100 mg and 500 mg powder for concentrate for solution for infusion
pemetrexed
What Pemetrexed Reig Jofre is and what it is used for
Pemetrexed Reig Jofre is a medicine used to treat cancer.
Pemetrexed Reig Jofre is co-administered with cisplatin, another anti-cancer drug, for the treatment of malignant pleural mesothelioma, a form of lung sac cancer, in patients who have not previously received anti-cancer drug therapy.
Pemetrexed Reig Jofre is also used with cisplatin in the initial treatment of advanced lung cancer.
Pemetrexed Reig Jofre can be prescribed to you if you have advanced lung cancer and your disease has responded to treatment or if it is largely unchanged after initial drug treatment.
In addition, Pemetrexed Reig Jofre is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.
Pemetrexed contained in Pemetrexed Reig Jofre may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pemetrexed Reig Jofre
Do not use Pemetrexed Reig Jofre
- if you are allergic (hypersensitive) to pemetrexed or any of the other ingredients of Pemetrexed Reig Jofre (listed in section 6).
- if you are breastfeeding. You should stop breastfeeding during treatment with Pemetrexed Reig Jofre.
- if you have recently been vaccinated or are just about to be vaccinated against yellow fever.
Warnings and cautions
Talk to your doctor or pharmacist before receiving Pemetrexed Reig Jofre.
Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get Pemetrexed Reig Jofre.
Before each infusion, blood samples will be taken to determine if the function of the kidneys and liver is sufficient and to check that the amount of blood cells is sufficient to obtain Pemetrexed Reig Jofre. Your doctor may choose to change the dose or postpone your treatment depending on your general condition and if your blood levels are too low. If you are also taking cisplatin, your doctor will make sure that you have been given enough fluids and that you will receive appropriate treatment before and after the cisplatin treatment to prevent vomiting.
If you have received radiation therapy or if such treatment is planned, tell your doctor, like radiation therapy and Pemetrexed Reig Jofre may cause immediate or late side effects.
If you have recently been vaccinated, you should tell your doctor, as Pemetrexed Reig Jofre in connection with vaccination may cause unwanted reactions.
Tell your doctor if you have, or have previously had, heart disease.
If you have fluid accumulation around your lungs, your doctor may decide to remove the fluid before treatment with Pemetrexed Reig Jofre.
Children and young people
There is no relevant use of Pemetrexed Reig Jofre in children and adolescents.
Other medicines and Pemtrexed Reig Jofre
Tell your doctor if you are taking any medicine for pain or inflammation (swelling), such as so-called non-steroidal anti-inflammatory drugs ( NSAIDs ), including over-the-counter medicines (such as ibuprofen ). There are many different types of these drugs with varying duration of action. Knowing the date of the planned infusion of Pemetrexed Reig Jofre and/or your renal function status, your doctor must advise you on which medicines you can take and when you can take them. If you are not sure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant or planning to become pregnant or think you may be pregnant, tell your doctor. Treatment with Pemetrexed Reig Jofre should be avoided during pregnancy. Your doctor will discuss any possible risks of Pemetrexed Reig Jofre during pregnancy. Women should use effective contraception during treatment with Pemetrexed Reig Jofre.
Breast-feeding
Tell your doctor if you are breastfeeding. Breast-feeding should be discontinued during treatment with Pemetrexed Reig Jofre.
Fertility
Men are advised not to have children during and up to 6 months after Pemetrexed Reig Jofre treatment and should therefore use an effective method of contraception during Pemetrexed Reig Jofre treatment and up to 6 months after stopping treatment. If you plan to have children during treatment or the following 6 months after treatment, consult your doctor or pharmacist. You may want to seek advice on sperm preservation before starting treatment.
Driving and using machines
Treatment with Pemetrexed Reig Jofre may make you feel tired. Be careful when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Pemetrexed Reig Jofre
Pemetrexed Reig Jofre is given in a dose of 500 mg per square meter of body surface area. Your height and weight are used to calculate the body surface area. Your doctor will use the measurement of your body surface area to calculate the correct dose for you. This dose can be adjusted or the treatment can be postponed depending on blood levels and your general condition. A hospital pharmacist, nurse, or doctor will have mixed the Pemetrexed Reig Jofre powder in a sterile 9 mg/ml (0.9%) sodium chloride solution before giving it to you.
Pemetrexed Reig Jofre is always given as an infusion in a friend. Infusion one lasts for about 10 minutes.
Then Pemetrexed Reig Jofre is given in combination with cisplatin: Your doctor or hospital pharmacist will have calculated the required dose using your height and weight. Cisplatin is also given as an infusion into a vein and is given approximately 30 minutes after the end of the Pemetrexed Reig Jofre infusion. Infusion one of cisplatin lasts for about 2 hours.
You usually receive an infusion once every three weeks.
Other medicines:
Corticosteroids: Your doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone twice daily). You should take these tablets the day before, on the day of treatment, and the day after treatment with Pemetrexed Reig Jofre. The tablets are given to reduce the frequency and severity of the skin reactions that may occur during cancer treatment.
Vitamin supplement: Your doctor will prescribe a preparation of folic acid ( vitamin ) to be taken by mouth or a multivitamin preparation containing folic acid (350 to 1000 micrograms) that you should take once a day during treatment with Pemetrexed Reig Jofre. You should take at least 5 doses during the seven days before the first dose of one of Pemetrexed Reig Jofre. You should continue to take folic acid for 21 days after the last Pemetrexed Reig Jofredos. You will also receive a vitamin B12 injection (1000 micrograms) the week before the Pemetrexed Reig Jofre infusion .one and then approximately every 9 weeks (equivalent to 3 courses of treatment with Pemetrexed Reig Jofre). Vitamin B12 and folic acid are given to reduce the potentially harmful effects of cancer treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Pemetrexed Reig Jofre than you should
You will be given this medicine in a hospital and it is unlikely that you will get too much. If you are worried that you have been given too high a dose or if you have any questions about the dose you have been given, talk to your doctor or nurse who will give you the medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you notice any of the following side effects:
- Fever or infection (common): if you have a temperature of38 ° C or more, sweating, or other signs of an infection (as you may have a lower than normal white blood cell count, which is very common). Infection one (blood poisoning) can be serious and lead to death.
- If you start to feel chest pain (common) or have a fast heart rate (less common).
- If you feel pain, redness, swelling, or soreness in your mouth (very common).
- Allergic reaction: if you get a rash (very common) / burning or stinging sensation (common) or fever (common). Skin reactions can be serious and lead to death (rare). Contact your doctor if you get a lot of rash, itching, or blisters ( Stevens-Johnson syndrome or toxic epidermal necrolysis ).
- If you get tired, feel weak, get short of breath easily, or if you look pale (because you may have less hemoglobin than normal, which is very common).
- If there is bleeding from the gums, nose, or mouth or you get any bleeding that does not want to stop, reddish or pinkish urine, unexpected bruising (because you may have fewer platelets than normal, which is very common).
- If you experience sudden shortness of breath, intense chest pain, or cough with bloody cough (less common) (may indicate a blockage in the blood vessels of the lungs)
The frequency of possible side effects is defined below as follows:
Very common (may affect more than 1 patient in 10)
Common (may affect 1 to 10 patients in 100)
Uncommon (may affect 1 to 10 patients in 1,000)
Rare (may affect 1 to 10 patients in 10,000)
Very rare (may affect less than 1 patient in 10,000).
Other side effects of Pemetrexed Reig Jofre that may occur:
Very common
Decreased white blood cell count
Low hemoglobin ( anemia )
Reduced platelet count
Diarrhea
Vomiting
Pain, redness swelling, or soreness in the mouth
Nausea
Decreased appetite
Fatigue (fatigue)
Rash
Hair loss
Constipation
Loss of feeling
Kidneys: abnormal blood counts
Usual
Allergic reaction: skin rash/burning or stinging sensation
Infection (including sepsis)
Fever
Dehydration
Kidney failure
Skin irritation and itching
Chest pain
Muscle weakness
Conjunctivitis (inflamed eye)
Troublesome stomach
Abdominal pain
Taste changes
Liver: abnormal blood counts
Tear-filled eyes
Increased skin pigmentation
Less common
Acute renal failure
Fast heart rate
Inflammation of the esophageal mucosa (esophagus) has occurred with Pemetrexed Reig Jofre and radiation therapy
Colitis ( inflammation of the wall of the colon, which may be accompanied by bleeding from the intestines)
Interstitial pneumonitis (scarring of the lungs)
Edema (accumulation of fluid in any body tissue that causes swelling).
Some patients have had a heart attack, stroke, or “mini-stroke” during treatment with Pemetrexed Reig Jofre, usually in combination with other cancer treatments.
Pancytopenia – combined low number of white blood cells, red blood cells, and platelets
Radiation pneumonitis (scarring of the air bubbles in connection with radiation therapy) can occur in patients who have also received radiation therapy either before, during, or after treatment with Pemetrexed Reig Jofre. Pain and low temperature in arms or legs with discoloration have been reported. Blood clots in the pulmonary blood vessels ( pulmonary embolism )
Rare
Skin rash, which looks like severe sun damage, can occur on skin that has previously (several days or years ago) been subjected to radiation treatment.
Bullous conditions (skin diseases with blistering) including Stevens-Johnson syndrome and toxic epidermal necrolysis
Hemolytic anemia ( anemia caused by the destruction of the red blood cells )
Hepatitis (hepatitis)
Anaphylactic shock (severe allergic reaction )
No known frequency: can not be calculated from the available data
Increased urine output
Thirst and increased water intake
Hypernatremia – increased sodium content in the blood
Inflammation of the skin, primarily the lower extremity with swelling, pain, and redness
You may get any of these symptoms and/or ailments. If you start to experience any of these side effects, talk to your doctor as soon as possible.
If you have any side effects, talk to your doctor.
How to store Pemetrexed Reig Jofre
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
This medicine has no special storage instructions.
Dissolved drug and infusion solution: The drug should be used immediately. Chemical and physical shelf life for 24 hours in a refrigerator or 25 ° C has been demonstrated for the reconstituted stock solution and the infusion solution of pemetrexed if reconstituted according to the instructions.
This medicine is for single use only. Any unused solution should be disposed of to local requirements.
Contents of the pack and other information
Content declaration
The active substance is pemetrexed.
Pemetrexed Reig Jofre 100 mg: One vial contains 100 mg of pemetrexed (as disodium pemetrexed 2.5 H 2 O).
Pemetrexed Reig Jofre 500 mg: One vial contains 500 mg pemetrexed (as disodium pemetrexed 2.5 H 2 O).
After reconstitution, the solution contains 25 mg / ml pemetrexed. Further dilution of healthcare professionals is required before injection.
The other ingredients are mannitol, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).
What the medicine looks like and the contents of the pack
Pemetrexed Reig Jofre is a powder for concentrate for solution for infusion in a vial. It is a white to light yellow or greenish-yellow, freeze-dried powder.
The package contains a vial.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Laboratory Reig Jofre SA
Grand Captain, 10
08970 Sant Joan Despí (Barcelona)
Spain
Local representative:
Bioglan AB
Box 50310
202 13 Malmö
Manufacturer:
Laboratory Reig Jofre SA
Jarama 111, Poligono Industrial
45007 Toledo
Spain
This medicinal product is authorized under the European Economic Area under the names:
Denmark: Pemetrexed Reig Jofre
Iceland: Pemetrexed Reig Jofre 100 mg powder for concentrate for solution for infusion
Pemetrexed Reig Jofre 500 mg concentrate for solution for infusion
Norway: Pemetrexed Reig Jofre
Spanien: Pemetrexed Sala 100 mg powder for concentrate for EFG perfusion solution
Pemetrexed Sala 500 mg powder for concentration for EFG perfusion solution
United Kingdom: Pemetrexed 100 mg powder for concentrate for solution for infusion
Pemetrexed 500 mg powder for concentrate for solution for infusion