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PROLEUKIN 18 MILLION IU POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ALDESLEUKIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
1317489 GB

PROLEUKIN®

18 million IU powder for solution for injection or infusion
Aldesleukin

Read all of this leaflet carefully before you are given 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.
What is in this leaflet:
1. What Proleukin is and what it is used for
2. What you need to know before you are given Proleukin
3. How Proleukin is used
4. Possible side effects
5. How to store Proleukin
6. Contents of the pack and other information

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1. What Proleukin is and what it is used for
Proleukin is the brand name of aldesleukin. It is a synthetic
protein, very similar to a protein produced by the body called
interleukin-2 (IL-2). This protein is part of the immune system.
IL-2 activates certain white blood cells in the body called
lymphocytes, which fight against diseases and infections.
IL-2 stimulates the production of lymphocytes in the body,
and enhances the body’s defences.
Proleukin is used to treat kidney cancer which has spread
to other organs (also called metastatic renal cell carcinoma).
2. What you need to know before you are given Proleukin
Follow carefully all instructions given to you by your doctor.
Your doctor may carry out tests before you are treated with
Proleukin. He/she may perform a blood test to check the level of
sugar in your blood and check your kidney and liver function. He/she
may also test your heart, respiratory and mental performance.
He/she will check your response to the treatment at regular
intervals and take any necessary action.
You should not be given Proleukin
• If you are allergic (hypersensitive) to aldesleukin or any of the
other ingredients of this medicine (listed in Section 6).
• If you are confined to bed for more than half the day.
• If it is less than 24 months since your kidney cancer was
diagnosed and you have cancer symptoms, even if the cancer
has spread to other organs.
• If you have a history of heart disease.
• If you have an infection for which you are taking antibiotics.
• If you have a shortage of oxygen in your blood.
• If you have serious problems with your liver, kidneys or any
other organs.
• If you suffer from seizures (convulsions or fits), or from brain
cancer that has not been successfully treated.
• If you have had an organ transplant.
• If you currently use medicines called corticosteroids to treat
inflammatory reactions or if you may require these during
Proleukin therapy.
• If you have had rheumatoid arthritis, Crohn’s disease or any
other disease caused by your own immune system.
If any of the above applies to you, talk to your doctor. You should
not be given Proleukin.

Also, Proleukin should not be given to you if blood tests show that:
• You have a low level of white blood cells, platelets or red blood cells.
• You have creatinine or bilirubin levels outside the normal range.

Proleukin contains sodium
Proleukin contains less than 23mg sodium per 1ml, and can therefore
be considered as ‘sodium free’.

Take special care with Proleukin
• If you have chest pain or irregular heart beat. In some patients
an electrocardiogram (ECG) will be carried out at regular intervals.
• If you become short of breath or you start breathing faster
during treatment.
• If you feel extremely tired or sleepy, because this may be a
signal that you are losing consciousness.
If you get any of the symptoms listed above, tell your doctor
immediately.

3. How Proleukin is used
Proleukin can be given to you:
• either as a drip into a vein (intravenous infusion). This should
be carried out in the hospital, under supervision of a doctor or
nurse experienced in the use of medicines to treat cancer,
• or by injection directly under the skin (subcutaneous injection).
This can be administered in a hospital, in an outpatient’s
department or at home, under supervision of a doctor or nurse.

You should also take special care:
• If you have a fever, shivers, chills, nausea and/or diarrhoea.
• If you feel dizzy and notice a fast heart beat. This may be a sign
that you have low blood pressure, often seen within 2 to 12 hours
after starting Proleukin administration.
• If you have a bacterial infection, since Proleukin treatment puts
you at a higher risk of infection.
• If you notice mood changes. These in general return to normal
after stopping therapy.
• If you have diabetes. Your blood sugar levels may increase or
decrease more than usual.
• If you have a very itchy red rash or if your skin gets extremely
dry during the treatment with Proleukin.
If any of the symptoms listed above gets severe, tell your doctor.
Other medicines and Proleukin
Some medicines can decrease the effect of Proleukin, or increase
side effects.
Tell your doctor or pharmacist if you are using any of the following
medicines (or have recently used them).
• Chemotherapy medicines, called tamoxifen, interferon-alpha,
cisplatin, vinblastine and/or dacarbazine, used to treat cancer.
• Medicines called glucocorticoids (a type of steroid), used to treat
inflammatory reactions.
• Medicines called beta-blockers, used to treat high blood pressure.
• Medicines that affect the heart, central nervous system, liver,
kidneys or bone marrow. Consult your doctor if you are not sure
what these are.
• Contrast fluids used in Computerised Tomography (CT) scanning.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Children and adolescents (below 18 years)
Proleukin is not recommended for children and adolescents
younger than 18 years.
Older people (65 years and over)
Older patients may be more susceptible to the side effects of Proleukin.
Medical staff should take extra care when treating older people.
Pregnancy and breast-feeding
• Tell your doctor before starting treatment if you are pregnant,
if you suspect that you are pregnant, or if you intend to become
pregnant. Your doctor will discuss with you the risks and benefits
of taking Proleukin during pregnancy.
• Both male and female patients should use effective
contraception while being treated with Proleukin in order to
prevent pregnancy. This is done with most other medicines
used to treat cancer.
• Stop breast-feeding during treatment with Proleukin as there
is a possibility that serious side effects could affect the baby.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
Driving and using machines
Do not drive or use any tools or machines because Proleukin has
side effects which may influence your ability to carry out these
activities.

1317489_GB_p1_LFT.indd 1

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

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1317489
Comp. Description: Leaflet_PROLEUKIN_LYVI 18 I6 GLW GB
Comp. Number New: 1317489 GB
Comp. Number Old: N/A
Format/Dimension: 540 x 318mm
Tech. Drawing No.: Leaflet Proleukin 540 x 318_v3

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Font Type: News Gothic, Times, Times New Roman
11/11/2014

Follow all instructions given to you by your doctor or nurse carefully.
If you have been given more Proleukin than you should
If you have or think you have been given too much Proleukin, contact
your doctor or nurse immediately. You might get some of the side
effects described in section 4.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. The side effects of this medicine usually
disappear within two days after stopping the treatment.
Your doctor may consider it necessary to treat the side effects of
Proleukin with other medicines.
Some side effects can be serious
Very common (may affect more than 1 in 10 people) or common
(may affect up to 1 in 10 people):
• Blood disorders: low levels of white blood cells (leucopenia) with
symptoms of fever or increased risk of infections; low levels of
platelets in your blood with bruises and spontaneous bleeding
(thrombocytopenia); low levels of red blood cells (anaemia) with
symptoms such as fatigue and pale skin; blood clotting disorders
with sudden onset of shortness of breath, bloody sputum, leg pain
or easy bleeding; high levels of white blood cells called eosinophils
which may cause heart or lung problems due to inflammation.
• Heart and circulation problems: heart attack (myocardial
ischemia); disorders of heart and blood vessels, such as abnormal
or insufficient pumping force of the heart (heart failure);
awareness of an abnormal heart beat (palpitations); chest pain;
low blood pressure (hypotension) or high blood pressure
(hypertension) associated with dizziness, blurred vision or
constant headache; irregular heart beat (arrhythmia); fast heart
beat (tachycardia); blue colour to the lips, tongue and skin due
to oxygen deficiency in the blood (cyanosis).
• Breathing and lung problems: coughing; shortness of breath
(dyspnoea) or chest discomfort; accumulation of water in the lung
(pulmonary oedema); deficiency of oxygen in the organs (hypoxia);
coughing up blood (haemoptysis).
• Acute inflammation present throughout the entire body, frequently
associated with fever and elevated white blood cell count or low
white blood cell count and lower-than-average temperature, and
vomiting are possible signs of blood poisoning.
• Kidney and urine problems: low urine production (oliguria), with
high levels of urea and creatinine in the blood with symptoms such
as vomiting, inability to produce urine, sleepiness, poor muscle
tone or difficult breathing; blood in the urine (haematuria); kidney
failure associated with fatigue, sleepiness, loss of appetite,
vomiting or swollen legs.
• Digestive and organ problems: stomach, intestine and rectal
bleeding (resulting in black stools); vomiting blood
(haematemesis); swelling of the belly (ascites); difficulty in
swallowing (dysphagia); abdominal swelling, discomfort,
possible signs of enlargement of the liver and/or of the spleen.
• Nerve problems: sudden unconsciousness or fainting (syncope);
loss of ability to speak.
Continued overleaf

Proleukin®

giving a daily dose of 18 million IU/m2 over 24 hours, for 5 days.
As for all injections, check for the presence of particles or
discolouration before administration. Do not use Proleukin if you see
particulate matter in the solution or if the solution is cloudy or more
than slightly yellow in colour.

18 million IU powder for solution for injection or infusion
Aldesleukin

––Days 1 to 5: a daily dose of 18 million IU/m2 of body surface area

INFORMATION FOR HEALTHCARE PROFESSIONALS

Special precaution for storage
Keep out of the sight and reach of children.
Do not use Proleukin after the expiry date which is stated on
the pack.
Store the unopened vials in a refrigerator (2°C–8°C). Do not freeze.
Store in the original package in order to protect from light.
Shelf-life following reconstitution
Reconstituted solution of Proleukin can be stored for 24 hours in a
refrigerator (2°C–8°C), if not used immediately.
Diluted solution of Proleukin should be used within 48 hours after
reconstitution, including duration of the infusion.
How to prepare and administer Proleukin
––Use a sterilised injection syringe and injection needle.
––Inject 1.2 ml Water for Injections into the vial of Proleukin.
Direct the Water for Injections against the side of the vial to
avoid excessive foaming.
––Swirl gently to allow the powder to dissolve completely. Do not
shake.
––The solution contains 18 million IU or 1.1 mg Proleukin
(aldesleukin) per millilitre.
The solution is now ready for subcutaneous administration or
should be further diluted for administration by intravenous
infusion.

One treatment cycle usually consists of:

over 24 hours as a continuous infusion. The line will remain in
the vein throughout the therapy.
––Over the next 2 to 6 days: no Proleukin treatment.
––Then, another 5 consecutive days of continuous infusion.
After three weeks without Proleukin administration, a second cycle
as described above should follow.

If the condition of the patient has improved or stabilised after
completing two cycles, treatment with Proleukin might be continued
as five days of therapy every 4 weeks. Up to four maintenance cycles
can be administered.
Depending on the response to the treatment, a higher or lower dose
may be suggested.
Each vial is for single use only.
Disposal
Do not throw away any medicine via wastewater or household waste.
Any unused solution, vial, syringe and needle should be disposed
of in an appropriate way. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect
the environment.

Instructions for proper use of Proleukin
Subcutaneous (s.c.) administration
––Once reconstituted, the product should be used within 24 hours.
––The product should be brought to room temperature before
administration and used immediately.
––The appropriate dose can then be withdrawn and injected
subcutaneously.
––Proleukin should be injected into subcutaneous tissue. The best
areas for injection are loose and soft (flabby) areas away from
joints, nerves, bones and other important structures.
––The injection site should be changed at regular intervals if
Proleukin is administered subcutaneously. This helps prevent
pain and redness at the injection site.
One treatment cycle usually lasts four weeks.
––Week 1
Days 1 to 5: a dose of 18 million IU Proleukin every day
Days 6 and 7: no Proleukin treatment

––Weeks 2, 3 and 4

Days 1 and 2: a dose of 18 million IU each day
Days 3, 4 and 5: a dose of 9 million IU every day
Days 6 and 7: no Proleukin treatment
After one week without Proleukin administration, a second 4-week
cycle should be given.
If the condition of the patient has improved or stabilised, treatment
with Proleukin can be continued with additional 4-week cycles.
Depending on the response to the treatment, a higher or lower dose
may be suggested.
Intravenous (i.v.) administration

––With a sterile syringe, withdraw the appropriate dose of the
Proleukin solution from the vial.

––Dilute as necessary to up to 500 ml with glucose 50 mg/ml (5%)

solution for infusion, containing 1 mg/ml (0.1%) human albumin.
The human albumin should be mixed with the glucose solution
prior to the addition of the reconstituted aldesleukin.

11/11/2014 07:34

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Before and during your Proleukin therapy, your doctor may perform
regular blood tests and chest X-rays, to check your organs and your
blood cell counts.

––The appropriate dose can then be administered intravenously,

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• Decreased or increased thyroid activity (hypo- or hyperthyroidism)
with symptoms such as weight gain, weight loss, sweating
or loss of hearing; high blood calcium level (hypercalcaemia)
with symptoms such as feeling sick (nausea), vomiting or
constipation.
• Difficulty breathing, tiredness, vomiting, drowsiness possible signs
of high levels of lactic acid in the blood.
• Feeling cold due to low body temperature (hypothermia); low level of
calcium (hypocalcaemia) with possible muscle weakness, twitching
or tingling of fingers; high level of potassium (hyperkalaemia)
associated with cramps, abnormal heart rhythm, dizziness and
headache.
If you experience any of the effects listed above, contact your doctor
immediately or go to the nearest emergency unit.

Other side effects
Very common (may affect more than 1 in 10 people):
• Loss of appetite (anorexia).
• Difficulty in sleeping (insomnia).
• Anxiety; confusion; dizziness; headache; drowsiness
(somnolence).
• Cough.
• Feeling sick (nausea) with or without vomiting; diarrhoea; mouth
sores with inflammation (stomatitis).
• Redness of the skin (erythema), skin rash; peeling; itching,
sweating.
• Reactions at injection site, such as pain and inflammation.
• Flu-like symptoms (fever, chills, malaise, fatigue); pain; weight
loss, weight gain.
• Fluid accumulation (oedema).
If any of these gets severe, tell your doctor or pharmacist.
1317489_GB_p1_LFT.indd 2

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1317489
Comp. Description: Leaflet_PROLEUKIN_LYVI 18 I6 GLW GB
Comp. Number New: 1317489 GB
Comp. Number Old: N/A
Format/Dimension: 540 x 318mm
Tech. Drawing No.: Leaflet Proleukin 540 x 318_v3

Both

Production Site:
CTM:
Printing Colours:

Catalent UK
Goodchild, Keith
PANTONE 412 C

Technical Colours: Cutting
Dimensions

Minimum Font Size: 9.0pt
Font Type: News Gothic, Times, Times New Roman
11/11/2014

Marketing Authorisation Holder
Novartis Pharmaceuticals UK Ltd
Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR.
Manufacturer
Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany.
This leaflet was last revised in 11/2014

Uncommon (may affect up to 1 in 100 people):
• Allergy reactions (hypersensitivity) leading to runny eyes,
runny nose, skin rash or distress.
• Muscle weakness (myasthenia)
• Skin discolouration (vitiligo).
If any of these gets severe, tell your doctor or pharmacist.
Rare (may affect up to 1 in 1,000 people):
• Diabetes.
• Skin rash with small blisters filled with fluid (vesiculobullous rash).
• Tissue damage (necrosis) at injection site.
If any of these gets severe, tell your doctor or pharmacist.
Inflammation of the blood vessels (vasculitis) in the skin, brain,
and rest of the body, has also been reported.
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 via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Proleukin
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the pack. The expiry date refers to the last day of that month.
Store the unopened vials in a refrigerator (2°C–8°C). Do not freeze.
Store in the original package in order to protect from light.
Your doctor, nurse or pharmacist knows how to store Proleukin
properly.
6. Contents of the pack and other information
What Proleukin contains
• The active substance is aldesleukin, providing 18 million
International Units (IU) (1.1 mg) per millilitre of solution
reconstituted as recommended.
• The other ingredients are mannitol (E421), sodium laurilsulfate,
sodium dihydrogen phosphate dihydrate and disodium hydrogen
phosphate dihydrate.

1317489 GB

11/11/2014 07:34

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Proof Number: 1
Braille:

What Proleukin looks like and contents of the pack
Proleukin is a sterile, white powder available in packs containing
1 or 10 vials.
Not all pack sizes may be marketed.

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Uncommon (may affect up to 1 in 100 people), rare (may affect up
to 1 in 1,000 people) or not known (frequency cannot be estimated
from the available data):
• Blood disorders: low levels of white blood cells with signs and
symptoms of sudden high fever, severe sore throat, and more
frequent infections (agranulocytosis or neutropenia); formation
of blood clot (thrombosis); bleeding (haemorrhage).
• Heart problems: irregular heart beat; disease of the heart muscle
with symptoms such as chest pain, fever or malaise; loss of
consciousness (sudden loss in cardiac function); chest discomfort
or pain (abnormal accumulation of fluid around the heart).
• Lung problems: sudden onset of breathing difficulty due to blood
clots in the lung (pulmonary embolism); extreme difficulty in
breathing (adult respiratory distress syndrome).
• Serious allergic reactions: anaphylaxis, leading to swelling of the
face and throat and difficulty breathing (Quincke’s oedema);
high fever, skin rash with small blisters, joint pain and/or eye
inflammation (Stevens Johnson syndrome).
• Digestive and organ problems: recurring (severe) inflammation of
the bowels (Crohn’s disease) accompanied with diarrhoea, pain
in lower abdomen, fever, and weight loss; inflammation of the
pancreas (pancreatitis) accompanied with severe pain in upper
abdomen radiating to the back; constipation, swollen abdomen,
abdominal pain (intestinal obstruction); upper abdominal pain
(cholecystitis); liver failure with abdominal pain, fatigue, yellowish
skin and eyes or dark yellow urine; a group of symptoms
consisting of severe abdominal pain, nausea, fever, vomiting
(gastrointestinal perforation).
• Nerve problems: seizures (convulsions or fits); paralysis; coma;
disturbances of the sight (optic neuropathy); central nervous
lesion with tingling, numbness (paraesthesia) or loss of control
of movement; weakness or paralysis of limbs or face, difficulty
speaking (cerebrovascular bleeding/cerebrovascular accident/
leucoencephalopathy).
• Low glucose level (hypoglycaemia) associated with symptoms
such as feeling hungry, sweating, dizziness, heart palpitations.
• Muscle problems: muscle spasms, fever, red-brown urine
possible signs of muscle disorder: pain or weakness in muscles.
If you experience any of the effects listed above, contact your
doctor immediately or go to the nearest emergency unit.

Common (may affect up to 1 in 10 people):
• Nose, throat and pulmonary infections; stuffed nose (nasal
congestion).
• Nose bleeding (epistaxis).
• Dehydration with signs such as dryness of the mouth or feeling
thirsty.
• Mood changes, e.g. irritability, excitement and restlessness
(agitation), depression, observation of things which are not there
(hallucinations).
• Loss of control of movements, observation of itching and tingling
of fingers or toes without cause (paraesthesia, neuropathy).
• Loss of taste.
• Lethargy with signs of lack of energy, tiredness and sleepiness.
• Stomach discomfort after meal (dyspepsia); constipation.
• Inflammation of the lips (cheilitis); inflammation of the stomach
resulting in stomach ache and nausea (gastritis).
• Loss of hair (alopecia); itchy rash.
• Muscle pain; joint pain.
• Eye inflammations (conjunctivitis) with itching redness and
swelling.
• Swelling and reddening of a vein (phlebitis).
• Inflammation of mucous membranes (mucositis); swelling with
nodes (nodules) at site of injection.
• High level of blood glucose (hyperglycaemia) with signs such as
excessive thirst, hunger, urination or fatigue.
• Blood tests indicating a change in liver function e.g. high level of
bilirubin (hyperbilirubinaemia) or liver enzymes in the blood
(liver transaminase, alkaline phosphatase and lactate
dehydrogenase).
If any of these gets severe, tell your doctor or pharmacist.

Matt Batch

! P LEA SE TU RN OV E R P R I NT I N G O N !
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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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