Jylamvo

Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. Posology Rheumatological and dermatological diseases 3 Important warning about the dosage of Jylamvo (methotrexate) In the treatment of rheumatological or dermatological diseases, Jylamvo (methotrexate) must only be taken once a week.

Dosage errors in the use of Jylamvo (methotrexate) can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully. The prescriber should ensure that patients or their carers will be able to comply with the once weekly regimen.

The prescriber should specify the day of intake on the prescription. The dose and duration of treatment are determined individually on the basis of the patient’s clinical picture and the tolerability of methotrexate. Treatment of active rheumatoid arthritis, severe JIA, severe psoriasis and severe psoriatic arthritis represents a long-term treatment.

5 ml) should not be exceeded. Doses exceeding 20 mg (10 ml)/week can be associated with a substantial increase in toxicity, especially bone marrow depression. Concurrent folic acid supplementation of 5 mg twice weekly (except on the day of administration) is indicated additionally.

75 ml) methotrexate once weekly. 25 ml) per week. Response to treatment can be expected after approximately 4-8 weeks. After the desired treatment outcome is achieved, the dose should be reduced gradually to the lowest possible effective maintenance dose.

Symptoms may return after treatment discontinuation. Dosage in children and adolescents with polyarthritic forms of juvenile idiopathic arthritis Patients with JIA should always be referred to a rheumatology unit specialising in the treatment of children/adolescents.

5 ml)/m² body surface area (BSA)/week. In therapy-refractory cases the weekly dosage may be increased to 20 mg (10 ml)/m² BSA/week. However, an increased monitoring frequency is indicated if the dosage is increased. 5 ml) be administered one week prior to initiation of therapy, in order to detect early occurring adverse reactions.

If, one week later, appropriate laboratory tests are normal, treatment may be initiated. 75 ml) methotrexate once weekly. The dose should be increased gradually but should not, in general, exceed a weekly dose of 25 mg of methotrexate.

Summary of the safety profile In general, the incidence and severity of side effects are considered to be dose-related. In the antineoplastic treatment, myelosuppression and mucositis are the predominant dose-limiting toxic effects of methotrexate.

The severity of these reactions depends on the dose, mode and duration of application of methotrexate. Mucositis generally appears about 3 to 7 days after methotrexate application, leucopenia and thrombocytopenia follow a few days later.

In patients with unimpaired elimination mechanisms, myelosuppression and mucositis are generally reversible within 14 to 28 days. Most serious adverse reactions of methotrexate include bone marrow suppression, pulmonary toxicity, hepatotoxicity, renal toxicity, neurotoxicity, thromboembolic events, anaphylactic shock and Stevens- 13 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 occurrence and severity of adverse reactions depend on dosage level and frequency of administration of methotrexate. 4). Most adverse reactions are reversible if they are detected early. 9). Methotrexate therapy should only be resumed with particular caution, after careful consideration of the need for treatment and with increased vigilance for the possible recurrence of toxicity.

Tabulated list of adverse reactions Frequencies in the table are defined according to the MedDRA 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.

The oral solution contains 2 mg of methotrexate in each ml of solution; the scaling of the dosing syringe is in ml and not mg; care should be taken that the correct dosing volume is prescribed. Patients with rheumatological or dermatological diseases must be informed unequivocally that treatment is to be taken just once a week and not daily.

Incorrect use of methotrexate can result in severe and even fatal adverse reactions. Medical staff and patients must be clearly instructed. The prescriber should specify the day of intake on the prescription. The prescriber should make sure patients understand that Jylamvo (methotrexate) should only be taken once a week.

Patients should be instructed on the importance of adhering to the once-weekly intakes. Patients must be appropriately monitored during treatment so that signs of possible toxic effects or adverse reactions can be detected and evaluated with minimal delay.

Therefore, methotrexate should only be administered by, or under the supervision of, doctors whose knowledge and experience includes treatment with antimetabolites. , following prior radio- or chemotherapy), impaired general condition as well as advanced age and in very young children.

Because of the possibility of severe or even fatal toxic reactions, patients should be extensively 6 informed by the treating doctor of the risks involved (including early signs and symptoms of toxicity) and the recommended safety measures.

Patients should be informed that they must notify the doctor immediately if any symptoms of an overdose occur and that the symptoms of the overdose need to be monitored (including regular laboratory tests). Doses exceeding 20 mg (10 ml)/week can be associated with a substantial increase in toxicity, especially bone marrow depression.

2). Methotrexate should be used only with great caution, if at all, in patients who have a significant liver disease, particularly if this is/was alcohol-related. Fertility Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction and amenorrhoea in humans during and for a short period after the discontinuation of treatment, affecting spermatogenesis and oogenesis during the period of its administration - effects that appear to be reversible on discontinuing therapy.

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