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PEMETREXED 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PEMETREXED DISODIUM

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Package leaflet: Information for the user
Pemetrexed 25 mg/ml 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, pharmacist or nurse.
- 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, 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 25 mg/ml concentrate for solution for infusion is and what it is used
for
2.
What you need to know before you use Pemetrexed 25 mg/ml concentrate for solution
for infusion
3.
How to use Pemetrexed 25 mg/ml concentrate for solution for infusion
4.
Possible side effects
5.
How to store Pemetrexed 25 mg/ml concentrate for solution for infusion
6.
Contents of the pack and other information
1.
What Pemetrexed 25 mg/ml concentrate for solution for infusion 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 an 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 25 mg/ml concentrate for
solution for infusion
DO NOT use Pemetrexed 25 mg/ml concentrate for solution for infusion
• if you are allergic to pemetrexed or any of the other ingredients of Pemetrexed 25 mg/ml
concentrate for solution for infusion (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
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Talk to your doctor, pharmacist or nurse before receiving Pemetrexed 25 mg/ml concentrate
for solution for infusion.
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 25 mg/ml concentrate
for solution for infusion.
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 25 mg/ml concentrate for solution for infusion. 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 25 mg/ml concentrate for solution for
infusion.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad
effects with Pemetrexed 25 mg/ml concentrate for solution for infusion.
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 25 mg/ml concentrate for solution for infusion.
Children and adolescents
There is no relevant use of Pemetrexed 25 mg/ml concentrate for solution for infusion in the
paediatric population.
Other medicines and Pemetrexed 25 mg/ml concentrate for solution for infusion
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 25 mg/ml concentrate for solution for infusion 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.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of
Pemetrexed 25 mg/ml concentrate for solution for infusion 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
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Men are advised not to father a child during and up to 6 months following treatment with
Pemetrexed 25 mg/ml concentrate for solution for infusion 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 25 mg/ml concentrate for solution for infusion may make you feel tired. Be
careful when driving a car or using machines.
Pemetrexed 25 mg/ml concentrate for solution for infusion contains sodium
Each vial of 500 mg pemetrexed contains 63 mg sodium. To be taken into consideration by
patients on a controlled sodium diet.
Each vial of 100 mg pemetrexed contains 13 mg sodium.
3.

How to use Pemetrexed 25 mg/ml concentrate for solution for infusion

Dosage
The dose of pemetrexed is 500 milligrams for every square meter 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 25 mg/ml concentrate
for solution for infusion with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is
given to you.
Method of administration
You will always receive Pemetrexed 25 mg/ml concentrate for solution for infusion by
infusion into one of your veins. The infusion will last approximately 10 minutes.
Duration of use
You should usually receive your infusion once every 3 weeks.
When using Pemetrexed 25 mg/ml concentrate for solution for infusion 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.
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 25 mg/ml concentrate for solution for infusion 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:
• Folic acid: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin
containing folic acid (350 to 1,000 micrograms) that you must take once a day while you
are taking Pemetrexed 25 mg/ml concentrate for solution for infusion. 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.
• Vitamin B12: you will also receive an injection of vitamin B12 (1,000 micrograms) in the
week before administration of Pemetrexed 25 mg/ml concentrate for solution for infusion
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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.
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)
Side effects with Pemetrexed 25 mg/ml concentrate for solution for infusion 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

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chest pain
muscle weakness
conjunctivitis (inflamed eye)
upset stomach
pain in the abdomen
change in sense of taste
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
• immune mediated haemolytic anaemia (antibody-mediated destruction of red blood cells)
• hepatitis (inflammation of the liver)
• anaphylactic shock (severe allergic reaction)
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 25 mg/ml concentrate for solution for infusion

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 carton and vial. The
expiry date refers to the last day of that month.
Store unopened vial in a refrigerator (2°C - 8°C)
Do not freeze.
After first opening, use immediately.
Diluted Solutions: The product should be used immediately. When prepared as directed,
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chemical and physical in-use stability of the infusion solutions of pemetrexed were
demonstrated for 72 hours at refrigerated temperature (2°C to 8 C).
The solution is clear and ranges in color from colorless to yellow or green - yellow without
adversely affecting product quality.
Do not use if particulate matter is present.
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 25 mg/ml concentrate for solution for infusion contains
The active substance is pemetrexed.
Each ml of the concentrate for solution for infusion contains 25 mg of pemetrexed (as 30.21
mg pemetrexed disodium hemipentahydrate).
The 4 ml vial contains either 100 mg of pemetrexed (as 120.83 mg pemetrexed disodium
hemipentahydrate).
The 20 ml vial contains either 500 mg of pemetrexed (as 604.13 mg pemetrexed disodium
hemipentahydrate).
The other ingredients are mannitol, acetylcysteine, sodium hydroxide (for pH adjustment),
hydrochloric acid (for pH adjustment)and water for injections.
Further dilution by a healthcare provider is required prior to administration.
What Pemetrexed 25 mg/ml concentrate for solution for infusion looks like and
contents of the pack
This medicine is a concentrate for solution for infusion.
The concentrate is a clear, colourless or light yellow or light green-yellow solution. It is filled
in clear glass vials sealed with fluoropolymer-coated chlorobutyl/butyl rubber stoppers Type I
and aluminium snap-off caps.
Each vial contains 25 mg/ml pemetrexed.
Each pack contains 1 x 4 ml vial.
Each pack contains 1 x 20 ml vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Genus Pharmaceuticals Limited, Linthwaite, Huddersfield,
HD7 5QH, United Kingdom
Manufacturer: STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
DE:
AT:

Pemetrexed cell pharm® 25mg/ml Konzentrat zur Herstellung einer Infusionslösung
Pemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
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BE:
CZ:
DK:
FI:
FR:
HR:
HU:
IE:
IT:
LU:
NL:
PL:
RO:
SE:
SI:
SK:

Pemetrexed EG 25 mg/ml concentraat voor oplossing voor infusie
Pemetrexed STADA 25 mg/ml koncentrát pro infuzní roztok
Pemetrexed STADA
Pemetrexed STADA
Pemetrexed EG 25 mg/ml, solution à diluer pour perfusion
Pemetreksed STADA 25 mg/ml koncentrat za otopinu za infuziju
Pemetrexed Stada 25 mg/ml koncentrátum oldatos infúzióhoz
Pemetrexed Clonmel 25 mg/ml concentrate for solution for infusion
Pemetrexed EG
Pemetrexed EG 25 mg/ml solution à diluer pour solution
Pemetrexed CF 25 mg/ml, concentraat voor oplossing voor infusie
Pemetrexed STADA
Pemetrexed STADA 25 mg/ml concentrat pentru soluţie perfuzabilă
Pemetrexed STADA
Pemetreksed STADA 25 mg/ml koncentrat za raztopino za infundiranje
Pemetrexed STADA 25 mg/ml infúzny koncentrát

This leaflet was last revised in Feburary 2016.

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 25 mg/ml concentrate for
solution for infusion vials needed. Each vial contains an excess of pemetrexed to
facilitate delivery of the label amount.

3.

The appropriate volume of 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.

4.

Pemetrexed infusion solutions prepared as directed above are compatible with
polyvinyl chloride and polyolefin lined administration sets and infusion bags.

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.

Chemical and physical in-use stability of the solution for infusion has been
demonstrated for 72 hours at 2 C to 8 C. From a microbiological point of view, the
solution for infusion 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 normally not be longer than 24 hours at 2°C to 8°C, unless dilution has
taken place in controlled and validated aseptic conditions.

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 pemetrexed solution contacts the skin, wash
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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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