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PEMETREXED SYNCHRONY 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DISODIUM

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Package leaflet: Information for the user
Pemetrexed 500 mg
powder for concentrate for solution for infusion
pemetrexed (as pemetrexed disodium)
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 further questions, please ask your doctor or pharmacist or nurse.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
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.
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.
Pemetrexed is also given in combination with cisplatin for the initial treatment of patients with
advanced stage of lung cancer.
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.
Pemetrexed is also a treatment for patients with advanced stage of lung cancer whose disease has
progressed after other initial chemotherapy has been used.

2.

What you need to know before you use Pemetrexed

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 or hospital pharmacist before receiving Pemetrexed. It is especially important to
tell your doctor if:
you currently have or have previously had problems with your kidneys. You may not be able to
receive Pemetrexed.

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you have had or are going to have radiation therapy. There may be an early or late radiation
reaction with Pemetrexed.
you have been recently vaccinated. This can possibly cause bad effects with Pemetrexed.
you have heart disease or a history of heart disease.
you have an accumulation of fluid around your lungs. Your doctor may decide to remove the fluid before giving you 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
(receiving enough liquid) and receive appropriate treatment before and after receiving cisplatin to
prevent vomiting.
Children and adolescents
There is no relevant use of Pemetrexed in the paediatric population.
Other medicines and Pemetrexed
Please tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as
medicines called "nonsteroidal anti-inflammatory 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.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken or might
take any other medicines.
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. 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.
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 this period. 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.
Driving and using machines
Pemetrexed may make you feel tired. Be careful when driving a car or using machines.
Pemetrexed contains sodium
Pemetrexed contains approximately 2.4 mmol (54 mg) sodium per vial. To be taken into consideration
by patients on a controlled sodium diet.

3.

How to use Pemetrexed
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How much Pemetrexed is given
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 powder with 9 mg/ml (0.9%)
sodium chloride solution for injection before it is given to you.
How Pemetrexed is given
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.
How often you will be given Pemetrexed
You should usually receive your infusion once every 3 weeks.
Additional medicines:
Corticosteroids: 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
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must contact your doctor or nurse 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.

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Contact your doctor if you get a severe rash, or itching, or blistering (Stevens-Johnson
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 may include:
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
Hair loss
Constipation
Loss of sensation
Abnormal blood tests, indicating possible kidney problems
Common (may affect up to 1 in 10 people)
Allergic reaction: skin rash / burning or prickling sensation
Infection including sepsis (a condition in which the body is fighting a severe infection that has
spread via the bloodstream)
Fever
Dehydration (loss of too much fluid from the body)
Kidney insufficiency
Irritation of the skin and itching
Chest pain
Muscle weakness
Conjunctivitis (inflamed eye)
Upset stomach
Pain in the abdomen
Taste change
Abnormal blood tests, indicating possible liver problems
Watery eyes
Uncommon (may affect up to 1 to 100 people)
Acute kidney insufficiency
Fast 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.
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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 either before, during or after their
Pemetrexed therapy.
Hand or leg 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.
If you are concerned about any side effects, talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. 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 Pemetrexed

Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on the pack. The expiry date refers to the last day of
that month.
This medicinal product does not require any special storage conditions.
Reconstituted and infusion solutions: When prepared as directed, reconstituted and infusion solutions
of Pemetrexed contain no antimicrobial preservatives. Chemical and physical in-use stability of
reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at 2°C to 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.
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. Each vial contains 500 mg of pemetrexed (as
pemetrexed disodium).
After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further dilution by a
healthcare provider is required prior to administration.
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The other ingredients are mannitol, hydrochloric acid (for pH-adjustment) and sodium
hydroxide (for pH-adjustment). Pemetrexed contains sodium (See section 2).

What Pemetrexed looks like and contents of the pack
Pemetrexed is a powder for concentrate for solution for infusion in a type I glass vial with brombutyl
rubber stopper and white aluminium flip-off cap. It is a white to either light yellow or green-yellow
lyophilised cake or powder.
Pack of 1 vial.
Marketing Authorisation Holder
Synchrony Pharma Limited
Suite 52, Business & Technology Centre, Bessemer Drive
Stevenage, Herts, SG1 2DX
UK
Manufacturer
Thymoorgan Pharmazie GmbH
Schiffgraben 23
38690 Goslar
Germany
Pharmidea SIA
4 Rupnicu Str.
Olaine, LV-2114
Latvia

This medicinal product is authorised in the Member States of the EEA under the following
names:
Iceland: Pemetrexed W&H
Norway: Pemetrexed Medlite
Denmark: Pemetrexed Medlite
Germany: Pemetrexed LOGENEX
Netherlands: Pemetrexed B-Medical
Belgium: Pemetrexed B-Medical
Slovakia: Pemetrexed Pharmevid
Greece: Pemetrexed Vocate
Croatia: Pemetrexed Alpha-Medical
United Kingdom: Pemetrexed Synchrony
This leaflet was last revised in 02/2016.
-----------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Instructions for use, handling and disposal.
1.

Use aseptic techniques during the reconstitution and further dilution of pemetrexed for
intravenous infusion administration.

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2.

Calculate the dose and the number of Pemetrexed vials needed. Each vial contains an excess of
pemetrexed to facilitate delivery of the label amount.

3.

Pemetrexed:
Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for
injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Gently swirl each vial until the powder is completely dissolved. The resulting solution is a clear,
colorless or yellow or yellowish-green or brownish-yellow coloured solution. The pH of the
reconstituted solution is between 6.6 and 7.8. Further dilution is required.

4.

The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml
with 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, and
administered as an intravenous infusion over 10 minutes.

5.

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.

6.

Parenteral medicinal products should be inspected visually for particulate matter and
discolouration prior to administration. If particulate matter is observed, do not administer.

7.

Pemetrexed solutions are for single use only. Any unused product or waste material should be
disposed of in accordance with local requirements.

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. 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.

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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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