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PEMETREXED SUN 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DISODIUM

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Other medicines and Pemetrexed
Tell your doctor if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.

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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 1000 mg powder for concentrate for solution for
infusion
pemetrexed
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, please ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.

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 SUN 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.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your
doctor for advice before you are given this medicine. The use of Pemetrexed should be
avoided during pregnancy. Your doctor will discuss with you the potential risk of receiving
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.

1. What Pemetrexed is and what it is used for

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 are given Pemetrexed
You should NOT be given 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 before you are given Pemetrexed
- if you currently have or have previously had problems with your kidneys, as you may not
be able to receive Pemetrexed.
Before each infusion you will have samples of your blood taken to see 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 treatment before and after receiving cisplatin to prevent vomiting.
- if you have had or are going to have radiation therapy, as there may be an early or late
radiation reaction with Pemetrexed
- if you have been recently vaccinated, as this can possibly cause bad effects with
Pemetrexed
- if you have heart disease or a history of heart disease
- 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 children or adolescents.

The recommended 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 9 mg/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.

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.

Rare (may affect up to 1 in 1,000 people)
- allergic reaction: severe rash, or itching, or blistering (Stevens-Johnson Syndrome or
Toxic epidermal necrolysis).
Other side effects

Very common (may affect more than 1 in 10 people)
- low white blood cells
- diarrhoea
- vomiting
- nausea
- loss of appetite
- fatigue (tiredness)
- hair loss
- constipation
- loss of sensation
- kidney: abnormal blood tests

3. How Pemetrexed is used

You should usually receive your infusion once every 3 weeks.

Uncommon (may affect up to 1 in 100 people)
- fast heart rate
- blood clots in the blood vessels of the lungs (pulmonary embolism). You could
experience sudden breathlessness, intense chest pain or cough with bloody sputum

Tell your doctor as soon as possible about any of the following side effects:

Pemetrexed contains sodium
Pemetrexed 100 mg contains 11 mg sodium (≤ 1 mmol) per vial, i.e. it is essentially
“sodium-free”.
Pemetrexed 500 mg contains approximately 54 mg (2.35 mmol) sodium per vial. To be
taken into consideration by patients on a controlled sodium diet.
Pemetrexed 1000 mg contains approximately 108 mg (4.70 mmol) sodium per vial. To be
taken into consideration by patients on a controlled sodium diet.

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.

Very common (may affect more than 1 in 10 people)
- pain, redness, swelling or sores in mouth
- allergic reaction: skin rash. Rarely, skin reactions may be severe and could lead to death
- low level of haemoglobin (anaemia). You could experience tiredness, feeling faint,
becoming easily breathless or you could look pale
- low counts of platelets. You could experience bleeding from the gums, nose or mouth or
any bleeding that would not stop, reddish or pinkish urine, unexpected bruising
Common (may affect up to 1 in 10 people)
- fever or infection: 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
- chest pain
- allergic reaction: burning or prickling sensation and fever

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

Pemetrexed contains the active substance pemetrexed, which belongs to the group of
medicines used in the treatment of cancer. It is used:
- 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
- in combination with cisplatin for the initial treatment of patients with advanced stage of
lung cancer
- as a treatment for patients with lung cancer at an advanced stage if their disease has
responded to treatment or it remains largely unchanged after initial chemotherapy
- as a treatment for patients with advanced stage of lung cancer whose disease has
progressed after other initial chemotherapy has been used.

Serious side effects
Tell your doctor straight away about any of the following serious side effects:

Common (may affect up to 1 in 10 people)
- dehydration
- kidney failure
- irritation of the skin and itching
- 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
- 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), radiation pneumonitis (may
occur in patients who are also treated with radiation either before, during or after their
pemetrexed therapy)
- oedema (excess fluid in body tissue, causing swelling)
- heart attack, stroke or “mini-stroke”. Some patients have experienced these while
receiving pemetrexed usually in combination with another anticancer therapy
- pancytopenia (combined low counts of white cells, red cells and platelets)
- extremity pain, low temperature and discolouration
- blood clots in the blood vessels of the lungs (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
- haemolytic anaemia (anaemia due to destruction of red blood cells)
- hepatitis (inflammation of the liver)
- anaphylactic shock (severe allergic reaction).

If you have any further questions on the use of this medicine, ask your doctor, pharmacist
or nurse.

Pemetrexed 350x430mm-EUUK-15-01-16
15 January 2016 10:12:11

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 agents.

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

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.

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.

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. The osmolality of the reconstituted
solution is between 480 and 570 mOsm/kg.
Further dilution is required.

Pemetrexed 1000 mg:
Reconstitute each 1000 mg vial with 40 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.

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.

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.

Instructions for use, handling and disposal
1. Use aseptic techniques during the
reconstitution and further dilution of
pemetrexed for intravenous infusion
administration

The following information is intended for
medical or healthcare professionals only

pemetrexed

Pemetrexed 100 mg powder for
concentrate for solution for
infusion
Pemetrexed 500 mg powder for
concentrate for solution for
infusion
Pemetrexed 1000 mg powder
for concentrate for solution for
infusion

Continued overleaf...

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do not print here

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 SUN
Your doctor, pharmacist or nurse knows how to store Pemetrexed properly.
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 the vial and carton
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
After opening the vial, the product should be used immediately in order to avoid microbial
contamination. If not used immediately, in-use storage times and conditions prior to use
are the responsibility of the user and would normally not be longer than 24 hours at
2°C – 8°C, unless reconstitution/ dilution has taken place in controlled and validated
aseptic conditions. Allow the refrigerated solution to reach room temperature before
administration.

6. Contents of the pack and other information
What Pemetrexed contains
- The active substance is pemetrexed. Each vial contains 100, 500 or 1000 milligrams of
pemetrexed (as pemetrexed disodium heptahydrate). 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 and/or sodium hydroxide (for pH
adjustment) (see section 2 for further information).
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 lyophilized powder.
Pemetrexed is supplied in packs containing one vial.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member states of the EEA under the
following names
Austria:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg Pulver für ein
Konzentrat zur Herstellung einer Infusionslösung
Belgium:
Pemetrexed SUN 100 mg / 500 mg/ 100 mg/ Pulver für ein
Konzentrat zur Herstellung einer Infusionslösung/ poudre pour
solution à diluer pour perfusion/ poeder voor concentraat voor
oplossing voor intraveneuze infusie
Denmark:
Pemetrexed SUN 100 mg / 500 mg / 1000 mg pulver til
koncentrat til infusionsvæske, opløsning
Finland:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg kuiva-aine
välikonsentraatiksi infuusionestettä varten, liuos
France:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg poudre pour
solution à diluer pour perfusion
Germany:
Pemetrexed SUN 100 mg / 500 mg / 1000 mg Pulver für ein
Konzentrat zur Herstellung einer Infusionslösung
Hungary:
Pemetrexed SUN 100 mg /500 mg/ 1000 mg por oldatos
infúzióhoz való koncentrátumhoz
Italy:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg polvere per
concentrato per soluzione per infusione
Netherlands:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg poeder voor
concentraat voor oplossing voor intraveneuze infusie
Norway:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg pulver til konsentrat
til infusjonsvæske, oppløsning
Poland:
Pemetreksed SUN 100 mg / 500 mg/ 1000 mg proszek do
sporządzania koncentratu roztworu do infuzji
Romania:
Pemetrexed SUN 100 mg /500 mg/ 1000 mg pulbere pentru
concentrat pentru soluţie perfuzabilă
Spain:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg polvo para
concentrado para solución para perfusion EFG
Sweden:
Pemetrexed SUN 100 mg / 500 mg/ 1000 mg pulver till koncentrat
till infusionsvätska, lösning
United Kingdom:
Pemetrexed SUN 100 mg /500 mg/ 1000 mg powder for
concentrate for solution for infusion

044BP2164A

This leaflet was last revised in 12/2015

Pemetrexed 350x430mm-EUUK-15-01-16
15 January 2016 10:12:11

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.

044BP2164A

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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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