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Nordimet is a brand name for Methotrexate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Nordimet is indicated for the treatment of: - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, - moderate to severe plaque psoriasis in adults who are…
Verbatim from this product's EMA label. Tap a section to expand.
Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Patients must be educated and trained in the proper injection technique when self-administering methotrexate.
The first injection of Nordimet should be performed under direct medical supervision. Important warning about the dosage of Nordimet In the treatment of rheumatoid arthritis, active juvenile idiopathic arthritis, psoriasis, psoriatic arthritis and Crohn’s disease requiring dosing once a week.
Nordimet must only be used once a week. Dosage errors in the use of Nordimet can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully. 4 When switching from oral use to subcutaneous use, a reduction in the dose may be required, due to the variable bioavailability of methotrexate after oral administration.
Folic acid or folinic acid supplementation may be considered in accordance with current therapeutic guidelines. The overall duration of treatment is decided by the doctor. 5 mg of methotrexate once weekly, administered subcutaneously.
Depending on the individual activity of the disease and patient tolerability, the initial dose may be increased. A weekly dose of 25 mg should in general not be exceeded. However, doses exceeding 20 mg per week can be associated with significant increase in toxicity, especially bone marrow suppression.
Response to treatment can be expected after approximately 4-8 weeks. Once the desired therapeutic result has been achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose. Symptoms may return after treatment discontinuation.
Methotrexate treatment of rheumatoid arthritis represents long-term treatment. Dosage in patients with plaque psoriasis and psoriatic arthritis It is recommended that a test dose of 5-10 mg be administered subcutaneously one week prior to initiation of therapy, in order to detect idiosyncratic adverse effects.
5 mg methotrexate once weekly. The dose is to be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate. Doses exceeding 20 mg per week can be associated with significant increase in toxicity, especially bone marrow suppression.
Summary of the safety profile Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and Stevens-Johnson syndrome.
g. g. increased Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), bilirubin, alkaline phosphatase). Other frequently (common) occurring adverse reactions are leukopenia, anaemia, thrombopenia, headache, tiredness, drowsiness, pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia, oral ulcers, diarrhoea, exanthema, erythema and pruritus.
The most relevant adverse reaction is suppression of the haematopoietic system and gastrointestinal disorders. List of adverse reactions Frequencies are defined using the following convention: very common (≥ 1/10) common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations Uncommon:
Pharyngitis.
Rare:
Infection (incl. reactivation of inactive chronic infection), sepsis, conjunctivitis. Neoplasms benign, malignant and unspecified (including cysts and polyps) Very rare: lymphoma (see “description” below) 13 Blood and lymphatic system disorders Common: Leukopenia, anaemia, thrombopenia.
Uncommon:
Pancytopenia.
Very rare:
Agranulocytosis, severe courses of bone marrow depression, lymphoproliferative disorders (see “description below”).
Patients must be clearly advised that the therapy is to be administered once a week, and not every day. Incorrect administration of methotrexate can lead to severe, including potentially lethal adverse reactions. Healthcare professionals and patients should be clearly instructed.
Patients receiving therapy should be appropriately monitored, so that signs of possible toxic effects or adverse reactions can be recognised and assessed without delay. Hence, methotrexate should be only administered by, or under the supervision of, doctors whose knowledge and experience include the use of antimetabolite therapy.
Due to the risk of severe or even fatal toxic reactions, patients should be thoroughly informed by the doctor about the risks (including early signs and symptoms of toxicity) and recommended safety measures. They are to be informed about the necessity to immediately consult the physician if symptoms of intoxication occur, as well as about the subsequent necessary monitoring of symptoms of intoxication (including regular laboratory tests).
Doses exceeding 20 mg/week can be associated with significant increase in toxicity, especially bone marrow suppression. Skin and mucosal contact with methotrexate is to be avoided. In the case of contamination, the parts concerned should be rinsed with plenty of water.
Fertility and reproduction Fertility Methotrexate has been reported to cause oligospermia, menstrual dysfunction and amenorrhoea in humans, during and for a short period after cessation of therapy, and to cause impaired fertility, affecting spermatogenesis and oogenesis during the period of its administration.
These effects appear to be reversible on discontinuing therapy. Teratogenicity – reproductive risk Methotrexate causes embryotoxicity, abortion and foetal defects in humans. 6). The absence of pregnancy must be confirmed before Nordimet is used.
1. 2). - Alcohol abuse. 4). - Pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anaemia. - Immunodeficiency. - Serious, acute or chronic infections such as tuberculosis and HIV. - Stomatitis, ulcers of the oral cavity and known active gastrointestinal ulcer disease.
6). - Concurrent vaccination with live vaccines.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methotrexate in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Response to treatment can generally be expected after approximately 2-6 weeks. Depending on the clinical picture and the changes of laboratory parameters, the therapy is then continued or discontinued. Once the desired therapeutic result has been achieved, dose should be reduced gradually to the lowest possible effective maintenance dose.
In a few exceptional cases a higher dose than 25 mg might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate as toxicity will markedly increase. Methotrexate treatment of moderate to severe plaque psoriasis and severe psoriatic arthritis represents long-term treatment.
Dosage in adult patients with Crohn's disease:
Induction treatment 25 mg/week administered subcutaneously. Once patients have adequately responded to combination therapy, the corticosteroids should be tapered. Response to treatment can be expected after 8 to 12 weeks. Maintenance treatment 15 mg/week administered subcutaneously, as monotherapy, if the patient has entered remission.
2). 4).
The dose should be adjusted as follows:
Creatinine clearance (ml/min) Dose ≥ 60 100 % 30-59 50 % < 30 Nordimet must not be used Patients with hepatic impairment Methotrexate should be administered with great caution, if at all, to patients with significant current or previous liver disease, especially when caused by alcohol.
3). 4). Paediatric population Dosage in children and adolescents below 16 years with polyarthritic forms of juvenile idiopathic arthritis The recommended dose is 10-15 mg/m² body surface area (BSA) per week. In therapy-refractory cases the weekly dose may be increased up to 20 mg/m² BSA per week.
However, an increased monitoring frequency is indicated if the dose is increased. Parenteral administration is limited to subcutaneous injection. Patients with JIA should always be referred to a rheumatology unit specializing in the treatment of children/adolescents.
4). No data available. Method of administration It must be explicitly pointed out to the patient that Nordimet is applied only once a week. It is recommended to specify a certain day of the week as “day for injection”. ). The medicinal product is for single use only.
The solution is to be visually inspected prior to use. Only clear solutions practically free from particles should be used. Any contact of methotrexate with skin and mucosa is to be avoided. 6). Please refer to the package leaflet for instructions on how to use the pre-filled pen or […]
Not known:
Eosinophilia Immune system disorders Rare: Allergic reactions, anaphylactic shock, hypogammaglobulinaemia.
Metabolism and nutrition disorders Uncommon:
Precipitation of diabetes mellitus.
Psychiatric disorders Uncommon:
Depression, confusion.
Rare:
Mood alterations.
Nervous system disorders Common:
Headache, tiredness, drowsiness.
Uncommon:
Dizziness.
Very rare:
Pain, muscular asthenia, paraesthesia/hypoaesthesia, changes in sense of taste (metallic taste), convulsions, meningism, acute aseptic meningitis, paralysis.
Not known:
Encephalopathy/ Leukoencephalopathy.
Eye disorders Rare:
Visual disturbances.
Very rare:
Impaired vision, Retinopathy.
Cardiac disorders Rare:
Pericarditis, pericardial effusion, pericardial tamponade.
Vascular disorders Rare:
Hypotension, thromboembolic events Respiratory, thoracic and mediastinal disorders Common: Pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia. Symptoms indicating potentially severe lung injury (interstitial pneumonitis) are: dry, not productive cough, shortness of breath and fever.
Rare:
Pulmonary fibrosis, Pneumocystis jiroveci pneumonia, shortness of breath and bronchial asthma, pleural effusion.
Not known:
Epistaxis, pulmonary alveolar haemorrhage.
Gastrointestinal disorders Very common:
Stomatitis, dyspepsia, nausea, loss of appetite, abdominal pain.
Common:
Oral ulcers, diarrhoea.
Uncommon:
Gastrointestinal ulcers and bleeding, enteritis, vomiting, pancreatitis.
Rare:
Gingivitis.
Very rare:
Haematemesis, haematorrhea, toxic megacolon. 4) Very common: Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and bilirubin).
Uncommon:
Cirrhosis, fibrosis and fatty degeneration of the liver, decrease in serum albumin.
Rare:
Acute hepatitis.
Very rare:
Hepatic failure.
Skin and subcutaneous tissue disorders 14 Common:
Exanthema, erythema, pruritus.
Uncommon:
Photosensitivity reactions , loss of hair, increase in rheumatic nodules, skin ulcer, herpes zoster, vasculitis, herpetiform eruptions of the skin, urticaria.
Rare:
Increased pigmentation, acne, petechiae, ecchymosis, allergic vasculitis.
Very rare:
Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), increased pigmentary changes of the nails, acute paronychia, furunculosis, telangiectasia.
Not known:
Skin exfoliation / dermatitis exfoliative Musculoskeletal and connective tissue disorders Uncommon: Arthralgia, myalgia, osteoporosis.
Rare:
Stress fracture.
Not known:
Osteonecrosis of jaw (secondary to lymphoproliferative disorders) Renal and urinary disorders Uncommon: Inflammation and ulceration of the urinary bladder, renal impairment, disturbed micturition.
Rare:
Renal failure, oliguria, anuria, electrolyte disturbances.
Not known:
Proteinuria.
Reproductive system and breast disorders Uncommon:
Inflammation and ulceration of the vagina.
Very rare:
Loss of libido, impotence, gynaecomastia, oligospermia, impaired menstruation, vaginal discharge.
General disorders and administration site conditions Rare:
Fever, wound-healing impairment.
Not known:
Asthenia, injection site necrosis, oedema. Description of selected adverse reactions Lymphoma/Lymphoproliferative disorders There have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
The appearance and degree of severity of undesirable effects depends on the dosage level and the frequency of administration. However, as severe undesirable effects can occur even at lower doses, it is indispensable that patients are monitored regularly by the doctor at short intervals.
Only mild local skin reactions (such as burning sensations, erythema, swelling, discolouration, pruritus, severe itching, pain) were observed with subcutaneous use, decreasing during therapy. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are […]
If women of child bearing potential are treated, effective contraception must be used during treatment and for at least six months after. For contraception advice for men, see section