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Pemetrexed 25mg/ml concentrate for solution for infusion
Pemetrexed 25mg/ml concentrate for solution for infusion
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
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.
Talk to your doctor or hospital pharmacist before using Pemetrexed.
This medicine should not be used in children or adolescents, since there is no experience with this medicine in children and adolescents under 18 years of age.
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines, including medicines obtained without a prescription.
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.
If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. The use of Pemetrexed 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 and for 6 months after receiving the last dose.
If you are breast-feeding, tell your doctor.
Breast-feeding must be discontinued during treatment with Pemetrexed.
Men are advised not to father a child during and up to 3 months following treatment with Pemetrexed and should therefore use effective contraception during treatment with Pemetrexed and for up to 3 months afterwards. If you would like to father a child during the treatment or in the 3 months following receipt of treatment, seek advice from your doctor or pharmacist. Pemetrexed can affect your ability to have children. Talk to your doctor to seek advice about sperm storage before starting your therapy.
Pemetrexed may make you feel tired. Be careful when driving a car or using machines.
This medicine contains 140mg propylene glycol in each 4ml vial which is equivalent to 35mg/ml.
This medicine contains 700mg propylene glycol in each 20ml vial which is equivalent to 35mg/ml.
This medicine contains 1400mg propylene glycol in each 40ml vial which is equivalent to 35mg/ml.
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 hospital pharmacist, nurse or doctor will have mixed the Pemetrexed solution with sodium chloride 9mg/ml (0.9%) solution for injection or 5% dextrose 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.
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.
You should usually receive your infusion once every 3 weeks.
Your doctor will prescribe you steroid tablets (equivalent to 4 milligrams 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.
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Not known side effects (frequency cannot be estimated from the available data)
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 this leaflet. You can also report side effects directly via: Yellow Card Scheme at 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.
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 label after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not freeze.
Diluted solutions: the product should be used immediately. When prepared as directed, chemical and physical in-use stability of the diluted solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature. Store protected from light.
This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.
The active substance is pemetrexed.
One vial of 4ml concentrate contains 100mg pemetrexed (as pemetrexed diarginine).
One vial of 20ml concentrate contains 500mg pemetrexed (as pemetrexed diarginine).
One vial of 40ml concentrate contains 1000mg pemetrexed (as pemetrexed diarginine).
The solution contains 25mg/ml of pemetrexed. Further dilution by a healthcare provider is required prior to administration.
The other ingredients are L-Arginine, L-Cysteine, propylene glycol, citric acid and water for injections.
Pemetrexed is a clear, colourless to slightly yellow to brown, brown yellow or green yellow solution. It is provided in glass vials.
Each pack contains:
1 x 4ml vial (100mg/4ml) or
1 x 20ml vial (500mg/20ml) or
1 x 40ml vial (1000mg/40ml)
The vials are closed with a rubber stopper (bromobutyl), a cap and a flip-top.
Marketing Authorisation Holder:
This leaflet was last revised in November 2022
1010524 - P4.2S