25 mg / ml concentrate for solution for infusion
pemetrexed
What Pemetrexed Hexal is and what it is used for
Pemetrexed Hexal is a medicine used to treat cancer.
Pemetrexed Hexal 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 ( chemotherapy ).
Pemetrexed Hexal is also used with cisplatin in the initial treatment of advanced lung cancer.
Pemetrexed Hexal 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 chemotherapy.
In addition, Pemetrexed Hexal is used to treat advanced lung cancer in patients whose disease has progressed after the use of other initial chemotherapy drugs.
This medicine is only for the treatment of adults.
Pemetrexed contained in Pemetrexed Hexal 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 Hexal
Do not use Pemetrexed Hexal
- 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 Hexal.
- if you have recently been vaccinated or are just about to be vaccinated against yellow fever.
Warnings and cautions
Talk to your doctor or other healthcare professional before receiving Pemetrexed Hexal.
Talk to your doctor or other healthcare professionals if you have or have had kidney problems, as you may not be able to get Pemetrexed Hexal.
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 Hexal. 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 Hexal may cause immediate or late side effects.
If you have recently been vaccinated, you should tell your doctor, as Pemetrexed Hexal in connection with vaccination may cause unwanted reactions.
Tell your doctor if you have or have had heart disease in the past.
If you have fluid accumulation around your lungs, your doctor may decide to remove the fluid before treatment with Pemetrexed Hexal.
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 Hexal
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. If you are aware of the date of the planned infusion of Pemetrexed Hexal and/or your renal function status, your doctor should 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 other healthcare professionals if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
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 Hexal should be avoided during pregnancy. Your doctor will discuss any possible risks of Pemetrexed Hexal during pregnancy.
Women should use effective contraception during treatment with Pemetrexed Hexal.
Breast-feeding
Tell your doctor if you are breastfeeding.
Breast-feeding should be discontinued during treatment with Pemetrexed Hexal.
Fertility
Men are advised not to have children during and up to 6 months after Pemetrexed Hexal treatment and should therefore use an effective method of contraception during Pemetrexed Hexal 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 Hexal 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 Hexal contains sodium and propylene glycol
Pemetrexed Hexal 100 mg (4 ml vial )
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
This medicine contains 200 mg of propylene glycol per vial.
Pemetrexed Hexal 500 mg (20 ml vial )
This medicine contains 55.6 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 3% of the maximum recommended daily sodium intake for adults.
This medicine contains 1000 mg of propylene glycol per vial.
Pemetrexed Hexal 1000 mg (40 ml vial )
This medicine contains 111.2 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 6% of the maximum recommended daily intake of sodium for adults.
This medicine contains 2000 mg of propylene glycol per vial.
How to use Pemetrexed Hexal
How to use Pemetrexed Hexal
Pemetrexed Hexal should only be given under the supervision of a doctor who has experience in the treatment of anti-cancer drugs ( cytostatics ).
Pemetrexed Hexal 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 your blood levels and your general condition. A hospital pharmacist, nurse, or doctor will have mixed the Pemetrexed Hexal ‑ concentrate in sterile 9 mg/ml (0.9%) sodium chloride solution or 50 mg/ml (5%) sterile glucose solution before giving it to you.
Pemetrexed Hexal is always given as an infusion into a friend. Infusion one lasts for about 10 minutes.
When Pemetrexed Hexal 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 Hexal 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 Hexal. 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 Hexal. You should take at least 5 doses during the seven days preceding the first dose of one of Pemetrexed Hexal. You should continue to take folic acid for 21 days after the last dose of Pemetrexed Hexal‑. You will also receive a B 12 Vitamin Injection (1000 micrograms) the week before Pemetrexed Hexal Infusionone and then approximately every 9 weeks (equivalent to 3 treatments with Pemetrexed Hexal). 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 and very 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 (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 severe skin 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 blood clot in the blood vessels of the lungs).
Other side effects of Pemetrexed Hexal 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
- Amarketingbnormal 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 and muscle wasting 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 (the membrane that lies at the far end of the eyelids and covers the whites of the eyes)
- Dry eyes
- Tear-filled eyes
- Dried conjunctiva ( the membrane that lies at the far end of the eyelids and covers the white of the eyes) and the 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 with circular 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 in which 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)
- Colitis ( 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 in the 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 blisters
- 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 (pseudocellulitis)
- 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 Hexal
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 label after EXP. The expiration date is the last day of the specified month.
Unopened vial
Do not store above 25 ° C. Store in the original package. Sensitive to light.
After the first opening
The medicine should be used immediately. Any unused product should be discarded.
After dilution
100 mg vial
The stability of the reconstituted infusion solution has been demonstrated for 3 days in a refrigerator at 2-8 ° C, protected from light.
500 mg vial and 1000 mg vial
The stability of the reconstituted infusion solution has been demonstrated for 7 days at room temperature, protected from light, and for 14 days in a refrigerator at 2–8 ° C, protected from light.
From a microbiological perspective, the drug should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user, and the reconstituted solution should not normally be stored for longer than 24 hours at 2–8 ºC, unless dilution has taken place under controlled and validated aseptic (sterile) conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is pemetrexed (as pemetrexed disodium hemipentahydrate).
Each ml of concentrate for solution for infusion contains 25 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Each 4 ml vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Each 20 ml vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Each 40 ml vial contains 1000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
The other ingredients are sodium thiosulphate pentahydrate (E539), propylene glycol (E1520), hydrochloric acid (for pH adjustment), and sodium hydroxide (E524) (for pH adjustment), water for injections.
What the medicine looks like and the contents of the pack
Pemetrexed Hexal is a concentrated for solution for infusion. It is a clear, colorless yellow or greenish-yellow solution. The solution is virtually particle-free.
Pemetrexed Hexal is packaged in a type I glass vial with a bromobutyl rubber stopper and an aluminum cap with a light blue plastic snap cap.
Each vial contains 4 ml, 20 ml or 40 ml concentrate for solution for infusion.
Each pack contains 1 vial (with or without a protective plastic cover).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Hexal A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
EBEWE Pharma Ges.mH Nfg.KG, Mondseestrasse 11, 4866 Unterach am Attersee, Austria
or
Fareva Unterach GmbH, Mondseestrasse 11, 4866 Unterach am Attersee, Austria