25 mg / ml concentrate for solution for infusion
pemetrexed
What Pemetrexed Mylan is and what it is used for
Pemetrexed Mylan is a medicine used to treat cancer.
Pemetrexed Mylan is co-administered with cisplatin, another anti-cancer medicine, for the treatment of malignant pleural mesothelioma, a form of lung sac cancer, in patients who have not previously received anticancer medicine.
Pemetrexed Mylan is also used with cisplatin in the initial treatment of advanced lung cancer.
Pemetrexed Mylan 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 Mylan is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.
Pemetrexed contained in Pemetrexed Mylan 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 Mylan
Do not use Pemetrexed Mylan
- 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 Mylan.
- 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 taking Pemetrexed Mylan:
Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get Pemetrexed Mylan. 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 Mylan. 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 Mylan may cause immediate or late side effects.
If you have recently been vaccinated, you should tell your doctor, as Pemetrexed Mylan in connection with vaccination may cause unwanted reactions.
If you have or have had, heart disease, tell your doctor.
If you have accumulated fluid around your lungs, your doctor may decide to remove the fluid before treatment with Pemetrexed Mylan.
Children and young people
This medicine should not be used by children or adolescents as there is no experience with the medicine in children and adolescents under 18 years of age.
Other medicines and Pemetrexed Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
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 Mylan and/or your renal function status, your doctor will need to advise you on which medicines to take and when to take them. If you are not sure, ask your doctor or pharmacist if any of your medicines are NSAIDs.
Pregnancy, breastfeeding, and fertility
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, tell your doctor. Treatment with Pemetrexed Mylan should be avoided during pregnancy. Your doctor will discuss any possible risks when Pemetrexed Mylan is given during pregnancy. Women should use effective contraception during treatment with Pemetrexed Mylan.
Breast-feeding
Tell your doctor if you are breastfeeding.
Breast-feeding should be discontinued during treatment with Pemetrexed Mylan.
Fertility
Men are advised not to have children during and up to 6 months after Pemetrexed Mylan treatment and should therefore use an effective method of contraception during Pemetrexed Mylan 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 Mylan 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 Mylan contains propylene glycol
This medicine contains 140 mg of propylene glycol per 4 ml vial corresponding to 35 mg/ml.
This medicine contains 700 mg of propylene glycol per 20 ml vial corresponding to 35 mg/ml.
This medicine contains 1400 mg of propylene glycol per 40 ml vial corresponding to 35 mg/ml.
How to use Pemetrexed Mylan
Pemetrexed Mylan 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 Mylan solution with 5% dextrose or 0.9% sodium chloride solution before giving it to you.
Pemetrexed Mylan is always given as an infusion into a vein. Infusion one lasts for about 10 minutes.
Then Pemetrexed Mylan 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 Mylan infusion. Infusion one of cisplatin lasts for about 2 hours. You usually receive an infusion once every three weeks.
Other drugs
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 Mylan. 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 Mylan. You should take at least 5 doses during the seven days preceding the first dose of one of Pemetrexed Mylan. You should continue to take folic acid for 21 days after the last Pemetrexed Mylandos one. You will also receive a vitamin B12 injection (1000 micrograms) the week before Pemetrexed Mylan infusion one and then approximately every 9 weeks (equivalent to 3 courses of treatment with Pemetrexed Mylan). 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.
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 or very common): if you have a temperature of 38 ° C or more, sweating, or other signs of an infection (because you may have lower white blood cell counts than normal, 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 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 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 Mylan may occur:
Very common (may affect more than 1 user in 10)
Infection
Sore throat
Low neutrophil count ( white blood cell type )
Low white blood cell count
Low hemoglobin ( anemia )
Pain, redness, swelling, or soreness in the mouth
Decreased appetite
Vomiting
Diarrhea
Nausea
Rash
Flaking skin
Abnormal blood counts showing reduced kidney function
Fatigue (fatigue)
Common (may affect up to 1 in 10 people)
Blood infection
Fever with low neutrophil count ( white blood cell type )
Reduced platelet count
Allergic reaction
Dehydration
Taste changes
Muscle weakness due to damage to motor nerves, especially in the arms and legs
Loss of sensation, burning pain, and unsteady gait due to damage to sensory nerves
Dizziness
Inflammation or swelling of the conjunctiva ( membrane at the end of the eyelids and covering the whites of the eyes
Dry eyes
Tear-filled eyes
Dried conjunctiva ( membrane on the outer part of the eyelids and covering the whites of the eyes and cornea (the clear layer that protects the iris and pupil )
Swollen eyelids
Eye problems, such as dryness, tearing, irritation, and/or pain.
Heart failure (a condition that affects the pumping power of your heart muscle)
Irregular heartbeat
Indigestion
Constipation
Abdominal pain
Liver: increase in the substances in the blood produced by the liver
Increased skin pigmentation
Itching
Rash on the body therewith red marks
Hair loss
Hives
Kidney failure
Decreased renal function
Fever
Pain
Excess fluid in body tissue, which causes swelling
Chest pain
Inflammation and ulceration of the mucous membranes that line the digestive tract
Uncommon (may affect up to 1 in 100 people)
Reduction in the number of red and white blood cells and platelets
Stroke
Type of stroke when an artery to the brain is blocked
Bleeding inside the skull
Angina (Chest pain caused by decreased blood flow to the heart)
Myocardial infarction
Narrowing or blockage of the coronary arteries
Elevated heart rate
Reduced blood distribution to arms and legs
Blood clots in the pulmonary blood vessels ( pulmonary embolism )
Inflammation and scarring of the lungs with respiratory problems
Passage of bright red blood from the anus
Bleeding in the gastrointestinal tract
Broken intestine
Inflammation of the esophageal mucosa (esophagus)
Inflammation of the wall of the colon, which may be accompanied by bleeding from the intestines or rectum (seen only in combination with cisplatin)
Inflammation, edema , erythema, and erosion of the mucosal surface of the esophagus caused by radiation therapy
Inflammation of the lung caused by radiation therapy
Rare (may affect up to 1 in 1,000 people)
Destruction of red blood cells
Anaphylactic shock (severe allergic reaction )
Inflammatory conditions of the liver
Redness of the skin
Skin rash that may occur on skin that has previously been exposed to radiation therapy
Very rare (may affect up to 1 in 10,000 people)
Infection of skin and soft tissue
Stevens-Johnson syndrome (a type of severe reaction to skin and mucous membranes that can be life-threatening)
Toxic epidermal necrolysis (a type of severe skin reaction that can be life-threatening)
An autoimmune condition that results in skin rashes and blisters on legs, arms, and abdomen
Inflammation of the skin is characterized by the presence of bullous conditions with fluid-filled blistering
Fragile skin, blisters, and erosion as well as scarring of the skin
Redness, pain, and swelling mainly in the lower legs
Inflammation of the skin and fat under the skin (pseudo cellulite)
Inflammation of the skin ( dermatitis )
Skin that becomes inflamed, itchy, red, cracked, and rough
Intense itchy spots
Has been reported (occurs in an unknown number of users)
A form of diabetes that is primarily based on kidney pathology
Kidney disorder involving tubular epithelial cells (which form renal tubules) death.
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 Mylan
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 after EXP. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Do not freeze.
Diluted solution: The drug should be used immediately. Chemical and physical shelf life for 24 hours in a refrigerator has been demonstrated for the diluted solution of pemetrexed if reconstituted as directed. Protected from light.
This medicine is for single use only. Any unused solution should be disposed of by local requirements.
Contents of the pack and other information
Content declaration
The active substance is pemetrexed.
One 4 ml bottle of concentrate contains 100 mg of pemetrexed (as pemetrexed arginine).
One 20 ml bottle of concentrate contains 500 mg of pemetrexed (as pemetrexed arginine).
One 40 ml bottle of concentrate contains 1000 mg of pemetrexed (as pemetrexed arginine).
The solution contains 25 mg/ml pemetrexed. Further dilution of healthcare professionals is required before injection. The other ingredients are L- arginine, L- cysteine, propylene glycol, citric acid, and water for injections.
What the medicine looks like and the contents of the pack
Pemetrexed Mylan is a clear, colorless to light yellow, brown, brownish yellow, or greenish-yellow solution. It is supplied in a glass vial.
Pack sizes
1 x 4 ml vial (100 mg / 4 ml)
1 x 20 ml vial (500 mg / 20 ml)
1 x 40 ml vial (1000 mg / 40 ml)
The vials are closed with a rubber stopper (bromobutyl) and a torn cap.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Synthon Hispania SL
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Synthon sro
Brnĕnská 32 / čp. 597
678 01 Blansko
Czech Republic