancy (Category B3)
Results of animal reproduction studies indicate that recombinant interferon alfa-2b was not
teratogenic in rats or rabbits, nor did it adversely affect pregnancy, foetal development or
reproductive capacity in the offspring of treated rats. Animal studies have also shown that
interferons do not cross the placental barrier.
shown to have abortifacient
in rhesus monkeys
mulatta). Abortion was observed in all dose groups (7.5, 15 and 30 million IU/day IM from
Day 20 to Day 80 of gestation), and was statistically significant versus control in the mid- and
There are no adequate and well controlled studies in pregnant women. INTRON A should be
used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Use during Lactation
It is not known whether this drug is excreted in human milk. Because many drugs are
excreted in human milk and because of the potential for adverse reactions from INTRON A
discontinue the drug, taking into account the importance of the drug to the mother.
Use in Children
Experience in patients below 18 years of age has been limited and in such cases the
expected benefits should be carefully weighed against potential hazards. Results of two
studies indicate that the efficacy of interferon therapy remains uncertain in children with
chronic active hepatitis B where the presumed route of transmission is vertical.
INTERACTIONS WITH OTHERS MEDICINES
Interactions between INTRON A and other drugs have not been fully evaluated. Caution
should be exercised when administering INTRON A in combination with other potentially
A synergistic adverse effect on the white blood cell count may occur when INTRON A is
administered concomitantly with zidovudine. Patients receiving the two agents concomitantly
INTRON A treatment for all patients:
Standard haematological tests including complete blood counts (CBC), differential
white blood cell counts and platelet;
Blood chemistry including electrolytes, liver function tests, serum creatinine, serum
protein and TSH.
The haematological parameters of the patients should be followed closely as part of the
treatment because a certain degree of myelodepression has been reported in some patients
treated with INTRON A.
Patients with pre-existing thyroid abnormalities may be treated if thyroid stimulating hormone
(TSH) levels can be maintained in the normal range by medication. TSH levels must be
within normal limits upon initiation of INTRON A treatment and TSH testing should be
repeated at 3 and 6 months.
Those patients who have pre-existing cardiac abnormalities and/or who are in advanced
stages of cancer should have electrocardiograms taken prior to and during the course of
Multiple myeloma: Since multiple myeloma may impair renal function, patients should have
renal tests performed periodically.
Malignant melanoma: Liver function and white blood cell (WBC) count and differential should
maintenance phase of therapy.
Chronic hepatitis B: CBC and platelet counts should be evaluated prior to initiation of
INTRON A therapy in order to establish baselines for monitoring potential toxicity. These
tests should be repeated at treatment Weeks 1, 2, 4, 8, 12 and 16. Liver function tests,
including serum ALT, albumin and bilirubin, should be evaluated at treatment Weeks 1, 2, 4,
8, 12 and 16. HBeAg, HBsAg and ALT should be evaluated at the end of therapy as well as
3 and 6 months post therapy, since patients may become virological responders during the 6
month period following the end of treatment.
A transient increase in ALT
2 times baseline value (flare) can occur during INTRON A
therapy for chronic hepatitis B. In clinical trials, this flare generally occurred 8 to 12 weeks
after initiation of therapy and was more frequent in responders (63%, 24/38) than in non-
responders (27%, 13/48). Elevations in bilirubin
3 mg/dL (51.3
mol/L) occurred infrequently
(2%, 2/86) during therapy.
When ALT flare occurs, in general, INTRON A therapy should be continued unless signs
and symptoms of liver failure are observed. During ALT flare, clinical symptomatology and
liver function tests including ALT, prothrombin time, alkaline phosphatase, albumin and
bilirubin should be monitored at approximately 2-week intervals.
Chronic hepatitis C: Prior to initiation of INTRON A therapy, CBC and platelet counts should
be evaluated in order to establish baselines for monitoring potential toxicity. These tests
should be repeated at Weeks 1 and 2 following initiation of INTRON A therapy, and monthly
thereafter. Serum ALT should be evaluated after 2, 16 and 24 weeks of therapy to assess
response to treatment.
Adverse reactions of INTRON A are dose-related. Haematological, hepatic, cardiovascular
and neurological toxicities are more common with higher doses.
The most frequently reported adverse reactions were flu-like symptoms, primarily fever,
fatigue, headache, myalgia, rigors/chills and malaise which occurred in almost all patients
treated. These effects were reversible within 72 hours of interruption or cessation of
treatment and were dose-related.
Other less frequent adverse reactions reported with INTRON A therapy include:
Less common: Hypotension
Rarely reported: Tachycardia, hypertension, peripheral ischaemia, chest pain,
cardiomyopathy (see below)
Very rarely reported: Palpitations, postural hypotension, bradycardia, cardiac failure, atrial
fibrillation, arrhythmia, extrasystole, angina pectoris, thrombophlebitis, cardiac ischaemia,
myocardial infarction, cerebrovascular haemorrhage, cerebrovascular ischaemia,
Cardiovascular adverse reactions, particularly arrhythmia appeared to be correlated mostly
with pre-existing CVS disease and prior cardiotoxic therapy (see Precautions).
Cardiomyopathy that may be reversible upon discontinuation of interferon alfa has been
reported rarely in patients without prior evidence of cardiac disease.
Central and Peripheral Nervous System (including psychiatric adverse reactions)
Less common: Dizziness, somnolence, insomnia, confusion, impaired concentration,
depression, irritability, suicidal ideation, suicide attempts, suicide.
Rarely reported: Paraesthesia, impaired consciousness (including cases of encephalopathy,
see PRECAUTIONS), migraine, hypo-aesthesia, nervousness, anxiety, seizures, agitation,
emotional lability, flushing, neuropathy, peripheral neuropathy, polyneuropathy, psychosis
including hallucinations, aggressive behaviour towards others, vertigo.
Very rarely reported: Amnesia, stupor, convulsions, hypertonia, hyperaesthesia, hot flushes,
encephalopathy, tremor, coma, extrapyramidal disorder, paresis, speech disorder, syncope,
tinnitus, abnormal coordination, ataxia, aphasia, CNS dysfunction, abnormal gait,
hyperkinesia, dystonia, paralysis, impotence, personality disorder, abnormal thinking,
paroniria, apathy, aggravated depression, neurosis, feeling of ebriety, dementia.
Rarely reported: Hyperthyroidism, hypothyroidism, diabetes mellitus/hyperglycaemia.
Very rarely reported: Gynaecomastia, virilism, aggravation of diabetes, pancreatitis.
Less common: Vomiting, diarrhoea
Rarely reported: Abdominal pain, dyspepsia, loose stool, taste perversion, gingival bleeding,
stomatitis, constipation, right upper quadrant (RUQ) pain, glossitis.
Very rarely reported: Eructation, tenesmus, ileus, colitis, thirst, melena, increased saliva,
esophagitis, rectal bleeding after stool, dysphagia, gastrointestinal haemorrhage, gastric
ulcer, gingivitis, gum hyperplasia, rectal haemorrhage, oral leucoplakia, gastrointestinal
mucosal discolouration, abdominal distention, flatulence, tongue discolouration, taste loss,
Haematological System [See Laboratory Values under Adverse Effects]
Very rarely reported: Haemolytic anaemia, increased gamma globulins, coagulation disorder
Very rarely, alfa interferons, including INTRON A used alone or in combination with Rebetol
may be associated with aplastic anaemia or pure red cell aplasia.
Liver and Biliary System
Rarely reported: Hepatotoxicity including fatality.
Very rarely reported: Abnormal hepatic function tests, bilirubinaemia, jaundice,
hepatospleno-megaly, splenomegaly, hepatic encephalopathy.
Common: Arthralgia, back pain.
Less Common: Musculoskeletal pain.
Rarely reported: Rhabdomyolysis (sometimes serious) myositis.
Very rarely reported: Bone pain, muscle weakness, arthritis, arthrosis, myopathy.
Rarely reported: Menstrual disorders eg. menorrhagia, amenorrhoea.
Very rarely reported: Leucorrhoea, uterine bleeding, vaginal haemorrhage.
Resistant Mechanism Disorders
Rarely reported: Resistance mechanism disorders (e.g.: altered resistance to infection; these
effects rarely have been life-threatening or fatal), viral infections, conjunctivitis.
Very rarely reported: Sty, fungal infections, moniliasis, sepsis.
Rarely reported: Coughing, pharyngitis, dyspnoea, pulmonary infiltrates, pneumonitis,
pneumonia nasal congestion, sinusitis, rhinitis, respiratory disorder.
Very rarely reported: Hypoxia, stridor, bronchospasm, cyanosis, wheezing, pleural pain,
sneezing, nonproductive coughing, pulmonary embolism, pulmonary oedema, laryngitis,
Skin and Appendages
Less common: Alopecia, increased sweating.
Rarely reported: Rash (e.g. erythematous and maculopapular), injection site disorders ,
pruritus, dermatitis, dry skin, erythema.
Very rarely reported: Urticaria, acne, nail disorders, purpura, peripheral ischaemia,
furunculosis, non-herpetic cold sores, epidermal necrolysis, lacrimal gland disorder,
photosensitivity, skin discolouration, chloasma, abnormal hair texture, increased hair growth,
skin depigmentation, dermatitis lichenoides, melanosis, vitiligo, injection site necrosis, toxic
epidermal necrolysis, erythema multiforme, Steven Johnson syndrome.
Rarely reported: Renal insufficiency, renal failure, hyperuricaemia.
Very rarely reported: Micturition disorder, nocturia, polyuria, haematuria, micturition
frequency, cystitis, oliguria, nephrosis, urinary incontinence, nephrotic syndrome.
Visual and Auditory Disorders
Rarely reported: Eye pain, hearing disorder abnormal/blurred vision, hearing loss, retinal
haemorrhage, retinopathies (including macular oedema), cotton wool spots, and retinal
artery or vein obstruction, loss of visual acuity or visual field, optic neuritis and papilloedema,
lacrimal gland disorder.
Very rarely reported: Conjunctivitis, photophobia, blurred vision, diplopia, dry eyes,
oculomotor nerve paralysis, retinal disorder, night blindness, serous retinal detachment,
earache, deafness, hyperacusis.
Less common: Asthenia, dry mouth, flu-like symptoms (unspecified), pain, taste alteration.
Rarely reported: Herpes simplex, epistaxis, weight decrease, increased appetite, decreased
libido, weakness, leg cramps, face oedema.
Very rarely reported: Dehydration, hypercalcaemia, cachexia, peripheral oedema,
lymphadenopathy, periorbital oedema, malignant hyperpyrexia, transplant rejection, acidosis,
hypertriglyceridaemia sarcoidosis or exacerbation of sarcoidosis, hepatitis B reactivation in
HCV/HBV co-infected patients.
A wide variety of autoimmune and immune-mediated disorders have been reported with alfa
interferons including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic
purpura, rheumatoid arthritis, systemic lupus erythematosus, vasculitis, and Vogt-Koyanogi-
Cases of acute hypersensitivity reactions, including anaphylaxis, urticaria, and angioedema
have been reported.
sepsis), have been reported.
When INTRON A is used with hydroxyurea, the occurrence of cutaneous vasculitides may be
Clinically significant laboratory abnormalities, most frequently occurring at doses greater
than 10 million IU
include reduction in granulocyte and white blood cell counts;
decreases in haemoglobin level and platelet count; increases in alkaline phosphatase,
lactate dehydrogenase (LDH), serum creatinine, serum urea nitrogen levels and TSH levels.
Moderate and usually reversible reduction in all three blood elements – white blood cells, red
blood cells and platelets, have been reported. Increase in serum ALT/AST levels have been
noted as an abnormality in some non-hepatitis subjects and also in some patients with
hepatitis particularly those with chronic hepatitis B coincident with clearance of viral DNAp.
DOSAGE AND ADMINISTRATION
INTRON A may be administered using either sterilised glass or plastic disposable syringes.
During the course of treatment with INTRON A for any indication, if adverse reactions
develop, the dosage should be modified or therapy should be discontinued temporarily until
adequate dosage adjustment, or disease progresses, the treatment with INTRON A should
For maintenance dosage regimens administered subcutaneously, at the discretion of the
physician, the patient may self-administer the dose.
Hairy Cell Leukaemia
The recommended dosage of INTRON A is 2 million IU/m
3 times a week (every other day). Higher doses are not recommended. Normalisation of one
or more haematological variables usually begins within 2 months of therapy. Improvement in
all three haematological variables (granulocyte count, platelet count and haemoglobin level)
requirements. This dosage regimen should be maintained unless the disease progresses
rapidly or severe intolerance is manifested.
The minimum effective dose of INTRON A has not been established.
The recommended dosage for INTRON A is 30 million IU/m
three times a week, to be
intravenous infusion in a dose of 50 million IU/m
over a 30-minute period for 5 consecutive
Intravenous Infusion"). The minimum interval between treatments is 9 days. Either dosage
regimen should be maintained indefinitely unless the disease progresses rapidly or severe
intolerance is manifested.
Chronic Myelogenous Leukaemia
The recommended dosage of INTRON A is 2 to 6 million IU/m
administered daily by
subcutaneous injection. When the white blood cell count is controlled, the dosage may be
maintained unless the disease progresses rapidly or severe intolerance is manifested.
The recommended dosage is 3 million IU/m
administered three times a week (every other
day) by subcutaneous injection. The dosage regimen should be maintained unless the
disease progresses rapidly or severe intolerance is manifested.
Follicular Non-Hodgkin's Lymphoma
The recommended dosage is 3 to 5 million IU administered three times a week (every other
day) by subcutaneous injection for a duration of up to 18 months. The dosage should be
adjusted according to the patient's response and tolerance of the medication.
As induction therapy, INTRON A is administered intravenously at a dose of 20 million IU/m
daily for five days a week over a four-week period (refer to "Preparation of INTRON A (HSA-
free) Solution for Intravenous Infusion"). As maintenance treatment, the recommended dose
is 10 million IU/m
administered subcutaneously three days a week (every other day) for 48
If severe adverse reactions develop during INTRON A treatment, particularly if granulocytes
decrease to <500/mm
or ALT/AST rises to >5x upper limit of normal, treatment should be
temporarily discontinued until the adverse reactions abates. INTRON A treatment should be
restarted at 50% of the previous dose. If intolerance persists after dose adjustment or if
granulocytes decrease to <250/mm
or ALT/AST rises to >10x upper limit of normal,
INTRON A therapy should be discontinued.
maintenance of clinical benefit. For full clinical benefit, patients should be treated at the
recommended doses, with dose modification for toxicity as described.
Chronic Hepatitis B
Prior to initiation of INTRON A therapy, it is recommended that a liver biopsy be performed
to establish the presence of chronic hepatitis and the extent of liver damage. Patients with
causes of chronic hepatitis other than chronic hepatitis B or chronic hepatitis C should not be
treated with INTRON A. The physician should establish that the patient has compensated
The lowest effective dose of INTRON A is 3 million IU three times a week, administered
subcutaneously. Patients who do not respond within one month may be treated at doses of
5 million IU three times a week or up to 10 million IU three times a week or 5 million IU daily.
The dosage may be adjusted according to the patient's tolerance to the medication. With a
response, the selected dosage regimen should be maintained for up to four months unless
severe intolerance develops.
[See Laboratory Tests under Precautions for various tests to be conducted and timing of
Chronic Hepatitis C
Prior to initiation of INTRON A therapy, it is recommended that a liver biopsy be performed
to establish the diagnosis of chronic hepatitis and the extent of liver damage. Patients should
be tested for the presence of antibody to HCV. Patients with causes of chronic hepatitis
other than chronic hepatitis B or chronic hepatitis C should not be treated with INTRON A.
The physician should establish that the patient has compensated liver disease.
The recommended dose is 3 million IU administered subcutaneously three times a week.
Most patients who respond demonstrate improvement in ALT levels within 12-16 weeks. In
these patients, therapy should be continued with 3 million IU three times a week for up to 18
In patients who fail to respond after 12-16 weeks of treatment, use of INTRON A Injection
should be discontinued.
Current clinical experience in patients who remain on INTRON A Injection for 12-18 months
indicates that a higher proportion of patients demonstrated a sustained response after longer
durations of therapy than those who discontinued therapy after six months.
[See Laboratory Tests under Precautions for tests to be conducted and timing of these
Paracetamol has been used successfully to alleviate the symptoms of fever and headache
which can occur with INTRON A therapy. The recommended paracetamol dosage is 500 mg
to 1 g given 30 minutes before administration of INTRON A. The maximum dosage of
paracetamol to be given is 1 g four times daily.
Preparation of INTRON A (HSA-free) Solution for Intravenous Infusion
NO OTHER DRUG CAN BE INFUSED CONCOMITANTLY WITH INTRON A SOLUTION
The infusion should be prepared immediately prior to use. Any size vial of the INTRON A
(HSA-free) solution may be used to prepare the infusion, but the aim should be to minimise
The INTRON A solution can be diluted in sterile normal saline (0.9%). However, the final
concentration of diluted INTRON A solution must not be less than 0.3 million IU/mL.
For Kaposi’s Sarcoma
Prior to administration of each INTRON A infusion, the patient should have a 21-gauge
butterfly inserted or other intravenous access provided. An infusion of sterile normal saline
(at 200 mL/hr) should be started approximately 10 minutes before drug administration. This
normal saline infusion should be stopped just prior to the administration of INTRON A.
The calculated amount of interferon for the appropriate dose should be withdrawn from the
vial(s) and added to 50 mL of sterile normal saline. The diluted INTRON A solution should be
infused over a 30-minute period. After drug administration has been completed, the normal
saline infusion should be restarted for a 10-minute period at the original rate of 200 mL/hr.
For Malignant Melanoma
The appropriate dose should be withdrawn from the vials and added to 50 mL of sterile
normal saline solution in a PVC bag or glass bottle for intravenous use and administered
over 20 minutes.
Stability of Injectable Solution
Single dose vials: After opening, use once and discard any residue.
As with all parenteral drug products, the solution should be inspected visually for particulate
matter and discolouration prior to administration.
Most adverse reactions to recombinant interferon alfa-2b listed are dose-related. There is no
specific antidote in the event of overdose. Symptomatic treatment with frequent monitoring
of vital signs and close observation of the patient is indicated.
PRESENTATION AND STORAGE CONDITIONS
Injectable Solution (HSA-free):
Single dose vials
10 million IU/1 mL: 1s, 3s*, 5s, 6s* and 10s*
18 million IU/3 mL; 25 million IU/2.5 mL: 1s and 5s*
Note: Presentations marked with an asterisk are not marketed.
Store at 2° to 8
C. (Refrigerate. Do not freeze.)
NAME AND ADDRESS OF THE SPONSOR
Merck Sharp & Dohme (Australia) Pty Limited
Level 1 – Building A
26 Talavera Road
Macquarie Park NSW 2113
Schedule 4 – Prescription Only Medicine
DATE OF FIRST INCLUSION IN THE AUSTRALIAN REGISTER OF THERAPEUTIC
29 May 1997
DATE OF MOST RECENT AMENDMENT
05 December 2017
Summary for ARTG Entry:
INTRON A Interferon alfa-2b (HSA-free) 18 million IU/3mL injection
ARTG entry for
Merck Sharp & Dohme (Australia) Pty Ltd
North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Drug Safety Evaluation Branch
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
1. INTRON A Interferon alfa-2b (HSA-free) 18 million IU/3mL injection
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
Hairy cell leukaemia: for the treatment of hairy cell leukaemia in splenectomised or non-splenectomised patients. Kaposi's sarcoma in AIDS: for the
treatment of Kaposi's sarcoma in patients with acquired immune deficiency syndrome (AIDS). Chronic myelogenous leukaemia: for the treatment of
Philadelphia chromosome positive chronic myelogenous leukaemia in the chronic phase. Multiple myeloma: for the maintenance of control of multiple
myeloma once control has been achieved by chemotherapy. The effect on overall survival has not as yet been determined. Follicular non-Hodgkin's
lymphoma: as an adjuvant treatment of high tumour burden Stage III or IV follicular non-Hodgkin's lymphoma in conjunction with an appropriate
chemotherapy regimen. In controlled clinical trials in which efficacy was demonstrated, anthracycline chemotherapy was employed. Malignant
melanoma: as an adjuvant therapy of malignant melanoma following surgery in patients who are at high risk of recurrence. The potential benefit to the
patient should be assessed carefully. Although toxicity of the treatment may be substantial, for most patients, the benefit of therapy outweighed the risk.
Chronic hepatitis B: for the treatment of adults with histologically proven compensated chronic active hepatitis B. Patients should be serum HBsAg
positive and have evidence of HBV replication (such as serum HBeAg positive) and raised serum alanine aminotransferase (ALT) levels (>3 times the
upper limit of the reference range) for at least 6 months. [See Pharmacology for response rate]. Chronic hepatitis C: for the treatment of histologically
proven compensated chronic hepatitis due to hepatitis C (HCV antibody positive) in adult patients with persistently elevated serum alanine
aminotransferase (ALT). Studies in these patients demonstrate that Intron A Injection therapy can produce normalisation of serum ALT, clearance of
serum HCV RNA and improvement in liver histology.
Additional Product information
Store at 2 to 8
Do not Freeze
Pack Size/Poison information
1 x 3ml
(S4) Prescription Only Medicine
5 x 3mL
(S4) Prescription Only Medicine
1. Medicine Component
Route of Administration
Clear to opalescent, colourless to light yellow solution, essentially free of
6 million IU/mL
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Produced at 02.11.2017 at 11:36:11 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information