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PEMETREXED 25MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DIACID MONOHYDRATE

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Package leaflet:
Information for the user

Pemetrexed 25mg/ml
Concentrate for Solution for Infusion
Read all of this leaflet carefully before
you start receiving 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, nurse or pharmacist.
• If you get any side effects, talk to
your doctor, nurse or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
• The full name of this medicine is
Pemetrexed 25mg/ml Concentrate
for Solution for Infusion but within
the leaflet it will be referred to as
Pemetrexed.
What is in this leaflet:
1. What Pemetrexed is and what it is
used for
2. What you need to know before you use
Pemetrexed
3. How to use Pemetrexed
4. Possible side effects
5. How to store Pemetrexed
6. Contents of the pack and other
information
1. What Pemetrexed is and what it is
used for
Pemetrexed is a medicine used in the
treatment of cancer. It contains the active
substance pemetrexed. Pemetrexed
belongs to a group of medicines known
as folic acid analogues and disrupts
processes that are essential for cells to
divide.
Pemetrexed is given in combination
with cisplatin, another anti-cancer
medicine, as treatment for malignant
pleural mesothelioma, a form of cancer
that affects the lining of the lung, to
patients who have not received prior
chemotherapy.

Children and adolescents
There is no relevant use of Pemetrexed in
the paediatric population.
Other medicines and Pemetrexed
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines, including medicine
for pain or inflammation (swelling), such
as medicines called “nonsteroidal antiinflammatory drugs” (NSAIDs), including
medicines purchased without a doctor’s
prescription (such as ibuprofen). There
are many sorts of NSAIDs with different
durations of activity. Based on the planned
date of your infusion of Pemetrexed
and/or on the status of your kidney
function, your doctor needs to advise
you on which medicines you can take
and when you can take them. If you are
unsure, ask your doctor or pharmacist if
any of your medicines are NSAIDs.
Like other chemotherapy medicines
Pemetrexed is not recommended with
live attenuated vaccines. Inactive vaccines
should be used where possible.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be
pregnant or are planning to have a baby,
tell your doctor and ask for advice
before taking this medicine. The use of
Pemetrexed should be avoided during
pregnancy. Your doctor will discuss
with you the potential risk of taking
Pemetrexed during pregnancy. Women
must use effective contraception during
treatment with Pemetrexed.
Breast-feeding
If you are breast-feeding, tell your doctor.
Breast-feeding must be discontinued
during Pemetrexed treatment.

Pemetrexed can be prescribed to you
if you have lung cancer at an advanced
stage if your disease has responded to
treatment or it remains largely unchanged
after initial chemotherapy.

Fertility
Men are advised not to father a child
during and up to 6 months following
treatment with Pemetrexed and should
therefore use effective contraception
during treatment with Pemetrexed and for
up to 6 months afterwards. If you would
like to father a child during the treatment
or in the 6 months following receipt of
treatment, seek advice from your doctor
or pharmacist. You may want to seek
counselling on sperm storage before
starting your therapy.

Pemetrexed is also a treatment for
patients with advanced stage of lung
cancer whose disease has progressed after
other initial chemotherapy has been used.

Driving and using machines
Pemetrexed may make you feel tired.
Be careful when driving a car or using
machines.

2. What you need to know before you
use Pemetrexed

3. How to use Pemetrexed

Pemetrexed is also given in combination
with cisplatin for the initial treatment
of patients with advanced stage of lung
cancer.

Do not use Pemetrexed
• if you are allergic to pemetrexed or
any of the other ingredients of this
medicine (listed in section 6).
• if you are breast-feeding; you must
discontinue breast-feeding during
treatment with Pemetrexed.
• if you have recently received or are
about to receive a vaccine against
yellow fever.
Warnings and precautions
Talk to your doctor, nurse or hospital
pharmacist before receiving
Pemetrexed.
If you currently have or have previously
had problems with your kidneys, talk to
your doctor or hospital pharmacist as you
may not be able to receive Pemetrexed.
Before each infusion you will have samples
of your blood taken to evaluate if you
have sufficient kidney and liver function
and to check that you have enough blood
cells to receive Pemetrexed. Your doctor
may decide to change the dose or delay
treating you depending on your general
condition and if your blood cell counts are
too low. If you are also receiving cisplatin,
your doctor will make sure that you are
properly hydrated and receive appropriate
treatment before and after receiving
cisplatin to prevent vomiting.
If you have had or are going to have
radiation therapy, please tell your doctor,
as there may be an early or late radiation
reaction with Pemetrexed.
If you have been recently vaccinated,
please tell your doctor, as this can possibly
cause bad effects with Pemetrexed.
If you have heart disease or a history of
heart disease, please tell your doctor.
If you have an accumulation of fluid
around your lungs, your doctor may
decide to remove the fluid before giving
you Pemetrexed.

Pemetrexed 25mg/ml Concentrate for
Solution for Infusion will always be given
to you by a healthcare professional. The
dose of Pemetrexed is 500 milligrams
for every square metre of your body’s
surface area. Your height and weight are
measured to work out the surface area
of your body. Your doctor will use this
body surface area to work out the right
dose for you. This dose may be adjusted,
or treatment may be delayed depending
on your blood cell counts and on your
general condition. A hospital pharmacist,
nurse or doctor will have mixed the
Pemetrexed concentrate with 5% glucose
solution for injection before it is given to
you.
You will always receive Pemetrexed
by infusion into one of your veins.
The infusion will last approximately
10 minutes.
When using Pemetrexed in combination
with cisplatin:
The doctor or hospital pharmacist will
work out the dose you need based on
your height and weight. Cisplatin is also
given by infusion into one of your veins,
and is given approximately 30 minutes
after the infusion of Pemetrexed has
finished. The infusion of cisplatin will last
approximately 2 hours.
You should usually receive your infusion
once every 3 weeks.
Additional medicines:
Corticosteriods: your doctor will prescribe
you steroid tablets (equivalent to
4 milligram of dexamethasone twice a
day) that you will need to take on the day
before, on the day of, and the day after
Pemetrexed treatment. This medicine
is given to you to reduce the frequency
and severity of skin reactions that you
may experience during your anticancer
treatment.
Vitamin supplementation: your doctor
will prescribe you oral folic acid (vitamin)
or a multivitamin containing folic acid
(350 to 1000 micrograms) that you must
take once a day while you are taking

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!
Pemetrexed 25mg/ml
Concentrate for Solution
for Infusion
The following information is intended
for medical or healthcare professionals
only:
Instructions for use, handling and
disposal.
1. Use aseptic techniques during dilution
of pemetrexed for intravenous infusion
administration.
2. Calculate the dose and the number of
Pemetrexed vials needed.

3. Pemetrexed must only be diluted
with 5% glucose solution, without
preservative. The appropriate volume
of pemetrexed concentrate must be
diluted to 100ml with 5% glucose
solution and administered as an
intravenous infusion over 10 minutes.
4. Pemetrexed infusion solutions prepared
as directed above are compatible
with polyvinyl chloride and polyolefin
lined administration sets and infusion
bags. Pemetrexed is incompatible with
diluents containing calcium, including
lactated Ringer’s Injection and Ringer’s
Injection.

Pemetrexed 25mg/ml concentrate for Solution for Infusion leaflet - UK
item no:

AAAI6603

dimensions:

print proof no:

3

pharmacode:

origination date: 13.01.16
approved for print/date

min pt size:

124 x 560

colours/plates:
1. Black
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8

5.
6.

originated by:

jh

revision date:

20.01.16

Technical Approval

revised by:

sa

date sent:

supplier:

Nerviano

technically app. date: 13.01.16

13.01.16

Non Printing Colours
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Pemetrexed. You must take at least 5 doses
during the seven days before the first dose
of Pemetrexed. You must continue taking
the folic acid for 21 days after the last dose
of Pemetrexed. You will also receive an
injection of vitamin B12 (1000 micrograms)
in the week before administration of
Pemetrexed and then approximately every
9 weeks (corresponding to 3 courses of
Pemetrexed treatment). Vitamin B12 and
folic acid are given to you to reduce the
possible toxic effects of the anticancer
treatment.
Your condition will be closely monitored
during treatment. This routinely involves
blood tests, including checks on your liver
and kidney function. Your dose may be
changed or treatment delayed depending
on results from these tests.
If you have any further questions on the
use of this medicine, ask your doctor,
nurse or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
You must contact your doctor immediately
if you notice any of the following:
• Fever or infection (common): if you
have a temperature of 38°C or greater,
sweating or other signs of infection
(since you might have less white
blood cells than normal which is very
common). Infection (sepsis) may be
severe and could lead to death.
• If you start feeling chest pain
(common) or having a fast heart rate
(uncommon).
• If you have pain, redness, swelling or
sores in your mouth (very common).
• Allergic reaction: if you develop skin
rash (very common) / burning or
prickling sensation (common), or fever
(common). Rarely, skin reactions may
be severe and could lead to death.
Contact your doctor if you get a severe
rash or itching or blistering (StevensJohnson Syndrome or Toxic epidermal
necrolysis).
• If you experience tiredness, feeling
faint, becoming easily breathless or if
you look pale (since you might have
less haemoglobin than normal which is
very common).
• If you experience bleeding from the
gums, nose or mouth or any bleeding
that would not stop, reddish or pinkish
urine, unexpected bruising (since you
might have less platelets than normal
which is very common).
• If you experience sudden
breathlessness, intense chest pain
or cough with bloody sputum
(uncommon)(may indicate a blood clot
in the blood vessels of the lungs).
Other side effects:
Very common (may affect more than
1 in 10 people)
• Low white blood cells.
• Low haemoglobin level (anaemia).
• Low platelet count.
• Diarrhoea.
• Vomiting.
• Pain, redness, swelling or sores in your
mouth.
• Nausea.
• Loss of appetite.
• Fatigue (tiredness).
• Skin rash, peeling of the skin.
• Hair loss.
• Constipation.
• Loss of sensation.
• Kidney: abnormal blood tests.
Common (may affect up to 1 in 10 people)
• Allergic reaction: skin rash / burning or
prickling sensation.
• Infection including sepsis.
• Fever.
• Dehydration.
• Kidney failure.
• Irritation of the skin and itching.
• Hives.
• Chest pain.
• Muscle weakness.
• Conjunctivitis (inflamed eye).
• Upset stomach.
• Pain in the abdomen.
• Taste change.
• Liver: abnormal blood tests.
• Watery eyes.
• Dizziness.
Uncommon (may affect up to 1 in 100
people)
• Acute renal failure.
• Fast or irregular heart rate.
• Inflammation of the lining of the
oesophagus (gullet) has been
experienced with pemetrexed/
radiation therapy.
• Colitis (inflammation of the lining
of the large bowel, which may be
accompanied by intestinal or rectal
bleeding).
• Interstitial pneumonitis (scarring of the
air sacs of the lung).
• Oedema (excess fluid in body tissue,
causing swelling).
• Some patients have experienced a
heart attack, stroke or “mini-stroke”
while receiving pemetrexed usually in
combination with another anticancer
therapy.
• Pancytopenia-combined low counts of
white cells, red cells and platelets.
• Radiation pneumonitis (scarring of
the air sacs of the lung associated
with radiation therapy) may occur in
patients who are also treated with
radiation before, during or after their
pemetrexed therapy.
• Extremity pain, low temperature and
discolouration have been reported.
• Blood clots in the lung blood vessels
(pulmonary embolism).

Rare (may affect up to 1 in 1,000 people)
• Radiation recall (a skin rash like severe
sunburn) which can occur on skin
that has previously been exposed to
radiotherapy, from days to years after
the radiation.
• Bullous conditions (blistering skin
diseases) including Stevens-Johnson
syndrome and Toxic epidermal
necrolysis.
• Immune mediated haemolytic anaemia
(antibody-mediated destruction of red
blood cells).
• Hepatitis (inflammation of the liver).
• Anaphylactic shock (severe allergic
reaction).
You might have any of these symptoms
and/or conditions. You must tell your
doctor as soon as possible when you start
experiencing any of these side effects.
Reporting of side effects
If you get any side effects, talk to your
doctor, nurse or pharmacist. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the national reporting system
listed in the Yellow Card Scheme Website:
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 Pemetrexed
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the label and
carton after ‘EXP’. The expiry date refers to
the last day of that month.
Store and transport refrigerated
(2°C to 8°C).
Do not freeze.
Keep the vial in the outer carton in order
to protect from light.
Infusion Solution: Chemical and physical
in-use stability of infusion solution of
pemetrexed was demonstrated for 24
hours at room temperature and 14 days
at refrigerated temperature (2-8°C).
From a microbiological point of view, the
product should be used immediately.
If not used immediately, in-use storage
times and conditions prior to use are the
responsibility of the user and would not
be longer than 24 hours at 2°C to 8°C,
unless dilution has taken place in controlled
and validated aseptic conditions.
Pemetrexed should not been used if there
are any signs of particles.
This medicine is for single use only; any
unused solution must be disposed of in
accordance with local requirement.
6. Contents of the pack and other
information
What Pemetrexed contains
The active substance is pemetrexed.
One ml of concentrate contains
25mg pemetrexed (as pemetrexed
ditrometamol). Further dilution by a
healthcare provider is required prior to
administration.
One vial of 4ml concentrate contains
100mg pemetrexed (as pemetrexed
ditrometamol).
One vial of 20ml concentrate contains
500mg pemetrexed (as pemetrexed
ditrometamol).
One vial of 40ml concentrate contains
1000mg pemetrexed (as pemetrexed
ditrometamol).
The other ingredients are trometamol,
anhydrous citric acid, cysteine
hydrochloride monohydrate and water
for injection.
What Pemetrexed looks like and
contents of the pack
Pemetrexed is a clear, colourless to slightly
yellowish or yellow-greenish solution.
Pemetrexed is in colourless glass vial
(type I) with type I rubber (bromobutyl)
serum stopper and an aluminium cap with
polypropylene disk. Vials are sheathed in
protective sleeve.
Each pack of Pemetrexed consists of one
Pemetrexed vial.
Marketing Authorisation Holder
Caduceus Pharma Ltd.
6th floor
94 Wigmore Street
London
W1U 3RF
UK
Manufacturer
Actavis Italy S.p.A.
Nerviano Plant
Viale Pasteur 10
20014 Nerviano (Milan)
Italy
This leaflet was last revised in
January 2016

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AAAI6603

!
5. Parenteral medicinal products should
be inspected visually for particulate
matter and discolouration prior to
administration. If particulate matter is
observed, do not administer.
6. Pemetrexed solutions are for single
use only. Any unused product or waste
material should be disposed of in
accordance with local requirements.

If pemetrexed solutions contact the
mucous membranes, flush thoroughly
with water. Pemetrexed is not a vesicant.
There is not a specific antidote for
extravasation of pemetrexed. There have
been a few reported cases of pemetrexed
extravasation, which were not assessed as
serious by the investigator. Extravasation
should be managed by local standard
practice as with other non-vesicants.

Preparation and administration
precautions: As with other potentially
toxic anticancer agents, care should be
exercised in the handling and preparation
of pemetrexed infusion solutions.
The use of gloves is recommended.
If a pemetrexed solution contacts
the skin, wash the skin immediately
and thoroughly with soap and water.

AAAI6603

Pemetrexed 25mg/ml concentrate for Solution for Infusion leaflet - UK
item no:

AAAI6603

dimensions:

print proof no:

3

pharmacode:

origination date: 13.01.16
approved for print/date

min pt size:

124 x 560

colours/plates:
1. Black
2.
3.
4.

8

5.
6.

originated by:

jh

revision date:

20.01.16

Technical Approval

revised by:

sa

date sent:

supplier:

Nerviano

technically app. date: 13.01.16

13.01.16

Non Printing Colours
1. profile
2.
3.

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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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