Active ingredient
- pemetrexed disodium
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0061.
Pemetrexed 100 mg, 500mg , 1000 mg powder for concentrate for solution for infusion
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.
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
1. What Pemetrexed is and what it is used for
Pemetrexed contains the active substance pemetrexed, which belongs to the group of medicines used in the treatment of cancer. It is used:
2. What you need to know before you are given Pemetrexed
You should NOT be given Pemetrexed
Warnings and precautions
Talk to your doctor before you are given Pemetrexed
Children and adolescents
This medicine should not be used in children or adolescents, since there is no experience with this medicine in children or adolescents under 18 years of age.
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.
Please tell your doctor if you are taking
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 treatment with Pemetrexed.
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 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.
3. How Pemetrexed is used
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.
When using Pemetrexed in combination with cisplatin
You should usually receive your infusion once every 3 weeks.
Additional medicines
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Tell your doctor straight away about any of the following serious side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Other side effects
Tell your doctor as soon as possible about any of the following side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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
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
This medicinal product is authorised in the Member states of the EEA under the following names
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
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 infusie
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 polvo para concentrado para solución para perfusión EFG
Pemetrexed SUN 500 mg polvo para concentrado para solución para perfusión EFG
Pemetrexed SUN 1000 mg polvo para concentrado para solución para perfusión
United Kingdom: Pemetrexed SUN 100 mg/ 500 mg/ 1000 mg powder for concentrate for solution for infusion
This leaflet was last revised in 09/2020
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