Alimta. 500 mg. 1 flacon
ALIMTA is administered in combination with cisplatin - another anti-cancer medicine such as for the treatment of malignant pleural mesothelioma - a form of cancer that affects the lining of the lung in patients who have not previously received chemotherapy.
Alimta. 500 mg. 1 flacon
ALIMTA WHAT IS AND WHAT IT IS USED FOR ?
ALIMTA is a medicinal product used for the treatment of cancer .
ALIMTA is administered in combination with cisplatin - another anti-cancer medicine such as for the treatment of malignant pleural mesothelioma - a form of cancer that affects the lining of the lung in patients who have not previously received chemotherapy .
ALIMTA also be administered in combination with cisplatin for the first line treatment of patients with advanced lung cancer.
ALIMTA may not be prescribed if you have lung cancer in advanced stages , and if your disease responds to treatment or if it remains largely unchanged after initial chemotherapy.
ALIMTA is also a treatment for patients with lung cancer at advanced stage , in which the disease progresses , after having been used for other initial chemotherapy .
2 . WHAT YOU SHOULD KNOW BEFORE YOU USE ALIMTA ?
Do not use ALIMTA
- If you are allergic ( hypersensitive) to pemetrexed or to any other ingredients of ALIMTA (listed in section 6).
- If you are breastfeeding , you should stop breast-feeding during treatment with ALIMTA.
- If you recently had or will soon receive a vaccine against yellow fever.
Warnings and Precautions
Talk to your doctor or hospital pharmacist before taking ALIMTA.
If you have or have had kidney problems , talk to your doctor or the hospital , as you may not be able to receive ALIMTA . Before each infusion will take blood samples to assess whether they are adequate renal and hepatic function and to check that you have enough blood cells to receive ALIMTA . The doctor can decide whether to change the dose or delay treatment , depending on your general condition and if the number of blood cells is too low. If you also receive cisplatin , your doctor will make sure that you are properly hydrated and receive appropriate treatment for the prevention of vomiting before and after receiving cisplatin .
If you have had or will have radiation therapy , please tell your doctor, as with ALIMTA may have early or late radiation reaction.
If you have recently been vaccinated , please tell your doctor, as this could have a bad influence with ALIMTA .
If you have heart disease or have a history of heart disease , please inform your doctor.
If you have an accumulation of fluid around the lungs , the doctor may decide to remove the liquid before giving you ALIMTA.
Children and adolescents
There is no relevant use of ALIMTA in pediatric populations.
ALIMTA and other medicines
Please tell your doctor if you are taking any medicine for pain and inflammation ( swelling), such as medicines called " nonsteroidal anti-inflammatory drugs " ( NSAIDs ), including medicines obtained without a prescription (such as ibuprofen) . There are many types of NSAIDs with different durations of action. Depending on the planned date of infusion of ALIMTA and / or kidney function, your doctor needs to advise you which medicines you should take and when you 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 received any other medicines , including medicines obtained without a prescription.
Pregnancy, lactation and fertility
If you are pregnant, think you become pregnant or think you may be pregnant , tell your doctor. ALIMTA should be avoided during pregnancy . Your doctor will discuss with you the possible risks of taking ALIMTA during pregnancy. Women should use effective contraception during treatment with ALIMTA.
If you are breastfeeding , tell your doctor.
Breast-feeding should be discontinued during treatment with ALIMTA.
Men are advised not to father a child during treatment and for 6 months after treatment with ALIMTA and therefore must use effective contraception during treatment with ALIMTA and up to 6 months thereafter. If you wish to become a father during treatment or within six months after receipt of treatment , seek advice from your doctor or pharmacist. You can seek counseling on sperm storage before starting treatment.
Driving and using machines
ALIMTA may make you feel tired . Be careful when driving a car or operating machinery.
ALIMTA 500 mg contains approximately 54 mg of sodium per vial. Be borne in mind in patients who are on a controlled sodium diet on sodium. ALIMTA 100 mg contains approximately 11 mg of sodium per vial.
3 . HOW TO USE ALIMTA ?
The dose of ALIMTA is 500 milligrams per square meter of body surface area. Have been measured height and weight to calculate body surface area of your body. Your doctor will use this body surface area to calculate the correct dose for you. This dose may be adjusted, or treatment may be delayed depending on the number of your blood , and your general condition . A hospital pharmacist , nurse or doctor will have mixed ALIMTA powder with sodium chloride 9 mg / ml (0,9%).
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 calculate the dose you need based on your height and weight. Cisplatin is also given by infusion into one of the veins, and is given approximately 30 minutes after completion of the infusion of ALIMTA. Infusion of cisplatin will last approximately 2 hours.
You will usually receive your infusion once every 3 weeks .
Additional medicines :
Corticosteroids : Your doctor will prescribe steroid tablets (equivalent to 4 mg dexamethasone twice daily) , and will have to take on the day before, the day of and the day after ALIMTA treatment . This medicine is given to reduce the incidence and severity of skin reactions you might have during cancer treatment .
Vitamin supplements : Your doctor will prescribe you oral folic acid (vitamin ) or a multivitamin containing folic acid ( 350 to 1000 micrograms) , you will need to take daily while receiving ALIMTA. You should take at least 5 doses during the seven days before the first dose of ALIMTA. Will have to continue to take 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 about every 9 weeks (corresponding to 3 courses of treatment with ALIMTA ) . Vitamin B12 and folic acid are given to reduce the possible toxic effects of cancer 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 should immediately contact your doctor if you notice any of the following:
? Fever or infection (common ) : if you have a temperature of 38 C or more , sweating or other signs of infection ( as you may have fewer white blood cells than normal which is very common). Infection (sepsis ) may be severe and could cause death.
? If you start feeling chest pain ( common), or have a fast heart rate ( uncommon) .
? If you have pain, redness, swelling or sores in the mouth ( very common).
? Allergic reactions: if you develop a skin rash ( very common) / burning sensation or tingling ( common), or fever (often ) . Skin reactions can rarely be severe enough to cause death . Contact your doctor if you experience skin rash or itching, or blisters ( syndrome Stevens-Johnson and toxic epidermal necrolysis) .
? If you feel tired, weak , easily breathless or if you look pale ( since you have less hemoglobin than normal, which is very common).
? If you have bleeding from the gums , nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising ( as you may have less platelets than normal which is very common).
? If you experience sudden shortness of breath , severe chest pain or cough with bloody sputum ( uncommon) ( may indicate a blood clot in the blood vessels of the lungs)
Frequency of possible side effects listed below is defined as follows:
Very common ( may affect more than 1 in 10 patients)
Common (may affect 1 to 10 users in 100)
Uncommon (may affect 1 to 10 of 1000 patients)
Rare (may affect 1 to 10 of 10,000 patients)
Very rare (may affect less than 1 in 10 000 patients)
Side effects of ALIMTA may include:
- Low white blood cell count , low hemoglobin (anemia ), low platelet count
- Pain, redness , swelling or inflammation of the mouth , nausea
- Loss of appetite, fatigue ( tiredness) , skin rash, Hair loss , constipation
- Loss of sensation
- Kidney: abnormal blood tests
- Allergic reactions: skin rash / burning and stinging
- Infection , including sepsis
- Kidney failure
- Skin irritation and itching
- Pain in the chest
- Muscle weakness
- Conjunctivitis (inflammation of the eyes)
- Stomach discomfort
- Abdominal pain
- Change of taste
- Liver: abnormal blood count , watery eyes
- Acute renal failure Accelerated heart rate
- Inflammation of the lining of the esophagus has been observed during treatment with ALIMTA / radiotherapy
- Colitis ( inflammation of the lining of the large intestine, which may be accompanied by bleeding from the intestine or rectum )
- Interstitial pneumonitis ( scarring of the air sacs of the lung) edema (excess fluid in body tissues , causing swelling )
Some patients experienced a heart attack or stroke " mini-stroke " while receiving ALIMTA, usually in combination with other anti-cancer therapy Pancytopenia - reduced number of white blood cells , red blood cells and platelets together.
- Radiation pneumonitis ( scarring of the air sacs of the lung associated with radiation therapy ) may occur in patients who are also treated with radiation therapy , before, during or after treatment with ALIMTA
Been reported pain in extremity , lower temperature and discoloration Blood clots in the blood vessels of the lungs (pulmonary embolism) .
- Rash after radiotherapy ( rash like severe sunburn ) which can occur on skin areas exposed to radiotherapy , from days to years after irradiation . Conditions with blisters (skin disease with blisters ) - including Stevens -Johnson syndrome and toxic epidermal necrolysis
- Hemolytic anemia ( anemia due to destruction of red blood cells) Hepatitis ( liver inflammation ) Anaphylactic shock (severe allergic reaction)
You can have any of these symptoms and / or conditions. You should tell your doctor as soon as you start experiencing any of these side effects.
If you are worried about any side effects , talk with your doctor.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . HOW TO STORE ALIMTA?
Keep out of reach of children.
Do not use after the expiry date which is stated on the package .
This medicine does not require any special storage conditions.
Reconstituted and diluted solutions : The product should be used immediately. When prepared as reported , was observed chemical and physical stability after reconstitution of the pemetrexed infusion for 24 hours at refrigerated temperature or 25 ° C.
This medicine is for single use only , any unused solution should be discarded according to local regulations.
6 . PACKAGE CONTENTS AND ADDITIONAL INFORMATION
Contents of ALIMTA?
The active substance is pemetrexed.
ALIMTA 100 mg: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium) .
ALIMTA 500 mg: Each vial contains 500 mg of pemetrexed ( as pemetrexed disodium) .
After reconstitution, the solution contains 25 mg / ml of pemetrexed. Before use it is necessary to make further dilution by a healthcare professional .
The other ingredients are mannitol , hydrochloric acid and sodium hydroxide.
ALIMTA looks like and contents of the pack ?
ALIMTA is a powder for concentrate for solution for infusion in a vial. It is white to light yellow or green-yellow lyophilized powder.
Each pack of ALIMTA consists of one vial of ALIMTA. Not all pack sizes may be marketed.