What is it and how is it used?
ALIMTA is a medicine used in the treatment of cancer.
ALIMTA 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.
ALIMTA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
ALIMTA is also a treatment for patients with advanced stage of lung cancer after other chemotherapy has been used.
What do you have to consider before using it?
You should not be given ALIMTA
Take special care with ALIMTA
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 ALIMTA.
Before each infusion you will have samples of your blood taken to eva luate if you have sufficient kidney and liver function and to check that you have enough blood cells to receive ALIMTA. 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 ALIMTA.
If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with ALIMTA.
If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you ALIMTA.
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.
Taking other medicines
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 ALIMTA 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 hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy
If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of ALIMTA should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking ALIMTA during pregnancy. Women must use effective contraception during treatment with ALIMTA.
Breast-feeding
If you are breast-feeding, tell your doctor.
Breast-feeding must be discontinued during ALIMTA treatment.
Driving and using machines
ALIMTA may make you feel tired. Be careful when driving a car or using machines.
Important information about some of the ingredients of ALIMTA
ALIMTA 500 mg contains approximately 54 mg sodium per vial. To be taken into consideration by patients on a controlled sodium diet.
ALIMTA 100 mg contains approximately 11 mg sodium per vial.
How is it used?
The dose of ALIMTA 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 ALIMTA powder with 9 mg/ml (0.9 %) sodium chloride solution for injection before it is given to you.
You will always receive ALIMTA by infusion into one of your veins. The infusion will last approximately 10 minutes.
When using ALIMTA 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 ALIMTA has finished. The infusion of cisplatin will last approximately 2 hours.
You should usually receive your infusion once every 3 weeks.
Additional medicines:
Corticosteriods: 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 ALIMTA 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 ALIMTA. You must take at least 5 doses during the seven days before the first dose of ALIMTA. You must continue taking the folic acid for 21 days after the last dose of ALIMTA. You will also receive an injection of vitamin B (1000 micrograms) in the week before administration of ALIMTA and then approximately every 9 weeks (corresponding to 3 courses of ALIMTA treatment). Vitamin B and folic acid are given to you to reduce the possible toxic effects of the anticancer treatment.
If you any have any further questions on the use of this medicine, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, ALIMTA 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 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 (Stevens-Johnson 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).
The frequency of possible side effects listed below is defined as follows:
Very common (affects more than 1 patient in 10)
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1,000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from the available data)
Side effects with ALIMTA may include:
Very common
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
Allergic reaction: skin rash / burning or prickling sensation
Infection
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
Fast heart rate
Inflammation of the lining of the oesophagus (gullet) has been experienced with ALIMTA/ 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 stroke or “mini-stroke” while receiving ALIMTA usually in combination with another anticancer therapy.
Rare
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.
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.
Not known
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 ALIMTA therapy.
Extremity pain, low temperature and discolouration have been reported.
If you are concerned about any side effects, talk to your doctor.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use after the expiry date which is shown 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 25°C.
This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.
