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What Ebetrex is and what it is used for
Ebetrexat is a medicinal product with the following properties:
Inhibits the growth of a certain type of cells that are replicating rapidly (antitumor product);
Reduces side effects that are a protective mechanism of the body (immunosuppressant);
Has an anti-inflammatory effect.
Ebetrexate is used in patients with:
Acute rheumatoid arthritis (RA) in adult patients;
Polyarthritis (when five or more joints are affected) of severe, acute, juvenile idiopathic arthritis (JIA) when the response to non-steroidal anti-inflammatory drugs (NSAIDs) is unsatisfactory;
Severe psoriasis (skin disease), especially plaque formation, when response to other therapies such as phototherapy, PKU therapy and retinoids is unsatisfactory, and severe psoriasis affects the joints (psoriatic arthritis) in adult patients.
2. What you need to know before using Ebetrex
Important warning about the posology of Ebetrexat:
In the treatment of rheumatoid diseases or skin diseases Ebetrex should be used only once a week.
The incorrect dosage of Ebetrexat can cause serious side effects, including death. Please read section 3 of this leaflet very carefully. Please ask your doctor or pharmacist before using Ebetrex if you have any questions.
Do not use Ebetrex if:
Are allergic (hypersensitive) to methotrexate or any of the other ingredients of this medicine listed in section 6;
Have severe kidney disease (your doctor will determine the severity of your illness);
Have a severe liver disease (your doctor will determine the severity of your illness);
You have a disease of the bleeding system;
You consume large amounts of alcohol;
You have a compromised immune system;
Have a severe or existing infection, such as tuberculosis or HIV;
Have gastrointestinal ulcers;
Are pregnant or breast-feeding (see section "Pregnancy, breast-feeding and fertility");
With simultaneous administration of live vaccines.
Warnings and precautions
Talk to your doctor before using Ebetrex if:
You are receiving insulin treatment for diabetes mellitus;
You have inactive, prolonged infections (eg tuberculosis, hepatitis B or C, herpes zoster);
You have or have had any liver or kidney disease;
You have lung problems;
Have abnormal fluid retention in the abdominal cavity or in the lung cavity and chest (ascites, pleural effusions);
You are dehydrated or suffer from conditions leading to dehydration (vomiting, diarrhea, stomatitis).
Treatment is administered once a week.
Incorrect administration of Ebetrex may result in severe, potentially fatal, side effects.
Read carefully section 3 of this leaflet.
If you have skin problems after radiotherapy (radiation-induced dermatitis) and sunburn, these problems may recur after treatment with Everrexat (recall-reaction).
Children and adolescents
The dose is determined by body weight. Use in children under the age of 3 years is not recommended because experience in this age group is insufficient.
Children who are treated with Everrexat should be under close medical supervision by a specialist in the relevant field in order to identify possible side effects as early as possible.
Elderly patients receiving Ebetrexat should be under immediate medical supervision to identify possible side effects as early as possible. The dose in elderly patients should be relatively low due to age-related reduced liver and kidney function as well as lower folate reserves.
Exposure to UV radiation during treatment with Ebetrexat may cause worsening of the skin changes caused by psoriasis.
Recommended follow-up studies and precautions:
Even when Ebetrex is given in low doses, serious side effects may occur. In order to be recognized in time, your doctor should perform check-ups and laboratory tests.
Before starting treatment:
Before starting treatment, your doctor may perform blood tests and tests to determine the function of the liver and kidneys. You may also be given an X-ray of the chest. Additional studies may be conducted during and after treatment. Do not miss your blood tests.
If the results of the tests are not satisfactory, treatment will be resumed only when the values are normalized.
Other medicines and Ebetrexat
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Remember to tell your doctor about your treatment with Ebetrex if you are prescribed another medicine during treatment.
It is extremely important to tell your doctor if you are using:
Other medicines for the treatment of rheumatoid arthritis or psoriasis such as leflunomide, sulfasalazine (also used for treatment of ulcerative colitis), aspirin, phenylbutazone or amidopyrine;
Alcohol (alcohol consumption should be avoided);
If you are vaccinated with live vaccines;
Azathioprine (used to prevent rejection of a transplanted organ);
Retinoids (used to treat psoriasis and other skin disorders);
Amiconvulsive medicinal products (protect against seizures);
Medicinal products for the treatment of cancer;
Probenecid (against gout);
Pyrimethamine (used for the prevention and treatment of malaria);
Vitamin preparations containing folic acid;
Proton pump inhibitors (used to treat severe heartburn or ulcers);
Theophylline (used to treat asthma).
Ebetrexat with food, beverages and alcohol
During treatment with Ebetrex, you should not consume any alcohol, and you should avoid excessive consumption of coffee, beverages containing caffeine and black tea. You should also be sure that you are taking enough fluids during treatment with Ebetrex, as dehydration (reduction of water in the body) may increase the toxicity of Ebetrexat.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Everrexate during pregnancy or if you are trying to become pregnant. Ebetrexate can cause fetal death, congenital disorder or abortion, and therefore it is very important that it is not prescribed to pregnant patients or patients planning to become pregnant. Therefore, in pregnant women, any possibility of pregnancy should be ruled out by taking appropriate measures, such as a pregnancy test before the start of treatment.
You should avoid becoming pregnant during treatment with Ebetrexat and at least six months after it is discontinued. Therefore, you must apply reliable contraceptive measures throughout the treatment period.
It should be borne in mind that the optimal time to conception after the end of treatment with methotrexate is not known. Ask your doctor for advice.
If you become pregnant during treatment, you should be informed of the potential risk to the fetus.
If you want to become pregnant, you should check with your doctor who can refer you to a specialist before starting the planned treatment because Ebetrex is genotoxic, which means it can cause genetic mutations.
Do not breast-feed during treatment as methotrexate passes into breast milk. If your treating physician determines that treatment with Ebetrexat is absolutely necessary during the lactation period, you should stop breast-feeding.
Fertility in men
Ebetrexate may be genotoxic. This means it can cause genetic mutations. Ebetrexate may affect the formation of sperm and ova and potentially cause newborn defects. Therefore, you should avoid becoming a father while taking Everrexat and at least 6 months after treatment is over. It should be borne in mind that the optimal time to conception after the end of treatment with methotrexate is not known. Ask your doctor for advice. Because treatment with Ebetrexat may cause infertility, male patients may be advised to consider the possibility of semen storage prior to initiation of therapy.
Driving and using machines
Adverse reactions affecting the central nervous system such as fatigue and dizziness during treatment with Ebetrexat may occur. Therefore, in some cases, the ability to drive and / or operate machinery may be impaired. If you feel tired or dizzy, you should not drive or operate machinery.
Ebetrexate contains sodium chloride and sodium hydroxide
This medicinal product contains less than 1 mmol (23 mg) of sodium per week dose, ie. Practically does not contain sodium.
3. How to use Ebetrex
Ebetrex should only be prescribed by specialists who are familiar with the different characteristics of the medicinal products and their mode of action.
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Ebetrexat is given only once a week. Together with your doctor, you will decide which day is appropriate each week for your injection.
Incorrect administration of Ebetrexat can cause serious side effects, including those with fatal outcome.
The usual dose is:
Patients with rheumatoid arthritis
The recommended starting dose of Ebetrex is 7.5 mg once a week. Ebetrexate is administered once as a subcutaneous injection
Patients with renal impairment
Patients with renal impairment may require a dose reduction.
Method of administration and duration of treatment
The duration of your treatment will be determined by your doctor. Everrexate is injected once a week! It is recommended to define the exact day of the week as "day of injection".
Ebetrexate is given under the skin, in the muscle or in the vein, in children and adolescents should not be given intravenously.
Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis vulgaris, and psoriatic arthritis with Ebetrexat requires continued treatment.
Usually, an improvement in symptoms can be expected after 4-8 weeks of treatment.
Symptoms may recur after discontinuation of Ebetrexat.
Severe forms of psoriasis vulgaris and psoriatic arthritis (psoriasis arthropathy)
Treatment response can usually be expected after 2-6 weeks.
Depending on the clinical picture and changes in laboratory parameters, therapy may resume or cease.
When initiating treatment, Ebetrex may be injected by a health care professional. However, your doctor may decide that it is better for you to learn how to inject Ebetrex under the skin yourself. You will receive the appropriate training how to do it. Under no circumstances should you try to inject yourself if you have not been trained to do it.
If you use more Ebetrex than you should
Follow the dosing recommendations of your treating physician. Do not change the dose at your own discretion.
If you suspect that you (or anyone else) used more Ebetrexat than you should, please tell your doctor immediately or contact your nearest hospital emergency department. They will decide what treatment measures are necessary depending on the severity of the intoxication.
Overdose with Ebetrexat can cause serious toxic reactions. Symptoms of overdose may include: easy bruising or bleeding, abnormal fatigue, oral aphthous, nausea, vomiting, black or bloody stools, bloody sputum or vomiting that looks like coffee beans and reduced urination. See also point 4.
Take the package leaflet with you when you visit your doctor or the hospital.
Antidote in case of overdosage is calcium folinate.
If you forget to take Everrexate
Do not take a double dose to make up for the missed single dose and continue to take the prescribed dose. Ask your doctor for advice.
If you stop using Ebetrex
Do not interrupt or discontinue Ebetrex unless you have discussed this with your doctor. If you suspect serious side effects, talk to your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Tell your doctor if you experience sudden dizziness, difficulty in breathing, edema of the eye, face or lips, rash or itching (especially all over the body) and you feel you are faint (these may be signs of an allergic reaction or anaphylactic reaction Shock).
Serious side effects
If any of the side effects listed below occur, talk to your doctor straight away:
Pulmonary complaints (symptoms may be general illness, dry, irritating cough, shortness of breath, restless breathing, chest pain, or fever);
Severe scaling or scratching of the skin (may also affect your mouth, eyes or genitals);
Abnormal bleeding (including vomiting of blood) or bruising;
Wound in the mouth;
Bloody or tar waste;
Blood in the urine or faeces;
Small red spots on the skin;
Yellowing of the skin (jaundice);
Pain or difficulty in urinating;
Swelling of the hands, ankles or legs, change in urination frequency, reduction or absence of urine (symptoms of kidney failure);
Thirst and / or frequent urination;
loss of consciousness;
Blurred or impaired vision.
The following side effects have also been reported:
Very common (may affect more than 1 user in 10):
Loss of appetite, nausea, vomiting, abdominal pain;
Inflammation and ulcers in the mouth and throat;
Increase in liver enzymes.
Common (may affect up to 1 in 10 users):
Decreased blood cell formation by decreasing the number of white and / or red blood cells and / or platelets (leucopenia, anemia, thrombocytopenia);
Tingling, tingling, prickling or burning of the skin, rash, redness of the skin, itching;
Inflammation of the lungs (pneumonitis);
Uncommon (may affect up to 1 in 100 users):
Lymphoma (which undergoes spontaneous reversal in most cases after stopping Ebetrexat);
Hives (self), sensitivity to light, darkening of the skin;
Severe toxic skin reaction including blistering and peeling of the upper skin layer (Stevens-Johnson syndrome, Leyl syndrome);
Increase in rheumatoid nodules;
Joint or muscle pain;
Osteoporosis (reduction of bone mass);
Inflammation and ulceration of the bladder (possible blood in the urine), painful urination;
Malformations of the fetus;
Vaginal inflammation and ulcers;
Burning sensation or tissue damage after injection of Ebetrexat into the muscle.
Rare (may affect up to 1 in 1,000 users):
Very large red blood cells (megaloblastic anemia);
Temporary violation of perceptions;
Weakness of the volitional movements of the whole body;
Severe eye problems;
low blood pressure;
Inflammation of the digestive tract;
Inflammation of the gums;
Acute hepatitis (inflammation of the liver);
Nail color change, nail collapse;
Acne, red or purple spots due to bleeding of blood vessels;
Bone fractures due to physical effort;
Formation of inferior semen;
Very rare (may affect up to 1 in 10,000 users):
Herpes simplex (herpes simplex);
Severe damage to the bone marrow;
Immune deficiency (hypogammaglobulinaemia);
A change in the sense of taste (metallic taste);
Inflammation of the lining of the brain causing paralysis or vomiting;
Inflammation of the envelope around the heart, fluid in the envelope around the heart;
Pneumonia, breathing problems, asthma;
Vomiting of blood;
Infection around fingernails, boils, small blood vessels in the skin;
Protein in the urine;
Death of the fetus;
Problems with the formation of ova (in women) and semen (in males);
Lack of sexual desire;
Light skin reaction if Everrexate is administered under the skin.
Not known (can not be estimated from the available data):
Infections that may in some cases be fatal;
Swollen lymph nodes;
Haematopoietic cancer, e.g. Lymphoma, leukemia (the first signs may be fever, sore throat, mouth sores, severe fatigue, nose bleeds and bruising);
Impaired function of the immune system;
Inflammation of small blood vessels caused by an allergic reaction;
Inflammation of the lining of the abdomen;
Slow wound healing.
When Ebetrexat is given intramuscularly, common local side effects (burning sensation) or damage (formation of sterile abscesses, fatty tissue disorders) may often occur in the injection area. Subcutaneous administration is well tolerated. Only slight local skin reactions have been observed, which decrease during the course of treatment.
Ebetrexate can lead to a decrease in white blood cell counts and the resistance of your body to infections can be reduced. If you have an infection with symptoms such as fever and severe worsening of your general condition or fever with symptoms of a local infection, such as a sore throat / inflammation of the pharynx / inflammation of the mouth or urinary problems, you should immediately consult your doctor. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis). It is important to tell your doctor about your medicine.
Ebetrexate can cause serious side effects (sometimes life-threatening). Therefore, your doctor will perform tests to check for blood abnormalities (eg low white blood cell counts, low platelet counts, lymphoma) and changes in the kidneys and the liver.
How to store Ebetrex
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label of the pre-filled syringe and carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Store below 25 ° C.
The product should be used immediately after opening.
Do not use Everrexate if the solution is not clear and has particles.
Disposable. Any unused quantity should be destroyed!
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Ebetrex contains
The active substance is methotrexate.
1 ml solution for injection contains 20 mg methotrexate (as 21.94 mg disodium methotrexate).
1 pre-filled syringe with 0.375 ml solution for injection contains 7.5 mg methotrexate.
1 pre-filled syringe with 0.5 ml solution for injection contains 10 mg methotrexate.
1 pre-filled syringe with 0.625 ml solution for injection contains 12.5 mg methotrexate.
1 pre-filled syringe with 0.75 ml solution for injection contains 15 mg methotrexate.
1 pre-filled syringe with 0.875 ml solution for injection contains 17.5 mg methotrexate.
1 pre-filled syringe with 1 ml solution for injection contains 20 mg methotrexate.
1 pre-filled syringe with 1,125 ml solution for injection contains 22.5 mg methotrexate.
1 pre-filled syringe with 1.25 ml solution for injection contains 25 mg methotrexate.
1 pre-filled syringe with 1,375 ml solution for injection contains 27.5 mg methotrexate.
1 pre-filled syringe with 1.5 ml solution for injection contains 30 mg methotrexate.
The other ingredients are: sodium chloride, sodium hydroxide for pH adjustment and water for injections.
What Everrexat looks like and contents of the pack
Eutrexate pre-filled syringes contain a clear, yellowish solution for injection.
Each carton contains 1, 4, 5, 6, 12 or 30 pre-filled syringes of 0.375 ml, 0.5 ml, 0.625 ml, 0.75 ml, 0.875 ml, 1.0 ml, 1.125 ml, 1,375 ml and 1,5 ml solution for injection, disposable injection needles with or without a safety cap and alcohol swabs.
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