25 mg / ml concentrate for solution for infusion
pemetrexed
What Pemetrexed Accord is and what it is used for
Pemetrexed Accord is a medicine used to treat cancer.
Pemetrexed Accord is co-administered with cisplatin, another anti-cancer drug, for the treatment of malignant pleural mesothelioma, a form of lung cancer, in patients who have not previously received anti-cancer drug therapy.
Pemetrexed Accord is also used with cisplatin in the initial treatment of advanced lung cancer.
Pemetrexed Accord 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 Accord is used to treat advanced lung cancer whose disease has progressed, after other previous drug treatments have been used.
What you need to know before using Pemetrexed Accord
Do not use Pemetrexed Accord
- 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 Accord.
- 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 using Pemetrexed Accord.
Talk to your doctor or pharmacist if you have or have had kidney problems, as you may not be able to get Pemetrexed Accord.
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 Accord. 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 Accord may cause immediate or late side effects.
If you have recently been vaccinated, you should tell your doctor, as Pemetrexed Accord 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 Accord.
Children and young people
This medicine should not be given to children and adolescents as there is no experience with the medicine in children and adolescents under 18 years of age.
Other medicines and Pemetrexed Accord
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 drugs (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 Accord 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 or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pemetrexed Accord treatment should be avoided during pregnancy. Your doctor will discuss any possible risks of Pemetrexed Accord during pregnancy. Women should use effective contraception during treatment with Pemetrexed Accord.
Breast-feeding
Tell your doctor if you are breastfeeding.
Breast-feeding should be discontinued during treatment with Pemetrexed Accord.
Fertility
Men are advised not to have children during and up to 6 months after Pemetrexed Accord treatment and should therefore use an effective method of contraception during Pemetrexed Accord 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 Accord may make you feel tired. Be careful when driving or using machines.
Pemetrexed Accord contains sodium
The maximum recommended daily dose of one of these medicines contains 304 mg of sodium (the main ingredient in table salt/table salt) per dose. This corresponds to 15.2% of the highest recommended daily intake of sodium for adults.
Talk to your pharmacist or doctor about your need for Pemetrexed Accord daily for a long period, especially if you have been prescribed a low-salt diet.
How to use Pemetrexed Accord
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Pemetrexed Accord is 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.
Pemetrexed Accord is always given as an infusion into a friend. Infusion one lasts for about 10 minutes.
When Pemetrexed Accord 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 Accord 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 Accord. 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 1,000 micrograms) that you should take once a day during treatment with Pemetrexed Accord. You must take at least 5 doses during the seven days preceding the first dose of one of the Pemetrexed Accord. You should continue to take folic acid for 21 days after the last Pemetrexed Accord dose. You will also receive a vitamin B 12 injection ( 1,000 micrograms) the week before the Pemetrexed Accord infusion .one and then approximately every 9 weeks (equivalent to 3 treatment regimens with Pemetrexed Accord). 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 a lower white blood cell count 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 Accord that 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 eyes white 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 the limbs
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 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 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 some 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 Accord
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 label and carton after EXP.
Do not store above 25 ° C.
Infusion solutions: The medicine should be used immediately. Chemical and physical shelf life for 72 hours at room temperature has been demonstrated for the infusion solution of pemetrexed if reconstituted as directed.
Do not use this medicine for visible signs of deterioration.
This medicine is for single use only. 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. One ml of concentrate contains pemetrexed disodium hemipentahydrate equivalent to 25 mg pemetrexed.
One vial of 4 ml concentrate contains pemetrexed disodium hemipentahydrate equivalent to 100 mg pemetrexed.
One vial of 20 ml concentrate contains pemetrexed disodium hemipentahydrate equivalent to 500 mg pemetrexed.
One vial of 34 ml concentrate contains pemetrexed disodium hemipentahydrate equivalent to 850 mg.
One vial of 40 ml concentrate contains pemetrexed disodium hemipentahydrate equivalent to 1,000 mg.
The other ingredients are citric acid, L ‑ methionine, monothiolglycerol, sodium hydroxide, concentrated hydrochloric acid, and water for injections (see section 2 “Pemetrexed Accord contains sodium”).
What the medicine looks like and the contents of the pack
Pemetrexed Accord is a concentrate solution for infusion packaged in a glass vial. It is a clear, colorless to light yellow solution.
The pack contains a vial containing either 4 ml, 20 ml, 34 ml, or 40 ml of concentrate.
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n
Edifici Est 6ª planta
08039 Barcelona
Spain
Manufacturer
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
LABORATORI FUNDACIÓ DAU
C / C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain