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PEMETREXED 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DIACID / PEMETREXED DISODIUM / PEMETREXED DIACID / PEMETREXED DISODIUM / PEMETREXED DIACID / PEMETREXED DISODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pemetrexed 100mg powder for concentrate for solution for infusion
Pemetrexed 500mg powder for concentrate for solution for infusion
pemetrexed
Read all of this leaflet carefully before you start using 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.
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 (hypersensitive) 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 pharmacist before taking Pemetrexed
If you currently have or have previously had problems with your
kidneys, talk to your doctor or 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.
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 pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.

Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, or thinking about becoming pregnant, tell your
doctor. The use of Pemetrexed should be avoided during pregnancy.
Your doctor will discuss with you the potential risk of using 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 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.
Driving and using machines
Pemetrexed may make you feel tired. Be careful when driving a car or
using machines.
Pemetrexed contains sodium
Pemetrexed 500mg contains approximately 54mg (2.3mmol) of
sodium per vial. To be taken into consideration by patients on a
controlled sodium diet.
Pemetrexed 100mg contains approximately 11mg (less than 1mmol)
of sodium per vial, i.e. essentially ‘sodium-free’.

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 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 pharmacist, nurse or doctor
will have mixed the Pemetrexed powder with 9mg/ml (0.9%) sodium
chloride 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 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:
Corticosteroids: your doctor will prescribe you steroid tablets
(equivalent to 4 milligrams of dexamethasone twice a day) that you
will need to take 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 is 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.

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 38ºC 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).


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 100mg:
Reconstitute each 100mg vial with 4.2ml of 9mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution
containing 25mg/ml pemetrexed.
Pemetrexed 500mg:
Reconstitute each 500mg vial with 20ml of 9mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution
containing 25mg/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.

• 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)
Side effects with Pemetrexed 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
- 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
- Chest pain
- Muscle weakness
- Conjunctivitis (inflamed eye)
- Upset stomach
- Pain in the abdomen
- Taste change
- Liver: abnormal blood tests
- Watery eyes
Uncommon (may affect up to 1 in 100 people)
- 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 (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
- 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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in the leaflet.

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 requirements for cytotoxic
medicinal products.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pemetrexed contains
The active substance is pemetrexed.
Pemetrexed 100mg: Each vial contains 100 milligrams of pemetrexed
(as pemetrexed disodium).
Pemetrexed 500mg: Each vial contains 500 milligrams of pemetrexed
(as pemetrexed disodium).
After reconstitution, the solution contains 25mg/ml of pemetrexed.
Further dilution by a healthcare provider is required prior to
administration.
The other ingredients are mannitol, hydrochloric acid and
sodium hydroxide.
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 either light yellow or green-yellow
lyophilised powder.
Each pack of Pemetrexed consists of one Pemetrexed vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TAMARANG, S.A.
Balmes 84, 4º 2ª
08008 – Barcelona (Spain)
Manufacturer
Idifarma Desarrollo Farmacéutico
Polígono Mocholí, C/ Noáin 1
31110 Noáin - Navarra
Spain
Distributed by:
Aspire Pharma Limited
Unit 4 Rotherbrook Court, Bedford Road,
Petersfield, Hampshire, GU32 3QG
United Kingdom
This leaflet was last revised in 10/2016.

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. Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

XXXXXXX-P1.5


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 for cytotoxic medicinal products.
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.

Expand Transcript

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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