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METOJECT PEN is a brand name for Methotrexate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Metoject PEN is indicated for the treatment of active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe psoriasis in adult patients who are…
Verbatim from this product's MHRA label. Tap a section to expand.
Important warning about the dosage of Metoject PEN (methotrexate) In the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis, and Crohn’s disease, Metoject PEN (methotrexate) must only be used once a week.
Dosage errors in the use of Metoject PEN (methotrexate) can result in serious adverse reactions, including death. Please read this section of the summary of product characteristics very carefully. 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 Metoject PEN should be performed under direct medical supervision. Metoject PEN is injected once weekly.
The patient must be explicitly informed about the fact that Metoject PEN is administered once a week only. It is advisable to determine an appropriate fixed day of the week for the injection. Methotrexate elimination is reduced in patients with a third distribution space (ascites, pleural effusions).
4). 5 mg of methotrexate once weekly, administered subcutaneously. 5 mg per week. A weekly dose of 25 mg should in general not be exceeded. Doses exceeding 20 mg/week are associated with significant increase in toxicity, especially bone marrow suppression.
Response to treatment can be expected after approximately 4-8 weeks. Upon achieving the therapeutically desired result, the dose should be reduced gradually to the lowest possible effective maintenance dose. Paediatric population Posology 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)/once weekly.
In therapy- refractory cases the weekly dose may be increased up to 20 mg/m² body surface area/once weekly. However, an increased monitoring frequency is indicated if the dose is increased. Due to limited data availability about intravenous use in children and adolescents, parenteral administration is limited to subcutaneous injection.
Patients with JIA should always be referred to a rheumatology specialist in the treatment of children/adolescents. 4). Posology in patients with psoriasis vulgaris and psoriatic arthritis It is recommended that a test dose of 5-10 mg should be administered parenterally, one week prior to therapy to detect idiosyncratic adverse reactions.
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 ALAT, 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.
Tabulated list of adverse reactions The most relevant undesirable effects are suppression of the haematopoietic system and gastrointestinal disorders. The following headings are used to organise the undesirable effects in order of frequency: 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) 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).
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).
Not known:
Patients must be clearly informed that the therapy has to be administered once a week, not every day. Patients undergoing therapy should be subject to appropriate supervision so that signs of possible toxic effects or adverse reactions may be detected and evaluated with minimal delay.
Therefore treatment with methotrexate should only be initiated and supervised by physicians whose knowledge and experience includes the use of antimetabolite therapy. Because of the possibility of severe or even fatal toxic reactions, the patient should be fully informed by the physician of the risks involved and the recommended safety measures.
Recommended examinations and safety measures Before beginning or reinstituting methotrexate therapy after a rest period Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest x-ray and renal function tests.
If clinically indicated, exclude tuberculosis and hepatitis. During therapy The tests below must be conducted every week during the first two weeks, then every two weeks for the next month; afterwards, depending on leukocyte count and stability of the patient, at least once monthly during the next six months and at least every three months thereafter.
Increased monitoring frequency should also be considered when increasing the dose. Particularly elderly patients should be examined for early signs of toxicity in short intervals. 1. Examination of the mouth and throat for mucosal changes 2.
Complete blood count with differential blood count and platelets. Haemopoietic suppression caused by methotrexate may occur abruptly and with apparently safe doses. Any profound drop in white-cell or platelet counts indicates immediate withdrawal of the medicinal product and appropriate supportive therapy.
Patients should be advised to report all signs and symptoms suggestive of infection. g. leflunomide) simultaneously should be monitored closely with blood count and platelets. 3.
3. Patients with hepatic impairment Methotrexate should be administered with great caution, if at all, to patients with significant current or previous liver disease, especially if due to alcohol. 5 μmol/l), methotrexate is contraindicated.
3. Use in elderly patients Dose reduction should be considered in elderly patients due to reduced liver and kidney function as well as lower folate reserves which occur with increased age. 4). Method of administration The medicinal product is for single use only.
Metoject PEN solution for injection in pre-filled pen can only be given by subcutaneous route. The overall duration of the treatment is decided by the physician. Guidance on how to use Metoject PEN solution for injection in pre-filled pen can be found below.
Please note that all of the contents have to be used. Instructions for subcutaneous use of Metoject PEN with yellow cap and yellow injection button (three-step auto-injector) The most appropriate zones for the injection are: - upper thighs, - abdomen except around the navel.
1. Clean the area of and around the chosen injection site. 2. Pull the cap straight off. 3. Build a skin fold by gently squeezing the area at the injection site. 4. The fold must be held pinched until the Metoject PEN is removed from the skin after the injection.
5. Push the Metoject PEN firmly into the skin at a 90-degree angle in order to unlock the button. Then press the button (a click indicates the start of injection). 6. Do not remove the Metoject PEN from the skin before the end of the injection to avoid incomplete injection.
This can take up to 5 seconds. 7. Remove the Metoject PEN from the skin at the same 90-degree angle. 8. The protective shield automatically moves into place over the needle and is then locked. Instructions for subcutaneous use of Metoject PEN with translucent protective cap and blue needle cover (two-step auto-injector) The most appropriate zones for the injection are: - upper thighs, - lower part of the abdomen except within 5 cm around the navel.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5 mg of methotrexate once weekly, administered subcutaneously. 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.
Response to treatment can generally be expected after approximately 2-6 weeks. Upon achieving the therapeutically desired result, the dose should be reduced gradually to the lowest possible effective maintenance dose. Maximum weekly dose The dose should be increased as necessary but should in general not exceed the maximum recommended weekly dose of 25 mg.
In a few exceptional cases a higher dose might be clinically justified, but should not exceed a maximum weekly dose of 30 mg of methotrexate as toxicity will markedly increase. Posology in patients with Crohn’s disease • Induction treatment: 25 mg/week administered subcutaneously.
Response to treatment can be expected after approximately 8 to 12 weeks. • Maintenance treatment: 15 mg/week administered subcutaneously. There is not sufficient experience in the paediatric population to recommend Metoject PEN for the treatment of Crohn’s disease in this population.
Patients with renal impairment Metoject PEN should be used with caution in patients with impaired renal function.
The dose should be adjusted as follows:
Creatinine clearance (ml/min) Dose ≥60 100% 30-59 50% <30 Metoject PEN must not be used See section
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 or 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, short of breath and fever.
Rare:
Pulmonary fibrosis, Pneumocystis jirovecii 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 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 The appearance and degree of severity of undesirable effects depends on the dose 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.
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. Subcutaneous application of methotrexate is locally well tolerated.
Only mild local skin reactions (such as burning sensations, erythema, swelling, discolouration, pruritus, severe itching, pain) were observed, 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 asked to report any suspected adverse reactions via the Yellow Card Scheme at: […]
Liver function tests:
Treatment should not be initiated or should be discontinued if there are persistent or significant abnormalities in liver function tests, other non-invasive investigations of hepatic fibrosis or liver biopsies. Temporary increases in transaminases to two or three times the upper limit of normal have been reported in patients at a frequency of 13-20%.
Persistent elevation of liver enzymes and/or decrease in serum albumin may be indicative for severe hepatotoxicity. In the event of a persistent increase in liver enzymes, consideration should be given to reducing the dose or discontinuing therapy.
Histological changes, fibrosis and more rarely liver cirrhosis may not be preceded by abnormal liver function tests. There are instances in cirrhosis where transaminases are normal. Therefore, non-invasive diagnostic methods for monitoring of liver condition should be considered, in addition to liver function tests.
Liver biopsy should be considered on an individual basis taking into account the patient’s comorbidities, medical history and the risks related to biopsy. Risk factors for hepatotoxicity include excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of hereditary liver disorders, diabetes mellitus, obesity and previous contact with hepatotoxic drugs or chemicals and prolonged methotrexate treatment.
Additional hepatotoxic medicinal products should not be given during treatment with methotrexate unless clearly necessary. 5). Closer monitoring of liver enzymes should be undertaken in patients concomitantly taking other hepatotoxic medicinal products.
Increased caution should be exercised in patients with insulin-dependent diabetes mellitus, as during methotrexate therapy, liver cirrhosis developed in isolated cases without any elevation of transaminases. 4. 3). As methotrexate is eliminated mainly by renal route, increased serum concentrations are to be expected in the case of renal impairment, which may result in severe undesirable effects.
g. in the elderly), monitoring should take place more frequently. g. non-steroidal anti-inflammatory drugs) or that can potentially lead to impairment of blood formation. Dehydration may also intensify the toxicity of methotrexate. 5.
Assessment of respiratory system:
Alertness for symptoms of lung function impairment and, if necessary lung function test. Pulmonary affection requires a quick diagnosis and discontinuation of methotrexate. Pulmonary symptoms (especially a dry, non-productive cough) or a non-specific pneumonitis occurring during methotrexate therapy may be indicative of a potentially dangerous lesion and require interruption of treatment and careful investigation.
Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported. Although clinically variable, the typical patient with methotrexate-induced lung disease presents with fever, cough, dyspnoea, hypoxemia, and an infiltrate on chest X-ray, infection needs to be excluded.
Pulmonary diseases induced by methotrexate were not always completely reversible. This lesion can occur at all doses. In addition, pulmonary alveolar haemorrhage has been reported with methotrexate used in rheumatologic and related indications.
This event may also be associated with vasculitis and other comorbidities. Prompt investigations should be considered when pulmonary alveolar haemorrhage is suspected to confirm the diagnosis. 6. Methotrexate may, due to its effect on the immune system, impair the response to vaccination […]
1. Clean the injection site. 2. Firmly pull the translucent cap straight off. 3. Position the uncapped blue needle cover at a 90-degree angle against the skin. It is not necessary to build a skin fold. 4. Start the injection by pushing the Metoject PEN down all the way (a first “click” indicates the start of injection).
5. Continue holding the Metoject PEN down against the skin to complete the injection until: you hear a second “click”, shortly after the first or: the blue plunger rod has stopped moving and fills the inspection window or: 5 seconds have passed.
6. Remove the Metoject PEN from the skin at the same 90-degree angle. 7. The blue needle cover automatically moves into place over the needle and is then locked.
Note:
If changing the oral application to parenteral administration a reduction of the dose may be required due to the variable bioavailability of methotrexate after oral administration. Folic acid supplementation may be considered according to current treatment guidelines.
6), concurrent vaccination with live vaccines.