25 mg / ml concentrate for solution for infusion
pemetrexed
What Pemetrexed STADA is and what it is used
Pemetrexed Stada is a medicine used to treat cancer.
Pemetrexed Stada is given together with cisplatin, another anti-cancer medicine, for the treatment of malignant pleural mesothelioma, a form of lung cancer, to patients who have not previously received anticancer medicine.
Pemetrexed Stada is also used with cisplatin in the initial treatment of advanced lung cancer.
Pemetrexed Stada 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 Stada is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.
Pemetrexed contained in Pemetrexed Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pemetrexed STADA
Do not use Pemetrexed STADA
- if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6)
- if you are breastfeeding. You should stop breastfeeding during treatment with Pemetrexed Stada
- if you have recently been vaccinated or are just about to be vaccinated against yellow fever.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Pemetrexed Stada.
Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get Pemetrexed Stada.
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 Stada. 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 Stada may cause immediate or late side effects.
If you have recently been vaccinated, you should tell your doctor, as Pemetrexed Stada 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 lung, your doctor may decide to remove the fluid before treatment with Pemetrexed Stada.
Children and young people
There is no relevant use of Pemetrexed Stada for children and adolescents.
Other medicines and Pemetrexed STADA
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 ones (such as ibuprofen ). There are many different types of these drugs with varying duration of action. Knowing the date of the planned infusion of one of Pemetrexed Stada and/or 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, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, 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 taking this medicine. Treatment with Pemetrexed Stada should be avoided during pregnancy. Your doctor will discuss any possible risks when Pemetrexed Stada is given during pregnancy. Women should use effective contraception during treatment with Pemetrexed Stada.
Breast-feeding
Tell your doctor if you are breastfeeding. Breast-feeding should be stopped during treatment with Pemetrexed Stada.
Fertility
Men are advised not to have children during and up to 6 months after Pemetrexed Stada treatment and should therefore use an effective method of contraception during Pemetrexed Stada 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 Stada 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.
Pemetrexed STADA contains sodium
This medicine contains 110.03 mg sodium (the main ingredient in table salt/table salt) per dose (500 mg pemetrexed per square meter of body surface area). This corresponds to 5.51% of the highest recommended daily intake of sodium for adults.
How to use Pemetrexed STADA
Dosage
Pemetrexed Stada 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 Pemetrexed Stada with sterile sodium chloride 9 mg/ml (0.9%) solution before giving it to you.
Method of administration
Pemetrexed Stada is always given as an infusion to a friend. Infusion one lasts for about 10 minutes.
Treatment time
You usually receive an infusion once every three weeks.
When Pemetrexed Stada 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 Stada infusion. Infusion one of cisplatin lasts for about 2 hours.
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 Stada. The tablets are given to reduce the frequency and severity of the skin reactions that may occur during cancer treatment.
Vitamin supplement:
- Folic acid: 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 Stada. You must take at least 5 doses during the seven days preceding the first dose of one of Pemetrexed Stada. You should continue to take folic acid for 21 days after the last Pemetrexed Stada- dos.
- Vitamin B 12: You will also receive a Vitamin B 12 injection ( 1000 micrograms) the week before Pemetrexed Stada infusion one and then approximately every 9 weeks (equivalent to 3 courses of Pemetrexed Stada).
Vitamin B 12 and folic acid are given to reduce the possible harmful effects of cancer treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 of 38 ° C or more, sweating, or other signs of an infection (because you may have 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 (uncommon)
- 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 it bleeds 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).
Other side effects of Pemetrexed Stada that may occur:
Very common (may affect more than 1 user in 10):
- decreased white blood cell count
- low hemoglobin ( anemia )
- decreased platelet count
- diarrhea
- vomiting
- pain, redness, swelling, or soreness in the mouth
- nausea
- loss of appetite
- fatigue (fatigue)
- rash
- hair loss
- constipation
- loss of sensation
- kidneys: abnormal blood counts.
Common (may affect up to 1 in 10 people):
- 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)
- upset stomach
- abdominal pain
- taste changes
- liver: abnormal blood counts
- tear-filled eyes
- increased skin pigmentation.
Uncommon (may affect up to 1 in 100 people):
- acute renal failure
- fast heart rate
- inflammation of the esophageal mucosa (esophagus) has occurred with pemetrexed 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 (fluid accumulation in any body tissue that causes swelling).
- some patients have had a heart attack, stroke, or ‘mini-stroke’ during treatment with pemetrexed, 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 lungs in connection with radiation therapy) may occur in patients who have also received radiation therapy either before, during, or after treatment with pemetrexed.
- pain and low temperature in arms or legs with discoloration have been reported.
- blood clots in the blood vessels of the lungs ( pulmonary embolism ).
Rare (may affect up to 1 in 1,000 people):
- skin rash (which looks like severe sun damage) can occur on skin that has previously (several days or years back) been subjected to radiation treatment.
- bullous conditions (skin diseases with blistering) including Stevens-Johnson syndrome and toxic epidermal necrolysis
- immune-mediated hemolytic anemia (destruction of red blood cells caused by antibodies )
- hepatitis (inflammation of the liver)
- anaphylactic shock (severe allergic reaction ).
Has been reported (occurs in an unknown number of users):
- swelling of the legs with pain and redness
- dermatitis, primarily the lower extremity with swelling, pain, and redness
- increased urine output
- thirst and increased water intake
- hypernatremia – increased sodium content in the blood.
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 STADA
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 carton and bottle after EXP. The expiration date is the last day of the specified month.
Store the unopened vial in a refrigerator (2 ° C to 8 ° C).
Do not freeze.
Used immediately after the first opening.
Diluted solution: The drug should be used immediately. If the preparation instructions have been followed, chemical and physical durability have been demonstrated for pemetrexed infusion solutions for 72 hours in a refrigerator (2 ° C to 8 ° C).
The solution is clear and can vary in color from colorless to yellow or green-yellow without affecting product quality.
Do not use it if there are visible particles.
This medicine is for
single use only. Any unused solution should be disposed of per local requirements.
Contents of the pack and other information
Content declaration
The active substance is pemetrexed.
Each ml of concentrate contains 25 mg of pemetrexed (as 30.21 mg of pemetrexed disodium hemipentahydrate)
One 4 ml vial contains 100 mg pemetrexed (as 120.83 mg pemetrexed disodium hemipentahydrate).
One 20 ml vial contains 500 mg of pemetrexed (as 604.13 mg of pemetrexed disodium hemipentahydrate).
One 40 ml vial contains 1000 mg of pemetrexed (as 1208.26 mg of pemetrexed disodium hemipentahydrate).
The other ingredients are mannitol, acetylcysteine, sodium hydroxide (for pH adjustment ), hydrochloric acid (for pH adjustment ), and water for injections.
Further dilution of nursing staff is required before administration .
What the medicine looks like and the contents of the pack
This medicine is a concentrated for solution for infusion.
The concentrate is a clear, colorless to light yellow or light green-yellow solution. The concentrate is filled in clear type I glass vials with fluorine-coated chlorobutyl / butyl rubber stopper type I and aluminum snap-off caps.
[Each vial is packaged in a transparent PC container with a resealable safety-sealed PP flip-off lid.]
Each vial contains 25 mg / ml pemetrexed.
Each pack contains a 1 x 4 ml vial
Each pack contains a 1 x 20 ml vial
Each pack contains a 1 x 40 ml vial.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
STADApharm GmbH
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark