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PEMETREXED 500MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DISODIUM HEMIPENTAHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pemetrexed 100 mg powder for concentrate for solution for infusion
Pemetrexed 500 mg powder for concentrate for solution for infusion
Pemetrexed

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.
- If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
1.
2.
3.
4.
5.
6.

What Pemetrexed is and what it is used for
What you need to know before you use Pemetrexed
How to use Pemetrexed
Possible side effects
How to store Pemetrexed
Contents of the pack and other information

receipt of treatment, seek advice from your doctor or pharmacist. You may want
to seek counseling 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 500 mg contains approximately 54 mg sodium per vial. To be taken
into consideration by patients on a controlled sodium diet.
Pemetrexed 100 mg contains approximately 11 mg sodium per vial.

3. How to use Pemetrexed
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
1. What Pemetrexed is and what it is used for
dose for you. This dose may be adjusted, or treatment may be delayed depending
Pemetrexed is a medicine used in the treatment of cancer.
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 %)
Pemetrexed is given in combination with cisplatin, another anti-cancer
sodium chloride solution for injection before it is given to you.
medicine, as treatment for malignant pleural mesothelioma, a form of
cancer that affects the lining of the lung, to patients who have not received
You will always receive Pemetrexed by infusion into one of your veins.
prior chemotherapy.
The infusion will last approximately 10 minutes.
Pemetrexed is also given in combination with cisplatin for the initial
When using Pemetrexed in combination with cisplatin:
treatment of patients with advanced stage of lung cancer.
The doctor or hospital pharmacist will work out the dose you need based on your
Pemetrexed can be prescribed to you if you have lung cancer at an advanced
height and weight. Cisplatin is also given by infusion into one of your veins, and
stage if your disease has responded to treatment or it remains largely
is given approximately 30 minutes after the infusion of Pemetrexed has is given
unchanged after initial chemotherapy.
approximately 30 minutes after the infusion of Pemetrexed has finished. The
Pemetrexed is also a treatment for patients with advanced stage of lung
infusion of cisplatin will last approximately 2 hours.
cancer whose disease has progressed after other initial chemotherapy has
You should usually receive your infusion once every 3 weeks.
been used.
Additional medicines:
2. What you need to know before you are given Pemetrexed
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
Do not use Pemetrexed
- if you are allergic (hypersensitive) to pemetrexed or any of the other before, on the day of, and the day after Pemetrexed treatment. This before, on
the day of, and the day after Pemetrexed treatment. This medicine is given to you
ingredients of Pemetrexed (listed in section 6).
to reduce the frequency and severity of skin reactions that you may experience
- if you are breast-feeding; you must discontinue breast-feeding during during your anticancer treatment.
treatment with Pemetrexed .
supplementation: your doctor will prescribe you oral folic acid (vitamin)
- if you have recently received or are about to receive a vaccine against yellow Vitamin
or a multivitamin containing folic acid (350 to 1000 micrograms) that you must
fever.
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 least 5 doses during
Warnings and Precautions
the seven days before the first dose of Pemetrexed. You must continue taking the
Talk to your doctor or hospital pharmacist before receiving Pemetrexed .
folic acid for 21 days after the last dose of Pemetrexed. You will also receive an
If you currently have or have previously had problems with your kidneys, talk to injection of vitamin B12 (1000 micrograms) in the week before administration of
your doctor or hospital pharmacist as you may not be able to receive Pemetrexed. Pemetrexed and then approximately every 9 weeks (corresponding to 3 courses
Before each infusion you will have samples of your blood taken to evaluate if you of Pemetrexed treatment). Vitamin B12 and folic acid are given to you to reduce
have sufficient kidney and liver function and to check that you have enough blood the possible toxic effects of the anticancer treatment.
cells to receive Pemetrexed . Your doctor may decide to change the dose or delay If you have any further questions on the use of this medicine, ask your doctor or
treating you depending on your general condition and if your blood cell counts pharmacist.
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 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
receiving cisplatin to prevent vomiting.
gets them.
If you have had or are going to have radiation therapy, please tell your doctor, as
You must contact your doctor immediately if you notice any of the following:
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 • Fever or infection (common): if you have a temperature of 38ºC or greater,
sweating or other signs of infection (since you might have less white blood
cause bad effects with Pemetrexed.
cells than normal which is very common). Infection (sepsis) may be severe
If you have heart disease or a history of heart disease, please tell your doctor.
and could lead to death.
If you have an accumulation of fluid around your lungs, your doctor may decide to • If you start feeling chest pain (common) or having a fast heart rate
remove the fluid before giving you Pemetrexed.
(uncommon).
• If you have pain, redness, swelling or sores in your mouth (very common).
Children and adolescents
• Allergic reaction: if you develop skin rash (very common) / burning or
There is no relevant use of Pemetrexed in the paediatric population.
prickling sensation (common), or fever (common). Rarely, skin reactions
Other medicines and Pemetrexed
may be severe and could lead to death. Contact your doctor if you get a
severe rash, or itching, or blistering (Stevens-Johnson Syndrome or Toxic
Please tell your doctor if you are taking any medicine for pain or inflammation
epidermal necrolysis).
(swelling), such as medicines called “nonsteroidal anti-inflammatory drugs”
(NSAIDs), including medicines purchased without a doctor’s prescription (such as • If you experience tiredness, feeling faint, becoming easily breathless or if you
ibuprofen). There are many sorts of NSAIDs with different durations of activity.
look pale (since you might have less haemoglobin than normal which is very
Based on the planned date of your infusion of Pemetrexed and/or on the status of
common).
your kidney function, your doctor needs to advise you on which medicines you • If you experience bleeding from the gums, nose or mouth or any bleeding
can take and when you can take them. If you are unsure, ask your doctor or
that would not stop, reddish or pinkish urine, unexpected bruising (since you
pharmacist if any of your medicines are NSAIDs.
might have less platelets than normal which is very common).
Please tell your doctor or hospital pharmacist if you are taking or have recently • If you experience sudden breathlessness, intense chest pain or cough with
taken any other medicines, including medicines obtained without a prescription.
bloody sputum (uncommon)(may indicate a blood clot in the blood vessels
of the lungs)
Pregnancy, breast-feeding and fertility
Pregnancy
The frequency of possible side effects listed below is defined as follows:
If you are pregnant, or thinking about becoming pregnant, tell your doctor.
Very common (may affect more than 1 patient in 10)
The use of Pemetrexed should be avoided during pregnancy. Your doctor will
Common (may affect 1 to 10 patients in 100)
discuss with you the potential risk of taking Pemetrexed during pregnancy.
Uncommon (may affect 1 to 10 patients in 1,000)
Women must use effective contraception during treatment with Pemetrexed .
Rare (may affect 1 to 10 patients in 10,000)
Very rare (may affect less than 1 patient in 10,000)
Breast-feeding
If you are breast-feeding, tell your doctor.
Side effects with Pemetrexed may include:
Breast-feeding must be discontinued during Pemetrexed treatment.
Very common
Low white blood cells
Fertility
Men are advised not to father a child during and up to 6 months following Low haemoglobin level (anaemia)
treatment with Pemetrexed and should therefore use effective contraception Low platelet count
during treatment with Pemetrexed and for up to 6 months afterwards. If you Diarrhoea
would like to father a child during the treatment or in the 6 months following

Vomiting
Pain, redness, swelling or sores in your mouth
Nausea
Loss of appetite
Fatigue (tiredness)
Skin rash
Hair loss
Constipation
Loss of sensation
Kidney: abnormal blood tests
Common
Allergic reaction: skin rash / burning or prickling sensation
Infection including sepsis
Fever
Dehydration
Kidney failure
Irritation of the skin and itching
Chest pain
Muscle weakness
Conjunctivitis (inflamed eye)
Upset stomach
Pain in the abdomen
Taste change
Liver: abnormal blood tests
Watery eyes
Uncommon
Acute renal failure
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.
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.
Extremity pain, low temperature and discolouration have been reported.
Blood clots in the lung blood vessels (pulmonary embolism)
Rare
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.
Haemolytic anaemia (anaemia due to 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, 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack.
This medicine does not require any special storage conditions.
Reconstituted and Infusion Solutions: The product should be used immediately.
When prepared as directed, chemical and physical in-use stability of
reconstituted and infusion solutions of pemetrexed were demonstrated for 24
hours at refrigerated temperature or 25ºC.
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.
Pemetrexed 100 mg: Each vial contains 100 milligrams of pemetrexed
(as pemetrexed disodium 2.5 H2O).
Pemetrexed 500 mg: Each vial contains 500 milligrams of pemetrexed
(as pemetrexed disodium 2.5 H2O).
After reconstitution, the solution contains 25 mg/ml of pemetrexed. Further
dilution by a healthcare provider is required prior to administration.
The other ingredients are mannitol, hydrochloric acid (for pH adjustment) and
sodium hydroxide (for pH adjustment).
What Pemetrexed looks like and contents of the pack
Pemetrexed is a powder for concentrate for solution for infusion in a vial. It is a
white to faint yellow lyophilised powder.
Each pack of Pemetrexed consists of one Pemetrexed vial.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorio Reig Jofre S.A.
Gran Capitán, 10
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Laboratorio Reig Jofre S.A.
c/ Jarama 111 Pol. Ind.
45007 Toledo
Spain
This medicinal product is authorised in the Member States of the
EEA under the following names:
Denmark:
Pemetrexed Reig Jofre
Iceland:
Pemetrexed Reig Jofre 100 mg stofn fyrir innrennslisþykkni,
lausn
Pemetrexed Reig Jofre 500 mg stofn fyrir innrennslisþykkni,
lausn
Norway:
Pemetrexed Reig Jofre
Spain:
Pemetrexed Sala 100 mg polvo para concentrado para
solución para perfusión EFG
Pemetrexed Sala 500 mg polvo para concentrado para
solución para perfusión EFG
Sweden:
Pemetrexed Reig Jofre
United Kingdom: Pemetrexed 100 mg powder for concentrate for solution for
infusion
Pemetrexed 500 mg powder for concentrate for solution for
infusion
This leaflet was last approved in: 10/2015
Detailed information on this medicine is available on the website of United
Kingdom/MHRA
The following information is intended for medical or 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.
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 100 mg:
Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9%) sodium
chloride solution for injection, without preservative, resulting in a solution
containing 25 mg/ml pemetrexed. Pemetrexed 500 mg:
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 clear and ranges in colour from colourless to yellow or
green-yellow without adversely affecting product quality. 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.

B1XXXX-01

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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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